chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid on 25Aug2022 for COVID-19 Treatment. There were no known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
ARTHRUS TYPE REACTION WITH SWELLING OF THE UPPER ARM ALONG WITH SEVERE ERYTHEMA AND ITCHING.  DR ADVISED PATIENT TO USE COLD COMPRESSES AND APPLY LOTION TO THE SKIN.  I RECOMMENDED THE PATIENT USE IBUPROFEN TO HELP RELIEVE INFLAMMATION AND DISCOMFORT.
Diagnosed with shingles on 1/5/22. Started antiviral treatment (acyclovir) same day. Had been experiencing pain in arm for over a week but in the few days prior to 1/5 the pain started radiating down my whole arm, deep aching, skin sensitivity and burning sensations, and I developed blisters in different spots along same arm which enabled the provider to identify the cause as Shingles and the pain as nerve pain. The pain had been keeping me from sleeping and making it difficult to get through the day. The pain kept increasing until a couple days into taking the antiviral medication and has been decreasing over the course of the last two days. I have been using ibuprofen regularly to manage pain. I still have half of the antiviral course left to finish.
blood pressure reading have been like a roller coaster, up and down; right arm hurt; Diverticulitis; costochondritis; massive pain in the rib cage area; pressure in the lower abdomen; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (Diverticulitis) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 8370299) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia (missed diagnosis of COVID, treated for pneumonia as there were no COVID tests available.) in February 2020. Concomitant products included MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]), VITAMIN D NOS, PROBIOTICS NOS and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced DIVERTICULITIS (Diverticulitis) (seriousness criterion medically significant), COSTOCHONDRITIS (costochondritis), MUSCULOSKELETAL CHEST PAIN (massive pain in the rib cage area), ABDOMINAL DISCOMFORT (pressure in the lower abdomen   ) and VACCINATION SITE PAIN (right arm hurt). On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (blood pressure reading have been like a roller coaster, up and down). At the time of the report, DIVERTICULITIS (Diverticulitis), COSTOCHONDRITIS (costochondritis), MUSCULOSKELETAL CHEST PAIN (massive pain in the rib cage area), ABDOMINAL DISCOMFORT (pressure in the lower abdomen   ), BLOOD PRESSURE INCREASED (blood pressure reading have been like a roller coaster, up and down) and VACCINATION SITE PAIN (right arm hurt) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 155/84 (High) elevated blood pressure readings.     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.   Blood tests and CAT scan were done in the ER. Results were not provided.  Patient was treated with a 10 day course of two antibiotics.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report was received from a physician via company representatives, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 28-MAR-2014, the patient was vaccinated with an unspecified improperly stored dose of PNEUMOVAX 23 "10 Single dose 0.5mL Vls 10SDV" with lot number J009689 and expiration date of 28-JAN-2015 (route of administration and anatomical location were not reported), which was stored at 59.9 Fahrenheit (F) Degrees (15.5 Celsius) (highest recorded temperature) for a total of 888 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning his 19 year old daughter who on 24-AUG-2009 was vaccinated with a dose of PNEUMOVAX 23 and a dose of influenza virus vaccine (unspecified) in the same arm. Concomitant therapy included hormonal contraceptives (unspecified), EFFEXOR, SEROQUEL, VALIUM, and methylphenidate. On 24-AUG-2009 the patient developed swelling, hives, fever, pain at injection sites, myalgia and arthralgia and continued to have complaints. The physician placed her arm into a sling to immobilize the arm. There were no labs and diagnostic tests performed. The patient saw physician for medical attention. At the time of the report, the patient's status was not recovered. Follow up information has been received from a physician concerning the patient with no pertinent medical history and no drug allergies, who on 24-AUG-2009 was vaccinated with the first dose of PNEUMOVAX 23 (lot # 662041/0612X) IM in the right arm. On 24-AUG-2009 the patient developed fever, swelling, erythema and myalgia. The patient had recovered on 27-AUG-2009. Additional information has been requested.
Cold chills, hot flashes, night sweats, headache, dizziness, 105.6 F fever the following night/day and a 102.0 F fever the second day. Light headedness the third day with no fever
First dose April but did not get (second dose); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose April but did not get (second dose)) 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.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose April but did not get (second dose)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose April but did not get (second dose)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment medication was provided.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date later in 2016, the patient was treated for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient received 3rd dose of Pfizer Covid on 9/3/21 about 4:30pm.  Patient stated she went home and on 9/4 pretty much slept all day. On 9/5 she went to urgent care for fever and chills, she received antibiotic and was told she has cellulitis and abscess due to improper vaccination technique causing bacterial infection. She followed up with dermatologist 1 week later where she got cortisone cream and was told it was most likely due to improper technique. patient stated on 9/22 she has another follow up with dermatologist in 1 week.
Patient feeling itchy all over and hot.  Vital signs taken BP 181/95, T98, P71, SPO2 98%ra .  Given 25 mg Benadryl IM
Vaccine caused MS related symptoms which included, optic neuritis, photophobia, cluster migraines, fatigue, nausea, chills, confusion, diarrhea
made his arthritis worse; knees have been killing him; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknwon, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRITIS (non-serious), outcome "unknown", described as "made his arthritis worse"; ARTHRALGIA (non-serious), outcome "unknown", described as "knees have been killing him".  The lot number for [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a nurse and refers to a 21 female patients of unknown age. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot number N005274, expiration date: 03-APR-18, (dose, dose number, route of administration and injection site were not provided) for prophylaxis. There were no concomitant medications reported. The reporter stated, that the vaccines were subject to temperatures excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 29 minutes. The temperature excursion was captured using digital data logger. It was also reported, that the vaccines underwent previous temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 9 hours on unspecified dates. No adverse effects were reported. Additional information has been requested. Sender's Comments: US-009507513-1805USA001642: US-009507513-1805USA001643: US-009507513-1805USA001644: US-009507513-1805USA001645: US-009507513-1805USA001647: US-009507513-1710USA011550.
This spontaneous report as received from a physician refers to a patient, aged 6 month and 4 days, of unkonwn gender. No medical history concurrent conditions were provided. On 24-MAR-2014, the patient was vaccinated with a first dose of ROTATEQ (lot number, dose and route not provided). No co-suspect or concomitant therapies were provided. No adverse symptoms reported. Additional information has been requested.
arms hurt worse; This is a spontaneous report from a contactable consumer (patient).   A female patient of unknown age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration on 28Apr2021, at unknown dose single for COVID-19 immunization. She was not pregnant at time of vaccination. She received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), on  via an unspecified route of administration on 07Apr2021, for COVID-19 immunization. Medical history was not reported. No concomitant medicaton was reported. She  proceeded to share AE information regarding herself, her son, and her girlfriend. She said her "son's arm hurt, of course, and it was really weird. A day or two later her son said my head feels swooshy and his ears were clogged up. We thought it was water in his ears. Her girlfriend experienced the same thing".  After the second dose, she reported that "our arms hurt worse". Her son told her "every muscle aches". He went on a walk with a friend and "felt 100% better". She shared she was told by the vaccine nurse to "overly hydrate herself. I got body armor and drank one before and one after. I took a couple doses of Tylenol and felt better". She also shared that she doesn't drive because she has narcolepsy. The outcome of Event was unknown.   Information on the lot/batch number has been requested; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021861933 same reporter/drug/AE, different patient
Received the Moderna vaccination on 12/28/20 (1st dose). Developed induration, redness & itching at injection site after vaccine. Still present on day 7.
Patient was inadvertently given 2ml of the 0.3ml recommended dose of this vaccine. Only reactions that were reported over a 3 day post event were injection site soreness, fatigue, and fever lasting less than 4-5 hours.
Received vaccine on 9-7-22. By 11-16-22, patient said within 24 hours of 1st Shingrix dose. Patient had a severe acid reflux (until this moment 11/16/22), rash "blister" for 2-3 weeks, headache & muscle pain for 1 week.  And today 8-25-23, patient  mention she have fatty live now, still have acid reflux & rash once in a while
This spontaneous report was received from a pharmacist, concerning a patient of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On 10-APR-2017, the patient was subcutaneously vaccinated with an improperly stored dose of ZOSTAVAX vial 19400 DF reported as plaque forming unit (PFU) (dose and frequency were not reported) lot # M038864 with expiration date of 12-DEC-2017, for prophylaxis. The diluent MRK, lot # M042852 with expiration date of 30-MAY-2019, used to reconstitute the ZOSTAVAX was properly stored.  The temperature excursion of the ZOSTAVAX was 9.5 °F, the temperature excursion time frame was for 12 hours. No previous temperature excursion occurred. No adverse effects were reported. Data logger was involved. There was no product qualitycomplaint (PQC) involved. This is one of two reports received from the same source.  Additional information has been requested.; Sender's Comments:  US-009507513-1704USA012146:
Redness where shot was given; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 8th September 2021, the patient received Shingles vaccine. On 10th September 2021, 2 days after receiving Shingles vaccine, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received shingles shot two days before the reporting date and experienced redness where the shot was given on the reporting date. The reporter was asking if they should be worried about it.
5 days with fever. Headache, muscle pain, cough, trouble breathing, diarrhea, nausea, no appetite etc.
Discharge Provider: DO Primary Care Provider at Discharge: MD   Admission Date: 7/21/2022 Discharge Date: 7/23/2022  HOSPITAL COURSE: Patient is a 74 y.o. female with history of spinal stenosis, epilepsy, and hypertension who presented with worsening cough, fatigue and poor oral intake. In the ED, she was noted to be hypoxic to 88% requiring 2L nasal cannula. Labs significant for for an acute kidney injury with creatinine 1.41. CXR showed no acute cardiopulmonary disease. She was positive for COVID-19 on PCR. She was started on IVFs and decadron. She was admitted for further evaluation and management.    On admission, patient continued on decadron with Remdesivir. AKI resolved and IVF discontinued. She remained stable off oxygen. She did have urinary frequency and urinalysis concerning for infection, Rocephin started pending urine culture. She was seen by PT/OT and cleared to return home. Son with concerns about hygiene at home, home care set up for patient. She was discharged on two additional days of ciprofloxacin to complete a total of 3 days. They were instructed to follow up with PCP in the near future for urine culture results. She was discharged home in stable condition.
The vaccine was given about 1/2 hour past the 6 hour window tine frame.  The Pfizer vial was mixed at 10:50am and the vaccine was given between 5:10 and 5:30pm.
The patient has red raised erythematous patches abdomen chest neck arms and upper thighs. Upper back not affected but the lower back is.  Allergic reaction to COVID-19 vaccine - Primary   Hives   Urticaria, unspecified
Intracerebral hemorrhagic stroke: sudden left-sided paralysis, including facial droop, loss of sensation and movement in left extremities, was sent to the ED, CT showed large ICH, moved to NICU for 10 days and then SAR for 5 weeks
Pronounced redness around the injection site, there is also a white line around redness; chills; Body aches; She was not well; Flu like symptoms; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), MALAISE (She was not well), INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE ERYTHEMA (Pronounced redness around the injection site, there is also a white line around redness) and CHILLS (chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced DIZZINESS (Dizziness). On 12-Feb-2021, the patient experienced MALAISE (She was not well), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (chills) and MYALGIA (Body aches). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Pronounced redness around the injection site, there is also a white line around redness). On 11-Feb-2021, DIZZINESS (Dizziness) had resolved. On 15-Feb-2021, MALAISE (She was not well), INFLUENZA LIKE ILLNESS (Flu like symptoms), CHILLS (chills) and MYALGIA (Body aches) had resolved. On 16-Feb-2021, VACCINATION SITE ERYTHEMA (Pronounced redness around the injection site, there is also a white line around redness) had resolved. Not Provided          Concomitant medications were not provided. Treatment information was not reported.
This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age and unknown gender. On an unspecified date, the unspecified number of patients were vaccinated with doses of improperly stored GARDASIL 9 (lot # L007495 with an expiry date of 24-FEB-2017 and lot# L006547 with an expiry date of 07-MAR-2015). No adverse effects were reported. Additional information has been requested.
Patient arrived at vaccine clinic SOB and acutely decompensated around the time of vaccination. He was found to be in acute respiratory distress with a pulse of 62%. EMS called and pt was transported to the hospital. He has found to be in acute CHF and hypertensive urgency. Initial BP 249/138 He was given IV lasix, IV lopressor and started on oxygen. He was admitted to the Facility on BIPAP. Over the course of the next 2 days he had good diuresis and able to be weaned off oxygen.
I am 54 (almost 55) and haven't had period in 2 years.  Last week I started cramping, thought that was weird... followed by more symptoms of menstruation including bad cramps, enlarged and sensitive breasts, and bloating. This morning, for the first time in at least 2 years my period started... It is painful and very heavy.  SOMETHING WEIRD IS GOING ON!!
High Fever, Shivers, Dizziness, Weakness.  Having a hard time being able to walk back to bed.
on the 5th day, I started having pain in my left leg, the ankle got swollen and hot but not red. I waited for it to go away, and in 7 more days went to the doctor to get it tested. The swelling was less but the pain persisted. She gave me a referral to have a doppler test which didn't reveal DVT. The doctor suggested it could be neuropathy, however, I'm a dancer and I work out, and I never had any indication for such pain. I took antiinflammatory and did alternative therapies, pain subsided after 20 more days. Even now, sometimes when I walk I can suddenly feel a sharp pain in an unexpected location in my left leg.
My husband's arm was sore with both doses; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    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 PAIN IN EXTREMITY (My husband's arm was sore with both doses) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2021, the patient experienced PAIN IN EXTREMITY (My husband's arm was sore with both doses). At the time of the report, PAIN IN EXTREMITY (My husband's arm was sore with both doses) outcome was unknown.            no medication reported.
Pain, swelling of entire upper arm from shoulder to elbow, with red boundary line at bend of elbow, redness, heat, general malaise, unusual tiredness.
The morning after my 1st dose, I woke up Friday extremely fatigued and around 10:15 am I started to experience shortness of breath. About 2 minutes after that I began to experience nausea, body chills,  a fever, body aches, and a headache.  After 5 minutes, most of the symptoms dissipated and I was left with a headache and fatigue for the rest of the weekend.   After receiving my 2nd dose Tuesday morning, the next morning I experienced extreme fatigue, a headache, muscle aches, and a runny nose . The next day I experienced diarrhea, nausea, muscle aches, and fatigue. and the muscle aches, headache and fatigue continued throughout the week.