chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the TDAP was given instead of the DTAP with no reported adverse event; Initial information received on 28-Apr-2022 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 18 months old patient with unknown gender to whom tdap was given instead of the dtap with no reported adverse event while receiving vaccines Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] and Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 28-Apr-2022, the patient received a  dose of suspect  Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel]  suspension for injection and a dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine [Adacel] suspension for injection (dose, route, strength, lot number and expiry date: unknown) in unknown administration site for immunization.  On 28-APR-2022 the patient was given tdap instead of the dtap with no reported adverse event (wrong product administered) (latency: same day) following the administration of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine and Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I was given my influenza shot in the joint of my right shoulder instead of in the muscle. The influenza shot was given too high in my arm . Immediately it became swollen and was very painful. Also had tingling in my right hand and stiffness in the shoulder and hands.
Dose 1 Arm pain tiredness. 2-3 days later diarrhea  Dose 2 Arm pain tiredness. Next day tired body aches. Like pins were poking me in different places. Mostly left side. An icy hot sort of feeling would also pop up in different places. Everywhere. Left side neck pain and jaw pain. 2-3 days later diarrhea.
Redness surrounding site, edema, lump at site approximately 6 inches in diameter, low grade fever, chills edema to lymph node of left arm for 5 days.  Diagnosis Cellulitis.
silver dollar sized area of redness & induration w/itching lt deltoid area reported to nursing on 26JUN-still present since onset 20JUN;hydrocortisone cream 1% applied 26JUN;still hot,red, hard but smaller w/itching 27JUN;
Hives developed ~24 hrs after GARDASIL #2 (5-16-08).  On call MD called 5-18-08 when facial edema began.  BENADRYL recommended & taken.  5-19-08 - hives cont'd - seen in office - rec 24 hr antihistamine QD-BID x7d.
Expired vaccine used\233 Patients given expired doses; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used\233 Patients given expired doses) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021 at 1:24 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used\233 Patients given expired doses). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used\233 Patients given expired doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Patient was not immunocompromised.This expiration date was mistakenly thought as 07-Apr-2022. However, on 04-Feb- 2022 it realized that the expiration date was on 07-Nov-2021. Started using this lot on 19-Nov-2021 until 04-Feb-2022, administered the Booster dose of the Moderna Covid-19 vaccine to 236 people. 14 vials were utilized. All vials were stored in a vaccine freezer set to -20C. Depending on number of patients signed up for that day, either 1 or 2 vials were removed from the freezer and placed on counter at room temperature for 30 minutes to thaw. Temperature readings of fridge were at either 3.8C or 5.6C. No temperature excursions were noted at any time during the administration of the vaccine.  Treatment medications were not provided.
pt brought to ED via EMS in cardiac arrest; pt was at home with family and became unresponsive; positive test for COVID; CPR and intubation; despite EMS and ED staff's efforts the pt died in the ED
Nausea, shaky, (L) arm swollen. Went to ED - IV fluids given. Had temp of 102.
I had a temperature of 104 about four hours after getting the vaccination. I had the temperature for a few hours and then I started feeling nauseous and threw up. I felt terrible the next day with a very bad headache and  five days later I developed a rash on my arms and legs.  It finally subsided but then reoccurred the next day.
shingles; rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number L7SY9, expiry date 4th July 2021) for prophylaxis.   On 7th August 2019, the patient received Shingrix .5 ml. In August 2019, less than 2 weeks after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles was unknown and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The patient experienced rash but it was unknown when the rash was started. The reporter asked if Shingrix can cause shingles. The patient thought he had shingles but he had not been diagnosed by a doctor. There was discrepancy in the outcome reported in source document (recovering/resolving) and in the database it was reported as not recovered/not resolved. There was discrepancy in the reported route of administration in database (unknown) and in source document, it was reported parenteral.
pt recv vax in lt arm & devel a central (penny size) raise white appearance w/surrounding area of erythema; BP, pulse, 02 sat WNL; no wheezing; eventually changed to 20x40mm area of erythema; pt devel no untoward effects;
On 3/14/2021, I started to feel all aches from upper back to arms and back, followed by chills, felt feverish,  took my temperature, but that was within normal range.  Chills and aches lasted till approximately 10pm.  I took 2 Tylenol extra strength at 2:15pm, 6:15pm and again at 10pm
Patient's left eye got swollen and irritated, especially the area under the eye got really swollen. The swelling got improved by Friday.
Pain in shoulder on day after, headache almost daily including date of this report, chills, feeling feverish without increased temperature
Rashes on neck; High blood pressure; This is a spontaneous report from a contactable consumer (patient) via the Medical Information Team. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on 16Feb2021 (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she got her first BNT162B2 dose in in (institution name) in (state name) last 16Feb2021 and was scheduled on 09Mar2021 for her second dose. On an unspecified date, the patient experienced rashes on her neck and high blood pressure. The patient was given Benadryl and Aveeno lotion for the rashes. The patient added that already spoke to her doctor regarding this and was continuing to update him. Her doctor told her to call her vaccination provider. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of RESTLESSNESS (She just could not relax), ENERGY INCREASED (She had so much energy), VACCINATION COMPLICATION (She felt so weird), TREMOR (She was shaking) and MIDDLE INSOMNIA (woke up suddenly from her sleep) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced RESTLESSNESS (She just could not relax), ENERGY INCREASED (She had so much energy), VACCINATION COMPLICATION (She felt so weird), TREMOR (She was shaking) and MIDDLE INSOMNIA (woke up suddenly from her sleep). On 01-Feb-2021, RESTLESSNESS (She just could not relax), ENERGY INCREASED (She had so much energy), VACCINATION COMPLICATION (She felt so weird), TREMOR (She was shaking) and MIDDLE INSOMNIA (woke up suddenly from her sleep) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  About 8-9 hours after receiving the vaccine she started experiencing some side effects. It was like a shock to her immune system. The symptoms subsided after about 1 hour and 30 minutes. The patient had been fine since that one episode. The patient did not take anything to alleviate the symptoms. The patient had not reached out to her healthcare provider.
FLUSHING Narrative:  At approximately 1700 she was brought to the observation room due flushing of her face. Color was returning to normal but then she reclined in chair and stated that she was not feeling right. She reported feeling lightheaded and shaky. Pulse was regular, skin warm/dry. 1705 administered Benadryl 50mg PO. Monitored until 1735, stated she felt food and denied any issues.
rash that came up on back 5 days after vaccine, then rash on legs 2 weeks later, followed by rash on arms 3 weeks later
Hives began 2 hrs > shot. Covered most of body. Hands and feet peeled - prednisone Rx. Splotches. Unresponsive to BENADRYL.
Breakthrough case admission after 3 vaccine Pfizer 1/26/21 Lot# El9261;  Pfizer 2/16/21 LOt# EM9810;  Pfizer 11/9/21 lot# FG5327
Pain/soreness back of left arm started 9-10-13. Felt pain in same location at time of injection. Soreness at site of injection lasted 1-2 days. No redness/warmth. Feels a bump to side of vaccination site. Client is very concerned.
Pt. received her 2nd dose of  the Pfizer vaccine today at 9:00 a.m. to left deltoid. Almost immediately, noticed blotches of redness to left arm . VS stable. Also mentioned being itchy to her right foot and inner thigh.  Was relieved by a cold compress.  Will also take Benadryl at home if worsens. Patient was released to home with no other symptoms.
04/02/22 presents to ED for "chills". PMHx of "renal transplant, DVA, G6PD deficiency, seizure disorder, and recent hospitalization for infection with ESBL E-coli and then C-dif"
all my fingers were swelling, it started swelling on one hand each fingers, it red inflammation sore hurt and itchy all fingers all day; all my fingers were swelling, it started swelling on one hand each fingers, it red inflammation sore hurt and itchy all fingers all day; all my fingers were swelling, it started swelling on one hand each fingers, it red inflammation sore hurt and itchy all fingers all day; all my fingers were swelling, it started swelling on one hand each fingers, it red inflammation sore hurt and itchy all fingers all day; all my fingers were swelling, it started swelling on one hand each fingers, it red inflammation sore hurt and itchy all fingers all day; all my fingers were swelling, it started swelling on one hand each fingers, it red inflammation sore hurt and itchy all fingers all day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Nov2021 at 19:00 as dose 3 (booster), single (Lot number: 33030BD) at the age of 48 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (prev dose lot number=EW0175,, prev dose administration time=05:00 PM,, prev dose dose number=2,, prev dose vaccine location=Left arm), administration date: 23Apr2021, when the patient was 48-year-old, for COVID-19 immunization; BNT162b2 (prev dose lot number=Er8730,, prev dose administration time=12:00 PM,, prev dose dose number=1,, prev dose vaccine location=Left arm), administration date: 01Apr2021, when the patient was 48-year-old, for COVID-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), PERIPHERAL SWELLING (non-serious), INFLAMMATION (non-serious), PAIN IN EXTREMITY (non-serious), PRURITUS (non-serious), ERYTHEMA (non-serious) all with onset 24Nov2021, outcome "recovered with sequelae" and all described as "all my fingers were swelling, it started swelling on one hand each fingers, it red inflammation sore hurt and itchy all fingers all day". The events "all my fingers were swelling, it started swelling on one hand each fingers, it red inflammation sore hurt and itchy all fingers all day" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: Unknown results. Therapeutic measures were taken as a result of rheumatoid arthritis, peripheral swelling, inflammation, pain in extremity, pruritus, erythema.  Clinical course: On 24Nov, all of patient fingers were swelling, it started swelling on one hand each fingers, it red inflammation sore hurt and itchy all fingers all day, patient was treated with steroids medication and symptoms was referred to a Rheumatologist. Patient has been tested with many types of blood test to find out what caused the illness. Patient was treated with RA medication (Simponi) for 6 months from Mar2022, Sep2022 then had switched to Methotrexate on 22Oct2022.
This non-serious medically confirmed spontaneous report (initial receipt 30-SEP-2014) concerns a female patient. On 30-SEP-2014, the patient received AFLURIA (batch number T50707)  less than 0.5 ml once intramuscularly. AFLURIA had been stored correctly. ON 30-SEP-2014, while the nurse was administering the vaccine into the patient's arm, the nurse noticed that some of the vaccine came out of the injection site. Consequently, the patient did not receive the whole dose of vaccine. No adverse reactions have been reported since administration Outcome was reported as received on 30-SEP-2014. Reporter's comments: The reporter assessed the case as non-serious.
like they burnt their tong on hot tea/having a taste on their tong; tong is scratchy; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISCOMFORT (like they burnt their tong on hot tea/having a taste on their tong) and TONGUE PRURITUS (tongue is scratchy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013H21B) for COVID-19 vaccination.     The patient's past medical history included Miscarriage and Hemorrhage (experienced it twice in the past). Concurrent medical conditions included Allergy to nuts (She has allergy to tree nuts, and 2 years ago her face blew up and she was hospitalized due to the allergy.). Concomitant products included VITAMINS NOS for an unknown indication.    On 29-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced TONGUE DISCOMFORT (like they burnt their tong on hot tea/having a taste on their tong) and TONGUE PRURITUS (tong is scratchy). At the time of the report, TONGUE DISCOMFORT (like they burnt their tongue on hot tea/having a taste on their tong) and TONGUE PRURITUS (tongue is scratchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.
I tested positive on 03Mar2021; I tested positive on 03Mar2021; I was unknowingly exposed close contact; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 12Feb2021 and second dose via an unspecified route of administration on 26Feb2021 both at a single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient reported that i received the first vaccine on 12Feb2021. I received the second vaccine on 26Feb2021. I was unknowingly exposed close contact on 26Feb2021. I tested positive on 03Mar2021. I am asymptomatic as of today. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Mom reported moderate edema, redness in right thigh morning after injection date, edema increased by 24hrs post injection to knee. No fever reported, child was fussy. Motrin was given by mom and ice applied. 7pm on Day 2 edema involved entire thigh to knee and surrounding knee with redness. 9:30pm Day 2 redness had begun to decrease edema the same mom was giving Benadryl. child up walking and playing. Day 3 only slightly swollen and no redness. Day 4 very little edema, no redness child functioning normally.
Arm was itchy; Arm was swollen; hit ulnar nerve; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm was itchy), SWELLING (Arm was swollen) and PERIPHERAL NERVE DECOMPRESSION (hit ulnar nerve) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included Graves' disease, Hypoglycaemia and Malabsorption. Concurrent medical conditions included Penicillin allergy, Drug allergy (patient is allergic to Imitrex,sulfa drug, codeine, digitalis, vitamin c tablet.), Food allergy (Patient is allergic to shell fish, honey.), Fruit allergy (everything with same Amino Acid as pineapple, tomato, orange, kiwi, avocado.), Allergy to chemicals and Allergy to insect sting (patient is allergic to bees, wasp.).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced PRURITUS (Arm was itchy), SWELLING (Arm was swollen) and PERIPHERAL NERVE DECOMPRESSION (hit ulnar nerve). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, PRURITUS (Arm was itchy), SWELLING (Arm was swollen) and PERIPHERAL NERVE DECOMPRESSION (hit ulnar nerve) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment included Bendryl and cortisone ointment.
*PLEASE NOTE: The second Pfizer dose was received on 1/29/2021, could only enter one date on the previous form.* Patient awoke with profound paralysis and drooping on right side of face. Could not close right eye. No pain, numbness, or tingling. Patient contacted a doctor approximately 36 hours after onset of symptoms. Diagnosis of Bell's palsy via video examination and interview. Will visit local physician tomorrow (4/27).
2JUN low grade fever, sore arm then fine until 10JUN; 10JUN t104, ear infection dx; started on Amoxicillin & Pediaprofin; 11JUNt103 sz; 12JUN t105; pt seen @ hosp ER;
Frequent numbing tingling down left arm to hand. Feels something like when a pressure cuff is applied
Genital area worse; Body aches; Chills; Heartbeat increases a little bit; Wasn't feeling well overall/uncomfortable; Genital area is inflamed; Genital area is very pink (penis, lower abdomen); Shortness of breath; Dry cough; A spontaneous report was received from a consumer concerning a 74 years old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath, dry cough, body aches(myalgia), chills, heartbeat increased a bit (heart rate increased), was not well overall, uncomfortable (malaise), genital area inflamed (genital tract inflammation), genital area is very pink (penis, lower abdomen) (genital discoloration) and genital area worse (Condition aggravated).   The patient's medical history included heart disorder. Products known to have been used by the patient, within two weeks prior to the event, included blood thinners, supplements and heart medication.  On 03 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number:028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 03 Feb 2021, the patient experienced shortness of breath and dry cough. On 28 Feb 2021, the patient experienced body aches, chills, heartbeat increased a bit, was not well overall, uncomfortable, genital area inflamed, genital area is very pink (penis, lower abdomen). On 01 Mar 2021, the patient experienced genital area worse.  Treatment for the event included acetaminophen.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events shortness of breath and dry cough, body aches, chills, heartbeat increased a bit, was not well overall, uncomfortable, genital area inflamed, genital area is very pink (penis, lower abdomen) and genital area worse were unknown.
Patient had unresponsive episode 10- 15 minutes after injection, lasted less than 5 minutes. No prior history of seizures, syncope episode occurred in local store.
Began to have numbness, tingling, and muscle weakness in various parts of my body.  I was diagnosed with Guillian-Barre Syndrome.  10/1/09 Medical records received DOS 9/22/09 to 9/30/09. Assessment: "watch Guillain Barre Syndrome". Patient c/o numbness (R) lateral leg and foot. Later (L) leg and foot. Soreness C7-T1. Weakness / Fatigue L3-L5, (R) Flx wrist.
Left deltoid redness/swelling, fatigue 2 days after PNEUMOVAX injection.
received an expired dose of Shingrix today; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number EH9Z7, expiry date 8th March 2021) for prophylaxis.   On 17th June 2021, the patient received the 2nd dose of Shingrix. On 17th June 2021, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient received expired dose of Shingrix, which led to expired vaccine used. The reporter consented to follow up.
Pt. received his first dose of the J&J COVID vaccine  after which he had a brief syncopal episode of ~1 min, witnessed. Patient admits that he did not eat anything today and only had a coffee for breakfast with cream and sugar. After giving him some water to drink and laying the patient down, and monitoring his vitals he improved almost immediately. I then instructed the patient to sit up and have some sips of juice. He admitted that he feels much better. We kept him in observation for an additional 20 mins, gave him anticipatory guidance and let him go.
pt recv vax 3JUN97 & 26JUN97 pt devel a rash that looked like chickenpox & consisted of less than 50 spots;