chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse effects were reported; improperly stored vaccine administered; This spontaneous report was received from a physician regarding a patient of an unknown age and gender. The patient's pertinent medical history, drug reaction and drug allergies were unknown. The patient's concomitant therapies included sterile diluent. On 19-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R027993 and expiry date: 01-OCT-2020 (strength, dose, frequency, route not reported) for prophylaxis (product storage error). The vaccine underwent temperature excursion of 15 degree Fahrenheit (F) to 46 degree Fahrenheit (23F) for 3 hours. There was no previous temperature excursion involved. The call was due to digital data logger. No adverse effects reported (no adverse event). Product quality complaint was not involved.  This is one of several reports received from the same reporter.
dose that was given only contained the liquid vaccine component without the lyophilized vaccine component, with no reported adverse event; Initial information was received on 06-Jun-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 6 months old and unknown gender patient who experienced dose that was given only contained the liquid vaccine component without the lyophilized vaccine component, with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/IPV(vero)/HIB(PRP/T) vaccine [Pentacel (vero)].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 05-Jun-2023, the patient received 0.5 ml once dose 3 of suspect diphtheria/tetanus/5 hybrid ac pertussis/IPV(vero)/HIB(PRP/T) vaccine (lot number: UJ840AA, expiration date: 16-Feb-2024) via intramuscular route in the right thigh for Immunization (immunisation).  On 05-Jun-2023 the patient developed a non-serious event of "dose that was given only contained the liquid vaccine component without the lyophilized vaccine component, with no reported adverse event" (product preparation error) (unknown latency) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/IPV(VERO)/HIB(PRP/T) vaccine.  It was reported "about a PENTACEL that was administered by a nurse to a pediatric patient. The dose that was given only contained the liquid vaccine component (DTAP-IPV component) without the lyophilized vaccine component. She also wanted to know what to do next. Gender was unable to report during the call."  No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event dose that was given only contained the liquid vaccine component without the lyophilized vaccine component, with no reported 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 the guidelines. 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.
Chills After First Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills After First Vaccine) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced CHILLS (Chills After First Vaccine). In March 2021, CHILLS (Chills After First Vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-085551 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow-up information on received on 24 May 2021 and does not contain any new information.
Patient reports that she received influenza and pneumococcal vaccine around 9 am on 12/1/2020 and approximately one hour later, started developing pain in the left arm where the 2 vaccines had been given.  She presented to urgent care on 12/2/2020 with pain 10/10 , "patchy erythematous plaque-like rash over the lateral mid to distal deltoid area of the left arm. . No central clearing or central pallor. No papules, vesicles, or other skin lesion changes. Allodynia tenderness palpation." per provider  She was to continue to take acetaminophen and ibuprofen and start cetirizine.  Later on 12/2/2020, she presented to the emergency room with a fever Temperature maximum of 102, dysuria, tachycardia and leukocytosis. COVID-19 and influenza tests were negative. Per provider, the urinalysis was negative for infection and she was negative for sepsis and meningitis. At that time, the provider reported that there was some firmness and erythema on her left upper arm consistent with cellulitis. She was given fluids, pain medications and cephalexin. On 12/7/2020, she presented with increased edema since 12/2/2020.  She had taken 5 days of cephalexin and she chose to continue to take the cephalexin versus changing to another antibiotic at that time. On 12/10/2020, significant improvement noted by provider, with only tenderness to the area. Patient to continue to take cephalexin.
2 inch knot on right arm, red, hot to touch and rash around area less than 24 hours after.  Tylenol, antihistamine, ice to area.
Shoulder Injury Related to Vaccine Administration: I received a flue shot on 10/7/20. since then, I've had constant pain in my left arm near the injection site. I was hoping it would subside, but it's gotten worse. In December, it's hard to move my left arm to do daily tasks and I have sharp pain when I move my left arm. I had an exam on 12/18/20 by my primary care doctor, Dr. at the  Medical Plaza. She told me that I got frozen shoulder from flu shot. She referred me to have an MRI and physical therapy. I made appointments as soon as possible, but my first appointment with physical therapy is made 1/8/21, and I am still waiting for insurance authorization for MRI. In mean while, my left arm condition is getting worse daily.
Initial report received from a healthcare professional on 08 April 2014: A female patient (date of birth and age at the time of event was not reported) whose medical history and concomitant medications were unknown had received a dose of FLUZONE HD vaccine (lot number, dose number, route and anatomical site of administration were not reported) on an unspecified date. On an unspecified date, the patient developed rash on arms and trunk. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome was unknown. The patient required ER/doctor visit. Documents held by sender: none.
Woke up with shoulder pain the next day.  Pain has now persisted for 6 weeks.  In the last week has slowly migrated into chest and neck. No shortness of breath or any other symptoms. Somewhat relieved by ibuprofen.  Ongoing
Began having a headache on 10/17/19. Was given Tylenol but continued to get worse. Was taken to emergency room on 10/20/19 with pain in top of head down to forehead and was given Tylenol 3 for pain and referred to PCP. Saw PCP on 10/22/19 they said to continue to rotate the Tylenol with ibuprofen it it worsens call back. Still having pain in the top of his head and down into his forehead. Nothing seems to take the pain away.
He got his vaccine, didn't notice anything, didn't get sick or sore.  Then on 1/15/22 in the middle of the day he had an episode that he could not breath.  He got himself ready to go to the ER on his  own and had to take a bath and has problems with his leg and has to hang his leg out, and when he got out of the tub he had difficulty breathing.  He called his son who called his nephew across the road, and tried to calm him down.  He went by ambulance to the ER and they said that his oxygen was pretty good, but he was smothering from fluid on his lungs.  He was intubated and sedated him, and was then transferred to Hospital.  He was there for a week.  He was at Hospital and said that his lungs were filled with fluid and was transferred later to hospital.    Since being discharged he has been recovering.  He now has no energy and his legs will not carry him, cannot walk from tree to tree.  He has chairs everywhere where he can move from one to another.  He states he used to be healthy and strong, but not anymore.  He has been put on two more blood pressure pills since being in the hospital, Copidogrel 85 mg, Losartan 50 mg twice a day, and a diuretic Furosemide 20 mg, and also takes Famotidine.    His regular cardiologist told him that it was from the vaccine itself.
10mins post vaccination, pt c/o Flushing/sweating, dizzines, HA.  Pt was clammy to touch.  Pt was moved to the observation room to lay down.   Vitals: @17:19 BP 167/110, HR 73, RR 16, O2 Sat 100%  -- > @17:24 165/108, 71, 16, 99% -- > @17:30 158/106, 72, 98% -- > @17:37 156/104, 71, 15, 100% @17:19 Pt reports no more nausea/dizziness.  Given water.  Pt declined juice. @17:37 Pt states she is feeling better @17:40 Adverse symptoms resolved.  Pt reports improvements in dizziness, nausea and HA.  Denies other symptoms.  Educated to f/u w/ her PCP regarding her elevated BP.  Pt stable and released from the vaccination site.
My jaw, cheeks and wrists went  numb. It lasted around 30-40 minutes and then went away.
after receiving this vaccine she had redness, slight fever, and a stiffness in the arm that radiated to her neck as well. she has had flu shots before, but never has she experienced this. this started day of administration and lasted for 3 days.
Pt complained of numbness to left side of face and left jaw 30 minutes after getting the vaccine. Stated the same event happened to him after getting previous doses of Pfizer mRNA COVID -19 vaccine. Vital signs taken are as follows: BP 134/85 HR 81 SPO2 97%. Pt was seen and evaluated by Public Health provider. Pt was advised to wait additional 30 minutes after presentation of symptoms.
Sore throat; Headache; Left arm pain; This is a spontaneous report from a contactable nurse.  A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular on the left arm on 22Dec2020 18:15 at single dose for COVID-19 immunisation.  Medical history included she was COVID positive a few months ago.  There were no concomitant medications.  The patient previously got flu vaccine in Oct2020 for immunisation.  The patient experienced sore throat and headache on 23Dec2020 and left arm pain on 22Dec2020. The outcome of sore throat and headache were recovering and left arm pain was not recovered.
Given 1.5 ml of H1N1 inactivated flu vaccine instead of 0.5 ml. No adverse reaction. No complaints from patient. Observed for 45 minutes. Vital signs stable.
titanium parts - right hip, fusion site to lumbar/sacral spine and cardiac stents became extremely pain-filled; I could not function, sleep, sit without major discomfort; I could not function, sleep, sit without major discomfort; Got booster on 19Nov2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: Quick background - had Covid twice before Jan2021. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Received vaccine in Feb2021. 1st injection - mild reaction, 2nd injection put me down for about 36 hours), administration date: Feb2021, for COVID-19 immunization, reaction(s): "mild reaction", "put me down for about 36 hours".The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "Got booster on 19Nov2021"; PAIN (non-serious), outcome "unknown", described as "titanium parts - right hip, fusion site to lumbar/sacral spine and cardiac stents became extremely pain-filled"; SLEEP DISORDER (non-serious), DISCOMFORT (non-serious), outcome "unknown" and all described as "I could not function, sleep, sit without major discomfort". The lot number for bnt162b2 was not provided and will be requested during follow up.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Apr2023 as dose 3 (booster), single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 20Jul2023 to 25Jul2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
client "sick all day', had emesis X 2 swollen area @ injection site, did not apply ice, On 11-5-01, no fever, but still swollen arm, was advised to see MD if not better
Pneumococcal vaccine was administered to right deltoid 0.5ml on 06/16/2005.  At that visit patient had temperature of 98.0, pulse 60, blood pressure 152/58.  On 06/17/2005, patient presented with temperature 99.1, complaint of right arm swelling and pain night of 06/16/2005, in area of right biceps, which began on 06/16/2005, at sometime after injection.  Diagnosis of acute cellulitis of right arm made, patient was sent to ER where she was given prescription for Keflex, by mouth, with resolution.
developed a red rash; itchiness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A 75-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose number unknown, single), for COVID-19 Immunization; Covid-19 vaccine (DOSE NUMBER UNKOWN; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: RASH ERYTHEMATOUS (non-serious), outcome "unknown", described as "developed a red rash"; PRURITUS (non-serious), outcome "unknown", described as "itchiness".  Additional information: Patient was calling about the new Bivalent booster, Pfizer covid 19. Caller stated that the last time she got the Pfizer injection, she was fine, but she have developed this rash since that. Patient stated that the only sulfate contact she has had has been direct contact with the skin, never had a sulfate injection. Patient wanted to know if the new Pfizer vaccine have any sulfates.    The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
I haven't had a period in  at least 6 months and suddenly got one after getting the second dose. I also had heavy cramping after the first dose
pt recv vax 28DEC95 & 4JAN96 pt exp a large round sore on neck which resolved spontaneously;12JAN96 pt exp a rash all over back, chest, arms, & neck consisting of small, red, raised sores;pt seen by dermatologist who dx pityriasis rosea;
This spontaneous report as received from a nurse refers to a 13 year old patient of unknown gender. On 26-FEB-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
no AE; pneumonia vaccine and shingles vaccine administered on the same day; This spontaneous report as received from a lawyer refers to a 65-year-old female patient. The patient smoked cigarettes. Her concurrent conditions included pain, hot flush, high cholesterol, and fibromyalgia. The patient's medical history included shingles, pneumonia, varicella type rash, herpes zoster ophthalmicus, post herpetic neuralgia, hypertension, headache, stomach disorder, chickenpox, traumatic brain injury, depression and anxiety. Her concomitant therapies included influenza virus vaccine (unspecified) (manufacturer unknown), sumatriptan (IMITREX), duloxetine hydrochloride (CYMBALTA), estradiol acetate (FEMRING) and tramadol hydrochloride (ULTRAM).  On 28-OCT-2019, the patient was vaccinated with zoster vaccine live (manufacturer unknown) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On the same day, she was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis (contraindicated product administered). There was no adverse event reported.  This is one of two cases concerning the same patient (case in litigation, # 1811USA008725).; Sender's Comments:  US-009507513-1811USA008725:
LARGE AREAS OF RED BLISTERS ON BACK OF THIGH ON ONE LEG.  VERY ITCHY, WARM TO TOUCH, PAINFULL..  ALSO HAD FEVER, HEADACHE AND MUSCLE ACHES
vaccine was given on friday, felt weak over weekend went to Doctor on Monday and diagnosed with double pneumonia and sent straight to hospital and passed away within 4 days
ADMINISTRAION OF EXPIRED VACCINE TO AT LEAST MINIMUM 20 PATIENTS; This spontaneous report received from a health care professional concerned multiple patients. 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: 205A21A, expiry: 21-SEP-2021) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 22-SEP-2021, the patient experienced administraion of expired vaccine to at least minimum 20 subjects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administraion of expired vaccine to at least minimum 20 patients was not reported. This report was non-serious.
03/27/2021 afternoon- Diarrhea, body aches (worse on the pt's back), and fatigue- Still occurring
Patient received dose #3 (0.5ml), but should have received booster (0.25ml). Patient's 2nd dose was not in the local vaccine registry (ShowMeVax). Patient had two vaccine cards, one showing second dose and the other did not.
Redness/size of quarter and now it is size of hand; Hot and warm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness/size of quarter and now it is size of hand) and FEELING HOT (Hot and warm) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced ERYTHEMA (Redness/size of quarter and now it is size of hand) and FEELING HOT (Hot and warm). At the time of the report, ERYTHEMA (Redness/size of quarter and now it is size of hand) and FEELING HOT (Hot and warm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
05-19-17 immunization. 05-21-17 call a nurse - patient contact. 05-22-17 called off, made same day appt. 05-22-17 Dr saw patient.
mild injection site soreness; This is a spontaneous report from a contactable nurse received via a Pfizer sales representative.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced mild injection site soreness on Dec2020. The patient outcome of the event was unknown.  Information about Lot/Batch number has been requested.
blood pressure was high; Kidney function was poor; intense back pain; Pain in back causing loss of sleep; getting the flu; Initial information received on 11-Dec-2019 regarding an unsolicited valid serious case received from a consumer.  This case involves a 73 years old male patient who experienced getting the flu (influenza), his blood pressure was high (blood pressure increased), kidney function was poor (renal impairment) and intense back pain (back pain), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a serious getting the flu (influenza), blood pressure was high (blood pressure increased), intense back pain (back pain) and pain in back causing loss of sleep (insomnia) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. The patient was hospitalized for this event.  On an unknown date, the patient developed a serious kidney function was poor (renal impairment) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event.  Other relevant tests were not reported.  Final diagnosis was intense back pain, kidney function was poor, blood pressure was high and getting the flu.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown.  Information on the batch number was requested.; Sender's Comments: This case concerns an 73 years old male patient who presented with possible influenza, blood pressure increased, renal impairment and back pain after vaccination with FLUZONE HIGH DOSE. The time to onset is unknown. There is, however, no information regarding patient's condition at time of vaccination and lab tests do not rule out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
12/8/2009: patient given Flumist H1N1 vaccine at approximately 10 am.  Later that evening complained of sore throat. 12/9/2009: throat worse per patient and family, had a fever (100.5 - 102.8 at home) and over the course of the day had respiratory distress (retractions, not moving air, no cough present) and still sore throat (respiratory distress started at ~11 am).  Tried steam which didn't help and by 8 pm went to ED due to increasing respiratory distress.