chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bell's Palsy; Vertigo; face numbness; I also have episodes of excessive sweating and flushing; I also have episodes of excessive sweating and flushing; developed red sores on the edge of my lips; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 27Apr2022 as dose 3 (booster), single (Lot number: F35682) at the age of 41 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "allergies: Latex" (unspecified if ongoing), notes: Known allergies: Latex. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (prev dose lot number=ER8732,, prev dose number=2), administration date: 07Apr2021, when the patient was 40-year-old, for COVID-19 Immunization, reaction(s): "COVID-19", "Bell's Palsy", "Vertigo", "face numbness", "episodes of excessive sweating", "flushing"; BNT162b2 (prev dose lot number=EN6199,, prev dose number=1), administration date: 18Mar2021, when the patient was 40-year-old, for COVID-19 Immunization, reaction(s): "COVID-19". The following information was reported: BELL'S PALSY (disability, medically significant) with onset 28Apr2022, outcome "not recovered"; HYPERHIDROSIS (disability), FLUSHING (disability) all with onset 2022, outcome "not recovered" and all described as "I also have episodes of excessive sweating and flushing"; VERTIGO (disability) with onset 2022, outcome "not recovered"; CHEILITIS (disability) with onset 2022, outcome "not recovered", described as "developed red sores on the edge of my lips"; HYPOAESTHESIA (disability) with onset 2022, outcome "not recovered", described as "face numbness".  It was reported that, again 40-50 days after booster shot on 28Apr2022. Patient also developed red sores on the edge of his lips. Patient had never had either of these things before in his life. Until after the vaccine. He also had a breakthrough Covid infection in Aug2021. The events "bell's palsy", "vertigo", "face numbness", "i also have episodes of excessive sweating and flushing" and "developed red sores on the edge of my lips" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: If covid tested post vaccination: Yes. Therapeutic measures were taken as a result of bell's palsy, vertigo, hypoaesthesia, hyperhidrosis, flushing, cheilitis.  Follow-Up (23Jun2022): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200866994 Same patient, different dose and event;US-PFIZER INC-202200867634 Same patient and event, different dose;
1st dose on 03Nov/2020, 2nd on Aug2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 80-year-old male patient who received Herpes zoster (Shingrix) (batch number Y44ZT, expiry date 10th July 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 3rd November 2020, batch number DN74H which corresponds to a Shingrix adjuvant).   In August 2022, the patient received the 2nd dose of Shingrix. In August 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 04-NOV-2022 Reporter's Comments: The reporter asked for information about a patient never got the second dose in the next 6 months.  The reporter did not provide the exact date of the dose administered in August 2022 The reporter asked if the first dose counted or patient had to receive an extra dose of shingrix.  The reporter was consented to follow up.  Additional Supportive Information: The patient received 2nd dose later than the recommended interval, which led to lengthening of the recommended interval between vaccine doses.
We administered Pfizer vaccine to patient and billed her insurance with no issues. The next day, patient's son called to let us know that his mom had already received 2 doses of Moderna vaccine earlier in the year. She apparently wanted to be entered into the drawing for vaccines and may have memory issues (her per son.)
Couldn't get air in real good; Couldn't eat; Still is real weak; Hard to breath with exertion; Felt like she has COVID again; Threw up all night; Had fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Couldn't get air in real good), DECREASED APPETITE (Couldn't eat), ASTHENIA (Still is real weak), DYSPNOEA EXERTIONAL (Hard to breath with exertion) and SUSPECTED COVID-19 (Felt like she has COVID again) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 31-Dec-2020.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PYREXIA (Had fever). On an unknown date, the patient experienced DYSPNOEA (Couldn't get air in real good), DECREASED APPETITE (Couldn't eat), ASTHENIA (Still is real weak), DYSPNOEA EXERTIONAL (Hard to breath with exertion), SUSPECTED COVID-19 (Felt like she has COVID again) and VOMITING (Threw up all night). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at a dose of UNK dosage form. On 01-Mar-2021, PYREXIA (Had fever) had resolved. On 02-Mar-2021, DECREASED APPETITE (Couldn't eat) had resolved. At the time of the report, DYSPNOEA (Couldn't get air in real good), ASTHENIA (Still is real weak), DYSPNOEA EXERTIONAL (Hard to breath with exertion), SUSPECTED COVID-19 (Felt like she has COVID again) and VOMITING (Threw up all night) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow up information received and contains significant information- Event outcome updated for the events Dyspnoea, Suspected COVID-19 and  Vomiting from Unknown to Recovered/ Resolved, and for the events Asthenia and Dyspnoea exertional  outcome updated from Not recovered / Not resolved to Recovered/ Resolved.
intussusception; INTESTINAL OBSTRUCTION; Information has been downloaded US-EMA-20110131-rtevhumanwt-190621250.  This spontaneous report was received from  a health professional referring to a 4 month old male patient with no relevant medical history and no concurrent conditions.    On 08-JUL-1999, the patient was vaccinated with a dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (dose, lot #, expiration date, route,  therapy type and indication were not reported).  Other suspect therapies included diphtheria toxoid, pertussis acellular 4-component vaccine, tetanus toxoid(ACEL-IMUNE), hib conj vaccine (crm197) (HIBTITER), poliovirus vaccine inactivated (unspecified)(POLIOVIRUS VACCINE INACTIVATED (UNSPECIFIED)) (dose, lot #, expiration date, route and indication were not reported) and one dose of rotavirus g1 g2 g3 g4 reassortant vaccine live (human-rhesus)(ROTASHIELD), orally, (dose, lot # and expiration date were not reported) for immunization; all vaccines were administered on 08-JUL-1999. Concomitant therapies were not reported.     On 13-JUL-1999, the patient experienced intestinal obstruction and was hospitalized. On an unknown date, the patient experienced intussusception and was hospitalized. Later, on an unknown date,, the patient recovered from intestinal obstruction. By the time of the report, the outcome of intussusception was unknown.   The reporter's causality assessment between the suspect vaccines and the above mentioned events was not reported.  The reporter considered intestinal obstruction and intussusception to be life threatening and medically significant.; Sender Comments:Fax-ref: F1081D1
Itchiness at injection site; Red blotchy arm  that spread at injection site; Red blotchy arm  that spread at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red blotchy arm  that spread at injection site), VACCINATION SITE PRURITUS (Itchiness at injection site) and RASH MACULAR (Red blotchy arm  that spread at injection site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red blotchy arm  that spread at injection site) and RASH MACULAR (Red blotchy arm  that spread at injection site). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchiness at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red blotchy arm  that spread at injection site), VACCINATION SITE PRURITUS (Itchiness at injection site) and RASH MACULAR (Red blotchy arm  that spread at injection site) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment details included Antibiotics.
DISCHARGED FROM HOSPITAL  ON 12/29/21 WITH DIAGNOSIS OF PNEUMONIA AND A -FIB.  PT SEEN IN OFFICE ON 1/11/22 WITH SYMPTOMS OF FATIGUE, CHEST TIGHTNESS, DYSPNEA, FEVER, SYMPTOMS WORSENED OVER LAST 2 DAYS  ADMITTED TO HOSPITAL
Swelling on injection site, some numbness/tingling on left cheek. No hives or itching, no breathing problem.
Fever 100.8 on 6/4/14, fever 102.4 6/5/14, no other symptoms.
2 days post vaccine developed area of redness, soreness, HA, area tender to touch.
later the evening of the vaccine, pt noticed pain in the upper arm, redness, swelling. Pt went to pharmacy where vaccine was given was advised to ICE, Tylenol. Pt presents to office today with minimal swelling, redness the size of baseball continues to have pain, but states Tylenol + ICE do HELP. Patient was seen by Dr. on 3/10/2020 and was given an antibiotic for cellulitis Keflex 500 g TID x 10 days It was determined later that this patient has already had both doses of Shingrix in 2018. This was her 3rd dose! All doses were given at local pharmacies. Pt has been given a copy of her updated vaccine record to carry with her.
TOOK UNREFRIGERATED DOSES; This spontaneous case report (PVX2019-1946) was received from a pharmacist on 29-Jul-2019. It described a 42-year-old adult female consumer who "took unrefrigerated doses", while being on oral Vivotif (one capsule every other day) for typhoid prophylaxis.   Case report: The consumer left Vivotif out of the fridge for about 3 days. The consumer refrigerated it after she realized, and took it as directed. The doses were taken on 7-Jul-2019, 9-Jul-2019, 11-Jul-2019, and 13-Jul-2019.  Action taken with Vivotif was unknown.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.
Case number PHEH2015US021458 is an initial spontaneous report received from a pharmacist on 20 Oct 2015. This report refers to a 54 year old male patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514601) intramuscularly on 20 Oct 2015. On the same day, patient experienced immediate injection site reaction. It was reported that the site was a little red, hard and swollen. The outcome of the events was reported as complete recovery. Seriousness and causality of the events were not reported
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable consumer. The reporter is the patient. A 50-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Patient has no known allergies. Concomitant medications included: OMEPRAZOLE; ROSUVASTATIN. Patient received PAXLOVID as COVID 19 Treatment from 06Jul2022 to 10Jul2022 and experienced rebound symptoms, retested positive on rapid test (AER#202201041789). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Retested positive on rapid test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Outcome of the events was not recovered.
Fever 100.8F oral, body aches. Rest, Thera-Flu, OTC Flu RX. Felt better Sunday 1/23 and "normal" Monday 1/25.
patient called complaining of sore arm. she said shes been icing and using tylenol however it is not improving but not getting worse. recommended if the sore arm continues to go see a doctor but explained sore arm is common side effect with vaccine
Soreness, "nerve" pain, discomfort on side of injection - up neck and shoulder some nerve discomfort of face.
Rash started to appear around varicella injection sight on patient's left thigh on 01/03/2022. It then spread to her trunk, arms and neck the next day and injection sight appears bruised. Followed up with patient's mother on 01/05/2022 and mom states it looks like hives and is also on her face. Directed mom to contact their health provider and get recommendations on if she needs treatment and to see if it is break through chicken pox or a vaccine reaction.
I have had lots of hives and swelling since day 2 of the shot.  Some of the hives were so big.  The bottom of both of my feet were swollen for 2 days, then it jumped to my right hand, over to my left elbow.  I woke up with a swollen eye yesterday, and now today huge hives on my arm.  It has been 17 days and I have been living on Benedryl
feeling that I was going to pass out. faint; warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart; Fast heartbeat; headache; blood pressure went down drastically; tachycardia; weak; looked pale; Anxiety; This is a spontaneous report from a contactable Other HCP (patient). A 47-year-old female (not pregnant) patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 18Dec2020 10:00 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included patient was alergic to environmental or insect allergens. No food no medication''. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included loratadine. The patient receive other vaccines within 4 weeks prior to the COVID vaccine was immunotherapy vaccine against mold, insect, mites on 02Dec2020 on both arms. It was reported ''3mins post injection: warm feeling starting on my right arm going down to my left leg. feeling that I was going to pass out. faint. goes and come. I was feeling that I was going to pass out like 3 times , but I was in a wheelchair.. Thanks God and warm feeling from my right leg up to my heart. Fast heartbeat, and weak and sudden headache. Symptoms goes and come. it last 15 mins. Once I was brought to ER.. they estabilize my tachycardia and gave me benadryl. I did get better, but still weak. Stay 2 hours for observation. By the time I got to ER, I was a little better. Physician diagnoses as Anxiety event. because I got estabilize and never got a rash, difficulty breathing. I am 100%, my body for whatever reason it could be, did not welcome the vaccine. and blood pressure went down drastically...i looked pale as they told me.''. Adverse events start date was reported on 18Dec2020 10:03 AM. Case was non-serious. Treatment received for the adverse events included medicine for tachychardia and Benadryl. AE warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart and feeling that I was going to pass out. faint resulted in: [Emergency room/department or urgent care]. The outcome of the events ''warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart'' and ''feeling that I was going to pass out. faint'' was reported as recovered. The outcome of other events was unknown.  Information about Lot/batch number has been requested.
COVID-19 I tested positive for Covid on July 22, 2022, I experienced nasal congestion, mild headache, frequent cough with phlegm, no fever, those are the only symptoms that I've experienced. I sought a medical professional for my symptoms and was prescribed cough suppressant, the cough suppressant did not help so I went back to the Dr. and was prescribed hydrocodone cough suppressant.
Myalgia chills fatigue Narrative:  x4 d after #1 dose pain at site x3 d after #2 dose chills fatigue  Other Relevant History:
Patient has reported prolonged nosebleeds occurring every other day since he received the Janssen Covid vaccine on 03/30/2021. Today (04/12/2021) he cut himself shaving and experienced prolonged clotting time.
Swelling at injection site Narrative:  Patient received his second dose of the Moderna COVID-19 vaccine on 2/12/21. 4 days after injection, he was still experiencing pain and swelling at the injection site, along with myalgia and arthralgia. Pain was significant enough that patient had difficulty sleeping.
Stiffness and increasing pain in shoulder, arm.  Inability to sleep due to pain.  Unable to rollover at night, and loss of use of arm.  Saw 2 doctors, neither of which could identify the source of the pain.  Inability to rise from bed or couch without assistance.  Both doctors recommended physical therapy.    I waited to visit a doctor for a week, then another week to see a specialist.  I started physical about 3 weeks after the vaccine was admiistered.
The initial case was missing the following minimum criteria: Unspecified AE. Upon receipt of follow-up information on 11Sep2015, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable other health professional via a sales representative. A 94-year-old female patient received PREVNAR 13 (Lot # L77780, Exp Date Jan2017), intramuscular in the left deltoid at 15:00 on 14Aug2015 at 0.5 ml, single. No other vaccines were given on 14Aug2015 along with PREVNAR 13. Medical history included osteoporosis from Aug2014 and ongoing, ongoing glaucoma, ongoing chronic rhinitis and ongoing corneal transplant. Concomitant medications included dorzolamide hydrochloride, COSOPT (2-0.5% eye drops) one drop to right eye twice a day, SENNA PLUS ( 8.6-50 mg tablet) two tablet by mouth at bedtime, famotidine (40 mg tablet) one tablet by mouth daily, SOPTO CARPINE (1% eye drops) one drop three times a day, aspirin (81 mg) one day by mouth daily, carvedilol (6.25 mg tablet) one tablet by mouth at bedtime, amlodipine besylate (5 mg tablet) one tablet by mouth daily, PHOSPHOLINE IODIDE (0.125% eye drops) one drop in right eye once a week, MUCINEX as needed for chronic rhinitis and multivitamin capsule, one capsule by mouth daily. The patient received the vaccine in the HCP's office and she experienced cellulitis and abscess on an unspecified date which lead to hospitalization. A family member called and informed the HCP's office that the patient had to have surgery due to the reaction she had due to vaccine. The abscess was surgically incised and drained; a wound vac was applied to the left upper extremity wound. After discharge from the hospital, the patient was admitted to the Skilled Nursing Rehab Unit on 25Aug2015. While at the Skilled Nursing Rehab Unit, the patient was re-admitted to the hospital for hyponatremia on 01Sep2015. This hospital course complicated by management of a UTI (Urinary Tract Infection) with CIPRO 500 mg. The patent was treated at the hospital and discharged back to the Skilled Nursing Rehab Unit on 10Sep2015 with a diagnosis of hyponatremia. It is unknown if the patient still had the wound vac in place. Left upper extremity wound in healing. The patient cannot take FLONASE due to her glaucoma. She had bad reactions to antihistamines. The patient cannot take decongestants. Cultures drawn during the first hospital admission were negative. The patient underwent lab tests and procedures on 31Aug2015 which included calcium serum 8.1, chloride serum 78, glucose 111, osmolality 235 and sodium 113. It was also reported that the patient had atrial fibrillation (A fib) and hypertension both in Aug2015, gastrooesophageal reflux disease (GERD) on 14Aug2015, antidiuretic hormone secretion on 10Sep2015, unsteady gait on 28Aug2015 and sepsis on 26Aug2015, and she still had these problems. Therapeutic measures were taken as a result of abscess. The outcome of the events was unknown.
Psoriasis flare. Prior to the covid vaccine, psoriasis was limited to scalp, knees and elbows. After the vaccine, psoriasis lesions spread to both legs, both feet, both arms, lower back, upper back and abdomen. The lesions have persisted ever since. I have never had a psoriasis flare comparable to this.
Rash inside forearms March 13-16.... March 14th only! (fever, chills, body ache, fatigue, cough, loss appetite.)
Syncope. Pt. passed out after getting the flu shot. She woke up shortly after. (Stated she had a history of passing out with blood work).
Small red raised bumps developed on the arms. Since time of onset, red raised bumps have spread to the abdomen, face, and back. No fevers. No local injection site reaction noted.
PATIENT DEVELOPED A RASH ON STOMACH & BACK, NOT ITCHY, BUT A LITTLE RAISED. PATIENT FELT ACHY, CHILLS.  INJECTION SITE WAS RED, PUFFY, AND WARM.  RASH ON RIGHT ARM DEVELOPED BUT PATIENT RECEIVED VACCINE IN LEFT ARM.  ALL SYMPTOMS WERE RESOLVED BY TUESDAY THE FOLLOWING WEEK.
Redness, swelling & heat of left upper arm approximately 2/3 and posterior shoulder treated as if cellulitis.
Narrative: PATIENT REPORTS 8 HOURS AFTER 1ST DOSE PAIN IN ARM, L SHOULDER BLADE AND LEGS. WENT INTO NECK AND R SHOULDER. PAIN GOT BETTER DAY 2, NORMAL DAY 3.
Pt recvd a series of 3 doses of Engerix-B & exp no adverse exp, however did not seroconvert; plan to revax;
continuous-  headache; itchiness; all over body ache, brain fog/ confusion; dizziness; extreme  psoriatic arthritis flare up(upper spine, lower back, neck, hips, rib;  extremely cold sensation in extremities; chills with no fever;  jitteriness; fatigue; diminished short term memory;  light headedness at time of injection- pain, redness. itchiness, knot at injection sight; extreme headache treatments- cold compresses on injection sight; Benadryl; Arnica for pain; Arnica rub for pain
Red, sometimes slightly painful, sometimes itchy skin rash on hands/wrists. Examined at urgent care on 6 Dec 2021. Tried two topical antifungals, one topical antibiotic, and one antifungal pill, to no effect. Topical steroid helps but does not completely get rid of the rash. I am seeking treatment at a dermatologist on 22 Aug 2021
Received vaccine, got sick the same day and passed away that Saturday. I truly believe that the vaccine caused his death  Moderna