chrisvoncsefalvay/vaers-outcomes huggingface dataset:
breastfeeding; Itchy face; sneezing; Itchy throat; Itchy injection site; Rash on injection site; Red circle on injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (breastfeeding), PRURITUS (Itchy face), SNEEZING (sneezing), THROAT IRRITATION (Itchy throat) and INJECTION SITE PRURITUS (Itchy injection site) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939676) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergic reaction to drug (allergic to aspirin as child but it was resolved as adult).    On 18-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPOSURE VIA BREAST MILK (breastfeeding), PRURITUS (Itchy face), SNEEZING (sneezing), THROAT IRRITATION (Itchy throat), INJECTION SITE PRURITUS (Itchy injection site), INJECTION SITE RASH (Rash on injection site), INJECTION SITE ERYTHEMA (Red circle on injection site) and HEADACHE (headache). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) on 19-Jul-2021 for Seasonal allergy, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) on 19-Jul-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, EXPOSURE VIA BREAST MILK (breastfeeding), PRURITUS (Itchy face), SNEEZING (sneezing), THROAT IRRITATION (Itchy throat), INJECTION SITE PRURITUS (Itchy injection site), INJECTION SITE RASH (Rash on injection site), INJECTION SITE ERYTHEMA (Red circle on injection site) and HEADACHE (headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  Expiration date of suspect drug was given as 11-2021
pt began having stomach cramps which started out mild but w/in 1 1/2hr was having severe abd pain & n w/o v or diarrhea;pt laid on bathroom floor & could not stand to be touched;hurt all over as if starting flu;joints swollen;hives;
Approx 5 minutes after injection Pt became rigid all over, very stiff, and fell down to table. After several minutes then began to arise but was very groggy, clammy, pale and c/o ringing ears and could not hear. BP decrease 80/50.Watched and monitored over 30 minutes which at which time was lunching and felt better and released to home with mother. 12:45PM called Pt to check on her and mom states was doing very well.
Febrile seizure w/in an hr p/receiving DTP; Taken to ER where pt was admitted for observation;
POLYARTICULAR REACTIVE ARTHRITIS, swollen and extremely sensitive and painful joints, affecting all fingers in right hand, right wrist, right elbow, right knee, left big toe.  Treatment with Prednisone, initially 40mg daily, boosted to 50mg, partially effective after 2 weeks
Fatigue; Injection site pain; Rash at base of skull and behind ears that comes and goes; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash at base of skull and behind ears that comes and goes), VACCINATION SITE PAIN (Injection site pain) and FATIGUE (Fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L2OA and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to plants (rash), Hay fever, Fruit allergy (redness, hives) since 01-Jan-2021 and Lichen sclerosis atrophicus since 01-Aug-2020. Concomitant products included ALLIUM SATIVUM BULB, GINKGO BILOBA LEAF, ZINC PICOLINATE (TINNITUS FORMULA) from 01-Mar-2018 to 25-Jun-2021 and ALLIUM SATIVUM BULB, GINKGO BILOBA LEAF, ZINC PICOLINATE (TINNITUS FORMULA) from 01-Mar-2018 to 25-Jun-2021 for Tinnitus, CALCIUM PANTOTHENATE, FOLIC ACID, VITAMINS NOS (MULTI-VITAMINS VITAFIT) from 01-Jan-2018 to 12-Jul-2021 for an unknown indication.   On 21-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021, the patient experienced RASH (Rash at base of skull and behind ears that comes and goes). On 19-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection site pain). On an unknown date, the patient experienced FATIGUE (Fatigue). On 19-Mar-2021, VACCINATION SITE PAIN (Injection site pain) outcome was unknown. In April 2021, RASH (Rash at base of skull and behind ears that comes and goes) had resolved. At the time of the report, FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered RASH (Rash at base of skull and behind ears that comes and goes) to be not related. No further causality assessments were provided for VACCINATION SITE PAIN (Injection site pain) and FATIGUE (Fatigue).    The patient reported experiencing  a rash on the back of head and neck from January to April. The rash was eventually determined to be a reaction to the sap in pine cones which she was handling during that time frame. The rash resolved as soon as the pine cones were gone. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow-up received on 22-Jun-2021 and updated email-id. On 21-Jul-2021: No specific follow-up information recorded.
After receiving 4 vaccines, patient stood up & sit on exam table waiting for sister to get vaccinated. Pt fell to the floor after sl. waving of arms & legs x approx 3 secs. Nurse called for help v/s assessed, pt alert & reports didn't remember falling to floor. Redness to left shoulder.
Patient reports that first few days area was mildly red and sore. Then starting 2-3 days post vaccination noted increasing erythema, widening of reaction area. Also has developed blisters in the area. No fever or chills. No systemic symptoms. No non local skin reactions. On exam, has a 3-4 cm area of erythema, with 2-3 cm in the central portion more erythematous and with presence of multiple blisters. Mildy tender to palpation.   Mentioned reaction incidentally during a routine visit. Did not notify office/hospital of reaction when it started.
This spontaneous report was received from a nurse, refers to a patient of unknown age and gender. Medical history was not reported. On30-JUN-2014 the patient was vaccinated with an expired dose of M-M-R II injection, 0.5 ml, subcutaneous, lot # H012142, expiration date 29-JUN-2014. Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Redness, Edema, Warm to touch, tenderness.  Tx: warm compresses and alternate Tylenol/Motrin.
Low back pain; Rash; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Low back pain) and RASH (Rash) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029620A and 091A21A) for COVID-19 vaccination.     The patient's past medical history included Rash.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced BACK PAIN (Low back pain) and RASH (Rash). On 25-Feb-2021, BACK PAIN (Low back pain) had resolved. At the time of the report, RASH (Rash) outcome was unknown.            Treatment details included dermatology cream.
Friday had hardness and bruise noted on left deltoid area. Saturday had generalized malaise and pain radiating from left arm to center of back and burning sensation to toes. Pain in center of back was worse. Cannot raise arms over head. Pain in center of back and left arm burning constantly. Also had a headache. Treated with Tylenol and Advil. Dx'd with acute local flu vaccine reaction. Rx'd with Celebrex and ice to affected arm for 72 hours. Recovering.
significant pain, swelling, redness, and itching around the injection site.; significant pain, swelling, redness, and itching around the injection site.; significant pain, swelling, redness, and itching around the injection site.; significant pain, swelling, redness, and itching around the injection site.; Swelling was from the top of the patient's shoulder down to her elbow.; This spontaneous report was received from a pharmacist referring to a 62 years old female patient. The patient's pertinent medical history, concomitant medication and concurrent condition were not provided.    On 29-JUL-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (0.5 ml syringes; route, strength, lot# and expiration date were not provided) for prophylaxis.  On 30-JUL-2020 (the next day), the patient experienced significant pain, swelling, redness, and itching around the injection site. It was reported that the swelling was significant enough that you could see it. Swelling was from the top of the patient's shoulder down to her elbow. The swelling got worse every day until this morning. The patient took diphenhydramine hydrochloride (BENADRYL) for treatment. At the reporting time, it did look better but still itches. The outcome of the events was reported as recovering.  The causality between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) were not provided.  This is one of the linked reports from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2008USA001082: US-009507513-2008USA001498:
Chills, shakes; Fever; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills, shakes), PYREXIA (Fever), HEADACHE (Headache) and FATIGUE (Fatigue) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced CHILLS (Chills, shakes), PYREXIA (Fever), HEADACHE (Headache) and FATIGUE (Fatigue). On 29-Jan-2021, CHILLS (Chills, shakes), PYREXIA (Fever) and HEADACHE (Headache) had resolved. On 30-Jan-2021, FATIGUE (Fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported. The patient went through an eight hour period where he had those symptoms. He continued to be fatigued for another 24 hours.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
tinnitus, more apparent in one ear but in both; mild headache; pressure in head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Slightly overweight" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing), notes: High cholesterol managed by meds; "spontaneous tinnitus" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; manufacturer unknown), for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "tinnitus, more apparent in one ear but in both"; HEADACHE (non-serious), outcome "unknown", described as "mild headache"; HEAD DISCOMFORT (non-serious), outcome "unknown", described as "pressure in head". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Experienced tinnitus, more apparent in one ear but in both. Also a mild headache and pressure in head. Both symptoms started a few hours after receiving booster dose.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient calls clinic on 5/27/2021 stating that when she received the vaccine 7 days she started having pain under her breast like her lymph nodes were swollen. Provider, NP, was consulted and advised to go to ED if she did not improve. Pt calls back today 6/8/2021 stating that she now has ulcers in her mouth and she thinks it's from the shot as well.
Pruritus in left arm; This spontaneous case was received on 08-Nov-2021 from a pharmacist via Agency (reference number: SEQW21-05159) and concerned an 85-year-old, male patient.  The patient's concurrent conditions included high blood pressure and sugar. The patient's concomitant medications included lisinopril, finasteride, levothyroxine and glimepiride, all used for unreported indication.  On an unspecified day in Oct-2021, a month ago as reported the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number reported was 312841 and expiry date was 19-May-2022.  On an unspecified date in 2021, after receiving Fluad Quadrivalent, the patient experienced pruritus in left arm. The pharmacist suggested treatment with Benadryl (diphenhydramine hydrochloride), but patient did not want it due to other medications he was taking.  At the time of initial reporting on 08-Nov-2021, the patient had not recovered from the event. He was experiencing it at the time of reporting.  The reporter did not provide a causality assessment.  The reporter assessed the event was assessed as non-serious.  Company comment: The event of 'localised pruritus' is assessed as unassessable to Fluad Quadrivalent .; Sender's Comments: The event of 'localised pruritus' is assessed as unassessable to Fluad Quadrivalent .
Case number PHEH2016US028241, is an initial spontaneous report received from a pharmacist on 24 Oct 2016 (combine report). This is also a quality complaint report (QA reference number: 1017508). This report refers to a patient of an unknown age and gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUAD (batch number: 166002, expiry date: Apr 2017) on an unknown date. The pharmacist stated that , while administering the FLUAD vaccine to a patient, she noticed that the vaccine squirted out on the pants of the patient and did not know from where exactly the product leaked. The needle was placed in the sharp containers. It was also reported that, the patient received partial dose. No adverse event was reported following the maladministration (under dose and syringe issue).
Patient's booster dose was given two months earlier then recommended. Pt's second dose was 08/23/21 and booster was due 02/23/22 but was given 12/21/21.
no adverse effect; Proquad was inadvertently reconstituted with 0.4% sterile saline instead of sterlie diluent; This spontaneous report was received from a nurse referring to a 4 year-old patient of unknown gender. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant therapy were not reported. On 01-OCT-2019, the patient was about to be vaccinated with one dosage form of properly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength not reported) (therapy type Rha) (lot No. S003866 has been verified to be a valid lot number for [measles, mumps, rubella and varicella (oka-merck) virus vaccine live], expiration date reported as 08-AUG-2020, but upon internal validation established as 08-AUG-2024) was inadvertently reconstituted with properly stored 0.4% sterile saline (lot # U6338AA with expiration date of 20-AUG-2021) (dose not reported) (anatomical location and route not reported) instead of sterile diluent for prophylaxis (wrong solution used in drug reconstitution). No adverse effects were reported. No product quality complaint (PQC) was associated with this report.
I had a fever of 101.9  that lasted about 10 hours. I had bad body aches, body pain, and a sore arm that still hurts. This morning I woke up with a fever of 103 that lasted a couple hours. I?ve been taking Tylenol and ibuprofen. Now I only have a sore arm.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 28Mar2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 58 years, in left arm 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 included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative; (Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 of Paxlovid from 14Jun2022 to 19Jun2022.  Clinical course: The patient did not taken any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. Tested negative on day 9 with elimination of Covid symptoms and then tested positive again on day 12 with re-onset of symptoms. There were no known allergies.  No follow-up attempts were possible. No further information was expected.
Narrative: Patient passed away due to COVID-19. He was hospitalized and had received a COVID-19 Vaccine.
Severe abd pain with nausea-severe pain lasted 24 hrs then dull pain for 2 days after. Did also have pain, soreness at inj site, body aches and fatigue
Pt presented to health department for nurse to check arm post vax on Wednesday. Left arm red anteriorly, 2"x4", warm to touch, slightly swelled with brownish spots noted around injection site. Stated her arm hurt on 10/11 and 10/12 and then gradually became red by 10/18. Pt went to physician who stated local reaction and gave her anti-inflamatory drugs. Pt stated her arm was better today.
Swollen arm, tender. Difficulty sleeping - body temperature 1.9 degrees above normal, avg heart rate up 10 points, 2% deep sleep, fatigue and headache.
Felt faint and lightheaded thirteen minutes after receiving shot. Hypotension down to Systolic Blood pressure of 72. Became unresponsive; EpiPen used. Patient improved.  Taken by paramedics to emergency department
redness at the injection site; rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE RASH (rash at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 07-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site). On an unknown date, the patient experienced VACCINATION SITE RASH (rash at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE RASH (rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided. Concomitant medication was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the product safety profile
High fever (102)  , Headache  cortex area,  Chills, hives on back and forearms, lethargy. Most symptoms lasted only 36 hours. Headache and hives for approximately 72 hours.
9/1/2009 patient experienced a rash on his trunk and extremities with some itching.  09/02/2009 He started coughing, wheezing and has nasal congestion. Was told to see MD and notify the MD that he had receieved Tdap and Menactra 08/31/2009.
Mother stated child had DTAP 8/15/01 in the PM. Pt's right thigh became reddened and edematous. Mother stated it spread. Pt was taken to the ER in the evening of 8/16/01. Zithromax was ordered. Mother stated redness subsided without further treatment.
Fever 101 x 4 days.  Has gotten 4 teeth in past week.  Increased fatigue and lethargy x 5 days.  Increased irritability x 4 days.  Began dragging feet, tripping and falling x 3 days.