chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had the shot and the booster, and got the shingles anyway /Suspected Vaccination failure; had the shot and the booster, and got the shingles anyway !; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received shot and the booster, and got the shingles anyway. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation for shingles infection and time to event onset was unknown.
Erythema in injection site and induration 5cm x 4cm. Painful.
Pt. had rash on left side of neck to mid-clavicular line and slight ticking in her throat.  Pt. denies difficulty swallowing. SOB, other complaints.  Pt. was give 50 mg PO diphenhydramine w/ relief from S/S
Medical student accidentally pushed  on the plunger of syringe causing vaccine to leak on arm prior to injection. Less than half the dose was administered to left deltoid. Full dose re-administered to right arm deltoid per her medical instructor, Dr.
Dizziness and headache (improving after 3 days of vaccination) Stomach upset and Diarrhea (improving after 3 days of vaccination) Body aches and chills (improving after 3 days of vaccination) Swelling of all joints. especially those with pre-existing arthritis conditions (improving after 3 days) 99 degrees Temperature for 2 days after vaccination Redness and swelling at injection site and sore arm (still there 3 days after vaccination) Swollen lymph node in left armpit and left side of chest  near armpit, causing restriction of left arm movement (Still there after 3 days)
Wheezing, shortness of breath, difficulty breathing, and rash to the upper chest/throat area (reaction occurred approximately 3 to 4 minutes after injection).
Patient described onset as 6/10/2021 into 6/11/2021 - rash on stomach, back and neck; nausea; tiredness; and chills
For 3 weeks I had an afternoon fever that would start between 3 to 7pm, Low grade fever, it was accompainied by fatigue, headache, neck and shoulder pain and fever would go away by the morning.
JOINT INFLAMMATION; TIREDNESS; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included moderate to severe adult crohn's disease.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) 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 number. Concomitant medications included adalimumab for moderate to severe adult crohn's disease. On an unspecified date, the subject experienced joint inflammation, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tiredness and joint inflammation was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as case is assessed as non serious.
1/6 injection site arm soreness, 1/7 red raised bump R foot great and second toe  1/8 red raised bump on R foot side next to pinky toe  Narrative:  1/6 injection site arm soreness. 1/7 post vaccine day 1 noted great toe  and second toe with red raised bump on R foot. 1/8 post vaccine day 2 noted new  bump R foot on the side next to pinky toe. Instructed to call Covid hotline. 1/8  Covid result negative.
cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced NASOPHARYNGITIS (cold). At the time of the report, NASOPHARYNGITIS (cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient experienced cold after receiving first dose of Moderna vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2021-049740 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-049740:MOD21-056826 : Same reporter, reporter's husband
arm still hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 3 weeks after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the first shingle shot 3 weeks ago and still arm hurt. The patient could go back to get second one in 3 months when he/she off.
whole body is cold to the bone; she has so much pain/so painful she cannot stand it; felt so thirsty; so much body heat; she could not sleep since she was in so much pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (she has so much pain/so painful she cannot stand it), THIRST (felt so thirsty), HOT FLUSH (so much body heat), INSOMNIA (she could not sleep since she was in so much pain) and FEELING COLD (whole body is cold to the bone) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, the patient experienced PAIN (she has so much pain/so painful she cannot stand it), THIRST (felt so thirsty), HOT FLUSH (so much body heat) and INSOMNIA (she could not sleep since she was in so much pain). On 23-Nov-2021, the patient experienced FEELING COLD (whole body is cold to the bone). At the time of the report, PAIN (she has so much pain/so painful she cannot stand it), THIRST (felt so thirsty), HOT FLUSH (so much body heat), INSOMNIA (she could not sleep since she was in so much pain) and FEELING COLD (whole body is cold to the bone) outcome was unknown.            No concomitant drug details were reported. No treatment details were reported.
Evening of vaccination, the mother observed hives on the patient's face, abdomen and bilateral extremities. Mother took the patient back to the clinic and was advised by Dr to treat with Benadryl and report back after treatment.
INR was high; This is a spontaneous report from a Pfizer-sponsored program Support. A contactable male consumer (patient) reported that:  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 16Jan2021 as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. Medical history included heart problems and takes coumadin/ not clarified if patient had heart problems before or after covid vaccine. Concomitant medication was not reported. On 16Jan2021 patient received dose 1 of COVID-19 vaccine and week and half later tested and INR was high (Feb2021). HCP told to skip a pill. Again received dose 2 of COVID-19 vaccine and again tested with INR was high. The patient underwent lab tests and procedures which included international normalised ratio: high on Feb2021 and high on an unspecified date. The outcome of the event was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Vaccine given 9/10/14 - Dad called stating left leg was red/swollen with hives on both upper and lower extremities. Dad gave BENADRYL and this took away symptoms.
Info has been received from a health prof'l concerning a male who was vax'd on an unknown date w/Haemophilus B conjugate vax. Subsequently, the PT reported to his MD that he experienced a "horrible reaction" to the vax because it was grown using horse tissue." The reporter felt that the PT's "horrible reaction" was related to therapy w/Haemophilus B conjugate vax. Add'l info has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: tree nuts" (unspecified if ongoing), notes: tree nuts. Concomitant medication(s) included: SIMVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: still get a positive; Positive, notes: positive again; negative, notes: after 5 days. Therapeutic measures were taken as a result of covid-19.  Clinical course: Rebound effect. Felt better after 3 days. Tested negative after 5 days. On day 9 got mild symptoms and tested positive again. Now at day 12, symptoms have lessened but still get a positive result on test. Patient received treatment with Paxlovid (Lot: ga8852) from 11May2022 to 15May2022 for the treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient given wrong Meningococcal (Men B) vaccine by CMA, did not have RN or Dr. check her vaccines.  Mother was called and patient returned to clinic. No redness, edema, no adverse reaction noted at site.   Correct Vaccine paper and Meningococcal4 acwy given by RN in opposite Deltoid Right after reviewing CDC recommendations.  Observed for 20min after vaccine to ensure no A/R - none.
HEADACHE, SOB, FEVER, BODY ACHES, COUGH, HYPOXIA
Heat through body, Nausea, numbness in left hand, pressure in head, cognitive problems, pressure in head, memory problems, joint pain, right eye not focusing Have seen my primary, rheumatologist- received injection of steroid and put on oral steroids, chiropractor nerve stimulation, adjustment. Waiting to see a neurologist
March 24 my ears started ringing and they are still ringing to this day. On March 24 my ears were also full, stopped up and hurting. I went to regular Doctor on April 6 and he said it was just a malody and would go away to take another claritin daily. Went to ENT on April 15  and was given audiology exam and had slight hearing loss, tinnitus, stopped up ears, hurting ears and was put on Prednisone for 8 days tapering. I was intolerant to Prednisone but I took it anyway. Had anxiety, depression and horrible acid reflux while on prednisone. Also, had terrible hearing sensitivity (everything sounded real loud) while on Prednisone. Finished Presnisone and after about 2 weeks started feeling better from going off Prednisone but Tinnitus is still all day every day - ears better from fullness and  being stopped up but Tinnitus is still with me.
Tired; fever (99.4°F) for 3 days; No energy; No appetite; Felt rough; Nausea; Chills; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Jan-2021. The most recent information was received on 07-Jun-2021 and was forwarded to Moderna on 07-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (No energy), DECREASED APPETITE (No appetite), FEELING ABNORMAL (Felt rough), NAUSEA (Nausea) and CHILLS (Chills) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Allergy to sulfa) and Allergic reaction to antibiotics (Allergy to Amoxicillin).    On 15-Jan-2021 at 8:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced ASTHENIA (No energy), DECREASED APPETITE (No appetite), FEELING ABNORMAL (Felt rough), NAUSEA (Nausea), CHILLS (Chills) and PYREXIA (fever (99.4°F) for 3 days). On 19-Jan-2021, the patient experienced FATIGUE (Tired). On 17-Jan-2021, ASTHENIA (No energy), DECREASED APPETITE (No appetite), FEELING ABNORMAL (Felt rough), NAUSEA (Nausea) and CHILLS (Chills) had resolved. On 19-Jan-2021, PYREXIA (fever (99.4°F) for 3 days) had resolved. At the time of the report, FATIGUE (Tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Nov-2020, SARS-CoV-2 test: positive (Positive) rapid & sent to state. On 16-Jan-2021, Body temperature: 99.4°f (High) 99.4°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.  Patient was likely to buy hearing aid for left ear.   This case was linked to MOD-2021-053892 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up received on 07-Jun-2021 contains Patient demographic details, Medical History, second dose details, vaccine information.
Moderate-strong left arm muscle pain; Minor joint aches/pain; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E23247) via an unspecified route of administration in the left arm on 01Mar2021 at 10:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines. The patient had no known allergies to medications, food or to other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Mar2021, the patient experienced moderate-strong left arm muscle pain and minor joint aches/pain. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events moderate-strong left arm muscle pain and minor joint aches/pain was recovered on an unspecified date in Mar2021.   No follow-up attempts are needed. No further information is expected.
could not eat/walk; right knee swollen; could not eat/walk; diarrhea 2.5 weeks; fatigue; nausea; Headache; severe arthritis joint pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FOOD AVERSION (could not eat/walk), JOINT SWELLING (right knee swollen), GAIT DISTURBANCE (could not eat/walk), DIARRHOEA (diarrhea 2.5 weeks) and FATIGUE (fatigue) in a 74-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 reported.  Concomitant products included MULTIVITAMIN [VITAMINS NOS], KCL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), DICYCLOMINE [DICYCLOVERINE], FENOFIBRATE, LEVOTHYROXINE, liothiorinine, METOPROLOL, AMLODIPINE BESILATE (NORVASC), ROSUVASTATIN and GLICLAZIDE (DIAZIDE [GLICLAZIDE]) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced FOOD AVERSION (could not eat/walk), JOINT SWELLING (right knee swollen), GAIT DISTURBANCE (could not eat/walk), DIARRHOEA (diarrhea 2.5 weeks), FATIGUE (fatigue), NAUSEA (nausea), HEADACHE (Headache) and ARTHRALGIA (severe arthritis joint pain). The patient was treated with DOMPERIDONE (EMETROL [DOMPERIDONE]) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 06-Feb-2021, JOINT SWELLING (right knee swollen) had resolved. On 20-Feb-2021, DIARRHOEA (diarrhea 2.5 weeks) had resolved. At the time of the report, FOOD AVERSION (could not eat/walk), GAIT DISTURBANCE (could not eat/walk), FATIGUE (fatigue), NAUSEA (nausea), HEADACHE (Headache) and ARTHRALGIA (severe arthritis joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. The medical assistant reported that an excursion of SF for up to 3 minutes each day over the past 30 days, totaling 90 minutes. The product affected was M-M-R II (dose and route not reported), lot numbers of product involved in the excursion(s) were not reported. Excursion not supported. The product was also involved in a supported excursion on 13-JUN-2014 of 7F for up to 16 minutes. The reporter presumed that the vaccine had been administered post excursion but was not 100% sure. She stated that no one had reported any adverse effects post receipt of any vaccination administered at her office. This is one of several reports from the same reporter. Additional information has been requested.
given bivalent vaccine for the 1st dose/gave the bivalent booster dose to the patient at 0.5ml instead of the monovalent; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (given bivalent vaccine for the 1st dose/gave the bivalent booster dose to the patient at 0.5ml instead of the monovalent) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (given bivalent vaccine for the 1st dose/gave the bivalent booster dose to the patient at 0.5ml instead of the monovalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (given bivalent vaccine for the 1st dose/gave the bivalent booster dose to the patient at 0.5ml instead of the monovalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (given bivalent vaccine for the 1st dose/gave the bivalent booster dose to the patient at 0.5ml instead of the monovalent).    No concomitant medications were reported.  Reporter states that when they got the Moderna bivalent booster dose, the pharmacy manager told them that that is what they were now supposed to give, and they set aside their monovalent vaccines. One week ago, a patient came in for their 1st DOSE of the vaccine and they gave the bivalent booster dose to the patient at 0.5ml instead of the monovalent.   Reporter did not allow further contact
experienced sore arm after the 2nd dose of moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (experienced sore arm after the 2nd dose of moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (experienced sore arm after the 2nd dose of moderna vaccine). At the time of the report, PAIN IN EXTREMITY (experienced sore arm after the 2nd dose of moderna vaccine) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
pt recvd 1st dose of Hep B vax on 02NOV90 & devel a "heat rush"& tingling in face & fingers.Later pt exp persistent bilateral migraine h/a,& stiff neck.Later pt devel persistent,intermittent episodes of unilateral tinnitus & ear pain.
Pts LA swelled up, turned red and was warm to touch at injection site.  Instructed pt to put cold compress on site.
chills, fever 102, fatigue,  headache, sore throat, cough, SOB with exertion
Localized reaction, erythema, mild swelling and pruritus. To be treat with diphenhydramine.
Patient explained on 10/29/19 that her arm was severely swelled on the evening of 10/26/19, following Shingrix vaccination.
pt recvd vax & exp a cough w/chest cold,weakness,low grade temp;sx resolved 23JAN95;recvd 2nd vax 10FEB95 w/no recurrence of sx;
This second shot was given too high in my left arm.  Just barely below the shoulder bone.  I understand it was to be in the bigger part of my muscle a few inches down from the shoulder bone.  When the shot was given, it hurt a lot more than the first vaccination shot did.  In my own terms, "The shot made the top of my  humerus 'sparkle' with pain. " I grimaced until the vaccine was pushed all the way in.  She may have hit a nerve or my rotator cuff.   I am unable to raise my left arm in an and forward,  upward "fist punch" without pain.  Earlier today I couldn't raise it at all.  Also, I can't raise my arm out to the left side either without pain.  It is getting a little better, but I did take 2 ibuprophen and 2 tylenol about 3 hours ago. I can use the muscle in my arm to move a chair, for example, but it is painful to raise my arm over my head.  I don't want to get her in trouble, but I wanted to report it in case this pain continues.