chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 18-Feb-2019 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a three months (also reported as four months) old female patient who was vaccinated with a dose of PENTACEL, which was not reconstituted properly. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. Concomitant vaccinations included PREVNAR 13 for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation. On 14-Feb-2019, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: C5576AB and expiry date: 18-Oct-2019) (dose in series was not reported) via intramuscular route in the right thigh. It was a case of actual medication error due to inappropriate reconstitution technique as Pentacel had been diluted with regular saline and not the provided diluent. It was not reported if any adverse event occurred or not. 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 set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. List of documents held by sender: none.
Skin rash on the extremities of the right leg with itching and then an ulcer in the form of cellulitis, swelling in the legs and ankles.
red, hot, swollen bump at site of injection, starting to show a day or two after injection, reported to us 4 days after injection.
two days after vaccination he developed chills, myalgias and tactile fever.  He then developed rash consistent with Henoch-Schonlein Purpura in addition to gross hematuria, severe stomach pain.  These symptoms resolved, only to return two weeks later with severe stomach pain, hematuria and rash again.  He was given prednisone due to pain which relieved symptoms.  He completed 14 days of prednisone.  He continue to have 2-3 more episodes of gross hematuria before presenting to my office for further evaluation.
reports vague symptoms of feeling " lightheaded, foggy- changing to a heavy feeling in her occipital region."   no other associated S&S.   A&O x 3, conversant; following commands.  Symptoms improved but not resolved after 15 mins.   TX:  mask removal; fresh air; seat reclined X 10 mins; Sat upright & given bottle of water; will allow to relax & recheck after 15 mins.
Patient was inadvertently given an unreconstituted dose of the vaccine. Due to human error the vial was not reconstituted and I gave her the 0.3ml dose. The error was caught by staff administering the next vaccine. Patient was called and advised of error and told to watch out for worsening symptoms. At the time of notification patient had no side effects or symptoms at all. Patient was told to go to Emergency Department if any severe symptoms develop and she was advised in detail what common symptoms to look for. She was also told to let her employer know if she develops mild symptoms. Patient expressed understanding.
history of hypertension, mild cognitive impairment.  Prior COVID pneumonia treated as an outpatient November 2020.  Completed dose 2 of Pfizer  vaccine  4/11 with progressive fatigue low-grade fevers and white count of 14 CRP elevated at 4 (see this would equate to a CRP of 40 with most other lab references) on 04/27.  He was admitted and treated for community-acquired pneumonia with ceftriaxone and azithromycin.  He was discharged 04/30 and then presented again 5/5 with progressive right greater than left consolidative ground-glass opacities and hypoxemic respiratory failure requiring up to FiO2 80% of high-flow nasal cannula.  Infectious workup has been negative.  He has been too unstable to bronch.  COVID-19 testing has been negative.  He was started on high-dose steroids 5/8 with stability and slow gradual improvement.
Patient indicating that she experienced: chest tightness, fever, chills, hot flashes, nausea, vomiting, headache and a thick white crust on her tongue and around her mouth.  Today, however she is feeling fine and only has the headache that she admitted might be due to lack of caffeine.
Narrative: Patient received first COVID19 vaccine (Moderna) outside of facility. Per nursing note on 3/05/21, He already had one [COVID19 vaccine] and had a bad reaction that put him in the hospital so he will not be getting another one. No further details provided.
Itchy Rash on neck, back and upper chest; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Itchy Rash on neck, back and upper chest) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METOPROLOL, AMLODIPINE and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 29-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 RASH PRURITIC (Itchy Rash on neck, back and upper chest). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Itchy Rash on neck, back and upper chest) outcome was unknown. Not Provided      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.   Treatment medications provided by the reporter included  anti-itch ointment.
Fine papular rash all over body. Rash started on the trunk and spread to the extremities. H/O MMR 10 days prior. No fever.
Patient received the vaccine in the left arm and was fine. Patient sat and talk to family members and about 10 minutes he felt light headed and wanted to lie down.  His breathing was normal, no allergic or anaphylaxis reactions or symptoms,  3 times patient declined the need of 911 call.  Patient declined any medical service,  as does not need it. Patient rested on the chair with his leg up and then patient wanted to  rest on the floor with his leg elevated for  a few minutes.  Pharmacist called the manager to be present, again we offered water, drink or any foods patient would like.  He said that he was fine and that he just needed to sit and rest for a few minutes.  After about 10 minutes, he was fine, stood up and walked away without further light head symptom.
got an inflamed gallbladder; The patients were immunocompromised and got sick after taking the vaccine, and got COIVD; The patients were immunocompromised and got sick after taking the vaccine, and got COIVD; The patients were immunocompromised and got sick after taking the vaccine, and got COIVD; This is a spontaneous report from Pfizer via a contactable healthcare professional reporting different events under the same suspect product for 2 patients. This is one of 2 reports. A 76-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included immunocompromised. The patient's concomitant medications were not reported. The patient got sick after taking the vaccine and got COIVD. Patient got an inflamed gallbladder and the doctor wanted to remove it, that she did not agree with it was necessary organ. Outcome of the events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
12-27-2020 Injection; Volunteered for automated test for nasopharyngeal swab for Covid-19 Antigen on 1-7-2021.  No symptoms.  Nasal swab had some blood on it because of friable nasal mucosa.  The Test (SCV2-SPX-EP molecular test by the lab) was reported positive on 1-10-21.  Symptoms then were mild to moderate fatigue, occasional partially productive cough without respiratory distress (SpO2's on room air always > 94%), headache - mild and episodic,  dulled sensorium (clouded thinking at times)
Pt received the Moderna Covid vaccine, after the injection pts fingers hands and lips when numb. Pt is now okay reaction did not last long
Red, painful, swollen left shoulder, systemically fever present. No CP/SOB and no N/V/D
Develop an inflammatory lung disease; This spontaneous case was reported by a physician and describes the occurrence of PNEUMONITIS (Develop an inflammatory lung disease) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 008C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN and SILDENAFIL CITRATE (VIAGRA) for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONITIS (Develop an inflammatory lung disease). At the time of the report, PNEUMONITIS (Develop an inflammatory lung disease) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had a costophrenic chest x-ray on 19-May-2021, he has multiple 5 cm cavities, he only have inflammatory labs, no malignancy or infections.  Treatment information was not provided.   This case was linked to MOD-2021-215987 (Patient Link).
A sudden nose bleed out of both nostrils that did not stop until I came to the Emergency Room. I received gauze that were injected with medicine and had to be prescribed antibiotics.
Severe side effects - Swollen facial features especially evident in lips; began approximately 0730, 14JAN21 -  17JAN14; used diphenhydramine (50 mg ) at night to control swelling - weakness - fast heartbeat  Side effects (each of the side effects lasted around the same time period, 13JAN21-17JAN21; alternated acetaminophen and ibuprofen to try and relieve symptoms -injection site pain (began about 1 hour after injection) -headache (severe) -muscle pain -chills - joint pain (severe), began during sleep and I first felt it in my hands - fever (even while taking acetaminophen and ibuprofen, I still had a fever of 100.6 degrees)  -injection site swelling (13JAN21-19JAN21) -injection site redness
Burning, sharp pain in middle of chest and back. SCAD.  Hospitalized, angiogram and let it heal on its own for 5 weeks.  No stress. Outcome unclear.
Patient described experiencing swelling and a large lump at the injection site on her arm after the vaccination was administered.; Patient described experiencing swelling and a large lump at the injection site on her arm after the vaccination was administered.; This is a spontaneous report received from a contactable pharmacist. A 45-year-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown), dose 1 via intramuscular route of administration, administered in Arm Left on 19Apr2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Apr2021, the patient experienced swelling and a large lump at the injection site on her arm after the vaccination was administered. The outcome of the event was recovered on 21-Apr-2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Mild fever, diarrhea, and loss of appetite began on 07/01/15 Measles rash began on 07/08/15 and persisted for four days.  Inconsolable screaming for hours at a time and violent behaviors such as biting and hitting has persisted since the day after the vaccination.  Behaviorally he is different, more agitated, violent, and fussy throughout the entire day.
The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.; She states that no adverse reactions have been reported by any patients; doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.) and NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.) and NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.) and NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (She states that no adverse reactions have been reported by any patients) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 4-JUN-2023 and expired on 11-MAY-2023.).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was reported that no adverse reactions have been reported by any patients. The vial was initially stored in the refrigerator on 4-JUN-2023 and did not underwent any temperature excursions. No treatment medication was reported. This case is reported for patient 23 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case, Patient 1 out of 50 (Lot AS7143C was administered on 5-JUN-2023)
developed Erectile Dysfunction; lost all desire for sex; This is a spontaneous report from a contactable consumer (the patient). A 50-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0173) via an unspecified route of administration in right arm on 01May2021 14:45 at age of 50-year-old at single dose for COVID-19 immunisation. Medical history included high cholesterol, headaches and chronic pain. Concomitant medications received within 2 weeks of vaccination included oxycodone, topiramate and metoclopramide, all taken for an unspecified indication from an unspecified date. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7533) in right arm on 03Apr2021 02:45 PM at age of 50-year-old for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. After the 2nd dose, the developed erectile dysfunction and lost all desire for sex on 02May2021. He had not been able to have sex and all desire has disappeared. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the events. The outcome of the events was not recovered. The case was non-serious.
soreness and red; slightly swollen injection site.  About 1 inch by 3 inches
Left arm swelling; Warmth on the left arm; Redness; Generalized weakness; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Left arm swelling), VACCINATION SITE WARMTH (Warmth on the left arm), ERYTHEMA (Redness), ASTHENIA (Generalized weakness) and DIZZINESS (Dizziness) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 012M20A) for COVID-19 vaccination.     Concomitant products included RIVAROXABAN (XARELTO), ATORVASTATIN, METFORMIN, LEVOTHYROXINE SODIUM (LEVOTHYROXIN), PANTOPRAZOLE, SPIRONOLACTONE, ISOSORBIDE MONONITRATE and HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE) for an unknown indication.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced PERIPHERAL SWELLING (Left arm swelling), VACCINATION SITE WARMTH (Warmth on the left arm), ERYTHEMA (Redness), ASTHENIA (Generalized weakness) and DIZZINESS (Dizziness). On 08-Mar-2021, PERIPHERAL SWELLING (Left arm swelling), VACCINATION SITE WARMTH (Warmth on the left arm), ERYTHEMA (Redness), ASTHENIA (Generalized weakness) and DIZZINESS (Dizziness) had resolved. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow-up received on 3 May 2121.Patient contact information updated
Woke up screaming, started choking/struggling to breathe, no color, limp body, slight blue tint around mouth, unresponsive in ambulance to right side, soaked clothing. This went on for hours and child was not herself for days.
12:21pm  115/60 51 16 O2 96%;   12:27pm  124/80 66 16 O2 96%;   12:37pm  118/70 66 18 O2 99%;  12:42pm  124/80 66 18 O2 97%;   12:47pm 110/72 66 18 O2 98%;   12:52pm  114/70 67 18 O2 97% C/O dizziness, blurred vision. 12:52pm  Pt. denies any complaints; left with family member.
1st vaccine shot on 25jan ... no apparent side effects but looking back did notice a slightly burned feeling tongue & roof of mouth.  2nd Inoculation 24feb in morning-body aches by 9pm-progressed to body and head aches with hot/cold sweats & shakes by 230am-fatigue and head/body aches thru midday-then subsided- 2 days later started noticing tongue irritation but no trouble breathing , no swelling - followed by hives or histamine rash on scalp , face, scratchy nose, eyes got progressively more scratchy, red & swollen ... went to doctor on 5march, started taking D-Hist to help with itching & rash, flaky facial & scalp ... cold compresses on eyes ... very slowly becoming  somewhat better ... have an appt with acupuncturist on Friday 12march
Red blotchy rash-face, chest, back- immediately after vaccine- no hives under rx to cinnamon.
A non-serious spontaneous report of received expired FLUMIST was received from a health professional concerning a five-year-old male. Neither medical history nor concomitant medication was reported for this patient. The product expired on 02-Jan-2011. On 03-Jan-2011, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information received on 15-Mar-2011 and incorporated into case: no late occurring adverse events.
Fever (up to 101.6), severe headache, joint pain, nausea vomiting chills, increased heart rate (from normal 55 bpm to remaining 80-116 bpm). Severe for over 48 hours and then another 48 hours approximately of moderate symptoms. Lingering mild headache and joint pain remain.
On 4/25/2000, pt developed and injection site reaction characterized by redness and small red bumps at the site. This is 1 of 2 pts from this facility who developed and reaction.
Felt dizzy, wants to pass out, looked pale & said his arms are tingling 5-7 mins. after vaccines were given ? with O2 at Room air.
pt recvd vax & was sl sore; 16JUL94 arm became a little more sore but nothing too serious; 17JUL94 arm became very sore & painful w/a hard, reddish-purple knot about 1 inch in diameter; by 9PM 17JUL94 entire arm was numb w/swelling;
Skin started itching on Saturday night (2/27/21), and by Sunday morning hives had started forming on legs. Hives kept getting worse and spreading to groin, hip, arms, armpit, shoulder, and neck. When the hives reached my neck at 3pm CST, my voice started getting hoarse and I was taken to urgent care. Symptoms continued to increase to include abdominal pain and throat swelling while in urgent care.  Vital signs at urgent care: Temperature 98.4. Blood pressure 98/70. Heart rate 109. Pulse Oxygen 98%. At urgent care I was given a shot of epinephrine, where the hives and redness decreased and throat opened. After an hour, I was discharged to go home. (Time now about 6:15pm CST) Upon arriving at home, the hives started coming back and spread across my arms and entire stomach. My eyelids had hives too. I went to the ER at about 7pm CST and received Benadryl, Steroids, and Pepcid while getting IV fluids.  I was discharged with a prescription to take prenisone 50mg qd, as well as pepcid qd and benadryl as needed.
Myalgia, Fever, chills, ringing in ears, sore throat, extreme fatigue Narrative:  Employee stated after 2nd vaccine around 5:30pm developed fever 100, extreme fatigue, chills, sore throat bodyaches, ringing in ears. Took Tylenol and Motrin which has helped, feels better but continues to have some symptoms
On the day of (09/29/2022) and the following day of the vaccine, I experienced only mild tenderness at the injection site, no other symptoms. On the day  following the vaccine (09/30/2022), I began to experience intermittent heartburn/substernal pain after my lunch, which recurred on and off over the next 5 days, of varying and mostly mild or moderate degree.  I took Tums with no appreciable relief, but the pain subsided throughout each day. On 10/05/2022 at approximately 09:00 pm, the symptoms of substernal pain became so severe that I was concerned that I might be having a heart issue.  My heart rate was elevated above my normal rate by approximately 10-20 points. My pain level was 8 out of 10.  I then sought evaluation at an Urgent Care Center on 10/06/2022 at 08:30 am. The MD Assessment was "Normal ECG. Burning chest pain likely gastric reflux." He stated that he felt that I was experiencing acute GERD, new onset, unable to rule out connection with the Moderna Bivalent Booster dose.  He prescribed Pantoprazole 20 mg once daily 2 weeks, and to follow up with my PCP next week for further management.  I have scheduled that follow-up appointment for 10/13/2022.