chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bellafill facial filler was "hard as a rock"; This spontaneous case was reported by a consumer and describes the occurrence of INSTILLATION SITE INDURATION (Bellafill facial filler was "hard as a rock") in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included Dermal filler injection (Patient states the filler was put in 5 years ago) since April 2016. Concurrent medical conditions included Food allergy (Patient is allergic to wheat and oats) and Shellfish allergy (Patient is allergic to Shellfish allergy).  On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 26-Feb-2021, the patient experienced INSTILLATION SITE INDURATION (Bellafill facial filler was "hard as a rock"). At the time of the report, INSTILLATION SITE INDURATION (Bellafill facial filler was "hard as a rock") outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
tinnitus; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 68-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Dec2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Single), for COVID-19 Immunization, reaction(s): "Sore arm"; Bnt162b2 (Dose 1, Single), for COVID-19 Immunization, reaction(s): "Sore arm". The following information was reported: TINNITUS (non-serious) with onset Dec2022, outcome "unknown".  Additional information: Refers getting the primary series experiencing only soreness and after that a first booster dose on 06Dec2022. Eight hours after getting the Pfizer BioNTech COVID-19 booster, she experienced tinnitus. The caller wants to know if there is any information available regarding patients who received the PFizer BioNTech COVID-19 bivalent booster and experienced tinnitus. She refers wanting to get the bivalent booster but she has already cancelled three appointments to get it out of fear that the tinnitus would come back. Caller is an audiologist. Caller states she was looking for more information about Tinnitus, and research on the new bivalent vaccine.   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-202201398398 same patient, different vaccine dose/AE.;US-PFIZER INC-202201398399 same patient, different vaccine dose/AE.;
This spontaneous report was received from an administrator concerning patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, historical drugs or allergies were not reported. On 08-MAR-2019, the patient was vaccinated with one dose of improperly stored VARIVAX lot number R022117, expiry date 02-AUG-2020 (strength, dose, route and frequency were not reported) for prophylaxis. No adverse effects were reported. The administered dose of VARIVAX experienced a temperature excursion 15 fahrenheit (degrees F) to 46 degrees F (29.0 degrees F) for 4 hours and 3 minutes. With a previous temperature excursion of 6 degrees F to 14 degrees F (10.1 degrees F), (8.6 degrees F), (5.6 degrees F), (6.3 degrees F), (8.6 degrees F) for 45 hours and 27 minutes. It was not recorded by a data logger. No adverse effects were reported. No product quality complaint was involved.
This is a spontaneous report received from contactable consumer or other non-HCP (the patient). Case identifier: 22K-163-4446716-00). An 85-year-old female patient received the 3rd dose (first booster) of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), intramuscularly, single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (intramuscular), for COVID-19 immunization, reactions: dry cough, dry throat, falling, broken hip, interstitial lung disease and postnasal drainage; and the 2nd dose of BNT162B2 (intramuscular), for COVID-19 immunization, reactions: dry cough, dry throat, falling, broken hip, interstitial lung disease and post nasal drainage. The patient experienced arthralgia/joint pain and nausea, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Less than 6 months for administration of booster dose after 2nd dose; Swelling in right arm; Redness in right arm; Fatigue; Headache; Joint pain; Chills; Nauseousness; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 6 months for administration of booster dose after 2nd dose), VACCINATION SITE SWELLING (Swelling in right arm), VACCINATION SITE ERYTHEMA (Redness in right arm), FATIGUE (Fatigue) and HEADACHE (Headache) in a 71-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.     Concurrent medical conditions included Blood pressure high.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 6 months for administration of booster dose after 2nd dose), VACCINATION SITE SWELLING (Swelling in right arm), VACCINATION SITE ERYTHEMA (Redness in right arm), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain), CHILLS (Chills) and NAUSEA (Nauseousness). On 03-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Less than 6 months for administration of booster dose after 2nd dose) had resolved. At the time of the report, VACCINATION SITE SWELLING (Swelling in right arm), VACCINATION SITE ERYTHEMA (Redness in right arm), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain), CHILLS (Chills) and NAUSEA (Nauseousness) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications include High blood pressure medication. No Treatment information was reported.   This case was linked to MOD-2021-375447 (Patient Link).
1 yr IZ's given on 7-25-13 = PENTACEL, Hep A, MMR, Pneumo, Hep B.
Developed uncontrolled sneezing, coughing, rhinorrhea initially. Lip swelling with blister noted. Vomited x 1. Tachycardia 182. Pt was administered Epi Pen, Jr. In LT thigh @ 0915 with quick resolution of initial symptoms. Reddened generalized rash/hives developed approximately 1 hour later. No other symptoms noted. Pt was administered oral Benadryl @ 1025 with quick resolution of symptoms. Pt was released home after observation @ 1045 with PO Benadryl ordered. Specific discharge instructions given to mother to report to ER if symptoms resumed.
fatigue, heavy headache, muscle/joint pain, chills, nausea, fever (100.3f) -- took seveal excederin
Patient has had prolonged soreness, muscle weakness, and immobility of left shoulder, no relief since 11/4/18 when the vaccine was given.
Dry throat; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 12Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VAC-CINE, Solution for injection), via an unspecified route of administration on 02Apr2021 as a single dose for COVID-19 immunization. The patient was not certain but about the same time as had his first vaccine dose the patient began experiencing trouble with having a dry throat at night stating. The patient did not know if this was related to the vaccine or not. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recvd 1st vax on 1SEP94 & was sl irritable the 1st day then reveted back to nl self next day or two; weight gain slowed down briefly for 1 wk, then picked up again; also exp tonic sz x 30 seconds; also exp poor feeding;
person is now positive with symptoms of covid as of 4/3/21. runny nose, subjective fever, chills, myalgia, sore throat, cough
Arm pain, severe body ache, intermittent headache, rosy skin 5 inch circle where shot applied; all conditions begin peaking 7 hours after shot; fading after 48 hours.
On the drive home from my vacation, I got a deep pulmonary embolism. I toughed it out during the weekend but went to the ER Monday morning. I received a shot that dissolved the embolism and was prescribed Eliquis for 6 months.
Myalgia, Arthralgia & Fever Narrative: missed one day of work following second dose due to flu like symptoms
7 days after injection - red tender nodule at right thigh; No F/c - possible infection - no fructame, no d/c - will Rx with Aox to be safe
Injection site redness; Injection site tenderness; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE PAIN (Injection site tenderness) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE PAIN (Injection site tenderness). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE PAIN (Injection site tenderness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Burning sensation traveling from left shoulder to left side of neck. Burning sensation traveling from under left arm down to left side of waist. Burning sensation traveling down left arm, resulting in temporary loss of use of fingers on left hand. Soreness at injection site. Weakness in left arm. Alternating chills and hotness. Muscle and joint aches from top of head to bottom of feet. Fatigue. Headache. Intermittent nausea and dizziness. Never ran a fever. Spoke to primary care physician's office, who told me to report to this website.
Grand mal seizure took place about 10 minutes after administration. Paramedics arrived on scene after seizure had ended. Upon examining the patient, EMT determined the pt was fit to go home
Got Tdap on Thursday 7-30-09 - Saturday 8-1-09 went to ER - was told come back to clinic that gave shot. Rt arm slightly swollen with hard circular area - sore to touch - came to HD Wed 8-12-09 - told to use warm compresses.
A couple of days after my shot, I started to get extremely tired and fatigued.  Then later that evening on Friday, my body started to ache.  Saturday the symptoms continued with exhaustion and body soreness.  Ibuprofen helped with the aches.
The vaccine was given on 9/14/00, By Saturday evening on 9/18/00 the pt developed a fever of 99. His temp rose to 102 and then to 105 in one ear and 104.3 in the other. The pt was given Motrin. The pt then suffered a seizure. After being cooled down in the Ambulance, his fever was 104.3. His fever fluctuated in the 99 - 100 range. He also experienced a rash on his torso.
experiencing most of the general side effects; A spontaneous report was received from a consumer concerning a 79-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events most of the general side effects/adverse drug reaction.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 06 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unavailable) (unknown route) for prophylaxis of COVID-19 infection.  On Feb 2021, the patient experienced the event(s) most of the general side effects.  Treatment details included Not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), most of the general side effects was unknown.
Very hot; skin is burning and it is all over; itchiness all over body; Hives all over body; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 11Apr2021 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included losartan (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN), ethinylestradiol, norgestimate (TRI-SPRINTEC): all for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 21Mar2021 at 15:30 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. On 12Apr2021 at 23:00 the patient experienced hives and itchiness all over body, very hot like skin was burning and it was all over. On an unknown date, the patient underwent nasal swab, SARS CoV-2 test and the result was unknown. Since the vaccination, the patient had been tested for COVID-19. The event 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 hives and itchiness all over body, very hot like her skin was burning and it was all over were not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
Syncope about 10 minutes after the COVID19 Vaccine was received, followed by a brief state of disorientation, nausea, lightheadedness and diaphoresis.  No vomiting. Patient's initial SBP was 99 and it quickly dropped to 88. HR 32, Epinephrine administered. SBP rose to 91, HR to 42. 2nd dose of Epinephrine was administered and EMS called and took patient to the ED at hospital.
Pt reports feeling shaky/lightheaded several minutes after receiving his vaccine.  He was transported to medical observation by wheelchair.  He was visibly shaky on arrival, but vitals were WNL.  He denied shortness of breath, swelling of the face/tongue/throat, rash.  He remained anxious for several minutes while in medical observation, but continued to deny other symptoms.  His shakiness subsided after several minutes, and pt reported no symptoms at the time of discharge.  Pt discharged at 2:51pm.   He drove himself home.  Vitals as follows: 2:25pm HR- 95 BP- 140/71 SPO2- 99  2:30pm HR- 97 BP- 135/71 SPO2- 100  2:37pm HR- 104 BP- 146/63 SPO2- 100  2:43pm HR- 83 BP- 138/71 SPO2- 100  2:47pm- sitting HR- 89 BP- 137/68 SPO2- 99  2:51pm - standing HR- 104 BP- 144/63 SPO2- 100
Patient died / Cause of Death Cardiac Arrest; racing heart rate; started having shortness of breath; heaviness in chest; fatigue; This is a spontaneous report from a contactable consumer. This consumer reported for a 50-year-old male patient that, A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735) via an unspecified route of administration on 03May2021 (at the age of 50-years-old), as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included diabetes mellitus and Other medical history: diagnosed with diabetes while in hospital. Patient had no Known allergies.The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150) on 12Apr2021 as DOSE 1, SINGLE for COVID-19 immunisation. On 14Jun2021, patient died due to cardiac arrest, shortness of breath, racing heart rate, fatigue, heaviness in chest. Date of death: 09Jul2021. Autopsy was not performed. He was hospitalized for 15 days. Patient received treatment included medication. He did not have covid prior to vaccination. He was not tested for covid post vaccination. He was on other medicines in two weeks which included multivitamins. Patient did not take any other vaccine in four weeks. The patient underwent lab tests and procedures which included angioplasty: no blockage on, cardiac electrophysiologic study: unknown results on, cardiac stress test: unknown results on, echocardiogram: unknown results on.The outcome for the events was fatal.  The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Cardiac arrest
p/vax pt eyes glazed; 1 bloody mucousy stool; vomited x3; would not eat;became ghost white; dehydrated by evening;lethargic;adm to hosp; tests revealed obstruction;dx w/intussusception;surgery 4/24.  Annual follow-up received on 9/26/00 states that she has recovered but may have the irritable bowel syndrome for the rest of her life.
nurse gave an injection of expired DAPTACEL to a child, no adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other healthcare professional via Medical Information (Reference number- 00708308).  This case involves a three-year-old male patient who was given an injection of expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL], no adverse event (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  No concomitant vaccines was received by the patient.  On 02-Aug-2021, the patient received a 0.5ml dose (dose 4) of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C5624AA; expiry date: 10-Jun-2021) via intramuscular route in unknown administration site for prophylactic vaccination.  It was case of actual medication error due to expired vaccine used (latency: same day).  It was reported, "Office manager reports that a nurse gave an injection of expired DAPTACEL to a child; asking if this child would need to receive another dose of DAPTACEL. DAPTACEL had expired 10JUN2021."  No adverse events were reported at the time of reporting.   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. 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.
arm had been hurting/hurting worse; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on an unspecified date (at the age of 37-year-old), at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization; and had arm hurting. Patient received her second dose "today". Her arm had been hurting since she got the first shot. She got the second one in the same arm and it was hurting worse now and said it would probably get worse. She wanted to know why it was still hurting and how long from the first shot it will still be hurting. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Tingling sensation bilateral upper extremities; This is a spontaneous report from a contactable nurse. A 44-year-old male patient received her second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231) on her left arm, via an unspecified route of administration on 12Jan2021 17:45 at a single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included ibuprofen. Historical vaccine included on 22Dec2020 (first dose) and experienced Bilateral lower extremity numbness, Tingling and Foot pain. It was reported that the patient had tingling sensation bilateral upper extremities on 12Jan2021 18:00. Continues to present day. PCP following prescribed gabapentin. The outcome of the event was not recovered.
suspected covid 19; drug ineffective; This is a spontaneous report from a non-contactable consumer (patient daughter) through a Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. As per the reporter, her father (orthopedic surgeon) died of covid-19 vaccine on an unspecified date. The patient underwent lab tests and procedures which included had 2 negative PCR test 14 days later. The patient died on an unspecified date. It was not reported if an autopsy was performed.  No follow-up attempts are possible; batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: suspected covid
Felt swelling in back of throat within 30 minutes; reported to facility when he arrived for 2nd dose
Large red swelling at site of DTaP injection on right thigh with some fluid/vesicles, started about 72 hours after vaccination, resolved somewhat over next three days.
Pain in legs/arms, extremely high fever, chills, nausea, tiredness, severe headache, extreme dizziness, redness and swelling at injection site.
Information has been received from a registered nurse concerning a 19 year old female with no pertinent medical history or drug reactions/allergies who in November 2008, was vaccinated IM with a 0,5ml dose of GRADASIL (lot #: 659184/0843X). There was no concomitant medication. 3 days after the vaccination, the patient developed a cold. The patient experienced runny nose but no fever. At the time of this report, the patient was recovered. The patient did not seek medical attention. Additional information has been requested.
pt recvd vax & exp persistent crying, staring, spitting up, cranky, pale, sleepy;