chrisvoncsefalvay/vaers-outcomes huggingface dataset:
if i have secundary effects like cough and flu, it's normal?; if i have secundary effects like cough and flu, it's normal?; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (if i have secundary effects like cough and flu, it's normal?) and INFLUENZA (if i have secundary effects like cough and flu, it's normal?) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (if i have secundary effects like cough and flu, it's normal?) and INFLUENZA (if i have secundary effects like cough and flu, it's normal?). At the time of the report, COUGH (if i have secundary effects like cough and flu, it's normal?) and INFLUENZA (if i have secundary effects like cough and flu, it's normal?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no treatment information was provided no concomitant medication were reported
Immediate pain in shoulder. And arm. .  Chills.  Fatigue .  Headache.  Day3 still in pain.
Received shot 2/4/21, woke up 02/7/21 with a golf ball size knot under my left arm in my lymph nolde.  very tender, hurts to raise arm
received dose from vial that had black particulates in previous syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-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 PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe). At the time of the report, PRODUCT QUALITY ISSUE (received dose from vial that had black particulates in previous syringe) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication was not provided.
Pain in the left shoulder and left base of the neck.  Patient received her COVID vaccine on 1/7/2021 in the left arm and developed the pain in her left upper shoulder the following morning on 1/8/2021 and continues through today (1/11/2021).  Patient has not seen a provider or received treatment at this time, but will see her PCP today.
1. Intestinal upset and no appetite. Re-flux, Stomach Ache, excessive gas in stomach and colon. 2. Muscle and joint aches strong enough to remain in bed or a chair "attempting Not to move" 3. Momentary and random loss of balance in excess of normal events in both severity and frequency
This spontaneous report was received from a pharmacist and refers to a 34 year old male patient. The patient was a smoker and did not have any drug reactions or allergies. No other information regarding the patient's pertinent medical history and concomitant medications was provided. On 26-MAY-2017, the patient was vaccinated with PNEUMOVAX 23, injection in the upper right extremity, lot # N005597 with expiration date on 19-OCT-2018 (dose and route of administration were not reported) due to smoking. On 26-May 2017, following the administration of the vaccine, the patient developed a large hard bump at the injection (reported as "insertion") site. The patient did not seek medical attention for the adverse events and did not receive any treatment. There were no laboratory diagnostic studies performed. At the time of the report, the patient did not recover from the adverse events. There was no product quality complaint involved. The relatedness between the adverse events and PNEUMOVAX 23 was not reported. Additional information has been requested.
So weak; Watery stools; Crying uncontrollably; Suicidal thoughts; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (So weak), DIARRHOEA (Watery stools), CRYING (Crying uncontrollably) and SELF-INJURIOUS IDEATION (Suicidal thoughts) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 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 an unknown date, the patient experienced ASTHENIA (So weak), DIARRHOEA (Watery stools), CRYING (Crying uncontrollably) and SELF-INJURIOUS IDEATION (Suicidal thoughts). At the time of the report, ASTHENIA (So weak), DIARRHOEA (Watery stools), CRYING (Crying uncontrollably) and SELF-INJURIOUS IDEATION (Suicidal thoughts) outcome was unknown.            No concomitant medications were reported. No treatment was provided.
High fever, chills, weakness, flu like symptoms, unable to stand up. Unable to do much of anything, unable to eat. This lasted about 3 days.  We think he's ok now. Hopefully. He had to get this for work.
Swollen Both Legs; Rash on both legs; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen Both Legs) and RASH (Rash on both legs) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen Both Legs) and RASH (Rash on both legs). At the time of the report, PERIPHERAL SWELLING (Swollen Both Legs) and RASH (Rash on both legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02SL208) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness). At the time of the report, VACCINATION SITE ERYTHEMA (redness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Information was received from a pharmacist on 17-NOV-2016. The pharmacist reported that a patient received a dose of PNEUMOVAX (lot # M037669, expiry 09-MAY-2018) on 14-NOV-2016. Soon after the administration of the vaccine, the patient developed redness at the injection site in the deltoid region, along with some pain, swelling and hardness. The pharmacist reported that the symptoms then spread down near her elbow and "today it has spread to the joint in her inner elbow". The pharmacist reported that the patient has not been sleeping well because of the symptoms. The physician reported that the patient self-administered an unspecified "mild over-the-counter pain reliever to deal with it." The patient also received a dose of AFLURIA (lot and expiration unknown) on the same day (14-NOV-2016) in the same arm. They were able to determine that the reaction started with the PNEUMOVAX23 injection site. The pharmacist reported that the patient had an unspecified pneumococcal vaccine "many years ago" and did not experience any reaction from it. The patient had also received PREVNAR 13 on an unspecified date with no reaction.  No further information was provided regarding this patient. Additional information has been requested. This is one of several reports by the same reporter (1612USA001909, 1612USA001910). Sender's Comments:  US-009507513-1612USA001909: US-009507513-1612USA001910.
Pt got pneumococcal vaccine at medical center 3/31/08. Had chills that night then swelling/erythema of left arm. Injection site was in mid triceps according to the father
rPfizer-BionNTech COVID-19 Vaccine EUA  5-7 minutes after the vaccine Associate stated she did not feel right, mentioned chest pain. "My chest feels funny. It feels like when you have really bad heartburn coming on". "I feel flushed like when you get contrast for a CT".  Pulse 90 BP 160/90 checked later 130/90
Minimal soreness in  arm; nothing more immediately after vaccination Day 5: rash on right leg below knee, no itchiness. Day 8: injection arm red very, very, itchy rash; also rash om left leg below knee, not itchy
The day after I received a vaccine, I had higher than usual blood pressure and pulse rate. I also had a muscle pain in the arm and I felt tired during the day and in the evening. My pulse rate continues to be high. My pulse rate was 100 on the second day and for number of days it is around 95. Today it was 95 most of the day. I have not been regularly checking my pulse rate before, but based on what I found in some information in my medical record, it is most likely around 75. I notice the higher pulse rate through pulsation in the chest and temples. I have a hard time concentrating on work and reading things on the screen.
This spontaneous report was received from a father refers to his 16 year old son (who is also the patient). The patient had no pertinent medical history or drug reactions or allergies. On 21-MAR-2013, the patient was vaccinated with a dose of GARDASIL, (lot number, expiry date and route was not reported). On 25-MAR-2013, the patient had lump/mass on the right side of his neck. There was no pain associated with the lump. On 27-MAR-2013, ultrasound was conducted and results were awaited. The outcome of lump/mass on the right side of his neck was reported as not recovered. The patient sought medical attention. Additional information has been requested.
This spontaneous report as received from a physician refers to a 20 patients of unknown age and gender. On an unknown date, the patients were inadvertently vaccinated with improperly stored doses of VARIVAX (dose, frequency, route of administration and indication were not reported, lot # L017144 with expiration date: 13-MAY-2017). No adverse effects reported. Additional information is not expected. The reporter did not wish to be contacted.
Symptoms. Weak, severe headcahe, BP was high, numbness in fingers and ball of left foot felt funny.  then patient went to hospital. Patient was diagnosed with GBS (Guillian Barre Syndrome). In hospital trreatment for approx 30 days then to Rehab for approx 3 weeks
Was supposed to give Tdap, but gave DTaP by mistake. Dr checked with the CDC, which said that DTaP given to people age 11 or greater should count as Tdap vaccine.
Pt given all immunization in Vastus lateralis, on drive home, mother called stated, pt had hives, red, swollen eyes, feet hot and itching no respiratory problems.
Generalized vaccinia upper chest/back.  Occurred 10 days post vaccine.  No Rx.
Area around injection site started to become red, itchy and swollen starting 1 day and a half after administration. Has spread a little. Patient will take ZYRTEC and apply ice to area. Also, pt. said she will call her doctor.
Arm started to swell; Really flush; felt very weak; Not able to eat; fast heart rate; dizzy/like was going to faint; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm started to swell), FLUSHING (Really flush), ASTHENIA (felt very weak), DECREASED APPETITE (Not able to eat) and HEART RATE INCREASED (fast heart rate) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shingles in December 2020. Previously administered products included for an unreported indication: VALACYCLOVIR HCL until 17-Jan-2021.    On 14-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PERIPHERAL SWELLING (Arm started to swell), FLUSHING (Really flush), ASTHENIA (felt very weak), DECREASED APPETITE (Not able to eat), HEART RATE INCREASED (fast heart rate), DIZZINESS (dizzy/like was going to faint) and NAUSEA (nausea). On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, PERIPHERAL SWELLING (Arm started to swell), FLUSHING (Really flush), ASTHENIA (felt very weak), DECREASED APPETITE (Not able to eat), HEART RATE INCREASED (fast heart rate), DIZZINESS (dizzy/like was going to faint), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, Herpes zoster: positive RESOLVED.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Beginning right away the patient arm bleed more than normal. The arm was sore but became difficult to sleep on arm for 3 nights and it felt better then after 7 days the patient's arm started aching and she noticed a knot about 4" X 3" with some redness and tenderness. Patient took 800 mg of Ibuprofen and iced the area but is still experiencing pain.
no adverse event reported.  The husband came in for a bivalent booster and before administering it was noted he had already received it and was declined.  he was confused why his wife received it but he couldnt.   After looking into it, It was noted this patient had two profiles and had already received a bivalent boosted on 09-08-22.  she came in again for a booster but it was not flagged as having had it since it was located in another profile.  the patient had also lost her card so the RPh would not have known this was a duplication.
HEADACHE; MUSCLE ACHE; This spontaneous report received from a patient via a company representative 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, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.No concomitant medications were reported. On an unspecified date, the subject experienced headache, and muscle ache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and muscle ache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210353137.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Seizure-Mild, Systemic: Shakiness-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Pt fainted/blacked out while sitting down on her mothers shoulders.  She blacked out for a few seconds may have had a mild seizure or could have been shaking.  Laid patent flat and used moms soft backpack to put under her head.  Had bystander call 911 when onset of shaking/seizure that lasted for a couple seconds 2-3 minutes.  Fire department came to evaluate pt.  All vitals were normal.  They think it was sycopy and pt was scared and nervous of needles and only had a protein bar for lunch.
About 70 hours after vaccination I developed a rash. It was a red blotchy rash that started on my arms and it was everywhere. It stayed the same about ten days. It faded gradually over that time. It was not itchy or painful. The injection got puffy right around two inches which lasted about a week which started on the third day. It was itchy, red and hot. After the first dose I did not have any of these symptoms.
This case was reported in a literature article and described the occurrence of systemic lupus erythematosis flare in a subject of unspecified age and gender who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). Subject's medical condition included Systemic Lupus Erythematosus. On an unspecified date, the subject received an unspecified dose of Influenza vaccine unspecified (unknown route and injection site, batch number not provided). 12 weeks after vaccination with Influenza vaccine unspecified, the subject experienced systemic lupus erythematosis flare (SELENA-SLEDAI defined disease flare). Plasma samples were obtained from the subject on the day of influenza vaccination and at 12 weeks post vaccination. Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. Summary of the article: This literature article referred to 28 Systemic Lupus Erythematosus (SLE) patients (age and gender not specified) who exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. Subject's medical history and concomitant medications at the time of the event were unknown. Twenty-eight SLE patients exhibited SELENA-SLEDAI defined disease flare after 6 (n=13) or 12 (n=15) weeks post influenza vaccination (manufacturer, dosage and injection sites unknown) on an unspecified date. These 28 patients were part of a study conducted to understand mechanisms and identify biomarkers of flare to help prevent damage and improve management. Plasma samples were obtained from SLE patients on the day of influenza vaccination (BL) and at 6 and 12 weeks post (FU). Each SLE patient was matched to a unique SLE patient who did not flare (NF), and to a healthy control (HC). Samples from 13 SLE patients with flare were compared to samples from a non-flare year (self nonflare, SNF). Plasma samples were tested for 52 soluble inflammatory mediators using xMAP technology. SLE patients who exhibited disease flare had significantly (p < 0.01) higher levels of BL pro-inflammatory mediators, including Th1, Th2 and Th17-type cytokines compared to NF/SNF SLE patients and HC. Regulatory cytokines, including IL-10 and TGF-Beta were increased (p < 0.01) at BL in SLE patients not exhibiting disease flare (NF/SNF) compared to SLE flare and HC. TNFR family members, TNFRI, TNFRII, Fas, FasL, CD40L, were increased at BL in SLE flare patients. Select serum cytokines and chemokines are elevated in patients before SLE disease flare, providing important pathways to dissect for mechanism of flare, therapeutic selection or development.
c/o chills, body aches, swollen throat, low grade fever.  Called MD.  No treatment given.  Back at work, afebrile on 12/18.  Throat is still swollen.  No other distress.
This spontaneous report was received from a consumer and refers to 2 patients in their 60's (gender was unspecified). No information regarding the patients' pertinent medical history, concomitant medication and drug reactions or allergies was reported. On unknown dates, the patients were vaccinated with doses of PNEUMOVAX 23 (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided). It was also reported that the reporter was not certain if it was PNEUMOVAX 23 or another pneumococcal vaccine. On unknown dates, both patients developed pneumonia and both had cough. It was unspecified if the patients received the treatment or had lab diagnostic studies performed. The outcome of the events was not reported. The relatedness between the events and PNEUMOVAX 23 was not reported. Upon internal review, the event of pneumonia was considered to be medically significant. Additional information is not expected as no contact details were provided.
Administration after a below temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 30-Sept-2022 Reporter's comment: The reporter called to report a below temperature excursion where Boostrix and Shingrix were exposed to 27 degree Fahrenheit from the period of 27th July 2022 until 22nd September 2022, due to a malfunction of their fridge.  The reporter reported that during that period a total of 20 patients might had received these vaccines; 15 patients received Boostrix and 5 patients received Shingrix.  No lot number and expiration dates or any patients information was handy at the time was asked.  The vaccine administration facility was the same as primary reporter. Consented to follow up. Additional supportive information: The patient received Shingrix below temperature excursion, which led to incorrect storage of drug. This is 1 of 20 linked cases reported by same reporter for different patients.
rash 25JAN96 around noon;both arms, rt leg & both buttocks were all dark red, solid color (not blotchy);had fever (no thermometer, so how high unk);both arms swollen from shoulder to elbow;pt fussy, irritable, no appetite, doesn't move;
night sweats; fatigues; muscle aches; chills; sore arm; mild aches; fever; This is a spontaneous report from a contactable nurse (patient). A 45-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient is a NP who received his first dose of the Covid19 vaccine last week. He reported a sore arm and mild aches that resolved after 48 hours; then he developed night sweats, fatigues, muscle aches, and 3 days of a fever. He reported the fever has 'broken', but that chills continued along with fatigue. No one else in his household had these symptoms, so he didn't believe them to be infectious. Didn't seem to have any infectious disease symptoms. The outcome of the events sore arm, mild aches, fever was recovered, of the events fatigue and chills was not recovered, of the other events was unknown.   Information on the lot/batch number has been requested.