chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This non-serious spontaneous case, initially received from other non-health professional on 14-Nov-2018, concerning a female patient of unspecified age. On an unspecified date, the FLUCELVAX QIVc vaccine underwent first temperature excursion with maximum temperature (Tmax) 8.2 degree Celsius for 4 minutes. On 22-Oct-2018, vaccine underwent second temperature excursion with Tmax 9.8 degree Celsius for 23 minutes. On an unspecified date, two temperature excursions were identified after an audit. On 26-Oct-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 252672 and expiry date: 30-Jun-2019) which underwent temperature excursion. The patient did not experience any adverse effect after the vaccination. This case is linked to 201805262 (same reporter).
Large lump appeared June 2 around 630 pm, exactly 3 weeks after second dose of vaccine, went to dr office dr on staff examined it by ultra sound ordered a biopsy for 6/17/21 biopsy was completed test results are not definitive to what it is (according to dr and staff), want to schedule a surgery to have it removed. Size has significantly gone down since biopsy to less than one inch.
The pt experienced a painful rash on left side of face. A cluster of vesicles just in front of ear with a few vesicles scattered. Diagnosed with Shingles.
It's hard and it's on her back and butt area; skin allergy; This spontaneous case was reported by a patient and describes the occurrence of SKIN INDURATION (It's hard and it's on her back and butt area) and ALLERGY TO VACCINE (skin allergy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN INDURATION (It's hard and it's on her back and butt area) and ALLERGY TO VACCINE (skin allergy). At the time of the report, SKIN INDURATION (It's hard and it's on her back and butt area) and ALLERGY TO VACCINE (skin allergy) outcome was unknown.            No concomitant medications were reported.   Caller advised she got her 2nd dose in May and has now developed a skin allergy and at night it's hard and it's on her back and butt area. Caller advised her HCP prescribed a medication to her.  No treatment medication was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Appendicitis; Abdominal pain/abdominal soreness; stomach started bothering her; not feeling well; tired; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 25Mar2021 10:00 at a single dose for COVID-19 immunisation. Medical history included ongoing asthma (Never smoked a cigarette in my life), Hypothyroidism (started taking levothyroxine about 23 years ago), Diverticulitis (hospitalized for it once in 2015), allergy and environmental allergies. Concomitant medications included levothyroxine for hypothyroidism, loratadine for asthma is triggered by allergies, montelukast for allergy from 2017, fluticasone propionate, salmeterol xinafoate (SALMETEROL AND FLUTICASONE) taken for asthma from 2017, albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for asthma attack and fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) taken for environmental allergies from 2017 all were ongoing. The patient previously received first dose of BNT162B2 on 03Mar2021 for COVID-19 immunization (IM left arm); flu vaccine (Received every year for the past 14 years) and pneumonia vaccine (gotten the pneumonia vaccine the year prior) both for Immunisation. On 26Mar2021, caller stated that she was not feeling well, her stomach started bothering her and she thought she was going to have diarrhea, but she did not. She was really tired, stating she had to take her mom to an appointment, which was about an hour away and patient slept in the car on the way, and noted that she never sleeps in the car. Felt really really tired. On 28Mar2021 her stomach pain started. She thought it was diverticulitis and that she has history of having diverticulitis years ago and being hospitalized for it once in 2015. She got very sick very quickly. She went to the emergency room on 28Mar2021 at about 1130 and they did a CT scan and found out it was her appendix and she was operated on that afternoon at which time they removed her appendix. Appendicitis require a visit to the emergency room. The patient was hospitalized for appendicitis from 28Mar2021 to 29Mar2021. The doctor told her that she was very fortunate, there was a slight perforation and there was no leakage and she was able to go home on early Monday evening. Shortly after the surgery she felt better. She still does not feel 100% still tired. Glad she got the surgery when she did and it did not rupture. Stated she did not need pain medication. There were no additional vaccines administered on same date of Pfizer suspect. Outcome of the events appendicitis and stomach started bothering her was recovered on 29Mar2021, not feeling well recovered on 28Mar2021, event tired as not recovered while unknown for the other event.   Information on the lot/batch number has been requested.
All of the symptoms per mother had not been observed in clinic or in ER prior. Pt mother stated that at 6 PM on 04/26/2016, pt had swollen lip and red ear. Pt also having sore throat. Pt then was fine, resolved on its own. Pt the next day went to dentist and they recorded high blood pressure. Pt then went to ER, pt was fine in ER. Pt then had yellowing of feet. On examination in clinic on 04/27/2016 had no swelling, no resp dist, pt's alert and quite playful, no rash noted and pt w/no redness, no swelling at the site of the injection. No warmth at the site of the injection. Will check labs.
Information has been received from a registered nurse concerning a 14 year old female with no drug reactions/allergies or medical history who on 30-JUL-1995 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 23-FEB-2007 the patient developed breakthrough chickenpox rash after receiving the vaccine. The lesions were multiple tiny vesicles on the base of the trunk and scabs on lower lip and lower abdomen. The patient sought unspecified medical attention. No laboratory diagnostic tests were performed. The patient was recovering. There was no product quality complaint. Additional information has been requested. Follow up information. The registered nurse reported that the patient visited the physician on 27-FEB-2007 and that she had "hives" over body. On exam, the patient presented with multiple vesicles on erythema base of trunk, scab on lower lip and scabbed lesions on lower abdomen. On an unknown date the patient recovered. Follow up information received on 16-MAY-2007 reported that the patient was vaccinated with VARIVAX (Merck) and that she recovered on an unknown date. Additional information has been requested.
A mother reported that her 13 month old daughter received her 1st dose of Prevnar in mid 11/00. The child developed a rash that "looks like eczema" in mid 12/00. The rash started as dry patches on her face and has spread to her shoulders and neck. The rash is being treated with cortisone cream, which has "helped a little". The rash continues.
Information has been received from an office manager concerning a 21 year old female with no pertinent medical history who on 14-JUL-2010 was vaccinated with her first dose of GARDASIL (lot number: 663573/0969Y) (site and route not reported). The office manager reported that on 14-JUL-2010 about 10 minutes after receiving GARDASIL the patient was sitting on the exam table and was feeling dizzy and then fell off the exam table. The office manager reported that the patient had a split lip and bruise on her knee and arm. The office manager reported that the patient was then wheel chaired over to the emergency room (name, address and phone number unspecified) but was not admitted and was released. The patient improved on therapy. The office manager reported that the patient had recovered on an unspecified date. Additional information has been requested.
Dizziness; body chills; body aches (arm); headache; tired; sleepy; This is a spontaneous report from a contactable consumer (patient). An 87-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (brand: Pfizer) in left arm on 22Mar2021 12:30 at a single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Other. Medical history included high blood pressure, prostate cancer, COVID-19. Concomitant medications included amlodipine besylate, tamsulosin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced dizziness, body chills, body aches (arm), headache, sleepy, tired on 22Mar2021 23:00 with outcome of recovering. No treatment was received. Patient would like to know if the second dose of the vaccine will give me the same reaction. Prior to vaccination, was the patient diagnosed with COVID-19 was yes. Since the vaccination, has the patient been tested for COVID-19 was no.  Information on the lot/batch number has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 27-NOV-2017, the patient was inoculated with the ZOSTAVAX vaccine (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles. On an unknown date [reported as shortly after receiving ZOSTAVAX], the patient suffered symptoms of dyspnea, nausea, weakness, shortness of breath, angina and arrhythmia requiring hospitalization. The patient was then diagnosed with an acute myocardial infarction. The outcome of the event is unknown. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to using the ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of the patient's condition. Upon internal review, acute myocardial infarction was determined to be medically significant. Acute myocardial infarction was considered to be disabling. Additional information has been requested.
This spontaneous report as received from a Medical Assistant refers to 8 weeks old infant, gender not reported. On 17-NOV-2014, the patient was vaccinated with ROTATEQ, Lot # K004620, orally. It was reported that the administered vaccine was subjected to temperature excursion during storage. No adverse event was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Two days after receiving the vaccine the patient began experiencing shortness of breath. One week after onset of symptoms he presented to the hospital and was diagnosed with submassive pulmonary embolism. He underwent IR suction thrombectomy which removed 30% of the PE burden and spent two days in the ICU. He has now been transferred to the floor.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 09-JUN-2010, patient received improperly stored VARIVAX dose 2, from lot # 665413/1128Y expiry date: 07-AUG-2011. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
A day later, I was exhausted had fever and chills. I had heart palpitation. I did not see a doctor and it went way after 3 weeks.
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with the first 0.5 mL dose of GARDASIL. Subsequently, one month later after vaccination the patient developed "miluscumcontagiosum" (may be a molluscum contagiosum). The patient sought unspecified medical attention. At the time of the report, the outcome of the event was unknown. Follow-up information has been received from the physician concerning an approximately 13 year female old student with mood disorder who on 29-NOV-2009 was vaccinated intramuscularly with the first dose of GARDASIL (lot# 774170/0388Y). On 30-JAN-2008, the patient was vaccinated intramuscularly with the second dose of GARDASIL (Lot# 1742U). Concomitant therapy included PROZAC. After receiving the two vaccinations, in 2008 the patient developed outbreak of molluscum contagiosum. It was also reported that the patient was told by a dermatologist that could not rule out GARDASIL as a trigger. The outcome of molluscum contagiosum was not reported. The patient refused the final dose. There was no illness at time of vaccination. No laboratory was performed. No further information is available.
I was having a massive headache, fever, coughing, runny nose, diarrhea. A couple of days later I started having shortness of breath, coughing, fatigue and lost my sense of smell. I took a home COVID-19 test that came back positive. I called my doctor and had a telehealth visit, I cannot take PAXLOVID as I am a transplant patient. I was advised to stop taking one of my medications for three days and if I had difficulty breathing to go to the hospital. I am feeling better, I still have some fatigue and I get winded, but everything is getting back to normal. In June I had the antibody injection EVUSHELD, my doctor believes this may have helped my body COVID-19.
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated; Patient received bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg); This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated), ACCIDENTAL UNDERDOSE (Patient received bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg)) and NO ADVERSE EVENT (No adverse event) in a 6-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 14-Jun-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and ACCIDENTAL UNDERDOSE (Patient received bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated), ACCIDENTAL UNDERDOSE (Patient received bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg)) and NO ADVERSE EVENT (No adverse event) 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 (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial(10 mcg) instead of blue cap vial(25 mcg), when blue cap was indicated) and ACCIDENTAL UNDERDOSE (Patient received bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg)).    Concomitant product use was not provided by the reporter.  The route of administration of suspect Moderna bivalent was reported as BI.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2023: Upon internal review on 19-Sep-2023, significant corrections performed to add additional event of accidental underdose.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case Patient 1
10/31/2021 Sharp pain in lower right pubic area. Throbbing on right side of chest. 12/10/2021-1/23/2022 Multiple (12) occurrences - Heart pain, burning chest and lower part of throat, struggling to               keep steady flow of oxygen, face is hot. Occurs for 5-10 minutes with lingering numbness in face and chest.  Elevated blood pressure, dizziness, heart pain, burning chest, tiredness, jaw and face numbness for month and ongoing. Pericarditis diagnosed in February 2022, Medication prescribed. High blood pressure diagnosed in April 2022 Medication prescribed. Blocked artery diagnosed June 2022, Emergency Room Visit- worsened symptoms Heart Catheterization - Stent inserted, 6/24/2022, Blockage had erupted. Ongoing symptoms- Same as above Heart Catheterization- 8/9/2022. Microvascular disease a possibility - on medications
Within a few minutes of receiving the flu shot, patient began crying hysterically and developed dry heaving, throat clearing, and wheezing.
The morning of Jan 20, 2021, Patient was disoriented, could not communicate well, and fell when he tried to get out of bed.  He was taken to The Hospital by ambulance about 11:30 am. He is still hospitalized. Emerging symptoms include: passing a blood clot from his mouth, slight pneumonia, high white count, low kidney values, high fever, all of which fluctuated. A blood transfusion was given because of blood in the urine. He has been confused and disoriented until this morning.
Patient complained of dizziness after vaccine.  Initial set of VS were BP-116/79, P-74 (sitting) and BP- 97/74, P 89 (standing).  VS at 1900 were sitting  BP-109/71, P- 75 and standing- BP-98/74, P-90.  Then at 1920 sitting BP 120/78, P 72 and standing BP 110/77, P-89.  Oral fluids and snacks offered.  Patient was assessed by Dr onsite of clinic prior to leaving.
8/27/04: child developed rash and swollen fingers. 8/31/04: came to office. Diagnosis : Shingles
Systemic: Dizziness / Lightheadness-Severe, Systemic: Weakness-Severe, Additional Details: Due to weakness, pt. has fallen several times.
Difficulty breathing, severe diarrhea, vomiting -- pt did not call for help.
No additional adverse events; a patient was administered an improperly stored PNEUMOVAX 23; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.      On 11-AUG-2020, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S029542, expiration date 10-JUN-2021; strength, dose and route were not reported) for prophylaxis (product storage error). Temperature and time frame were reported as above 47 degrees Fahrenheit (70 degrees Fahrenheit) for 12 hours. There was no previous temperature excursion. Data logger was not involved. There was no additional adverse events. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S029542; expirationdate: 10-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date 19-Feb-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date 19-Feb-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date 19-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date 19-Feb-2022) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Feb-2022 at 1:52 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Feb-2022 at 1:52 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date 19-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date 19-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date 19-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date 19-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. Ethnicity was reported as Asian and dose number was reported as booster It was reported that vaccines went into 2-8 C thaw state on or above 24-Dec-2021 and were administered up until the MFG expiry date of 04-Apr-2022. No treatments were reported