chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hardness in the injection site; swelling in the injection site; Redness in the injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INJECTION SITE NODULE (hardness in the injection site), INJECTION SITE SWELLING (swelling in the injection site) and INJECTION SITE ERYTHEMA (Redness in the injection site) in an 86-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     It was unknown if patient had any relevant medical history or conditions, allergy, concomitant diseases and risk factor.     On 03-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE NODULE (hardness in the injection site), INJECTION SITE SWELLING (swelling in the injection site) and INJECTION SITE ERYTHEMA (Redness in the injection site). At the time of the report, INJECTION SITE NODULE (hardness in the injection site), INJECTION SITE SWELLING (swelling in the injection site) and INJECTION SITE ERYTHEMA (Redness in the injection site) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       It was unknown if any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Suspect vaccine dosage text was reported as unknown.  Treatment information was not provided.
Patient received vaccine past the recommended refrigeration period of 30 days. Vaccine removed from ultracold temps on 1/13/22 and expired after 30 days in refrigerator 2/12/22.  Vaccine was administered on day 2/15/22.
2 days after injection my whole body hurt. Toes, feet, legs, arms, hands, fingers. Painful feet and toes.  Achy, sore  feeling. In arms. Still have symptoms today. No treatment
This spontaneous report received from a patient concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcoholic, and non-smoker, and other pre-existing medical conditions included: Patient did not have any known allergies. Patient did not had any drug abuse or illicit drug usage. Patient had no medical history. The patient received Covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: unknown) dose was not reported, 1 total, administered at left arm on 12-APR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for prophylactic. In the beginning around the first week of AUG-2021, the patient started experiencing side effects such as bleeding/spotting, hot flashes, felt moody, felt lazy, weight gain, and not feeling well (Dose number in series 1). On 24-AUG-2021, gynecologist did some laboratory tests included: Blood test (NR: not provided) not reported, and Diagnostic ultrasound (NR: not provided) not reported. The patient took Tylenol prior to receiving vaccine and continued for 2 days. The patient had no side-effects initially after first dose until the menopause symptoms appeared. The patient received Covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: unknown) dose was not reported, 1 total, administered at left arm on 22-NOV-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with dose of Covid-19 vaccine ad26. cov2.s. (Dose number in series 2). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from not feeling well, and had not recovered from bleeding/spotting, hot flashes, felt moody, felt lazy, and weight gain. This report was serious (Other Medically Important Condition). It has been determined that this case is a master case 20220240146. This case 20220240216 will be deleted. All relevant information regarding this case will be submitted under 20220240146. Sender's Comments: V0: 20220240146-Covid-19 vaccine ad26.cov2.s-Bleeding/spotting. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
pain to left arm above elbow. Very tender to touch and area that felt crepitus; pain to left arm above elbow. Very tender to touch and area that felt crepitus; pain to left arm above elbow. Very tender to touch and area that felt crepitus; Dose 3; Other vaccine same date vaccine date 15Oct2021; Other vaccine same date vaccine date 15Oct2021; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Oct2021 16:00 (Batch/Lot number: unknown) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "hypothyroidism" (unspecified if ongoing); "Migraine" (unspecified if ongoing); "radiculopathy" (unspecified if ongoing); "gout" (unspecified if ongoing); "Shellfish allergy" (unspecified if ongoing); "Sulphur drugs" (unspecified if ongoing); "Latex" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, administration date 15Oct2021. Past drug history included: Amoxicillin, reaction(s): "known allergies: Amoxicillin". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EM9810, Location of injection: Arm Left), administration date: 30Mar2021, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8733, Location of injection: Arm Left), administration date: 05Mar2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Oct2021 16:00, outcome "unknown", described as "Dose 3"; PAIN IN EXTREMITY (non-serious), TENDERNESS (non-serious) all with onset 17Oct2021, outcome "not recovered" and all described as "pain to left arm above elbow. Very tender to touch and area that felt crepitus"; CREPITATIONS (non-serious) with onset 17Oct2021, outcome "recovered" (20Oct2021), PRODUCT USE ISSUE (non-serious), OFF LABEL USE (non-serious) all with onset 15Oct2021, outcome "unknown" and all described as "Other vaccine same date vaccine date 15Oct2021". Therapeutic measures were not taken as a result of pain in extremity, crepitations, tenderness.  Additional information: No other vaccines received 4 weeks prior to covid-19 vaccination. The patient had not tested positive for covid prior to vaccination and post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Immunization on 9/9/09. Mom noted quarter-sized erythema and warmth on 9/10/09. On 9/11/09, 9cm x 10cm area of warmth and erythema on R thigh in area of immunization administration.
Patient has not reported any adverse events from vaccination at the moment. She was administered a dose of the Moderna COVID-19 vaccine which is currently only approved for 18 yo and up. On day of inoculation, patient and her mother did not cite a reaction.
Pt recv vax on 10/16/97; on 10/28/97 pt exp injected eyes, runny nose, erythematous rash over body & face
After the 2nd dose vaccine,  around early June 2021, I started having pain in my left  eye and accompanied with blurry vision and dry eyes.   I went to my eye doctor ( optometrist ) who did an eye exam and said my vision has not changed that much.  I feel like my eyes are constantly straining.    The eye doctor could not find the source of the pain.  I was prescribed steroid drops to help with eye swelling.  After using the eye drops it did help with bringing the swelling down but the pain has not resolved.  He said to give it a few weeks and to follow up with an opthamologist if not resolved.  I also have notice left eye pain above my eye brow.  It shoots from my eye to my eye brow.
Horrible tinnitus and vertigo day 2 after 2nd shot.   Almost 3 weeks later the crippling tinnitus and vertigo are unchanged.  I am very scared and frustrated at this point.
RPh asked patient how she was feeling. Patient said she felt fine. RPh specifically asked pt if she felt light headed. Pt responded that she did not. Several minutes after patient left pharmacy, another shopper in store came to get pharmacist. Pharmacist ran to pt. Pt was lying on floor, with her friend at her head and another shopper holding up her feet. Her friend said he caught her and laid her down gently. The friend said she did not hit her head. Pt responded appropriately to questions about her name and how she was doing. Pt returned to pharmacy waiting area after she was feeling more comfortable to continue to recover. Pt was given soda, candy, and crackers. Pt began to feel better after eating. Pt stated she hadn't eaten since breakfast. RPh called pt at 6pm that night. Pt said she felt much better after she ate and was feeling good at time of call.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 01-JUL-2015, the patient was vaccinated with improperly stored M-M-R II lot # K000998 and 22-JAN-2016 (unknown strength and route). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Covid symptoms started on 12/24/2021 and felt like I had the flu. Symptoms were nasal congestion, coughing, body aches, and a slight fever. They lasted several days. I tested positive on 12/24/21. I started taking zpak 2 days ago. I also had chest pain, sinus issues, and a headache.
Symptoms : Dizzyness, blanked out, light headed    B/P 138/82
Diluent portion dropped up during reconstitution / final volume was 0.45ml / administered; Diluent portion dropped up during reconstitution / vaccines was administered; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number MB7RR, expiry date 8th October 2022) for prophylaxis.   On 26th May 2021, the patient received Shingrix .45 ml. On 26th May 2021, unknown after receiving Shingrix, the patient experienced accidental underdose and inappropriate reconstitution technique. On an unknown date, the outcome of the accidental underdose and inappropriate reconstitution technique were unknown.  Additional details were provided as follows: The reporter stated that, while administering Shingrix the diluent portion dropped up during reconstitution and the final volume was 0.45 ml, which led to inappropriate reconstitution technique and accidental underdose.  The reporter was looking for guidance. The reporter consented to follow up.
Patient developed 2 hives at varicella injection site. Redness resolved but still raised prominently at discharge. Patient discharged home from clinic with prednisolone PO and EpiPen Jr.
The evening I received my vaccine I experienced fatigue and side effects that you expect from COVID-19 vaccine. The next morning began experiencing diarrhea. Stools where very loose and I went to the restroom multiple times per day. Went in to see PCP because I was still having diarrhea and weakness. Dr. thought it could be a stomach bug that is going around and also advised me to increase my protein intake.
Prolonged soreness in left shoulder since time of injection. Three weeks to date. Have reached out to doctor - waiting to hear back.
Information was received 11-JUL-2017 via a phone call from a medical services manager who reported that a female employee of unspecified age, who is also a Medical Assistant, was administered MMR II on 30-JUN-2017 (Lot number M045395, expiration date 14-NOV-2018) and she did not know that she was approximately 3 weeks pregnant at the time. Concomitant product was MERCK STERILE DILUENT (Lot number not provided).  No adverse effects were reported. No further information was provided. Additional information was requested.
In the last 48 hours, have you had a fever* OR symptoms that are unrelated to a preexisting illness?: New cough, New sore throat, New muscle aches, Fever
The day after the vaccine I woke up with pain in my lower neck/shoulder area.  Then 5 days later three of my fingers on my right hand went numb.  The pain can be controlled by medication, but comes back and there is continuing numbness and tingling in my right arm and hand.
Information has been received from a consumer referring to her mother, a female patient of unknown age. Information about concurrent condition, concomitant medication and medical history was not provided. In approximately 2015 (reported about three years  ago), the patient received an initial dose of ZOSTAVAX (dose, lot# and expiration date were not reported) subcutaneously for prophylaxis. The patient asked for a dose of mammalian) SHINGRIX, but she received a dose of ZOSTAVAX 19400 plaque forming units (PFU) (1 dose format (DF); lot# and expiration date were not reported) subcutaneously for prophylaxis at an unspecified clinic on 30-MAR-2018. No adverse effects had been reported.
Patient with polyarticular joint pain, to include neck, Left Shoulder and right hand that patient states developed within days of receiving Hep B #2 vaccine and IIV on 8 Dec 2006. Patient was eventually diagnosed with rheumatoid arthritis and has been under the care of a rheumatologist since.
Breakthrough case admission after 4 vaccines Pfizer 2/22/21 lot# EL9267;  Pfizer 3/15/21 lot# EN6207; Pfizer 9/28/21 lot# Lot# FE3592;  Pfizer 10/12/22 lot# GJ6665
Patient does not have any side effects to report at this time. Patient requested Bivalent vaccine and was given Monovalent vaccine.
Patient phoned on 9/20/18 at 4:07 PM stating she developed soreness, tightness and tingling in legs last night approximately 11 hours after receiving the flu vaccine. States at one point she had difficulty moving right foot and ankle. Also had back pain that interfered with sleep. She took ADVIL which helped but then symptoms returned. Legs felt stiff and tight with tingling radiating up legs, with stiffness and tingling also in arms on 9/20/18 at time of call with low back pain. Describes "very strange deep muscle pain like nothing ever felt before." Per doctor, advised to rest, push fluids, avoid excessive heat and activity, go to E/R if symptoms worsen. Called patient the following day (9/21/18) to obtain update and she states symptoms were the same with flares of tingling and cramping pain in low back, arms and legs; constant tingling and cramping in right ankle and foot, and right hand and finger tips. Called patient on 9/25/18 and patient states she continues to feel uncomfortable, continues to have stiffness and tingling in legs, hands and feet. Back pain has subsided. Sleeping well. Taking ADVIL as needed. Doctor prescribed prednisone to take if symptoms become significant.
Expired vaccine given on 6/1/22. Vaccine had expired on 5/28/22. No adverse reaction
No aditional adverse events reported; An unspecified patient received a dose of Pneumovax 23 that was expired when adminstered; This spontaneous report was received from a licensed practical nurse concerning a 86-year-old female patient.   The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. Her concomitant medications included influenza virus vaccine inactivated (unspecified).  On 18-SEP-2020, the patient was vaccinated with an expired dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot number S004548, expiration date reported and validated as 12-AUG-2020) as prophylaxis (dose, dosage schedule, route of administration and site of administration were not provided). No adverse events were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: S004548; expirationdate: 12-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
PATIENT HAD TROUBLE SLEEPING THE NIGHT FOLLOWING VACCINATION.  AWOKE TO USE RESTROOM AND NOTICED DISCOLORATION IN HER FINGER NAILBEDS AND NAILS.  THE DISCOLORATION WAS ORANGE-BROWN IN COLOR AND SURROUNDED ALMOST EVERY NAIL ON BOTH HANDS.  SHE SAID "IT LOOKED LIKE THEY WERE BLEEDING AT FIRST" BUT NO ACTUAL BLOOD, ITCHING, PAIN, SKIN PEELING, OR OTHER ADVERSE EFFECTS WERE NOTED.  PATIENT SCRUBBED HER NAILS WITH BRUSH AND SOAP, BUT DISCOLORATION WAS STILL PRESENT.  SHE CAME TO PHARMACY TO REPORT THE NEXT DAY.
I woke up at 4am and I felt very dizzy with a very intense headache, and sweating. I went to walk downstairs and I was unstable and almost fell. I had to lean on the wall and walk slowly. My eyesight made it hard to keep myself stable enough to walk and feel steady on my feet. My legs felt very weak and very heavy at the same time. By the time morning came, I had to get my son up for school and I felt so weak and so sick to my stomach, I again almost lost my balance going down the stairs to the living room. By that night, I was so ill I could barely keep my head up and kept having these sudden extreme pains in my joints and muscles like a baseball bat hitting me. It almost felt at one point like I had done a very hard workout with weights and my muscles were not only sore, but like ripped and bruised. It lasted for three days now and I am still hurting and ill.
loss of taste off and on; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6201) via an unspecified route of administration in the left arm on 25Feb2021 at 11:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer on an unknown date in 2014. The patient previously took erythromycin (MANUFACTURER UNKNOWN) on unknown date for unknown indication and experienced drug allergy. Concomitant medications included amitriptyline hydrochloride (ELAVIL) from an unknown date for an unknown indication. The patient also received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Mar2021 at 07:00 the patient experienced loss of taste off and on (3 occasions). The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent SARS-CoV-2 test (Nasal Swab/PCR-polymerase chain reaction) on 05Mar2021and the result was negative. The patient did not receive any treatment for the reported adverse event. The clinical outcome of the event loss of taste off and on was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Patient began to have intense burning to her face when she washed her face. The burning became less intense but is still present. Patient advised to take Benadryl 50mg PO. If swelling or shortness of breath occurs, go straight to urgent care.
Tenderness at the injection site right after receiving the vaccine; Small rash at the injection site; Rash has progressed as big as a cantaloupe at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Tenderness at the injection site right after receiving the vaccine), VACCINATION SITE RASH (Small rash at the injection site) and VACCINATION SITE RASH (Rash has progressed as big as a cantaloupe at the injection site) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE PAIN (Tenderness at the injection site right after receiving the vaccine). In March 2021, the patient experienced VACCINATION SITE RASH (Small rash at the injection site) and VACCINATION SITE RASH (Rash has progressed as big as a cantaloupe at the injection site). At the time of the report, VACCINATION SITE PAIN (Tenderness at the injection site right after receiving the vaccine), VACCINATION SITE RASH (Small rash at the injection site) and VACCINATION SITE RASH (Rash has progressed as big as a cantaloupe at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was not provided by the reporter.  Treatment information was not provided.
This spontaneous report as received from a healthcare worker refers to a 12 months old patient of unknown gender. Concurrent conditions and medical history were not reported. On 24-SEP-2015, the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (lot number L027634 and expiration date 21-JAN-2017, therapy type, dose and route of administration were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Patient is a 36 y.o. male who received the Moderna Covid-19 Vaccine, mRNA-1273 (PF) 100 mcg/0.5 mL IM Susp, Lot 044A21A on 3/15/2021. The patient experienced the following reaction(s) during the immediate of observation: 3:21pm Patient c/o "feeling faint." Patient requested to lay down on mat. Patient alert and oriented. No loss of consciousness noted. Patient reports having fear of needles causes him to feel faint. Patient was treated/managed as follows:  3:23pm VS BP 130/78, HR 73, RR 18, O2 sat 97% on room air. Patient reports symptoms resolving.  3:33pm VS BP 132/86, HR 78, RR 18, O2 sat 96% on room air. Patient reports feeling better. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 3:36pm Escorted to car by nurse.
Child developed "pimples" around vaccination area that went up thigh and to buttocks area. Pimples are in no other area.