chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 72-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included lidocaine (Lidocaine Cream). On 12th May 2018, the patient received the 1st dose of SHINGRIX. On 12th August 2018, 92 days after receiving SHINGRIX, the patient experienced shingles, rash, pain and pruritus. On an unknown date, the outcome of the shingles, pain and pruritus were not recovered/not resolved and the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the shingles, rash, pain and pruritus to be related to SHINGRIX. Additional details were reported as follows: The patient experienced shingles rash on her right ear, neck, and scalp.  The patient missed her second dose because of the shingles, and was currently past the 6 month period. The patient planned to continue follow up with her physician on an unknown date. The reporter consented to follow up.
Fever 99.9; body aches; Injection site tenderness, swelling, redness x 10 days; Injection site tenderness, swelling, redness x 10 days; Injection site tenderness, swelling, redness x 10 days; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via an unspecified route of administration at left arm, on 22Dec2020 10:15 at single dose for covid-19 immunisation. Medical history included having COVID prior vaccination. Patient has no known allergies. Patient is not pregnant. Concomitant medications included cetirizine hydrochloride (ZYRTEC), vitamins nos (MULTIVITAMIN). Patient did not receive other vaccine in four weeks. Patient experienced fever 99.9, body aches, Injection site tenderness, swelling, redness x 10 days, all on 23Dec2020 08:00. No treatment received for events. Patient did not test COVID post vaccination. Outcome of the events was recovered.
Patient reports feeling lightheaded and dizzy gradually came on evening after receiving flu vaccine. Continued several days off an on  worsened  with exertion.  Lasted about one week after vaccinations. Symptoms since resolved.
after receiving the flu immunization, the patient fainted for approx. 5 seconds while she was sitting in the chair.  Patient came to it and said she doesn't remember what happened.  Mom stated that she does get nervous with vaccinations and has a history of getting queasy.  It was also reported by Mom that there is a family history of fainting.  Mom had denied emergency services.  Blood pressure was taken 100/65.  Patient was given water to drink and a snack.  Mom was advised to report this incident to the pediatrician and to call emergency servies if needed.
Rapid heartbeat; Humming feeling throughout the body; Weakness; Severe chills; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events severe chills, humming feeling throughout the body, weakenss, rapid heartbeat.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 028L20A) Intramuscularly in right armor prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced the events severe chills, humming feeling throughout the body, weakenss, rapid heartbeat.She has reached out to few of her MD and they have advised her to wait and monitor the side effects.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, severe chills, humming feeling throughout the body, weakenss, rapid heartbeat were unknown.
Patient present via ambulance for allergic reaction. Symptoms included: tingling, voice hoarseness, difficulty swallowing, nausea, and weakness.  Patient recieved vaccine at 13:30 arrive at ED at 16:01. Patient received IV methylprednisolone, Benadryl and Pepcid. Patient was discharged with Epi Pen and prednisone prescriptions.  ED provider noted, no rash or visible swelling.
Woke up about 5 am the next day, her entire left arm was in excruciating pain and swollen.
developed itchy red rash near injection site and also sporadically on the rest of body. no other symptoms, no airway involvement. pt started on steroid 1/8/22 for possible allergic reaction and recommended to take antihistamines
ADMINISTRATION OF EXPIRED VACCINE; INCORRECT STORAGE OF DRUG; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820096, and expiry: 06-SEP-2021) dose was not reported, administered on 24-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-JUL-2021, the subject experienced administration of expired vaccine. On 24-JUL-2021, the subject experienced incorrect storage of drug. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine and incorrect storage of drug was not reported. This report was non-serious.
SKIN PEELING BETWEEN INSIDES OF FINGERS OF RIGHT HAND; HEADACHES; NAUSEA; BLURRY VISION; SORENESS OF KIDNEY/LOWER BACK AREA; MASSIVE BODY ACHES; DIZZINESS UPON STANDING (HYPOTENSION); CHEST TIGHTNESS; FOGGINESS; FATIGUE; This spontaneous report received from a patient concerned a 35 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included no known drug allergies and no drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, Laboratory data included: Pain scale (NR: not provided) 5-6 out of 10. On 09-APR-2021, the subject experienced fogginess. On 09-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced blurry vision. On 10-APR-2021, the subject experienced soreness of kidney/lower back area. On 10-APR-2021, the subject experienced massive body aches. On 10-APR-2021, the subject experienced dizziness upon standing (hypotension). On 10-APR-2021, the subject experienced chest tightness. On 10-APR-2021, the subject experienced headaches. On 10-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced skin peeling between insides of fingers of right hand. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fogginess, blurry vision, fatigue, massive body aches, dizziness upon standing (hypotension), headaches, nausea, chest tightness, skin peeling between insides of fingers of right hand, and soreness of kidney/lower back area. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Temp 100 f. for 24 Hours. Muscle ache. Joint pain. Sweats all night.
Myalgia, Fever, chills Narrative: Delayed second dose due to COVID-19 positive and was in isolation until 1/26 (dose was due 1/20)
Pt was only 13, not eligible for Moderna. Monitored and no other adverse outcome noted thus far. Reported as a med error through internal event reporting.
Hyperesthesia affecting left side of the body from shoulder to ankle. Started a few hours after injection along with chills and malaise. The hyperesthesia has persisted along with headaches.
R DELTOID + REDNESS, SWELLING, WARMTH, AND PAIN AT SITE OF INJECTION.
Small amount of noticeable hives to left upper/mid arm,  per patient arm was painful and warm to the touch starting 5/4/2022.  Arm today 5/5 still painful, no noted swelling or warmth.
Pt. states that after receiving the 3rd Booster of Moderna 11/22/2021, started experiencing symptoms that evening of fatigue, headache, chills, fever, and muscle aches lasting 24hrs (resulting in Fever-Blisters in and around the mouth). Primary communications recommendation to Report. Still experiencing fatigue and fever-blisters.
Patient received COVID booster shot on 11/9/2021. Within 24 hours patient's left arm became erythematous, warm, swollen, painful. Attending M.D. was notified and ordered course of doxycycline. No other reaction noted until the week beginning on 11/15/2021 the patient began having low grade fevers and was more subdued, quieter. The patient became more lethargic by 11/17/2021 and PO intake declined as a result. Attending M.D. ordered CBC, CMP, blood cultures and urine analysis with C+S on 11/17/21.    Labs did not have significant findings. The patient continued to be extremely lethargic, very minimal PO intake, having fevers, tachycardia. Patient deceased on 11/20/2021.
Systemic: Fainting / Unresponsive-Severe, Systemic: Seizure-Severe, Additional Details: Pt seized for about 3 minutes after administration of vaccination. No history of seizures. EMS called.
She developed a rash on or near the injection site roughly 7 days after the vaccination was given. The patient states that it itches and is hot to the touch. She also complained of tightness in her throat, like she had a lump in her throat.
experienced chills for 3 hours,  roughly 8 1/2 hours after receiving vaccine
Left upper thigh, 3cm x 2cm erythremic nodule with several small raised vesicles.
pt recv vax 21APR98 & c/o pain & unable to move lt arm;no heat;redness noted-muscle, tender;can move arm still hurts-red raised places on side of arm;can feel heat from them;no places @ site of inj;
10/15/19:Within 6 hours of receiving the vaccination he didn't want to put any pressure on that leg, walk, etc. By the next morning, the right thigh was swollen 2-3x normal size/left thigh. Still not wanting to walk or put pressure on it. Injection site was red and hot to the touch as well as very sore.
5/17/21 Pt presented to an urgent care with a one week history of URI symptoms including scratchy sore throat, cough, and congestion. Over that week she develops some chest tightness and wheezing. Because she was fully vaccinated and denied any ill exposures she was not tested for SARS-CoV-2. She was given a Zpack and a Medrol dosepak.  On 5/28 she returned to the urgent care because she was not feeling better. She was transferred to the ED and was admitted overnight. Patient is a 53 y.o. female patient of MD with history of asthma, factor V Leiden, and hypertension, now presented with COVID-19 pneumonia. Patient is a 53 y.o. female patient of MD with history of asthma, factor V Leiden, and hypertension, now presented with COVID-19 pneumonia. Patient is a 53 y.o. female patient of MD with history of asthma, factor V Leiden, and hypertension, now presented with COVID-19 pneumonia.   Pneumonia secondary to COVID-19 Of note, patient was fully vaccinated against COVID-19 in January with the Moderna vaccine.   Question is whether her current viral infection represents a true COVID-19 infection, or if she is an incidental carrier of COVID-19 with a separate viral infection. Maintained O2 saturations on room air therefore remdesivir was held.  Steroids were initiated as part of asthma exacerbation treatment States she is able to quarantine at home. Has a camper she can stay in.  Request to be re-tested - "I think its a false positive"  ADD: second COVID-19 test is negative. Call by infection control nursing staff that her isolation may be discontinued.  Patient did ask for a 3rd COVID test. Infection control states they have been in contact with ID and that any further testing should be completed by infectious disease. Called by nursing staff that patient does not want any further testing at this time and request discharge home.  Rx given course of steroids. She is to follow up with her PCP.    Asthma with acute exacerbation  Cough/deep breathing exercises.  Incentive spirometry.  Nebulized breathing treatments, scheduled.  Steroids.
pharmacist accidentally gave a 63 year old patient, 0.7 ml dose of Fluzone High Dose Quadrivalent, no AE; pharmacist accidentally gave a 63 year old patient, 0.7 ml dose of Fluzone High Dose Quadrivalent, no AE; Initial information was received on 01-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist via phone.  This case involves a 63 year old female patient who was vaccinated with a 0.7 ml dose of vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Prefilled syringe, lot number UJ450AA and expiration date 30-Jun-2021) via an intramuscular route in the upper arm on 01-Sep-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient did not receive any other vaccine concomitantly.    It was an actual medication error case due to inappropriate age at vaccine administration and overdose (latency was same day).  At the time of reporting, the patient had no adverse 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 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.
Fever; Chills; Sore throat; Headache; Body ache; Stomach ache; This is a spontaneous report from a contactable consumer, the patient, A 41-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Apr2021 at 06:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Mar2021 at 11:00 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. On 16Apr2021 at 15:00, the patient experienced fever, chills, sore throat, headache, body ache and stomach ache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, sore throat, headache, body ache and stomach ache was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient received the Moderna vaccine but he is below age 18 as outlined by the EUA for Moderna.
Coughing, mild wheezing, racing HR. Dr. evaluated. Pt sent to Emergency, no medicinal intervention required as symptoms started to resolve once arrived at ED.
OB patient (13 week gestation, EDC 6/3/2023) due for 2nd Covid shot.  First shot Monovalent was given  11/2/22.  Was inadvertently given Bivalent 0.5ml today.
Patients card stated she had pfizer 9/12/22. Staff administer bivalent and then discovered that the pfizer dose on the card was also a bivalent dose even though it wasnt indicated.
Child was given accidentally an expired dose of Kinrix. When I verified the expiration date I read it was July 4th instead of June 4th. Did not notice until after given that was expired. Mother was advised of the incident by nurse manager. Mother understood and all questions were answered. Per CDC guidelines, vaccine could have been re-administered today, but mother declined and will come back to receive vaccine. Vaccine records were printed and provided to mother with the vaccine highlighted so mother knew which vaccine needed to be repeated.
10 to 12 red papules. Red base withe yelllowish vesicles. Rash noticed 48 hours ago. Mom was using cortisone cream. Per Drs order patient was to avoid contact with others until blisters are gone or scabbed.
Patient's husband now has covid 18 also and was also fully vaccinated; Patient's husband now has covid 18 also and was also fully vaccinated; This is a spontaneous report from a non-contactable consumer (patient's wife) via a sales representative. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient now has "COVID 18" also and was also fully vaccinated. The patient underwent lab tests and procedures which included COVID: positive. 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101302275 Same reporter/drug, different patients
Pt received Moderna bivalent formulation was administered with a lower dose than recommended. Appt has been scheduled for pt to revaccinate.
This case was reported by a consumer via call center representative and described the occurrence of numbness in a adult patient who received SHINGRIX for prophylaxis. On 28th December 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced numbness, tingling, difficulty breathing, sleepiness and tiredness. On an unknown date, the outcome of the numbness, tingling, difficulty breathing, sleepiness and tiredness were unknown. It was unknown if the reporter considered the numbness, tingling, difficulty breathing, sleepiness and tiredness to be related to SHINGRIX. Additional case details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX and experienced severe reaction numbness in hands and feet, tingling in head, severe breathing issues, tired to the point of falling asleep in the car. The patient has been given the consent for follow up.
@ approx 25mins p/vax w/urticaria, generalized no angioedema; no respiratory distress; DPH given
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 30-JUN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a healthcare worker and a licensed nurse practitioner refers to a patient of unspecified age and gender. On 23-AUG-2013, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # H018786, exp date: 15-OCT-2014, 0.5 milliliter (ml), subcutaneous) (strength and indication not reported). The (Oka/Merck) VARIVAX had been stored at -10 C (celsius) (above recommended temperature range in product information) since July 2013. No adverse effects reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
started with mild headache and feeling tired after about 5 days, then it progressively got worse extremely tired and sleepy, headache over week, also develop diahrrea, today is almost 3 weeks, she still have mild headache and feel tired and headache, she sounds still lethargic, tired,  on phone call , so i asked her any shortness of breath, she said no. however, i advised her to go see her primary doctor dr. for complete check up . I called doctor office for her, they were closed, so advised patient to call them first thing in morning tomorrow.
Bump on L leg since receiving vaccinations at 15 months. Bump initially was red; then redness resolved, but firm mass remained under the skin. Mom state that lesion has had redness/swelling at intervals since July. Redness/swelling will only last for a small period of time/then resolves. Today mom got a call from daycare saying that he had had a bug bite and site was red/warm to touch and with a white spot on the center of the lesion. Mom says when she saw lesion at school today, it was "pulsing". Patient seems to have no pain on palpation of mass.There is only minimal redness on skin at present. 0.6 cm nodule/mass palpated under skin on L lateral thigh about 1.5 inches above knee. Minimal erythema on lesion. Very light blue color under skin.
FEVER; EXTRA FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: sjogrens, and vaccine allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced fever, and extra fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and extra fatigue. This report was non-serious.
I had recovered about 90% (with medication) since having COVID in December when I received my first dose of the COVID vaccine. Thirteen days after the vaccine I began to experience symptoms like when I had COVID. On day 13 I started to itch and my BP dropped and I became light headed. My vision started to go and I had a hard time breathing and forming words for my husband to help me with some water. This lasted about 20 min.    Since then I have been having heart rate increases up into the 150s with minimal effort. Bending like doing dishes or putting away groceries makes me extremely light headed. I have become so tired just folding a little bit of laundry. It wasn?t until a few weeks in that I noticed this was all exactly like when I had COVID. Including being okay in the morning but having so many issues by the evening. So weird.   I?m 3 weeks and 4 days past my second shot and finally starting to have some better days again but no day has been symptom free. I wish could know if this is happening to other long haulers and that it will most likely resolve, I have been starting to wonder about disability and really having a hard time facing the fact that I no longer can complete simple house hold chores like I used to.
Within 24 hours, temp rose to 102.3, extreme musculoskeletal pain, elevated blood glucose levels (350+) with correction doses of novolog not really helping