chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effect. Initial report received on 26 October 2006 from a health care professional. A 17 year old female patient, with no significant past medical history of obstetrician history, had received a .5mL left deltoid, intra-muscular injection of Adacel, lot number C2609AA, and a .5mL right deltoid, intra-muscular injection of Menactra, lot number U2150CA, on 26 October 2006. That afternoon, the patient found out that she was pregnancy with her first child. The date of her last menstrual period was on 15 September 2006. The expected date of delivery was not reported. For the reported, the patient has not experienced any adverse events since the administration of the Adacel and Menactra on 26/October/2006.
C/o injection reaction localized to injection site of recent covid vaccine.  Moderna covid vacc received 12/29/20 reaction began (8 days after injedtion) yesterday at injection site: itchy, hot, red, swelling, measures 11 1/2 x 7 1/2 cm on upper outer left arm. Patient reports she took benadryl with no relief; has been applying ice yesterday and during the day today.
No real adverse event. Vaccine was administered before receiving notification that the covid vaccines were no longer authorized.
swelling and redness in left arm at injection sire. Symptoms started on 01/20/2021
a patient was accidentally given only the liquid portion of Menveo and wished to know how to proceed; a patient was accidentally given only the liquid portion of Menveo and wished to know how to proceed; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA764A, expiry date 31-DEC-2023) for prophylaxis.   On an unknown date, the patient received the 1st dose of Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: a patient was accidentally given only the liquid portion of Menveo and wished to know how to proceed) and inappropriate dose of vaccine administered (Verbatim: a patient was accidentally given only the liquid portion of Menveo and wished to know how to proceed). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 31-May-2023 A physician wished to know how to proceed. Information about the event, vaccine and patient were disclosed. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient was accidentally given only the liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
This spontaneous report as received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. Since 04-AUG-2016, the patients were vaccinated with improperly stored doses of PROQUAD (lot # L044056, expiration date 02-MAY-2017 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 16.7 degrees Fahrenheit for 4 hours and 20 minutes. The previous excursion was of 26.2 degrees Fahrenheit during 14 hours. The cumulative excursion was of 26.2 degrees Fahrenheit for 18 hours and 20 minutes. Data logger was involved. This is one of two reports received from the same source. Additional information has been requested.
Information has been received from a pharmacist referring to 4 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time=822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 21-AUG-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Patient felt little ball in right upper arm after receiving last GARDASIL, ball persisted to grow and is tender. Patient was sent to hospital on 5-22-13. Patient advised hospital diagnosis is arm nodule inflammation. Patient was advised to use hot compression and follow up in a couple of days with doctor.
Received 2nd dose of Pfizer vaccine on 6/12/21. Intermittent headaches since that time. On morning of 6/14/21 developed chest pain (described as achy and in the center of the chest). Denies shortness of breath, radiation of pain, or fevers. 6/15/21-seen at Urgent Care , EKG completed and patient transferred to another hospital. From there he was transferred to one more hospital, given concern for myocarditis. Remains hospitalized as of 6/16/21
Afib; chest pains which kept him tossing and turning.; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Afib) and CHEST PAIN (chest pains which kept him tossing and turning.) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003AUA and 029L2CA) for COVID-19 vaccination.     The patient's past medical history included AFib.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, the patient experienced ATRIAL FIBRILLATION (Afib) (seriousness criteria hospitalization, medically significant and life threatening) and CHEST PAIN (chest pains which kept him tossing and turning.) (seriousness criteria hospitalization, medically significant and life threatening). The patient was hospitalized from 25-Oct-2021 to 26-Oct-2021 due to ATRIAL FIBRILLATION and CHEST PAIN. On 26-Oct-2021, ATRIAL FIBRILLATION (Afib) and CHEST PAIN (chest pains which kept him tossing and turning.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medication included IVs and patient cannot recall the names of any medications used in hospital.  Lab data include complete panel blood test and stress test with inconclusive result. Patient did not had any reactions to first and second dose. Also, patient has no previous diagnosis of covid.  Company comment; This case concerns a 73-year old, male subject with a medical history of atrial fibrillation, who experienced the serious unexpected events of Chest pain and Atrial fibrillation(AESI). The events, which resulted in hospitalization, occurred 2 days after the administration of a booster dose of mRNA-1273 vaccine. At the time of the report, outcome of the events was Recovered/Resolved. The rechallenge is not applicable as no additional dose is expected. The patient's age and medical history of atrial fibrillation remain as confounders. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 73-year old, male subject with a medical history of atrial fibrillation, who experienced the serious unexpected events of Chest pain and Atrial fibrillation(AESI). The events, which resulted in hospitalization, occurred 2 days after the administration of a booster dose of mRNA-1273 vaccine. At the time of the report, outcome of the events was Recovered/Resolved. The rechallenge is not applicable as no additional dose is expected. The patient's age and medical history of atrial fibrillation remain as confounders. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
My son received his second shot on June 26 10 AM, 8:45 AM the next morning fainted in his bedroom. Pediatrician recommended hospital visit. He was fine but dehydrated. Almost fainted a second time at the hospital. After IV fluids he was much better. Monitoring things now.
Patient experienced dizziness and wanting to faint.   Patient sat down for awhile.  Patient left the pharmacy on her own will.  Followed up with patient at 7:49 pm and patient stated she was fine.
Starting 07/08/2022, I started having a headache, sore throat and congestion. Shortly after, I tested myself with an at-home COVID-19 test which was positive. These would be the only symptoms I would experience this entire case. I called my doctor right after testing positive and he prescribed me PAXLOVID. That evening, I started taking it, and over the next 5 days the symptoms would gradually improve. By 07/14/2022, I was feeling better and I could go outside with a mask on. I tested myself with an at-home COVID-19 test and it was negative. On 07/16/2022, my throat started getting sore again followed by a headache and congestion. I took another COVID-19 test that day and it was positive. I called my doctor to let them know I was positive again and decided not to take any medicine this time. The symptoms were pretty much identical to the first episode and I decided to just ride it out. By 07/25/2022, I tested negative for COVID-19, and again on 07/27/2022 I tested negative. My symptoms lingered a little longer this time with a slight headache and slight sore throat off and on. The only symptom I have to date is intermittent phlegm in the throat but otherwise I am feeling fine.
if covid tested post vaccination Yes; if covid tested post vaccination Yes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 19Apr2021 as dose 1, single (Lot number: Ew0169), on 18Jun2021 as dose 2, single (Lot number: Ew0187), on 25Oct2021 as dose 3 (booster), single (Lot number: Fe3590) and on 23Jun2022 as dose 4 (booster), single (Lot number: FN2908) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol at that time only, minor other unrelated health concerns; "known allergies: New stings" (unspecified if ongoing), notes: known allergies: New stings. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "if covid tested post vaccination Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown result, notes: COVID test type post vaccination: Nasal Swab.  Clinical Information: if COVID prior vaccination was Yes. if COVID tested post vaccination was Yes. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
31JUL92 recvd Engerix-B & pt is not exhibiting any untoward effects following the administration of twice the recommended dose;
About 2 weeks after my first vaccine I started experiencing heart palpitations and tightness in my chest, it feels like hard to breath and like my airway is constricted and my heart beat is rapid and it sort of feels like an anxiety attack
Within 10 minutes of injection, patient became light headed and passed out. Approximately 20 minutes after injection nausea and vomiting began. Sent to ER due to persistence of feeling ill.
Employee was working with patient on 1/14/2021 who seroconverted to covid positive on 1/15/2021.  She was not aware and proceeded with covid vaccine #2 on 1/18/2021.  She developed typical low grade temp and flu like symptoms that resolved by 2/20/22.  She felt fine until the evening of 2/22 when she had low grade temps, worsening myalgais and chills as well as chest heaviness.  She tested positive by antigen test 0n 2/23.  She then tested negative by PCR on 1/26.  She was managed as covid positive. Reporting given she had completed her second covid 19 vaccine.
Individual pox-like sores randomly appeared with extreme itching and pain after zostrix injection (second one).
This spontaneous report as received from a LPN refers to multiple patients of unknown ages and gender. On an unknown dates the patients were vaccinated with VAQTA for prophylaxis or GARDASIL 9, or PNEUMOVAX 23. The nurse reported the patients had received the vaccines after they were stored improperly at 47F to 77F over 8 hours and 30 minutes and from 32F to 35F for 16 hours and 30 minutes. No previous excursions. No adverse events noted. Call was due to data logger.  Lot numbers were unknown. Additional information has been requested.
Fever, malaise, tired, no appetite, several blotch red spots, not itchy, largest red area is approximately equal to 5 inches in diameter; no itch, no SOB. Pt went to Dr 8-25 and Dr gave Rx for MEDROL dose pk and KEFLEX.
Breakthrough varicella diagnosed per office visit 11/20/06, Varivax given 10/05/2006.
This is in follow-up to report(s) previously submitted on 5/14/2000. Information has been received from a certified medical assistant concerning a 15 year old female patient with a sulfonamide allergy, who in June 2007, August 2007 and December 2007 was vaccinated intramuscularly with the first, second and third dose 0.5 ml doses of GARDASIL (Lot # first dose 0469U, second dose 0530U and third dose 0530U), respectively. On 29-SEP-2007, after her second dose of GARDASIL, she had an abnormal pap of atypical squamous cells. The patient went to the physicians office for a pap and follow up. She also had a colposcopy that identified HPV types: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68. At the time of this report the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. Follow up information received indicated that there was no adverse event. The patient's father thought that by getting the vaccine it would expose his daughter and therefore give a false positive. The certified medica assistant was just seeking additional information. No further information is available.
he had sort of pimples as if it were a rash; rash was in his left ear area only; he had pain, only at the area of his left ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 43 year-old male patient received bnt162b2 (BNT162B2), administration date 28May2021 (Batch/Lot number: unknown) at the age of 43 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid 19", start date: Jul2020 (unspecified if ongoing); "varicose vein" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ACNE (non-serious) with onset 2021, outcome "unknown", described as "he had sort of pimples as if it were a rash"; RASH (non-serious) with onset 2021, outcome "unknown", described as "rash was in his left ear area only"; EAR PAIN (non-serious) with onset 2021, outcome "unknown", described as "he had pain, only at the area of his left ear".  Additional information: Varicose veins were not swollen but they were visible on his legs behind the calves, to the side of the calf and on the sides of the leg. He had heard some vaccines had caused clots or things like that. He received his 1st dose on 28May2021, he then developed a rash that was causing him pain; the rash was in his left ear area only. A few days after bnt162b2 that, he had sort of pimples as if it were a rash. Because of the rash, he did not get the 2nd dose because they did not know if it was recommended after getting the rash. Agent states that she referred caller to speak with her husband's healthcare professional regarding the 2nd dose. When he was due the second dose, he did not receive it, he was told to come back at 8 weeks or her wife did not remember the exact date. . No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
approx 6:00pm, front of left leg from knee to ankle went numb. No pain , strange like it fell asleep.  After approx 24 hrs later started getting feeling back.  Today, 2/23 back to normal.
Stroke,3mm focu of ischemia, subacutet CVA in right frontal gyrus.     No obvious outward symptoms.
Had swelling of tongue and face, difficulty breathing. Was driven to the Emergency Room where she received epinephrine, Benadryl, and Solumedrol.
Fever; Chills; Muscle aches; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 07May2021 at 09:30 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. Medical history included known allergy to sulfa drugs since an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the arm left on 05Apr2021 at 12:15 (at the age of 30-years-old), as a single dose for COVID-19 immunisation. On 07May2021 at 21:00, the patient experienced fever, chills and muscle aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not 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, muscle aches, and fatigue was resolved on an unknown date in May2021.   No follow-up attempts are possible. No further information is expected.
Left shoulder (shot arm) inflammatory arthralgias/arthritis lasting several weeks requiring visit to Orthopedist, needed oral anti-inflammatory medications to subside.
No additional AE details provided; Improperly stored PROQUAD administered vaccine; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug allergies or reactions were not reported.   On 26-JUL-2021, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (strength, dose, route were not reported, lot # T029103, expiration date: 23-FEB-2022) for prophylaxis (product storage error).         It was reported that the suspect vaccine was exposed to a temperature of 9.6 degree Celsius for a time frame of 80 minutes. There were no previous temperature excursions. No additional adverse event (AE) information was provided.
STAFF CALLED PATIENT TO FIND OUT WHY SHE DIDN'T SHOW UP FOR HER APPOINTMENT AND SHE STATED THAT SHE HAD A REACTION THAT NIGHT. SHE STARTED WITH FEVER AND GENERAL MALAISE IN THE EVENING AND FAMILY TOOK HER TO THE HOSPITAL. SHE WAS RELEASED WITH DOXYCYCLINE FOR POTENTIAL INFECTION, BUT WOKE UP THE NEXT MORNING WITH A SWOLLEN FACE. FAMILY TOOK HER TO HER CANCER SPECIALIST AT MEDICAL CENTER ON 3/20/21 AND SHE WAS ADMITTED FOR 4 DAYS AND GIVEN STEROIDS. SHE STATES SHE IS FINE NOW. SPECIALIST ADVISED HER NOT TO GET THE 2ND DOSE.
Fever 101-102. Soreness in arm and shoulder. Ache all over - headache - weakness and dizzy - arm red at site of injection lasted abt 4 days took MOTRIN
High-pitched screaming for 2 solid hrs p/immun; stopped for approx 40 minutes while pt slept; began again & cont for 3 more hrs; MD called twice during this period of time; MD office phoned clinic;
Severe headache, blood pressure approx. 200/150, fast heart rate - 118, temperature of 103.4, delirium
"I was affected by Bells Palsy on Sunday 05/30/21. I had to go to the emergency room. Its been a week now and there is no improvement in my face"; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the second dose of bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection, Batch/Lot Number: EW0170), via an unspecified route of administration, administered in left arm on 18May2021 at 14:30 (at the age of 34-year-old) as a single dose for Covid-19 immunisation at other facility. The patient medical history included unspecified allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection, Batch/Lot Number: EW0173) via an unspecified route of administration, administered in left arm on 27Apr2021 at 15:30 (at the age of 34-year-old) as a single dose for covid-19 immunisation at other facility. The patient previously took ibuprofen and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 30May2021 at 18:30, the patient experienced Bells palsy which resulted in emergency room. It's been a week and there was no improvement in her face. Patient received steroids and antiviral medication as a treatment for the events. The reporter assessed the event as non serious. The outcome of the event was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Pt was vaccinated and released after 15 minutes. While walking out, she began to feel numbness in her R hand. No other symptoms reported.  Pt reports that she fell 2 days ago, striking her R elbow and still has abrasion. Cap refill, sensation, and strength are intact and equal bilaterally. VSs normal. Pt released home, recommend follow up with PCP.
Rhabdomyolysis --> Renal Failure --> Dialysis. CPK >500,000. Fever 99.5 to 102. AST 2918.10/23/2009 hospital records for 10/2-10/9/2009 with Neuro and GI consults. Patient presented with c/o's rt hand numbness/tingling, poor grip strength and speech impairment. Patient found to have elevated LDH, LFT's and CPK, UA + for UTI. Tx: Dialysis, IV ABX . DC Dx Renal failure, Rhabdomyolysis ? etiology
Patient reports he developed new onset high-pitch tinnitus 3 days after receiving 2nd dose of Pfizer and xanthomatous skin lesions after 1 week.
A red rash surrounds injection site, it's hot to the touch and slightly itchy. It hasn't changed in 24 hours.
This spontaneous case was received from a physician regarding a patient of unknown age and gender, with no historical conditions, concurrent conditions, or concomitant medications provided. On 30-JAN-2018, the patient received an expired dose of PNEUMOVAX, intramuscular, lot: M026317, expiration date: 11-JAN-2018, for prophylaxis purposes. There were no known adverse effects after the vaccination with the expired dose of PNEUMOVAX.
pt recv vax 18OCT95 & 21FEB96 pt exp varicella-like lesions (8 lesions on head, neck, extremities, trunk) which were consistent w/chicken pox, only smaller;No further details were provided;
Rash on upper front of trunk, shoulder to shoulder. Red, papules and a few pustules, 1-3mm diameter, no itching. No fever. No dyspnea. No redness/warmth at injection site.