chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Major swell lips; Major swell mouth; This is a spontaneous report from a non-contactable consumer, the patient. A 77-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 29Mar2021 at 08:15 (at the age of 77-years old) in left arm as a single dose for COVID-19 immunisation. Medical history was reported as unknown. No allergies to medications, food, or other products. Concomitant mediation was reported as unknown. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was tested for COVID-19 and the result was unknown. On 29Mar2021 at 08:15, the patient experienced lip swelling and mouth swelling. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic treatment received for the events was reported as unknown. The clinical outcome of the events of lip swelling and mouth swelling was not recovered at the time this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm soreness) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm soreness). At the time of the report, VACCINATION SITE PAIN (Arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment medications reported.
Excessively flowing menstrual cycle; extreme nausea (vomited) : usually have regular, light menstrual cycles
Patient complained of tingling on lips and throat. 25 mg oral Benadryl given, patient stayed in observation 30 mins was still having symptoms and was taken or emergency department after.
COVID vaccine breakthrough case. Pfizer  EL9261 1/29/21, EM 98102/19/21 and boosted Moderna 043B21A 8/18/21, Pfizer GLO446 10/25/22
Moderate muscle pain and stiffness in the right upper back muscles starting 2 days after the vaccine. This is a site of previous injury from a presumed electrical shock in ~2000. In 2011 I have had shooting nerve pain from the spine along this area. This is the first time I have had muscle pain and stiffness there. DURATION:  the mild to moderate pain continued for ~7 days with new tiredness during days 2 through 6. The stiffness with very mild discomfort continues. This localized pain feels confined to the muscles/ tissue of my right upper back next to the spine.  One of the days of tiredness was accompanied with whole body stiffness, feeling warm, chest tightness and hyperventilation. I did not take my temperature
chest pressure, SOB, scratchy throat, light headedness, hoarse voice 12/29 - about 15 min after receiving the vaccine employee reported mild chest pressure/pain, hoarse voice, SOB, light-headedness, and scratchy throat. (She was given the vaccine in the ED because of a history of anaphylaxis with taking antibiotics). Her physical examination and vital signs were normal. No evidence of swelling to lips, tongue or throat. No treatment was required. Employee was observed for 4 hours and discharged to home. She was diagnosed with a minor allergic reaction.
Patient received both Moderna and Pfizer covid vaccine on the same day.  No symptoms currently reported.
27Jun90 began to cry, unconsolable, waking out of a sleep, screaming X14 hrs, Temp 103 F, no interest in feeding, local rxn red, 25 cc size. 28Jun90 Temp. normal, child improved.
Neuropathy; Arms very hot this morning; A lot of headache; Chills; Pain in his arm; Swelling in his arm; Couldn't sleep due to headache; Feeling that his head is boiling, very hot inside; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy) in a 60-year-old male patient who received   COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Neuropathy. Concomitant products included AMLODIPINE for Blood pressure, NABUMETONE (RELAFEN) for Muscle relaxant, GABAPENTIN (NEURONTIN) for Pain in spine, TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) and OMEPRAZOLE for Unevaluable therapy.   On 06-Apr-2021, the patient received first dose  (Intramuscular) 1 dosage form. On 06-Apr-2021, received first dose (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in his arm), PERIPHERAL SWELLING (Swelling in his arm), INSOMNIA (Couldn't sleep due to headache), HEAD DISCOMFORT (Feeling that his head is boiling, very hot inside), HEADACHE (A lot of headache) and CHILLS (Chills). On 07-Apr-2021, the patient experienced FEELING HOT (Arms very hot this morning). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criteria medically significant). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy), PAIN IN EXTREMITY (Pain in his arm), PERIPHERAL SWELLING (Swelling in his arm), INSOMNIA (Couldn't sleep due to headache), HEAD DISCOMFORT (Feeling that his head is boiling, very hot inside), FEELING HOT (Arms very hot this morning), HEADACHE (A lot of headache) and CHILLS (Chills) outcome was unknown.               Treatment was not reported/ unknown.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Additional Details: Pt was brought in by uncle, reported feeling nauseous during 15 min mandatory wait after vaccine administration. Was given a bag and pt decided to sit on the floor to be more comfortable. Then pt fainted for less than 1 min then regained consciousness. Patient was given water and his blood pressure was checked q5-10minutes for a total of 4 blood pressure and heart rate readings for period of 30 minutes. After BP and HR readings were normal, pt reported feeling good and left.
Began with numbness and muscle weakness in the right leg on 11/18/2010 at 5PM, this spread to the left leg by 6PM at which time I went to the emergency room due to inability to move my legs.  Over the next 4-5 hours this spread throughout my body to include total paralysis by early 11/19/2010.  I was admitted to the hospital.  The evening of 11/19/2010 I began having trouble breathing and at one point was unable to breathe at all.  Code blue was called and BiPap was used through the night.  On 11/20/2010 an MRI was performed to rule out brain lesions and during this time I was again unable to breathe. Doctors again administered Bipap and I was moved to the ICU.  Early 11/21/2010 I was unable to breathe for an extended amount of time at which I was placed on a ventilator.  I remained on a ventilator until 11/23/2011 at which time it was removed and I suffered from ventilator aquired pneumonia.  I left the hospital on 11/25/2010 and returned on 11/27/2010 where I was admitted again due to weakness and similar breathing issues and was released on 12/2/2010.  Recovery was long and slow requiring months of physical and speech therapy to regain strength.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ADULT OBSTRUCTIVE SLEEP APNEA, MODERATE PULMONARY EMBOLISM W INFARCTION, UNSPECIFIED  6/9/2022 & 2/9/2023 - RECURRENCE OF SAME SYMPTOMS
COVID vaccine breakthrough case  All Moderna dose 1 1/18/21  027L20A dose 2 2/15/21 011M20A dose 3 11/19/21 067F21A
BREAKTHROUGTH COVID: 62 yo M FULLY VACCINATED AND BOOSTED3 TIMES, admitted to the ED with upper respiratory symptoms, vomiting, and diarrhea. Patient tested positive for COVID. Symptoms improved somewhat after 2L IV fluids, Zofran, Reglan, Benadryl, Fentanyl, and a breathing treatment. Creatinine slightly elevated. Patient likely dehydrated from N/V/D. Pt prescribed Nirmatrelvir & Ritonavir .
numbness in both hands/ numbness in both feet; tingling in both hands; Pain in tip of pinky finger; This case was reported by a consumer via call center representative and described the occurrence of numbness in hand in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   In June 2019, the patient received the 2nd dose of Shingrix (intramuscular). In June 2019, 1 day after receiving Shingrix, the patient experienced numbness in hand, tingling of extremity and pain in fingers. On an unknown date, the outcome of the numbness in hand, tingling of extremity and pain in fingers were not recovered/not resolved.   It was unknown if the reporter considered the numbness in hand, tingling of extremity and pain in fingers to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's husband. The patient received dose of Shingrix in the left arm. The patient received 1st dose of Shingrix in the month of March 2019. Approximately 1 to 2 days after vaccination with Shingrix, the patient experienced numbness and tingling in both hands, and the tip of pinky finger was painful to the touch. The reporter reported that, the numbness and tingling was more noticeable in the left arm. The patient also experienced numbness in both feet, however numbness on the left foot extends up the leg to the knee. The Patient reported that, it was continuous throughout the day. The reporter consented to follow up. The reporter gave permission the patient's physician to be contacted. The patient and her husband, both received two doses at the same time. This is 1 of the 2 cases reported by the same reporter. There was discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
Pt. was given a second menveo vaccine that he already received on 10/21/21. Pt. and parent were notified by doctor.
I am an APRN, my husband is a Medical Doctor. These symptoms are new. I am on post menopausal hormones stable for over 5 years. 10 days post vaccine: First time shingles outbreak, joint pain, short of breath, unable to perform regular exercise routine due to heart palpitations and rapid heart rate after 1 minute, Tingling and numbness in arms, hands, legs and feet. Joint pain. Foggy. 14 days post vaccine: Headaches begin with severe pressure and moderate pain in the back of the neck, top of the head, forehead, over sinuses, inside both ears, jaw pain. All other symptoms continue. 15,16 &17 days post vaccine:New symptom Nausea, no vomiting. Headaches, ear pressure, jaw pressure and all other symptoms continue.
extra dose of ACTHIB was administered to a patient with no reported adverse event; Initial information received on 01-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old male patient to whom extra dose of acthib was administered with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Sep-2022, the patient received 0.5 mL dose of suspect HIB (PRP/T) VACCINE (formulation and strength not reported; lot U7260AA, expiry date: 30-Mar-2023) via intramuscular route in the left vastus lateralis for prophylactic immunization.  On 01-Sep-2022, (latency: same day) the patient had extra dose of acthib was administered to a patient with no reported adverse event (extra dose administered) following the administration of HIB (PRP/T) VACCINE.  It was reported, "An extra dose of ACTHIB was administered to a 6 month old male patient. This was ACTHIB dose number four in the series. The patient received their third dose of ACTHIB on 11Aug2022".  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the guidelines. 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.
This spontaneous report as received from a pharmacist refers to a 68 year old female patient with no drug reactions or allergies and with no medical history. On 26-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX injection administered subcutaneously (0.65 ml, lot # K007989 with expiry date: 03-SEP-2015, reported as: 20-SEP-2015), therapy reason for use: vaccination. No concomitant medications were reported. Post administration of ZOSTAVAX, on 01-OCT-2014, the patient noticed red spots/rash the size of a dime, one above and one below injection sites. On 02-OCT-2014 (reported as this morning), an additional red spot/rash appeared on her bicep. Then, on 02-OCT-2014, the physician assistant called and reported that the patient presented to her with the VZVID packet, and the physician assistant stated that the patient's rash "definitely looks like shingles". The outcome of the event was unknown. No laboratory test were performed and no treatment was given. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Vaccine was administered 15 Mar 2009, during Mobilization Orders activity. Vaccines were administered at the facility.  Pt states, and the immunization record verifies that she received an Anthrax shot #4 (Lot # FAV 159), and a Typhoid Vaccine (Lot # B03472) both vaccines were given in the Left Deltoid Region. The Chief Medical Officer assessed the vaccine region as a Moderate Anthrax Vaccine Reaction, and recommended Motrin for the patient. Immunization records show that the Typhoid vaccine was administered 18 months too early. She received a Typhoid vaccine on 13 Sept 2008 and another dose on 15 Mar 2009. The vaccine booster schedule is every 2 years. A VAERS report will be prepared.
On 11/12/2020 DR ORDER A HEP A AND FLUVACCINE, THE MEDICAL ASSISTANT GRAB HPV VACCINE INSTEAD OF THE HEP A.
overall "fog-like" feeling; arm swollen; bright red rash under injection; fatigue; headache; joint pain in hips; bright red rash under injection site; puking; It was worse; Lost of taste; Face was swollen; Night sweats; Arm pain; joint pain in lower back; rash hot to the touch; pyrexia; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (It was worse), AGEUSIA (Lost of taste), SWELLING FACE (Face was swollen), NIGHT SWEATS (Night sweats) and PAIN IN EXTREMITY (Arm pain) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (JUNEL FE) for Birth control.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PYREXIA (pyrexia). On 18-May-2021, the patient experienced CONDITION AGGRAVATED (It was worse), AGEUSIA (Lost of taste), SWELLING FACE (Face was swollen), NIGHT SWEATS (Night sweats) and PAIN IN EXTREMITY (Arm pain). 18-May-2021, the patient experienced BACK PAIN (joint pain in lower back), VACCINATION SITE WARMTH (rash hot to the touch), PERIPHERAL SWELLING (arm swollen), VACCINATION SITE RASH (bright red rash under injection), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain in hips), VACCINATION SITE ERYTHEMA (bright red rash under injection site) and VOMITING (puking). On an unknown date, the patient experienced FEELING ABNORMAL (overall "fog-like" feeling). At the time of the report, CONDITION AGGRAVATED (It was worse), AGEUSIA (Lost of taste), SWELLING FACE (Face was swollen), NIGHT SWEATS (Night sweats), PAIN IN EXTREMITY (Arm pain), BACK PAIN (joint pain in lower back), VACCINATION SITE WARMTH (rash hot to the touch), FEELING ABNORMAL (overall "fog-like" feeling), PERIPHERAL SWELLING (arm swollen), VACCINATION SITE RASH (bright red rash under injection), FATIGUE (fatigue), HEADACHE (headache), ARTHRALGIA (joint pain in hips), VACCINATION SITE ERYTHEMA (bright red rash under injection site), VOMITING (puking) and PYREXIA (pyrexia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 104 (High) 104.         Treatment information not provided.   This case was linked to MOD-2021-162904 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Significant follow up added on 30-Jul-2021 and updated patient demographics, Added Concomitant medication and new event.
Pt recieved 2 doses of Pfizer + then a third shot of Moderna by mistake
pt recvd vax; pt devel hand, foot & mouth disease;on 11nov94, dx w/ pneumoccocal meningitis;adm to hosp x 2 days;lab evaluation of spinal fluid revealed pneumoccocal serotype 19;on 14nov pt died of cardiac arrest;
The mother noted large red area on leg (11 1/2 x 8 cm with 4x3 central area of induration). Cool compresses, and Augment ES seen next day with area larger but central clearing and overall less erythema and induration.
Began with red papules which increased in size and became vesicular and scabbed. Occuring in crops for several days.
6-7 hours following vaccination, L arm began to burn and became hot, red, swollen, and hard.  Area involved extended from shoulder to elbow and was 5-7" wide.  Burning subsided after approximately 2 days and after 3-4 days redness changed to bruising.  Pt noticed a small improvement each day and did not report incident to her md (or to SHD until 4/14/21)  She reported that the reaction resolved after 7 days.  She did report reaction through V-safe.
1/12/09- Area swelled red raised.  Very sore.  Mom gave BENADRY & ice to area - still present 1/15/09-
Constant crying and extreme irritability for a couple days. Very sick and slept a lot. We could not console him. 103.5 fever.
Patient fainted after receiving MMR, polio, and influenza vaccines. Upper extremity jerking and lower extremities drawn to chest. LOC approx. x 10-15 seconds. Was A/O x 3. Patient reports no residual problems/symptoms.
No further adverse effect reported; patient received a dose of improperly stored VAQTA; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions/allergies were not reported.    On 24-FEB-2020, the patient received improperly stored hepatitis a vaccine, inactivated(VAQTA) (lot #: S025993, expiration date: 17-OCT-2020) 1 dose (strength and route of administration were not provided) as prophylaxis (product storage error). The vaccines were exposed to temperature of below 36 degrees Fahrenheit (34 degrees Fahrenheit) for 27 minutes. No previous excursions was reported. The data logger was involved. No adverse effects were reported. No product quality compliance was reported.
Jynneos administered intramuscularly; Case reference number US-BN-2022-001690 is a spontaneous case report initially received on 27-Jul-2022 from other health care professional via Communication (reference number: USBAV22-0690) and concerns a *23-year-old female patient.*  The patient's medical history and concomitant medication details were not reported.  On *13-Jul-2022*, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: FDP00002), at dose of 0.5 mL, administered intramuscularly (IM) in the *left deltoid region*, for pre-exposure prophylaxis (PrEP) (explicitly coded as 'Inappropriate route of vaccination'). As reported, the patient worked in a lab that handled monkeypox samples.  At the time of this report it was known that the patient did not experience any adverse event due to Jynneos vaccination.  This case is linked with cases no. US-BN-2022-001673, US-BN-2022-001687, US-BN-2022-001688, US-BN-2022-001689, US-BN-2022-001691, US-BN-2022-001692, US-BN-2022-001693, US-BN-2022-001694, US-BN-2022-001695, US-BN-2022-001696, US-BN-2022-001697, US-BN-2022-001698, US-BN-2022-001699, US-BN-2022-001700, US-BN-2022-001701, concerning the same reporter.  Non-significant case correction received from on 29-Jul-2022 included an additional reference number.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from a health care professional via on 09-Aug-2022 included patient details and additional information about the administrated dose of Jynneos.; Reporter's Comments: A 23-year-old female patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the left deltoid region, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 23-year-old female patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the left deltoid region, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.