chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse refers to multiple patients of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were unknown. On unspecified dates in March 2018, the patients were vaccinated with improperly stored doses of ROTATEQ (dose, units and frequency unknown) (lot # N000175 and expiration date 20-SEP-2018), (lot # N013884 and expiration date 05-DEC-2018) and PNEUMOVAX 23 (dose, units and frequency unknown) (lot # N020688 and expiration date 09-MAR-2019). The temperature excursion was at 32 degree F to 35 degree F (35.1F) (degree Fahrenheit) for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was reported. This is a non-valid report due to lack of patient identifiers. As on 26-SEP-2018, all telephone attempts to obtain follow-up information have been unsuccessful. A request was made for patient identifiers and date of vaccination. Upon receipt of follow-up information it was determined that this case is now valid because patient identifiers was received. Follow up information has been received on 27-SEP-2018 referring to a patient of unknown gender, currently 38 year old. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On an unknown date in 2018, the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, units and frequency unknown) (lot # N020688 and expiration date 09-MAR-2019) for prophylaxis. On 13-APR-2018, the PNEUMOVAX 23 underwent temperature excursion. It was also reported that, no doses of ROTATEQ (lot # N000175 and expiration date 20-SEP-2018) was administered. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA013793: Original Case: 1804USA006915; US-009507513-1809USA013794: US-009507513-1809USA013795.
Injection site reaction. A nsg reported that a pt rec'd his 1st Prevnar in 4/01 and immediately developed an injection site reaction characterized by erythema, tenderness and itchiness. Erythema and tenderness resolved within 4-5 days. and itchiness resolved within 10-14 days. The pt rec'd Prevnar because he is immunodeficient and is not to 21 valent pneumococcal vaccine (manufacturer unknown). Additional info rec'd on 5/23/01 indicated that the pt is IgG deficient and had a decreased antibody response following receipt of Prevnar.
My appointment was Saturday at 7:30 am.  I sat for 20 minutes, felt fine, went home, ate breakfast, went to take a nap, woke up with a headache, body aches, felt nausea, felt so weak. I had to call off work. I didn't start to feel better until later in the afternoon on Sunday. I stayed home, took Tylenol, drank water and tea, treated it like a flu. I did not go to the doctor. On March 25, 2022, I went to the hospital (I work for the hospital) and I worked 11 pm to 7 am, when I got off work my coworker called a code blue because I couldn't breathe. They admitted me and I have been here ever since.
pt came in today (4/28/19) and showed are red area "below where needle went in" approximately 2.5" in diameter that was red and warm to touch.   otherwise feels fine.  never has had issue with previous immunizations.  recommended some ibuprofen and cold compress.  if worsens to visit md.  or if not improved by tuesday 4/30/19 to visit md
Pt stated that the night that she received the shot she was woken up by intense pain her legs. The following morning she also has no energy where she is usually very active. Pt believes it is intense muscle pain. I advised the patient to take an Ibuprofen that I provided her at the time of the shot to see if that helps or not.
Swollen, warmth, red, itchy, and tender left arm (deltoid) after injection.
Severe diarrhea, vomiting, stomach cramps, dehydration, muscle fatigue, low grade fever (99.6), headache, overall weakness - make phone call to PCP and they advised me to hydrate as much as possible
Chills with moderate sweats, starting  at 6 hrs and lasting 24+ hrs. Moderate abdominal pain, with cramping, diarrhea, nausea, starting at 20 hrs and lasting 12+ hrs. Full body weakness, with dizziness and fatigue, starting at 20 hrs and lasting for 24+ hrs.
SORE ARM; INCREASED HEART RATE; SHORTNESS OF BREATH; DIZZINESS; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 165 pounds, and height was 65 inches. The patient's concurrent conditions included: outdoor allergies, social alcohol drinker, and non-smoker. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 13-AUG-2021 11:00 for prophylactic vaccination. Concomitant medications included salbutamol. On 13-AUG-2021, the patient experienced increased heart rate. On 13-AUG-2021, the patient experienced shortness of breath. On 13-AUG-2021, the patient experienced dizziness. Laboratory data included: Heart rate (NR: not provided) 115 Beats per minute, 90 Beats per minute. On 14-AUG-2021, the patient experienced sore arm. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) 62 Beats per minute (normal). The action taken with covid-19 vaccine was not applicable. The patient had not recovered from increased heart rate, shortness of breath, dizziness, and sore arm. This report was non-serious.
Left lymph node under armpit has swelled significantly; 100.8-101.2 fever; Strong headache; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 12Apr2021 at 12:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis and psoriatic arthritis. The patient was allergic to penicillin (PCN). Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and diphenhydramine, paracetamol, phenylpropanolamine hydrochloride (BENADRYL), both taken for unspecified indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 22Mar2021 at 12:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Prior to 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 four weeks prior to the vaccination. On 13Apr2021 at 08:00, 20 plus hours after the vaccination, the patient had fever of 100.8 to 101.2, strong headache and on 13Apr2021 at 18:00, 30 hours after the vaccination, the patient experienced that the lymph node under armpit had swelled significantly and the patient was unable to put the arm down. The patient did not seek treatment and wanted to reevaluate next morning. 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. The clinical outcome of the events fever, strong headache and left lymph node under armpit had swelled were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
feels like the flu; Feels like I was hit by truck; Left arm finger feels numb; Left arm finger feels tight; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feels like I was hit by truck), HYPOAESTHESIA (Left arm finger feels numb), MUSCULOSKELETAL STIFFNESS (Left arm finger feels tight) and INFLUENZA LIKE ILLNESS (feels like the flu) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced FEELING ABNORMAL (Feels like I was hit by truck), HYPOAESTHESIA (Left arm finger feels numb) and MUSCULOSKELETAL STIFFNESS (Left arm finger feels tight). On 25-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (feels like the flu). At the time of the report, FEELING ABNORMAL (Feels like I was hit by truck), HYPOAESTHESIA (Left arm finger feels numb), MUSCULOSKELETAL STIFFNESS (Left arm finger feels tight) and INFLUENZA LIKE ILLNESS (feels like the flu) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up information received on 14-MAY-2021, Email information added,AE contact information was updated.
Sharp Headache  for 3 days after the 2nd dose; Second shot about 3 months after the first shot; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Sharp Headache  for 3 days after the 2nd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot about 3 months after the first shot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Angioma (Patient suffers from Angioma takes Acetaminophen, Tramadol, and Flexeril.). Concomitant products included PARACETAMOL (ACETAMINOPHEN), TRAMADOL and CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]) for an unknown indication.    On 08-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced HEADACHE (Sharp Headache  for 3 days after the 2nd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot about 3 months after the first shot). On 08-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot about 3 months after the first shot) had resolved. On 11-Mar-2021, HEADACHE (Sharp Headache  for 3 days after the 2nd dose) had resolved.            Treatment information was not  provided.   This case was linked to MOD-2021-318486, MOD-2021-318515 (Patient Link).
My COVID symptoms have returned after I completed my first dose; My COVID symptoms have returned after I completed my first dose; 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 male patient received BNT162b2 (BNT162B2), as dose 1, 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: SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "My COVID symptoms have returned after I completed my first dose".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient presented 10/29/2012 to establish care with and received a pneumococcal vaccine (right arm). On 10/30, the patient experienced fever to 103 degrees along with pain and erythema at injection site on right arm. He presented to the ER 10/31 for further evaluation where he received IV vancomycin for cellulitis; ID was consulted. While in the hospital, the patient received vancomycin, clindamycin and aztreonam. Blood cultures and hemolysis labs were obtained 11/1/12; results were negative. Patient remained afebrile while hospitalized. Patient was discharged 11/2/12 on oral clindamycin 450mg q8h for 7 days to complete a 10 day course. Symptoms: swelling at injection site.
Tongue swelling and prickly, heart racing, sweats, claming hands and feet, felt ill, face swelling. Came in waves for about one hour to two hours.  Face swelling 3 days. Every once in a while still heart racing.
pt recvd vax & did not respond; pruritic; hives were quite massive in size; reports some chest heaviness or discomfort;
Injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, feeling unwell, swollen lymph nodes  Had these side effects for 24 hours, but the injection site swelling has lasted for a week.  Took tylenol  for the side effects and it helped.
Pt recv vax on 11/6/98; on 11/7/98 pt exp hives; tx=Benadryl
Vomiting, hypotensive lethargic generalized rash and redness, puffy under eyes, ears red and puffy color pale around eyes.  Benadryl 1/2 teaspoon by mouth, epinephrine 0.25q, Solumedrol 40mg IM.
C/O redness and swelling at injection site, (+) fever 1 day after injection; treated at student health services 1/12/09 for severe local reaction vs cellulitis.
Felt the same Heart racing; This spontaneous case was reported by a nurse and describes the occurrence of PALPITATIONS (Felt the same Heart racing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Felt the same Heart racing). At the time of the report, PALPITATIONS (Felt the same Heart racing) outcome was unknown.        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.   No concomitant and treatment medications were reported.   This case was linked to MOD21-037045 (E2B Linked Report).; Sender's Comments:  MOD21-037045:
weakness, fatigue, body ache Narrative:  67-year-old male with past history of diabetes type 2, hyperlipidemia, left BKA, who presented to hospital 2/14/21 with generalized weakness, fatigue, body aches and left leg pain for the past 5 days. He reported it started after receiving his COVID-19 vaccine on 2/09/21. He also had associated nausea, vomiting, diarrhea. He denied fever, chest pain, shortness of breath, abdominal pain. Labs showed mild leukocytosis 12k, AKI with Cr 4.6, K 3.2, Bili 2.9, trop 0.01, lactate 2.2. He was given 3L IVF, vanco blue in ED at 18:35. Asystole on monitor. ACLS initiated and once eventually stabilized he was transferred to ICU. Pt again coded 2 more times while in ICU with were halted due to medical futility.
Vaccination 3:30pm. By 10:30pm - chills, shivering, eventually vomiting at 1:00 AM. Extreme leg pain.
Pt's right arm got red and swollen about 6 hrs after receiving his immunizations. He had a shooting pain down his arm and took ibuprofen for the pain. After 24 hrs, the pt said he was improving but still experiencing symptoms.
I started symptoms late Sunday 4/11/2021,  on  Monday 4/12/2021 I became very lethargic, aches and pains, severe headache, all night has night sweats and chills., temperature reached 101.4 Tuesday 4/13/2021, felt disoriented, (this bothered me, I couldn?t even have a conversation with work or psychiatrist.  I could think straight. Still headache, no fever.  Very sleepy and achy..  started feeling better later in the evening.   Wednesday, 4/14/2021.  Hardly any side affects at all. Minor headache and sweats.
This spontaneous case reported by a consumer and describes the occurrence of feeling abnormal (got a little bit bad), pyrexia (fever), chills, headache and malaise (not feeling too well) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 014C21A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On May 4, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced  feeling abnormal (got a little bit bad), pyrexia (fever), chills, headache, malaise (not feeling too well), depressed mood (feeling down) and heavy menstrual bleeding (one day before vaccination, started menstrual period; and more than a week after still on her period). The patient treated with acetaminophen at a dose of 1 dosage form. At the time of the report, feeling abnormal (got a little bit bad), pyrexia (fever), chills, headache, malaise (not feeling too well), depressed mood (feeling down) and heavy menstrual bleeding (one day before vaccination, started menstrual period; and more than a week after still on her period) outcome: unknown. Concomitant medication not reported.
Patient complains of pain at injection site, shoulder joint, states "feels like it's in the bone".  Complained of "bump" at injection site.
I21.4 ACUTE NON ST ELEVATION MI 4/28/2023 DM 2 WO COMPLICATIONS I21.9 ACUTE MI 4/28/2023 DM 2 WO COMPLICATIONS
Patient that evening developed fever greater than 100 degrees F, chills, aches. Arm was sore as well.
headache after getting second Moderna vaccine that had gotten worse; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache after getting second Moderna vaccine that had gotten worse) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ZINC, VALSARTAN, ROSUVASTATIN CALCIUM (CRESTOR) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 03-Feb-2021, the patient experienced HEADACHE (headache after getting second Moderna vaccine that had gotten worse). At the time of the report, HEADACHE (headache after getting second Moderna vaccine that had gotten worse) had not resolved.            Treatment was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
I believe I contracted it because I traveled for work. I did not feel symptoms until I was on the place ride back. I thought at first I had a very bad cold but it was lasting much longer than a typical cold plus I was feeling very fatigued and did not want to eat. I was having cold symptoms as well like sniffling , sore throat and a cough. I was prescribed an antibiotic to help. I took a COVID test and it came back positive. I did not visit a doctor just called and had medication prescribed.
pt recv vax 27MAY97 returned to office 29MAY97 w/rt arm swollen, red & warm to touch over the site of inj;
This spontaneous report as received from a pharmacist refers to a 61 year old patient with unknown gender. On 30-OCT-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # J009827, expiration date 10-AUG-2014, 0.5 ml, intramuscular). No adverse effects were reported. The outcome of the event was not reported. No product quality complaint (PQC) involved. This one of several reports received from the same source. Additional information has been requested.
Information has been received from a health professional concerning a 6 year old female child with no past medical history who on 03/12/1997 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live. On 12/25/2001 the child experienced rash and headache. She was seen in the physician's office and diagnosed with a mild case of chickenpox. Subsequently, the child recovered. The child's two sisters (WAES0201USA02949 and 0201USA02951) also developed chickenpox following exposure to their sister and varicella virus vaccine live. No further info is available.
Patient noticed itching and finally look at injection side and reports erythema and swelling, induration 12 x 7.5 cm and itching.
chills; low grade fever; cough; aches; Initial information regarding an unsolicited valid non-serious case from the Agency (Reference number- 00790611) was received from a consumer and transmitted to Sanofi on 29-Sep-2021.  This case involved a 71-year-old female patient who experienced chills, low grade fever (pyrexia), cough and aches (pain) while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot UJ716AA (expiry date not provided) via intramuscular route in the left deltoid.  On 23-SEP-2021 the patient developed a non-serious chills, low grade fever (pyrexia), cough and aches (pain) following the administration of vaccine.  No relevant laboratory data was provided.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was resolved for the event chills, low grade fever, and pain and was not resolved for the event cough.
FREEZING; BACKACHE; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced backache. On 12-MAR-2021, the subject experienced freezing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from freezing, and the outcome of backache was not reported. This report was non-serious.
strong reaction to the first shot/pretty rough night; very intense body aches; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (strong reaction to the first shot/pretty rough night), MYALGIA (very intense body aches), PYREXIA (Fever) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Fibromyalgia, Arthritis, Hives (breaks in hives in response to foods.) and Food allergy.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (strong reaction to the first shot/pretty rough night), MYALGIA (very intense body aches), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination adverse reaction, Myalgia, Pyrexia and Chills, at an unspecified dose and frequency. In 2021, VACCINATION COMPLICATION (strong reaction to the first shot/pretty rough night), MYALGIA (very intense body aches), PYREXIA (Fever) and CHILLS (Chills) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication inhaler was provided.   This case was linked to MOD-2021-307238, MOD-2021-307256 (Patient Link).