chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TREMORS; NAUSEA; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a pharmacist concerned a 19 year old female. The patient's height, and weight were not reported. The patient's past medical history included: cardiac transplant, and other pre-existing medical conditions included: Patient was not pregnant at the time of vaccination. Patient did not have any drug allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 12-MAR-2021 for prophylactic vaccination. Age at time of vaccination 18 years old. The batch number was not reported and has been requested. The patient received non company co-suspect included: Paxlovid (nirmatrelvir/ritonavir) (form of admin, oral and batch number was not reported) dose was not reported, administered on 21-MAY-2022 till therapy end date 25-MAY-2022 for treatment of covid-19. The patient received Non-company suspect drugs included: tacrolimus (form of admin, route of admin, and batch number were not reported) dose was not reported, frequency, and therapy dates were not reported for cardiac transplant.  On MAY-2022, the patient experienced suspected covid-19 infection and hence suspected clinical vaccination failure. On 25-MAY-2022, the patient was presented to an emergency department with tremors and nausea. On an unspecified date, the patient was hospitalized. Number of days of hospitalization was not reported. Laboratory data (dates unspecified) included: Drug (tacrolimus) level more than 60. The action taken with covid-19 vaccine ad26.cov2.s was not applicable, action taken with tacrolimus was not reported and Paxlovid was treatment discontinued. The patient was recovering from nausea, and tremors, and the outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint.; Sender's Comments: V0: 20220610106- covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure, covid-19, tremors. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related. 20220610106- covid-19 vaccine ad26.cov2.s nausea. The case causality is considered NOT RELATED. Rationale: vaccine taken on 21 march-2021 and nausea occurred on 25-may-2022, considering the long duration for the event to occur and also patient is on co-suspect medication of tacrolimus.
during observation a few minutes after receiving immunization, patient developed dizziness, low blood pressure and heart rate (vasovagal response), improved within 5 minutes with leg elevation and drinking water
Numbness, tingling, burning, yet extreme sensitivity to my left Antecubital area. It feels as if someone left a tourniquet on too long and keep trying to draw blood from the area. The sensitivity is to the skin only. It started the day after My flu shot. I thought it was because I had my long sleeves rolled up, but the feeling did not resolve after I rolled them down. This is day two, the feeling persists constantly. It is numbing, yet oddly painful to the touch.
developing autoimmune diseases/ diagnosed with Rheumatoid Arthritis; booster; 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 (005570). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101698326 (Pfizer).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Jan2021, for COVID-19 immunization; Bnt162b2 (Dose 2), administration date: Feb2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset Oct2021, outcome "unknown", described as "booster"; RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "developing autoimmune diseases/ diagnosed with Rheumatoid Arthritis". Clinical course: Developing autoimmune diseases after receiving the Pfizer COVID-19 vaccines and boosters. The patient had since been diagnosed with Rheumatoid Arthritis. There very well could be a correlation considering the effects of the vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
weird dreams; fever of 100.6; arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore), ABNORMAL DREAMS (weird dreams) and PYREXIA (fever of 100.6) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm sore). On 13-Mar-2021, the patient experienced ABNORMAL DREAMS (weird dreams) and PYREXIA (fever of 100.6). The patient was treated with PARACETAMOL (TYLENOL) on 12-Mar-2021 at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm sore), ABNORMAL DREAMS (weird dreams) and PYREXIA (fever of 100.6) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.
12 hours after second Moderna shot, I had slight fever of 100 degrees, slight headache, lymph node swollen/ache under left arm pit, and some fatique.  All side effects went away after about 2 days. Injection site was sore/tender  with both shots. Side effects went away in 2 days.
Injection site became warm, swollen, and itchy 8 days after vaccine received. Still experiencing these symptoms 9 days after vaccine received.
This spontaneous report as received from a physician via company representative refers to a 1 year old child. No current or historical conditions were reported. On an unknown date, the patient was vaccinated with a dose of (Merck) VARIVAX (dosing regimen, route of administration and indication not provided). No concomitant therapies were reported. On an unknown date, the patient developed a complicated case of shingles after administration of (Merck) VARIVAX at the back and leg. The outcome of the event was unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information is expected.
Bruising, swelling, and pain at injection site. Swelling starts at thigh and continues down to the foot
Case number PHHY2011US61533 is an initial spontaneous report received from a consumer on 08 Jul 2011. This report refers to a patient of unspecified age and gender. The patient was vaccinated with only half a dose of MENVEO (batch number not provided) intramuscularly on unspecified date. No adverse event was reported following this under dose.
This spontaneous report was received from a physician regarding a female patient of unknown age. No medical history and concurrent conditions were reported. On 04-NOV-2014, the patient was vaccinated with the first dose of GARDASIL (dose and frequency were unknown). On 13-JAN-2015, the patient was vaccinated with second dose of GARDASIL. On an unspecified date in 2015 after vaccination with the second dose of GARDASIL, the patient experienced occasional headaches and abdominal pain. On 23-MAY-2015, the patient was presented with viral gastritis. On 26-MAY-2015, the patient was vaccinated with the third dose of GARDASIL. After vaccinated with the third dose, the patient reported increased in the occasional headaches and abdominal pain. The patient's mother stated that "all hell broke loose" after the third dose. The patient's mother also reported that the patient's abdominal pain become so severe that she spent a lot of time in the fetal position to ease the pain and the headaches became dehabilitating. The patient was taken to several physicians included a neurologist, gastroenterologist, and a pediatric surgeon. The physician noted that the patient had many diagnostic tests completed including abdominal ultrasound, blood work and MRI of the brain and all were reported to be within normal limits. On an unspecified date in 2015, the patient had undergone abdominal CT scan which showed constipation. The patient began a gluten free diet (date unspecified), although her celiac test was negative on 08-JUN-2015. This diet improved the abdominal symptoms although if the patient does intake a food product with gluten, the abdominal pain was back and the patient has brain fog. On an unspecified date in 2015, the patient visited the pediatric neurologist and was diagnosed with occipital neuralgia. Treatment provided to the patient for occipital neuralgia included TOPAMAX. The patient was under the care of the homeopathic physician who diagnosed the patient "leaky gut syndrome". On an unspecified date in 2015, the patient's gynecologist diagnosed the patient with amenorrhea, however, the gynecologist suggested that this was secondary due to stress. The physician also noted the patient's hair was thinning as well. Additionally the physician also mentioned that the only other related occurrence during this time frame- was a bout of viral gastritis diagnosed on 23-MAY-2015. The outcome of all the events was reported as not recovered. The relatedness of all the events with GARDASIL was not reported. No product quality complaint was reported. Additional information has been requested.
Pt got PNEUMOVAX 23 on 11-11-13 and said that night she had neck stiffness, her arm has sore above site of injection and below injection site then felt a knot. Symptoms went away next morning.
Received 2 vaccines in L deltoid. Distal to injection sites, area of erythema 3in x 3.5in which initially appeared as several hives (per mom's photos). Not tender. Slight itch, not warm to touch.
Tingling/numbness in hands going on 23 days .; Numbness in hands going on 23 days .; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Gn6204), via an unspecified route of administration in the left arm on 23Mar2021 at 11:00 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included labetalol (MANUFACTURER UNKNOWN), paracetamol (TYLENOL), prenatal vitamins (MANUFACTURER UNKNOWN) and probiotics (MANUFACTURER UNKNOWN); all from unknown dates for unspecified indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Gn6206), via an unspecified route of administration in the left arm on 02Mar2021 at 11:15 (at the age of 36-years-old), as a single dose for COVID-19 immunisation. The patient previously took doxycycline (MANUFACTURER UNKNOWN) on unknown date for an unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 23Mar2021 at 12:30, the patient experienced tingling/numbness in hands going on for twenty-three days. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tingling/ numbness in hands were not resolved at the time of reporting.    No follow-up attempts are needed. No further information is expected.
Rash noticed by PCP during annual assessment. Patient had a pink red pimply rash with numerous scabs on his front torso and back. The patient was very itchy during the physical exam on 1/12 and was unaware he had an extensive rash. As of 1/18/21, patient has been scheduled for follow-up with dermatology to determine whether rash was due to allergic reaction. Patient is in stable condition at his ALF, and is still recovering from the rash.
Patient c/o shooting pain (8/10 on pain scale) which migrates in location from his posterior shoulder, his acromion, and his left bicep s/p second COVID injection.
sever pain in my left elbow; Pain is going all the way to my hands and is making me drop things; Sever pain in left sholder; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date (at the age of 32-year-old) as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date the patient experienced severe pain in left elbow and left shoulder and the pain was going all the way to hands and was making the patient to drop things. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe pain in left elbow and left shoulder and pain was going all the way to hands and was making the patient to drop things was not recovered at the time of this report.     The lot number for BNT162b2 was not provided and will be requested during follow up.
I've had to reach out to my cardiologist to seek medication for treatment of increased flare-ups.
Returned on 10-28-14 with large hematoma of left deltoid. Bruising of various colors in about 3-4 inch diameter of upper left deltoid. Noticed on 10-22-14 when woke up.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 68-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6-degree celsius (explicitly coded as incorrect product storage). On 22-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number was mapped to FLUAD (TIV). Hence, the suspect vaccine was coded as FLUAD (TIV). At the time of this report, no adverse event was reported. This case 201805435 was crossed linked to original cases 201804863 due to same reporter.
Shortly after receiving vaccine, participant c/o dizziness and SOB;  Oxygen saturation :  88%  - 97%  B/P  166/82;  appeared to  'pass out', when aroused, opened eyes and had a 'dazed' look;  called EMS;  complained of feeling 'light-headed' ;  EMS arrived and assessed participant and transported to hospital.
The patient presented with redness, swelling, and pain on the arm of injection. Patient also received a flu shot in the same arm spaced out by 1 inch.
Patient has swelling in both hands bad enough that she can't make fists as well as facial swelling
Patient developed hives around midnight on evening of shot. Medicated with BENADRYL. Pt. still experiencing reaction with use of diphenhydramine.
Severe diarrhea, dizziness, stomach pain, nausea, headache, tiredness, weakness, pain, redness and hot at injection sight, lightheaded.
Broke out in shingles within 10-12 days on chest, both arms, both legs ,stomach, waist
Severe upper arm pain on injection arm (left arm) that radiated up shoulder and down arm to elbow 2hrs post injection, fever (alternating chills and sweats) and headaches that lasted approx 24 hours post injection, generalized fatigue. Arm pain persisted for 3 days with slow reduction in soreness over time. Fever and headaches were controlled by ibuprofen at regular intervals on 10-23-15.
Patient was adinistered Pneumococcal Vaccine Right Deltoid IM, Reported back the next day with Pain, swelling, redness of Right Deltoid area up to shoulder and down to elbow area
I had throat constitution and severe sore throat and runny nose. I took a home test for COVID-I9 and the results were positive.  The illness came on really fast, but it didn't last too long. I called to make an appointment via telehealth on the of June after dealing with the symptoms for a few days. The doctor prescribed Paxlovid. These symptoms lasted for about days.
Brain fog; Bust out in rash all over the body; Rash all over body and was burning; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Rash all over body and was burning), FEELING ABNORMAL (Brain fog) and RASH (Bust out in rash all over the body) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21 and 091D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced BURNING SENSATION (Rash all over body and was burning) and RASH (Bust out in rash all over the body). On 24-Aug-2021, the patient experienced FEELING ABNORMAL (Brain fog). In September 2021, FEELING ABNORMAL (Brain fog) had resolved. At the time of the report, BURNING SENSATION (Rash all over body and was burning) and RASH (Bust out in rash all over the body) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.  It was reported that the pharmacist recommended to take but patient didn't took it as she did not like drugs. 1 month after bump down arm she got injection in back and so was rash all over body.   This case was linked to MOD-2021-329732 (Patient Link).
Patient had redness, inflammation down to his elbow, along with a fever.  This was increasing in severity over the course of past 3 days until he visited a doctor today.  He was diagnosed with cellulitis.
pt recv vax 8APR97, on 15APR stiffness shoulders, 16APR upon waking both hands & wrists were swollen, 2+ pitting edema, both hands & wrists joints were still & very painful;employee hlth was notified on 16APR, 17APR went to pvt MD;
Dizziness, Myalgia, Soreness at injection site. Feeling dizzy. Loss of sense of taste and smell. Fatigue. Missed work 12/30/20, left work early on 1/11/21 Narrative:
Tested COVID19 positive; Sore Throat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested COVID19 positive), OROPHARYNGEAL PAIN (Sore Throat) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat) and HEADACHE (Headache). On 19-Jan-2021, the patient experienced COVID-19 (Tested COVID19 positive). At the time of the report, COVID-19 (Tested COVID19 positive), OROPHARYNGEAL PAIN (Sore Throat) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment details were not provided.
Can barely walk/Use a walker; Balance is off; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: GAIT DISTURBANCE (non-serious), outcome "unknown", described as "Can barely walk/Use a walker"; BALANCE DISORDER (non-serious), outcome "unknown", described as "Balance is off". The events "can barely walk/use a walker" and "balance is off" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of gait disturbance, balance disorder. Additional information: Caller is calling about "Super COVID-19 vaccine". She had the vaccine and can barely walk and a lot of people she knows had the same thing. Her balance is off and she has to use a walker. There is one lady at church and were the only 2 that got vaccinated and both have some problem. She is really pissed off. She has been to Physical Therapy and everything and done a lot of testing. She knows the vaccine caused this. She has seen her primary care doctor and neurologist. She states hang on she has to take this call.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s): PFIZER INC-202300051110 same product and event, different patient;
PATIENT RECEIVED A PEDIATRIC PFIZER COVID MONOVALENT VACCINE AT AGE 4 YEARS OLD.  THE PRODUCT RECEIVED IS ONLY APPROVED FOR PATIENTS AGES 5 TO 12 YEARS.  PER PATIENT'S MOTHER THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS FROM THE VACCINE.
an hour  after  the vaccine  headache  cheat pain  nausea swelling in right arm  weak  chills
About 20 minutes post shot (both first and second) I got weird tongue swelling. Went away after about 20 min.  Later in the evening after 2nd shot on the 31st my arm became red, hot to the touch, swollen, and hard. Very painful and at times itchy. This lasted 4 days. The next day after the second shot (April 1st) I got severe nausea and severe joint pain to where I could not stand or lie down comfortably at all. No relief. Also got chills and felt very feverish although I had no fever. This lasted most of the day but subsided by late evening.