chrisvoncsefalvay/vaers-outcomes huggingface dataset:
internal tickle in her chest that has been happening on and off since the initial symptom; Throat tickle; Allergies; Internal tickle in her chest that has been happening on and off since the initial symptom; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Internal tickle in her chest that has been happening on and off since the initial symptom), CHEST DISCOMFORT (internal tickle in her chest that has been happening on and off since the initial symptom), THROAT IRRITATION (Throat tickle) and HYPERSENSITIVITY (Allergies) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced PARAESTHESIA (Internal tickle in her chest that has been happening on and off since the initial symptom) and HYPERSENSITIVITY (Allergies). 28-Jan-2021, the patient experienced THROAT IRRITATION (Throat tickle). On 28-Jan-2021 at 6:30 PM, the patient experienced CHEST DISCOMFORT (internal tickle in her chest that has been happening on and off since the initial symptom). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Allergy, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Internal tickle in her chest that has been happening on and off since the initial symptom), CHEST DISCOMFORT (internal tickle in her chest that has been happening on and off since the initial symptom), THROAT IRRITATION (Throat tickle) and HYPERSENSITIVITY (Allergies) had resolved.            The patient reported that since the event throat tickle began the day she had the second dose, it obviously was not related, it had to be allergies. She did not check with a doctor.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: The event, throat irritation was added. The treatment information was added. On 07-Jul-2021: Event outcome was updated and event was added. Corrections made to initial report: suspect product (first dose start date and lot number added) and concomitant medication added.
This spontaneous report was received from a registered nurse referring to two patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PROQUAD (Merck), lot # L023114, expiration date 24-DEC-2016, (dose was not provided). Concomitant medication was not reported. No adverse effects reported. Additional information has been requested.
warm sensation/hot flash 2x post vaccination. Heart rate elevated & racing  Pt. has history of duisautonomia. Took pulse ox & took blood pressure. Symptoms resolved after 20 mins & pt was released. No tongue swelling, no shortness of breath, no tightening of chest, no difficulty breathing. Pt felt better & was d/c unlikely to be allergic Rx
A non-serious spontaneous report of FLUMIST administration to a 21 month old was received from a health professional concerning a 21-month-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. On 14-Nov-2011, FLUMIST was inadvertently administered to a 21 month old patient. 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. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months or age.
Narrative:  COVID infection following COVID vaccine series 03/26, Pfizer, dose #1 04/16, Pfizer, dose #2 08/14 pt cc: exposure: unknown 08/14 SARS-COV-2 Variant Sequencing results: pending 08/14 COVID swab, result: detected 08/25 COVID swab, result: not detected
Information has been received from a nurse practitioner refers to a number of unspecified patients. Nurse practitioner reported that unspecified number of improperly stored VARIVAX (Merck) (dose, route, lot# not reported) and PROQUAD (merck) (dose, route, lot# not reported) doses had been administered to unspecified patients. No adverse effects reported. It was unknown if the patient sought medical attention. At the time of report, the status of patient was unknown. Additional information has been requested.
After the booster, left arm was numb in 5mins and was given an ice pack and sat there for total 30minutes, Tuesday itching mild and swelling lymph notes left and sonography showed lymph notes were swollen from the booster.
Breakthrough case admission after 3 vaccines Moderna 3/11/21 lot# 002B21A;  Moderna 4/8/21 lot# 040B21A;  Moderna 11/2/21 lot# 032F
Rash on face.  Using Benadryl for the rash.  No other symptoms noted.
The patient reached out to Dr. stating she had been feeling sick ever since she got her tdap vaccine. She reported sx of fatigue, chills, headaches and woke up nasueated Friday morning and woke up and vomitted Saturday morning. She reports her sx come intermittently and that sometimes she feels ok and sometimes not and wondered if this was normal.  She also mentions that her arm got a red swollen patch from the shot.
First dose: Her arm was sore; bruise; It has been almost 80 days, and she is still having extreme pain, in every part of her joints.; Her period stopped after she got the covid vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A 50-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP7537), via intramuscular route of administration, administered in Left Arm on 24Mar2021 14:00 (at the age of 50-years-old) as 1st Dose, Single Dose for COVID-19 immunization. The patient's medical history included migraine, she takes migraine medication as needed. The patient's concomitant medications were not reported. The reporter stated that on an unspecified date in 2021, It has been almost 80 days, and she is still having extreme pain, in every part of her joints. On 25Mar2021, first dose: Her arm was sore: It lasted for three or four days. on an unspecified date in 2021, It hurt like a bruise would, but there was no bruise. on an unspecified date in 2021, her period stopped after she got the covid vaccine. Her period has always been really heavy. The patient last had her period a month before the covid vaccine. The patient thought she would let it be for a while. The patient went and saw her OBGYN (obstetrics and gynaecology), and he said that she could call Pfizer and report about it. Her OBGYN told her that a lot of women are having interruptions with their period, some women's periods are not coming back, or are coming back heavier. The patient's last period was 10Feb2021. The patient uses a period tracking app. The patient's period was 84 days late. The patient did not undergo any laboratory test. The event her period stopped after she got the covid vaccine included physician Office Visit. The outcome for the events was unknown.   Follow-up attempts are possible, additional information has been requested.
HYPERtension Narrative: Employee saw PCP today for follow up continues with HTN.
Vomiting onset 23:00 02/05/04 through night until 08:00 02/06/04.  Vomited approximately every hour (per mom).  Recovered afterward, no residual effects.  No diarrhea.  Note: Family members began vomiting and diarrhea 02/07/04.
arm is sore; This is a spontaneous report from a contactable consumer, the patient. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 as a single dose for COVID-19 immunisation. Medical history included the patient had a broken clavicle. The patient's concomitant medications were not reported. On an unknown date the patient experienced his arm is sore. The patient stated that he has a broken clavicle that is healing, and he is supposed to have Physical Therapy today for that, and he is wondering if the stretching and pulling that they would do during physical therapy will be okay after getting the vaccine yesterday. The patient stated that his arm is sore, and he anticipated that. The patient also inquired what he can take for the pain.  The clinical outcome of the arm is sore was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
date of vax 26JAN95; 5 hrs post inject persistant screaming, crying lasting 4-5 hrs; around 0200 27JAN95 noted tightening/release of upper body similar look to sz activity; t101.7
Child woke up day after vaccine vomited for 8 hours. Seemed "dizzy" to parent. Toppled when trying to sit or crawl. Seemed distant when spoken to. Taken to emergency room on next day, but developed canker sores in mouth. MD said above was probably virus.
High fever; Chills; Throbbing pain through the entire arm radiating to the wrist ( left arm)/ Sore mid part of body; Sore throat; Swollen neck lymph nodes; Excessive sweating; Headache; Insomnia; Lower back pain; Sensitive to touch mid part of the body; Muscle pain; Joint pain; Excessive vaginal discharge; Dizziness; Throbbing pain through the entire arm; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05May2021 at 11:15 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified contraceptive pills from unknown date and unknown if ongoing. The patient did not receive other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 14Apr2021 at 14:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. On 05May2021 at 23:30, the patient experienced high fever, chills, throbbing pain through the entire arm radiating to the wrist (left arm), sore throat, swollen neck lymph nodes, excessive sweating, headache, insomnia, lower back pain, sore, sensitive to touch mid part of the body, muscle and joint pain, excessive vaginal discharge, and dizziness. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events high fever, chills, throbbing pain through the entire arm radiating to the wrist (left arm), sore throat, swollen neck lymph nodes, excessive sweating, headache, insomnia, lower back pain, sore, sensitive to touch mid part of the body, muscle and joint pain, excessive vaginal discharge, and dizziness was resolving at the time of this report.  No follow-up attempts are required, information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a healthcare administrator referring to a patient of unknown age and gender. On 23-JUN-2016 the patient was vaccinated with improperly stored ROTATEQ (lot # L048854, expiration date 31-AUG-2017, dose not reported) orally. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Fever, pain, warmth, redness & swelling at injection site. Right Thigh
Local : erythema, swelling, redness, tender. 1. at site of injection right hip. 2. right inguinal glands swollen: redness, tenderness.
Information has been received from a licensed practical nurse concerning a 73 year old female patient who on 22-SEP-2010 was vaccinated with a first 0.5 ml dose of PNEUMOVAX 23 (Lot No. 665707/1407Y). On 22-SEP-2010, within 2-3 hours after receiving the PNEUMOVAX 23 injection, the patient experienced pain and redness at the injection site. The patient was seen in office on 23-SEP-2010 and on exam the area of her right arm from elbow to shoulder was crimson red with several small blisters, fever to touch, extremely painful with nausea. Diagnosis was cellulitis, treated with AUGMENTIN 875mg twice a day for 14 days. She saw the doctor again on 24-SEP-2010, and the area was less swollen, no fever, still had pain in the medial side of right upper arm radiating into shoulder. Patient thought there was some improvement. She did not receive PNEUMOVAX 23 in the past. At the time of the report, the patient was recovering. This is one of several reports from the same source. Additional information has been requested.
brief syncope @ school, light headedness once each day on 3rd & 4th day p/vax;pt examined on 28APR-nl, BP, HR, nl exam;no specific treatment given;
Narrative: COVID infection following COVID vaccine series 11/09/21, Pfizer, dose#1 11/30/21, Pfizer, dose #2 01/03 COVID swab, result: detected 12/26/21 pt cc: cough, congestion, fatigue, shortness of breath, exposure: unknown 01/03 CXR impression: 2 views of the chest. No coalescent lung consolidation. No pneumothorax. No pleural effusion. Cardiac silhouette within normal limits. No acute osseous abnormality seen 01/03/22 pt admit ED cc: cough, congestion, fatigue, shortness of breath, dx: Covid-10 LOS:1 day 01/06 clinically resolved
Had injections. Walked out into waiting room and told Mom she "didn't feel good".  c/o feeling dizzy. Laid down on bench and immediately felt better.  B/P 92/62.
Began with tingling down my right arm, and I became a little shaky.  Drank some water and the shakiness continued to get worse.  Went to the restroom and felt like I was going to pass out.  Tingling came back  across my upper body (chest level to shoulder level), I began to shake excessively, my mouth got very dry and my skin became splotchy.  I was breathing hard like I had just ran flights of stairs.  Nurses were called and I was given Benadryl and taken to the Emergency Room at a neighboring hospital where they hooked me up to I believe heart and BP monitors.  My blood pressure was very high and my heart was pounding so hard.  Was given steroid pills.  All day I urinated excessively and my heart pounded hard.
inflamed stomach; Hurts to breath under left breast by the rib; MD thinks it could be side effects that could have activated a bacteria in her stomach/Felt bad; continued vomiting; Once she eats, she starts vomiting blood; Feels thirsty too; weak legs; stomach pain left side; chills; fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMATEMESIS (Once she eats, she starts vomiting blood) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21R and 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   No Medical History information was reported.  On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain left side), CHILLS (chills) and PYREXIA (fever). On 15-Apr-2021, the patient experienced HAEMATEMESIS (Once she eats, she starts vomiting blood) (seriousness criterion medically significant), THIRST (Feels thirsty too) and MUSCULAR WEAKNESS (weak legs). On 29-Apr-2021, the patient experienced GASTRITIS (inflamed stomach), PAINFUL RESPIRATION (Hurts to breath under left breast by the rib), VACCINATION COMPLICATION (MD thinks it could be side effects that could have activated a bacteria in her stomach/Felt bad) and VOMITING (continued vomiting). At the time of the report, HAEMATEMESIS (Once she eats, she starts vomiting blood) had not resolved and ABDOMINAL PAIN UPPER (stomach pain left side), THIRST (Feels thirsty too), MUSCULAR WEAKNESS (weak legs), GASTRITIS (inflamed stomach), PAINFUL RESPIRATION (Hurts to breath under left breast by the rib), VACCINATION COMPLICATION (MD thinks it could be side effects that could have activated a bacteria in her stomach/Felt bad), VOMITING (continued vomiting), CHILLS (chills) and PYREXIA (fever) outcome was unknown.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Computerised tomogram: abnormal (abnormal) CT scan showed inflamed stomach.  The action taken with mRNA-1273 in response to the event was not applicable.  Treatment for the events included Nexium and ondansetron.  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.
Severe local reaction and cellulitis of injection site - fared and spread x 3 days requiring treatment with oral steroid (Prednisone), oral antihistamine, oral antibiotics (Keflex) and Ibuprofen. Maximum spread 10 inches x 7 inches of erythemia.
tingling / burning sensation in throat about ~12 minutes after vaccine. Did not progress to airway compromise. Sensation changed to a numbness but did not worsen. Patient given Benadryl and Pepcid, monitored. Improvement in symptoms noted, discharged home.
PFIZER vaccine that was stored in pharmacy refrigerator given outside of 31 day expiration. Vaccine received at hospital on 11/19/2021. Expiration date on vial 02/2022. NDC# 59267100001.
Six hours after injection,  a 2 inch x 1 inch bruise appeared above my elbow and a blood clot  in my upper arm.  They both resolved on their own in time.
Per patient: I received the  pneumonia vaccine I got in my right arm and I had a reaction to it. The site was red for over 4 days and very sore. I developed a temperature of 100.6 about 32 hours later and felt very tired with body aches. It lasted about 12 hours. I read up that this can be a normal reaction; however, the site of the injection is still sore to the touch and itchy.   Day 9 post vaccine  Provided homecare instructions for immunization reaction
Friday 6/3- Mother called regarding swollen injection site- firm nodule at injection site and the rash and redness were spreading. Mother noticed the rash yesterday, Thursday 6/2,  (injection was 2 days ago); Mother gave zyrtec yesterday morning; the area became firm by Thursday night; Last night, alternated warm and cool compresses. Mother marked the area last night and sent email picture this morning. The rash was continuing to spread. PEr Dr. advised mother to give cephalexin 2.5 ml twice a day for 5 days. Cover site with 2x2 and band aid.  Call in 5 days if no improvement. Mother stated understanding. Mother stated pt was happy and no fever.
Swollen axillary nodes and supraclavicular; Dose Number:3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 12:00 (Lot number: FG3527) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8732, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 27Mar2021, when the patient was 36 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EWQ169, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 17Apr2021, when the patient was 36 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021 12:00, outcome "unknown", described as "Dose Number:3"; SWELLING (non-serious) with onset 19Nov2021 12:00, outcome "not recovered", described as "Swollen axillary nodes and supraclavicular". Therapeutic measures were not taken as a result of swelling.  No follow-up attempts are possible. No further information is expected
Vax given 1030-11AM no sx noted; @ approx 3PM mom calls stating pt is limp, pale & unresponsive; advised to see family MD;
Patient received TD on 08/23/2005, reported that approximately 48 hours later on 08/25/2005 she developed hives around injection site on left arm and on left side of neck and left trunk.  Took Benadryl for 1 day, hives slowly resolved over next 4 days.  She was not seen in any medical facility.
Red patch about 3 inches round and a little swelling and itching at the injection site.
A patient received first and only dose of GARDASIL 9 while pregnant.; No additional adverse events were reported; This spontaneous prospective pregnancy report was received from a medical assistant and refers to a 17-year-old female patient. The patient did not have drug reactions or allergies and no pertinent medical history. There were no concomitant medications.     On 14-SEP-2023, the patient was vaccinated with a first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscularly, 1 dose, lot # 1957404, expiration date 05-OCT-2025 ,for immunisation. The patient was vaccinated while she was pregnant (exposure during pregnancy). The last menstrual period and estimated date of delivery were not reported. The pregnancy outcome was pending. No additional adverse events were reported.
Case number PHEH2014US019168 is an initial spontaneous report received from a nurse on 19 SEP 2014. This report refers to a 22 year old male patient. His medical history and concomitant medication were not reported. On 18 SEP 2014 he was inadvertently vaccinated with FLUVIRIN 2014/2015 (batch number: 1412001) intramuscularly at a dose of 01 ml stead of the recommended 0.5 ml dose. Currently no complain was received from the patient. No adverse event was reported following this maladministration (vaccine overdose).
Pt called stating she has "hives" at site of injection. No other symptoms. Apply ice take BENADRYL, see provider if no improvement.
Breakthrough case after three vaccines  Moderna 3/30/21 Lot#025B21A;  Moderna 4/27/21 Lot# 006C21A;  Moderna 1/4/22 Lot# 030H21B
Choking due to a restriction in the throat not from food or drink. Husband did Heimlich Maneuver twice before airway opened up enough for me to catch my breath. Next day, difficulty swallowing food unless it was soft or cut up finely.