chrisvoncsefalvay/vaers-outcomes huggingface dataset:
then reports having chills/sweats; then reports having chills/sweats; Still feels groggy and sweaty; did not sleep well; he developed a small headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021349166 (Pfizer).  A 68 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 09Mar2021 14:00 (Lot number: EN6204, Expiration Date: 30Jun2021) at the age of 68 years as dose 1, 30 ug, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE; MELOXICAM; VIT D. Vaccination history included: Flu shot, administration date: Oct2020, when the patient was 68 years old, for Flu prevention. The following information was reported: CHILLS (non-serious), HYPERHIDROSIS (non-serious) all with onset 29Mar2021, outcome "unknown" and all described as "then reports having chills/sweats"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "he developed a small headache"; SOMNOLENCE (non-serious) with onset 29Mar2021, outcome "unknown", described as "Still feels groggy and sweaty"; POOR QUALITY SLEEP (non-serious) with onset 29Mar2021, outcome "unknown", described as "did not sleep well".  Additional information: It was reported that it is been three weeks today since he received his first dose of the Pfizer Covid 19 Vaccine and is scheduled for his second dose. Eight days in from his first dose Pfizer Covid 19 Vaccine he got chills and sweating, and again last night this occurred. Caller is scheduled for the second dose Pfizer Covid 19 Vaccine today and does not know if he should get it or not. Caller reported these same symptoms three weeks ago and filed a report, calling today because he had the same symptoms last night. He clarifies further he called before when his first symptoms occurred 8 days after receiving Pfizer Covid 19 Vaccine, and he is wondering why this happened again last night. Caller does not have a reference number for the previous report. He clarifies he is not shivering so much last night, more so sweating. Caller reports he still feels groggy and sweaty and did not sleep well because of it. Caller is worried about receiving the second dose Pfizer Covid 19 Vaccine. HCP: Caller does not wish to provide any information; states he doesn't have all that information. Caller is supposed to see his doctor today. His second dose of the Pfizer Covid 19 Vaccination he is supposed to receive is given in same building his doctor resides in. Caller states he takes blood pressure medicine but that about it. States name starts with the letter A. Caller confirms medication names and doses, does not provide any further information. The patient did not visit emergency room and Physician office. The patient did not receive Prior Vaccinations within 4 weeks. Caller states when he gets a flu shot, sometimes he gets a littleflu-ish, he had a flu shot in October.  No follow-up attempts are possible. No further information is expected.
Inflammation in Hands, lower legs and feet. Tingling, sharp pain in hands and feet Swelling in hands, lower legs and feet Numbness in left foot
LOT OF PAIN IN MY FEET AND LEG(VEIN); VEINS ARE BIGGER AND IT IS PAINFULLY; FEELING PAIN IN THE CHEST; I COULDN'T WALK; COULD NOT DO ANYTHING ELSE BESIDES SLEEP; A LOT OF PAIN IN MY BODY AND LEGS; FEELING SICK; PAIN IN MY KNEE; PAIN IN LEG; This spontaneous report received from a patient concerned a female 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: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced lot of pain in my feet and leg (vein). On APR-2021, the subject experienced veins are bigger and it is painfully. On APR-2021, the subject experienced feeling pain in the chest. On APR-2021, the subject experienced i couldn't walk. On APR-2021, the subject experienced could not do anything else besides sleep. On APR-2021, the subject experienced a lot of pain in my body and legs. On APR-2021, the subject experienced feeling sick. On APR-2021, the subject experienced pain in my knee. On APR-2021, the subject experienced pain in leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from lot of pain in my feet and leg(vein), and veins are bigger and it is painfully, and the outcome of could not do anything else besides sleep, a lot of pain in my body and legs, pain in my knee, feeling pain in the chest, i couldn't walk, feeling sick and pain in leg was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Redness beginning Wednesday, pain, swelling, itchiness total arm to below elbow.  To doctor Thursday - antibiotic for 1 wk - still red @ site.
Severe hair loss on head darting July 2021 to this date. Massive hair loss, I have loss 2/3 of my hair.
"Shaking" of left arm with pain- ER evaluation was muscle tightening treat with heat and ibuprofen.
It's anxiety provoking; nasal congestion for a couple of weeks; chronic sinusitis; lips started to tangle; bit of numbness up above her lips into her nose; Feels a little pressure on her upper cheeks; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (lips started to tangle), HYPOAESTHESIA (bit of numbness up above her lips into her nose), SKIN DISCOMFORT (Feels a little pressure on her upper cheeks), ANXIETY (It's anxiety provoking) and NASAL CONGESTION (nasal congestion for a couple of weeks) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cold sores.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PARAESTHESIA ORAL (lips started to tangle), HYPOAESTHESIA (bit of numbness up above her lips into her nose) and SKIN DISCOMFORT (Feels a little pressure on her upper cheeks). On 14-Feb-2021, the patient experienced ANXIETY (It's anxiety provoking), NASAL CONGESTION (nasal congestion for a couple of weeks) and CHRONIC SINUSITIS (chronic sinusitis). The patient was treated with PHENYLEPHRINE HCL at a dose of 10 milligram and GUAIFENESIN (GUAFENSIN) at a dose of 400 milligram. At the time of the report, PARAESTHESIA ORAL (lips started to tangle), HYPOAESTHESIA (bit of numbness up above her lips into her nose), SKIN DISCOMFORT (Feels a little pressure on her upper cheeks), ANXIETY (It's anxiety provoking), NASAL CONGESTION (nasal congestion for a couple of weeks) and CHRONIC SINUSITIS (chronic sinusitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided
Information has been received from a physician concerning a 4 month old male who was vaccinated with his second dose of ROTATEQ. Subsequently the patient experienced hematochezia within 48 hours of vaccination. The patient was seen by the physician for medical attention. The outcome was unknown. There was no product quality complaint. Upon internal review, hematochezia was determined to be an other important medical event. Additional information has been requested.
lethargic, headache, generalized body ache , arm weakness, arm pain swollen and painful
Ringing in the ears (more in the right ear); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Ringing in the ears (more in the right ear)) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced TINNITUS (Ringing in the ears (more in the right ear)). At the time of the report, TINNITUS (Ringing in the ears (more in the right ear)) outcome was unknown.            No concomitant medications were reported. No corrective treatment was provided.   This case was linked to MOD-2021-089251 (Patient Link).
This is a spontaneous report from a contactable physician received via a Pfizer sales representative.   A 16 years old patient of unspecified gender received TRUMENBA on an unspecified date, at 0.5 ml single dose, intramuscular, for immunization. Medical history and concomitant medications were not reported. On an unspecified date, after vaccination, the patient experienced severe swelling, headache and fever. These events required the patient's hospitalization. Events outcome was unknown.
personality and behaviour changes; behaviour changes; This case was reported by a consumer via call center representative and described the occurrence of personality disorder in a patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced personality disorder and behavior abnormal. On an unknown date, the outcome of the personality disorder and behavior abnormal were unknown.   It was unknown if the reporter considered the personality disorder and behavior abnormal to be related to Engerix B.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient asked if the patient discloses their mental health problems and the doctor did not warn of personality and behavior changes risks before giving the vaccine, it should be a material risk the doctor should warn of regarding Engerix B. The follow-up would not possible, as no contact details were available.
Very Bad Chills ACHY very Tired Headache waves of nausea630 pm 1/19/1951 till present
Pt recvd vax & pt exp soreness of arm & difficulty of movement which inc; also on 11APR93 pt began w/ sx of head cold & hoarseness which also inc;  exp aches & pains all over as well as in lt arm; pain down in deltoid area;
daughter got the dry heaves after her 2nd dose of the Moderna Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (daughter got the dry heaves after her 2nd dose of the Moderna Vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RETCHING (daughter got the dry heaves after her 2nd dose of the Moderna Vaccine). At the time of the report, RETCHING (daughter got the dry heaves after her 2nd dose of the Moderna Vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No lab data has been provided by the reporter. No Treatment medication has been provided by the reporter. No concomitant medicines.   This case was linked to US-MODERNATX, INC.-MOD-2021-095547, US-MODERNATX, INC.-MOD-2021-094798 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-095547: US-MODERNATX, INC.-MOD-2021-094798:
Information has been received from a nurse practitioner referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history, drug reactions or allergies was not provided.  On 28-MAR-2018, the patient was vaccinated with an expired dose of VAQTA (1 DF, lot # M036459, expiration date 18-JAN-2018; route was not reported) for prophylaxis. No adverse effects was reported.
I felt fatigue and my arm was immediately swollen hard and hot to the touch. My arm was back to normal after a week.
On 7/2/20 Pt came in to let us know that she had a reaction to her shingrix vaccine.  7/1/20 : pt noticed hard lump, hot , red and itchy at site of injection. Pt states it hurt a bit. On tues/wed of the same week pt reported having flu like sx; aches, joint pain, chills and sweat. But pt reports feeling better 7/2/20  I calle dmd at 1130 am to inform md of situation. Left a message. At 225pm staff called back fr md office and I Faxed over the pts adverse rxn and asked md to follow up w pt. Will not re-challenge pt with second dose.  7/2/20 Pt states she is feeling  better but the redness at site of reaction is still present.
Within several hours of receiving his 5th anthrax inoculation this 32 year old AD service member had progressive edema, erythema and pain of his left arm and shoulder muscle that spread from the shoulder down his arm to just below his elbow to his forearm. He denied receiving any other injections that day. Except for some localized.
This spontaneous report was received from a Registered Nurse and refers to a unknown patients of unknown age and gender. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On unknown dates, the patients were vaccinated with improperly stored unspecified doses of GARDASIL 9  for prophylaxis (lot number M036059, with an expiration date of 03-JUN-2019) (strength, dose and frequency were not reported). No concomitant medications were provided. The doses of the vaccine experienced a temperature excursion from 32 degrees Fahrenheit (F) to 35 degrees F for 228 hours and from 47 degrees F to 77 degrees F for 18 hours and 20 minutes. The aforementioned temperature was identified due to a data logger. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA003014: US-009507513-1704USA003224: US-009507513-1704USA003228: US-009507513-1704USA003226: US-009507513-1704USA003227: US-009507513-1704USA003225.
vaccine administered on 5/11/2022 expiration date was 5/31/2022 but beyond use date was 04/18/2022
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Nov2022 as dose number unknown (booster), single (Lot number: GJ6742) at the age of 53 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 04May2022 as dose number unknown, single (Lot number: FL3197), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "allergies: IV contrast dye" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Colazol, reaction(s): "known allergies: Colazol". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID from 29Aug2023 to 02Sep2023.
When given vaccine patient felt a moment of shortness of breath, advised the staff also had flushing Benadyl 25 mg given to patient.  Patient waited 30 minutes.  all vitals were normal patient escorted to his car,  drove home.
After having COVID 19 my sense of smell and taste had returned to normal.  After having the vaccine, I again lost nearly all of my sense of smell.  My sense of taste is greatly diminished and distorted.    Foods that I previously enjoy now have a strange and undesirable taste and smell.    I had fever 100.5 degrees for about 1.5 day.   The taste and smell issues are ongoing as of today 11/10/21.
4 inch x 2 1/2 wide irregularly shaped red raised and hot area, 3 inch below injection site. Improvement noted after 24 hours after antibiotic treatment started.
At 3:45 I started to experience tingle sensation in my throat along with a cough. A few minutes later I started having difficulty breathing and itchiness on my torso/chest and face. After that I began to turn red and break out in hives on my face, back, arms, and chest. I was seen by a Doctor. At 4:00 pm I was given a dose of oral Benadryl, my vitals were taken and I was monitored. My symptoms began to dissipate after I took the medication. I was discharged with an Adult Epi Pen for home use if a secondary reaction occurred.
This spontaneous report was received from a certified medical assistant referring to multiple unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot# M014301 with expiration date 22-SEP-2017 and albumin status of rHA (recombinant human albumin); and lot number reported as M025186 with expiration date 15-MAY-2018) (strength, dose, frequency, route of administration and anatomical location were not reported) for prophylaxis. The vaccine doses were exposed to a temperature excursion between 15 and 46 Fahrenheit degrees for 7 hours (also reported as "23.9 F"); and between 6 and 14 Fahrenheit degrees for 8 hours and 30 minutes; digital data logger was involved. No adverse effects were reported. Reportedly, the reporter did not know which improperly stored vaccines were administered. Additionally, it was reported that the sterile diluent (unspecified) used to reconstitute the administered vaccine did not undergo a temperature excursion (Lot # M015992 with expiration date 26-NOV-2018; Lot # L037795 with expiration date 04-MAY-2018; Lot # L019306 with expiration date 04-MAR-2018; Lot # L006552 with expiration date 12-NOV-2017; Lot # M001834 with expiration date 08-MAR-2018; Lot # M022946 with expiration date 17-DEC-2018; Lot # M024781 with expiration date 21-FEB-2019). There was not product quality complain (PQC) reported. This is one of three reports received from the same reporter. Lot number M025186 is an invalid lot number for Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live. Additional information has been requested. Sender's Comments: US-009507513-1704USA001189: US-009507513-1704USA001190.
Diarrhea; Stomach pain; Back pain; Dizziness; Vertigo; Desquamation in the hands; Whole body itchiness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach pain), BACK PAIN (Back pain), DIZZINESS (Dizziness) and VERTIGO (Vertigo) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METFORMIN for an unknown indication, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN/HYDROCHLOORTHIAZIDE).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach pain), BACK PAIN (Back pain), DIZZINESS (Dizziness), VERTIGO (Vertigo), SKIN EXFOLIATION (Desquamation in the hands), PRURITUS (Whole body itchiness) and NAUSEA (Nausea). The patient was treated with NAPROXEN at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach pain), BACK PAIN (Back pain), DIZZINESS (Dizziness), VERTIGO (Vertigo), SKIN EXFOLIATION (Desquamation in the hands), PRURITUS (Whole body itchiness) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Patient currently has mild outbreak "pock marks" on left arm. Area of injection swollen and red area. Facial "pock" on left cheek.
I had a positive Covid test on December 16th with mild symptoms (Headaches, fatigue and loss of smell only). Day after vaccine i had severe chills, body ache and 101 temperature. following morning i was fine except for lingering COVID fatigue, and headaches. I am only sharing this for your records/study so you have it. otherwise  I am fine.
immunocompromised patient given the booster dose (not the 3rd dose?); This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient given the booster dose (not the 3rd dose?)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 041A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient given the booster dose (not the 3rd dose?)). In August 2021, ACCIDENTAL UNDERDOSE (immunocompromised patient given the booster dose (not the 3rd dose?)) had resolved.            No concomitant medications were reported. No treatment information were reported.
Feelings of intense fear, panic and loss of control (including depressive thoughts) multiple times a day lasting 15-30min until the 9th day post vaccine where I suddenly felt 100% back to normal. I?ve never experienced anything like this in my past- extremely disruptive and terrifying.
725pm - patient complained of dizziness and headache. patient was alert and calm. vital signs stable (blood pressure 120/70, heart rate 80, oxygen saturation 99%). 738pm - patient complained of chills and headache. patient was alert and calm. blood pressure 150/80, heart rate 72, oxygen saturation 88%. 744pm - patient insisted to go home with her husband. she refused to go to hospital for check up.
Headache, nausea, dizziness and general body aches. Starting feeling better on 3rd day of vaccination.
Patient claims he started tremors and chills and abdominal pain with diarrhea . He went to ER but got confused and did not know where he was. Someone help him out and call ambulance and he was treated in nearby ER. He said vital signs were normal but oxigen was given to him and he was discharge from the hospital by 9:00pm.
Patient was transferred to hospital on 8/8 via medical flight from his facility due to persistent intermittent bleeding from his trach and mouth. Subsequently goals of care transitioned to CMO only and patient passed away on 8/17.  Regarding covid, patient had mild infection without hypoxemia and was given course of remdesivir. Patient is fully vaccinated.
Pain - Left upper arm at site of injection, Patient subjectively felt weakness to left hand, reported to physician & had physical exam on 9-19-2012. Symptoms occurred daily since 6-27-2012 injection.
patient was given pediarix and is out of the recommended age for this vaccine.  As far as we know the patient did not have any reactions to this vaccine