chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt said that sometimes he faints after vaccine. He was instructed to wait an extra 15 min in addition to the already 15 min required. After about 5 min he felt sick. We gave him water and asked if he would like us to call 911. He declined. He was given water multiple times and his blood pressure was taken twice and came amount normal. Pt was still feeling sick after some time so we called 911 and ems arrived. He was alert and talking on his phone the entire time.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Weakness-Mild, Additional Details: Patirnt left the vacination roon and went to the recovery area and appear weak and trip and his mom caught him and the store manager called 911. when 911 came on the phone mom said her son is fine and he just get supper excited with vaccines and she told 911 her son did not need to go to the hospital. The mom got the same vaccine and no reaction. Pharmacist advice mom not to give patient anything to eat nor drink and pt was observed to be fine upon leaving the pharmacy.
Severe migraine lasting more than 48 hours, swelling severe pain and itching at the injection site.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" (Sep2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Sep2023) Negative, notes: Had 2 negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid (Lot number: GJ5741) from 18Sep2023 to 23Sep2023 for treatment of COVID-19.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300312929 Same reporter/patient, different drug/event.;
Dermatomyositis triggered by the flu shot. CPK's in 2-9K range treated with steroids.
lowest temperature reached 30.63 Fahrenheit  (F)  and the total excursion lasted 1 hour and 15 minutes with no reported  adverse event; Menactra was administered post excursion with no reported  adverse event on 14-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old male patient and it was reported that temperature reached 30.63 Fahrenheit (F)  and the total excursion lasted 1 hour and 15 minutes with no reported  adverse event and Menactra was administered post excursion with no reported  adverse event , for  vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [Menactra].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 13-Jun-2022, the patient received a  0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, once ( lot: U7211AA ; expiry date: 14-Mar-2023)  via intramuscular route in the left deltoid for immunization  On 13-Jun-2022 the lowest temperature reached 30.63 Fahrenheit (F)  and the total excursion lasted 1 hour and 15 minutes (product storage error) (latency: same day) for vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE ( Menactra) . And then on the same day , Menactra was administered post excursion (poor quality product administered) . there were no adverse reactions reported  Action taken : not applicable for both the events.  Outcome: unknown for both the events   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.
Soreness in arm for a day and a half.; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 02Apr2021 at 04:15 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies to medications, food or other products. Concomitant medications included tamsulosin (MANUFACTURER UNKNOWN) taken for unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 03Apr2021, the patient experienced soreness in arm for a day and a half. The event did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event soreness in arm for a day and a half was recovered on 04Apr2021.   No follow-up attempts are possible. No further information is expected.
Reactions began 4-5 hours after receiving vaccine. Severe joint aches, nausea, severe arm pain to left upper arm into shoulder, chills/shakes, headache, temperature 101, body aches, fatigue, loss of appetite, general weakness. This lasted approximately 48 hours after injection. Continue to have malaise and slight headache.
This is a spontaneous case, initially received from other non-health professional on 24-Jan-2018, concerning a male patient of an unspecified age of body weight 260 lbs and height 72 inches. The patient's concomitant medication included ketoconazole shampoo, Iron, CALTRATE, SPIRIVA, ADVAIR, SYNTHROID, CENTRUM, furosemide, Aspirin, Vitamin D3, potassium chloride, losartan, Clobetasol, Atorvastatin, oxygen for unknown indications. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, manufacturer, trade name and expiry date: not reported). On 27-Apr-2010, the patient started ZEMAIRA 966 mg Vial (alpha-1-antitrypsin, dose: 60 mg/kg, weekly) (ongoing), route of administration: Intravenous, batch number: X408809 and expiry date: 09-Sep-2020) for alpha-1-antitrypsin deficiency. On an unspecified date, the patient had shortness of air, low O2 saturation (reported as, in 70's), tachycardia and hospitalized on 21-Jan-2018. At the time of this report, the outcome of the events was not reported. The reporter assessed the events as serious due to hospitalization.
Resident had Hx of DM T2, Hx of prostate CA. Started having swallowing difficulties in November. Increased c/o nausea and decreased appetite. 25% per meal average. Decreased energy to participate in activities and refused getting out of bed or meals.  Was vaccinated on 1/13/21. Hospice care started on 1/25/21. Resident passed away 2/23/21.
One week post vax, the vaccinee experienced swelling in injected arm, elbow swelling, pain, and fatigue. Initially, cancer was suspected and the vaccinee was referred to an oncologist. The oncologist believed these symptoms were related to vax. Unspecified treatment was given. Testing indicated positive results for Lyme disease.
Bad bellyache; Felt so weak; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Bad bellyache), ASTHENIA (Felt so weak), NAUSEA (Nausea) and VOMITING (Vomiting) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Flu vaccination and Drug allergy (allergic to a lot of medications including metformin).    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced NAUSEA (Nausea) and VOMITING (Vomiting). On 10-Mar-2021, the patient experienced ABDOMINAL PAIN (Bad bellyache) and ASTHENIA (Felt so weak). At the time of the report, ABDOMINAL PAIN (Bad bellyache) and ASTHENIA (Felt so weak) outcome was unknown and NAUSEA (Nausea) and VOMITING (Vomiting) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment was reported.
Pt took first dose of oral Typhoid 2/9/13. Had temps remainder of weekend up to 101 degrees F. C/o "horrible fatigue and weakness.
I got my series #5 anthrax shot on Tuesday afternoon (15 June) and my left arm (the one which got the shot) swelled significantly and the swelling started almost immediately and slowly got worse.  By Thursday mid-day, my left arm from the injection site to the elbow had swelled and I began to get shooting pains from the injection site down to my palm.  I went to the flight doctor and he said the swelling is probably causing weird pressures which is causing the pain.  It is Friday evening and the pain is still there.  The pain is very sharp and extremely uncomfortable.  A heating pad helps slightly, but as soon as the heating pad is removed, the slight relief immediately disappears.
(4/19/2021-present(less severe now)): -leg spasms (mainly in left leg/thigh and hip area)  (4/18/2021-4/20/2021): -chills -chest pain -fever -severe headache Present: -leg spasms -mild headache
per the EUA we have to report when the patient is admitted to hospital after vaccination. The patient was COVID-19 positive and has COVID-19 pneumonia
Information has been received on 27-NOV-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 11-DEC-2014, a licensed practical nurse at a medical center administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 24-AUG-2016, the patient was treated by a physician at a medical center for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Additional information has been requested.
Had extreme pain in arm that lasted a few weeks. Ran a fever, this highest it got to was 106. The vaccine seemed to accelerate all of my other chronic conditions. I went to my dr. and was given prednisone.
Starting about 15 hrs after receiving Shingrix awakened with shaking chills. Soon after started hyperventilating and heart racing. I thought it might be from injection (retired nurse), so I did relaxation breathing and within 20 minutes or so my breathing started to relax as well as sense of heart racing. Chills continued for about 1 hr 30 min. Eventually fell asleep then awakened with headache and nausea. The headache and nausea contnued until this morning -about 18 hours after start of event.
Developed generalized rash 10 days after shots were given. Saw doctor on 1/15/2004. He said side effects to MMR. No treatment given.
a little bit itchy; skin is red, at the injection site and towards her elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (a little bit itchy) and VACCINATION SITE ERYTHEMA (skin is red, at the injection site and towards her elbow) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included NAPROXEN for Back pain, HYDROCHLOROTHIAZIDE, PROPRANOLOL, DULOXETINE, POTASSIUM and NYSTATIN (STATIN [NYSTATIN]) for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PRURITUS (a little bit itchy) and VACCINATION SITE ERYTHEMA (skin is red, at the injection site and towards her elbow). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (a little bit itchy) and VACCINATION SITE ERYTHEMA (skin is red, at the injection site and towards her elbow) outcome was unknown.
Patient noticed large, erythematous area of swelling that tingled on 8/5/15 around the injection site.
SHAKING; STIFF BODY; SHIVERING; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included chronic breathing problems .The  patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 09-APR-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 09-APR-2021, the subject experienced shaking. On 09-APR-2021, the subject experienced stiff body. On 09-APR-2021, the subject experienced shivering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the shaking, shivering and stiff body was not reported. This report was non-serious.
SUDDEN ONSET OF RED SPOTS IN THE DIAPER AREA THAT QUICKLY GENERALIZED. CHILD FUSSY DUE TO ITCHING.
Resident became hypotensive, chest pain, low O2 SAT, diaphoretic, body aches, fatigue and chills on 1/14/21.  Second episode on 1/15/21 of nausea, body aches and lethargy.
Daily hives that get worse around my cycle. Have done multiple rounds of steroids. The hives come back about 3 days after I stop taking steroids.
t101 R on 18JUL92; later broke out in red rash on 18JUL92; then no temp to MD on 19JUL92;  MD confirmed roseola on 19JUL92;
An area 1-2 inches from the injection site that was sore and bruised; An area 1-2 inches from the injection site that was sore and bruised; This is a spontaneous report from a contactable pharmacist via Pfizer sales representative. This pharmacist reported same events for two patients. This is the first of two reports.  An elderly female patient of an unspecified age (age: >65 year old) received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13; lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced an area 1-2 inches from the injection site that was sore and bruised on an unspecified date. The events recovered on an unspecified date in 7-10 days.  Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019201610 same reporter/drug/event, different patients;US-PFIZER INC-2019201610 same reporter/drug/event, different patients
Red splotchy rash + swelling of face/ eye's - started 2 hours after vaccination. Vaccine ~1pm> rash ~2:30pm.
Patient came to the Pharmacy today and told me he has a rash or allergy reaction and he thinks it was either Fluzone HD or Prevnar 20 he got on 10/7/2022. I asked when it started and he said, it was Saturday after he trimmed high grass around the house AT 3PM. I told him it could be an allergy due to the trimming but he said that it has never happened before. During the interview I told him that he could take benadryl every 8 hours and apply cortisone twice daily. He indicated that he did and is not working. I got the information and called his Doctor, told them what happened and that the patient will go to the office for check up. Told him I will notify and Vaers and to give us a call if needed.
Patient called pharmacy on 07/21 and reported that he noticed red rash patches appearing over his body. Patient stated that it happened after he received his 2nd SHINGRIX shot and nothing has changed in his diet or activities so thought it was because of the shot. Patient has not experienced any breathing difficulties or itching, just rash formation. Patient states it has not spread further and plans to follow up with doctor on Monday. I recommended treatment with BENADRYL and told him if it got any worse or if he had trouble breathing to go to ER .
Patient developed intractible migraine that lasted for solid 3 days on 3 occasions and only relieved for a few hours the days in between her Booster dose on 11/5/2021 and being seen in the clinic on 11/16/2021
menstruation; leg pain,foot pain; She had not menstruated in over 3 years before that; chills; vomiting; headache; fever; More than 36 days since caller got the first dose and still has not the second; missed dose; pain on her nipples; pain on her breasts; tenderness on her breasts; menstrual cramps; urinary track infection; hemorroids; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (menstruation), PAIN IN EXTREMITY (leg pain,foot pain), URINARY TRACT INFECTION (urinary track infection), HAEMORRHOIDS (hemorroids) and NIPPLE PAIN (pain on her nipples) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Amenorrhea (amenorrhea.).    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced URINARY TRACT INFECTION (urinary track infection) and HAEMORRHOIDS (hemorroids). In June 2021, the patient experienced NIPPLE PAIN (pain on her nipples), BREAST PAIN (pain on her breasts), BREAST TENDERNESS (tenderness on her breasts) and DYSMENORRHOEA (menstrual cramps). On an unknown date, the patient experienced MENSTRUAL DISORDER (menstruation), PAIN IN EXTREMITY (leg pain,foot pain), MENSTRUATION IRREGULAR (She had not menstruated in over 3 years before that), CHILLS (chills), VOMITING (vomiting), HEADACHE (headache), PYREXIA (fever), PRODUCT DOSE OMISSION ISSUE (More than 36 days since caller got the first dose and still has not the second) and PRODUCT DOSE OMISSION ISSUE (missed dose). At the time of the report, MENSTRUAL DISORDER (menstruation), PAIN IN EXTREMITY (leg pain,foot pain), URINARY TRACT INFECTION (urinary track infection), HAEMORRHOIDS (hemorroids), NIPPLE PAIN (pain on her nipples), BREAST PAIN (pain on her breasts), BREAST TENDERNESS (tenderness on her breasts), DYSMENORRHOEA (menstrual cramps), MENSTRUATION IRREGULAR (She had not menstruated in over 3 years before that), CHILLS (chills), VOMITING (vomiting), HEADACHE (headache), PYREXIA (fever), PRODUCT DOSE OMISSION ISSUE (More than 36 days since caller got the first dose and still has not the second) and PRODUCT DOSE OMISSION ISSUE (missed dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication information was reported.  Other treatment  Medication provided was antibiotics for UTI and  over the counter Cream for Hemorrhoids.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Added new event.
Patient started feeling tired and getting a headache at 4:00pm. She developed full body aches around 7:30pm. The next day these symptoms continued and she had a fever of 100 degrees.  She didn't recover until Monday and the vaccine was administered on Friday morning.
Continual phantom pain in stump of right leg with below knee amputation beginning at 3:00 AM after vaccination and continuing for over 12 hours thus far with no sign of stopping causing an inability to sleep due to severity of pain.   In the past, any phantom pain would occur in short busts lasting no longer than an hour.
This spontaneous report as received from a registered nurse refers to multiple patients. There was no information about the patients' concurrent conditions, any known allergies or reactions, medical history or concomitant medications. On an unknown date, multiple unspecified patients were vaccinated with improperly stored ROTATEQ lot # M032636 with expiration date of 06-APR-201, lot # M044030 with expiration date of 13-JUN-2018; for prophylaxis (dose, route of administration were not reported). No adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 0°C to 1°C degrees Centigrade degrees for 4 hours and 20 minutes. Data logger was not involved. There were previous excursions of 0°C to 1°C for 51 hours (6 cycles). No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA009565: US-009507513-1709USA009566: US-009507513-1709USA009276.
Pt developed a rash 11 days past injection. Rash started with 2 red bumps at injection site. Now red bumps on belly. Pt was on Amoxicillin for R Otitis Media. DR changed to Omnicef.
Patient described feeling dizzy, vitals stable negative assessment. Patient refused care at hospital and now released to son.  BS 172, 140/78, 87, 98%