chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immediately after 2nd dose, client c/o itchiness all over her body. No redness or rash noticed. Client did not have any reactions or symptoms with 1st dose. No s/sx or resp distress, SOB, or chest tightness. Vitals taken and are as follows: bp 138/90, HR 88, o2 98%, R 18. No med dx, no medications taken. Allergies to Bactrim and sulfa. Client verbalized taking benadryl whenever she has this kind of itchiness and client does not want to been seen by HCP. Advised to stay for longer observation in which client stated reaction symptom diminished. Client was advised to notify HCP of reaction and to monitor for other adverse reactions. Client left clinic at 2:05 PM accompanied by husband and friend.
Moderna Vaccine lot #005C21A was affected due to out of temperature range. No adverse reactions from patients.
Barking cough; Getting sick easier; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in 2021 and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history included asthma, hypothyroidism, and obesity. The patient was intolerant to lactose. The patient  received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On 01Apr2021, about 12-15 hours after 1st dose, the patient experienced barking cough, was getting sick easier than she ever had before and she got sicker than other people with similar bugs. The patient stated, it was like her immune system didn't work. The event barking cough was still continuing at the time of this report. On 21Apr2021, the patient underwent nasal swab test and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event barking cough which included treatment with cough medicine. The clinical outcomes of barking cough and getting sick easier were not resolved at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient was exposed to employee who was diagnosed with the shingles prior to receiving the Flumist. Physician suspects the Flumist decreased the patient's immune response enough to have an outbreak of the shingles. He was diagnosed with Herpes Zoster on 21 October 2007. He was treated at a local Emergency Room, given Zovirax for treatment and placed on quarters for 72 hours.
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 20-year-old male. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse events associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause of the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 12-May-2009: product complaint investigation results.
I have cancer; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 17Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient took first shot Pfizer at Hospital on 17Apr2021. The patient didn't get the second shot because the patient was in the hospital and the patient had cancer so the patient missed the appointment. The patient want to take the 2nd shot on Sunday. When probed for permission to probe, Consumer refused and said that he/she really didn't feel better. He/she just had a question. The outcome of the event was not recovered.   Information about lot/batch number has been requested.
Systemic: Hypotension-Mild, Systemic: Weakness-Mild, Additional Details: pt stated  she did not feel good, maybe nauseous and lightheaded, instructed her to sit with head between knees, too bp 98/61, and had pt lie on floor repeated bp every 4-5 minutes 107/63, 115/71, sat up in chair and gave juice and bp rose t o 123/74. She left  a few minutes later with significant other.
Treatment of COVID-19; Treatment of COVID-19; COVID -19 rebound; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 02Dec2021 at 14:00 as dose 3 (booster), single (Lot number: EW0217) at the age of 51 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Colitis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 09Aug2022, outcome "not recovered", described as "COVID -19 rebound"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient took Paxlovid from 31Jul2022 to 05Aug2022 for Treatment of COVID-19. Patient reported he tested COVID positive today (09Aug2022) and he was experiencing a COVID -19 rebound case today after previously testing negative on 06Aug2022 after taking Paxlovid for 5 days. His COVID symptoms today include runny nose, congestion, sneezing, headache, slight sore throat.
pt was taken to ER 30min p/shots w/shaking, trembling & eyes rolled back in head;lab test done to r/o other underlying problems;ER nurse stated pt had febrile sz;t104.5 on arrival;
1 1/2 hours after immunization the patient had hives on his trunk, back and extremities. The evening and night of 09/28/2001 the patient had a fever of 103F. The patient's arm was red and swollen with spider like marks. The patient was treated with Benadryl and instructed to go to the ER if the symptoms persist. Two hours later the patient was sleeping and had only a rash.
i WANTED TO UPDATE MY VACCINE, DUE TO BECOMING A GRANDMA, RECENTLY.  SO, I WENT TO WALGREENS TO DO SO.  EVER SINCE, I'VE HAD PAIN IN MY ARM, BRUISING AND A BUMP.  I TYPICALLY DON'T GET VACCINATED DUE TO BEING A CANCER SURVIVOR WITH IMMUNE CANCER, AS ADVISED BY MY MEDICAL DOCTOR.  BUT, THOUGHT HAVING A NEW BABY AROUND, IT WAS A GOOD IDEA.  OBVIOUSLY NOT!
Few hours after HIB/PVC #1 Baby had 10 sec episode of stiffening and 2 weeks "out of it" - poor eye contact, not happy.
Tingling nerve pain in cranium,face,neck,and  left arm every day since third dose
tinnitus began within 2 days.  started out mild and became moderate over the course of a year. no previous tinnitus.
Fever and diarrhea since 3/4. Tested positive for COVID on 3/7 and was admitted as an inpatient.
administered Menveo with sterile water; administered Menveo with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA581A, expiry date 31st August 2022) for prophylaxis.   On 31st August 2021, the patient received Menveo. On 31st August 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter was a Medical assistant. The patient was administered Menveo with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Left shoulders, arm and hand became numb immediately after the 2nd shot and remain so to date. Began suffering from extreme dizziness and confusion about 11 weeks after. Diagnosed as "vertigo"; prescribed meclizine, PRN.
mom called 1 hr p/leaving office to report pt stopped breathing x 3; EMS called by mom per phone reported pt alert, in no resp distress, pink in color; To ER for apnea evaluation;
Reports 2 hours after vaccination breaking out in welts and having difficulty breathing. Resolved after administration of Benadryl.
A nurse reported that an 18 month old male received vaccinations on 9/26/00 and the next day, developed a fever of 100F and "cried when walking". He also developed an injection site reaction characterized by warmth and swelling at the site of Acel-Imune administration. The mother treated the child with Tylenol. On 9/28/00, the mother reported that the child slept restlessly and that the swelling now extended from the upper thigh to the knee. That same day, he was seen by the physician who noted that his "right knee appeared larger that his left knee" and that the fever, swelling and difficulty walking had resolved. He recovered.
This spontaneous report as received from a physician refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with dose 1 of GARDASIL (lot number, expiry date, dose and route were not reported). No concomitant medications were reported. On an unspecified date, the patient received the 2nd dose of GARDASIL (lot number, expiry date, dose and route were not reported) 11 months after the first dose and then was given the third dose of GARDASIL (lot number, expiry date, dose and route were not reported) 2 months after the second dose and no adverse effect reported. Additional information has been requested.
Painful injection site Nausea some dry heaves Chills Headache Myalgia  Arthralgia Weakness Body rash/itching Very dark urine
Information has been received from a physician and a health care worker concerning apt who was vaccinated SC with a 0.5 ml dose of Pneumovax 23. Subsequently the pt developed "swelling and heated skin in the area of the injection". It was reported that the pt sought unspecified medical attention and was hospitalized. At the time of the report, it was unknown if the pt recovered. Additional information has been requested.
10/7/11 16:00 - Gums & lips burning, congested chest, eyes red. 16:15 Swelling face, eyes, lips & tongue. Intermittent chest discomfort, became anxious. 18:30 ED - Antihistamine, steroid - IV. Some decrease in symptoms. 10/8/11 Symptoms gone. 10/8 - 10/17 Still lethargic.
patient received an expired dose of MENACTRA; Initial information was received on 01-Jun-2021 regarding an unsolicited valid non-serious case from a other health professional (Agency Inquiry number: 00623308).  It was reported that a 57-year old female patient received an expired dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (Suspension For Injection) (lot number: U6594AB, expiry date: 21-May-2021) on 28-May-2021 via intramuscular route at right arm for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used.  At the time of report, no adverse event reported.  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.
Within a day my son developed eczema that steadily progressed in severity. He began spiting up considerably. We didn't realize ti at first, but he was reacting to foods through my milk. He never showed ANY signs of allergies or sensitivity before this. It wasn't until he began solids that we realized his allergies. Having FPIES, he would begin severe vomiting two hours after ingesting the allergen. He would have to be rushed to the hospital for fluids as he would become lethargic and risked going into shock. There is no test to determine his allergies; it's all based on trialing foods. Foods that he could safely consume a few weeks ago, could turn into an allergen later on.
Information has been received from a registered nurse concerning a 51 year old female who on 15-APR-2009 was vaccinated with a single dose of PNEUMOVAX (lot number, route and site not reported). On 15-APR-2009 after receiving the vaccine, the patient's arm became very swollen and she could not lift her arm. It was unspecified if the patient sought medical attention. Her outcome was unknown. Follow-up information was received from the registered nurse. The nurse reported that on 14-APR-2009 the patient was vaccinated with the second dose of PNEUMOVAX (lot number 661527/0112Y) SQ into her left arm. On 14-APR-2009, 12 hours past injection the patient's injection site ("fatty part" of her left arm) got swollen, red, pain and difficulty lifting her arm and the symptoms continued into the next day. The patient also felt nauseated during this time. There was no illness at time of vaccination. There were no known drug allergies. Additional information has been requested.
Began having a dizzy spell that progressively became worse over a few days that turned into months that was later accompanied by numbness and difficulty walking. Also had severe congestion one week after vaccination.
510 pm dizzy after vaccine was given, arm felt like its asleep, dry mouth water was given BP taken at 5:30 much improved.
On Day 6 Post Vaccination of Booster dose Moderna, patient reports still feeling extremely fatigues, lack of appetite, unable to eat, elevated blood sugar level, unable to walk,  and general feeling of being unwell.   On Day 6, she is just starting to be able to eat small amounts of food.    Patient advised to seek medical attention if symptoms persist.  **Note--patient reported that with the previous dose her vaccinated arm not only hurt, but it swelled up x 6 weeks.
On day after vaccine woke up vomiting, fever, body aches, chills, extreme headache, unable to control Vomiting. Went to ER for fluids and rescue meds. Given toradol, reglan and Benadryl via peripheral IV w bolus fluids.    Improved w continued Tylenol, ibuprofen and rest.  3 days off work.  I am a registered nurse.  Arm was very sore for two days.
Pain at injection site and arm muscleon the evening of shot, dull on day 2 and injection site tender on day 3.  Chills overnight of day 1 through day 2, with sweating/overheating while sleeping, feverchecked on day 2 @ 99.2F, lack of energy and tired day 2 with multiple naps, headache beginning day 1 evening treated with 500 mg acetamenophen, dull headache day 2.
This spontaneous report has been received from a pharmacist referring to a 62 year old female patient. Information regarding pertinent medical history and concurrent conditions were not provided. The patient had no known allergies. On 25-MAY-2016, the patient was vaccinated with ZOSTAVAX, injection, subcutaneous, lot # L040442, expiration date 15-JAN-2017. Concomitant therapies were not provided. On 07-JUN-2016, the patient went to the pharmacy and reported that after vaccination on an unspecified date in 2016, she was experiencing tingling, burning, itching and blistering around her mouth and lips. The reporter stated that the patient did not seek medical attention. At the time of reporting the outcome of the tingling, burning, itching and blistering around her mouth and lips was not recovered. The relatedness between the event and ZOSTAVAX was not reported. This is one of two reports received from the same reporter. The pharmacist refused to receive the Varicella Zoster Vaccine packet at this time. Additional information has been requested.
This is a spontaneous report from a COVID- sponsored program via a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration, on an unspecified date as 1st dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she was happy and only got a sore arm after her first dose on an unspecified date. The outcome of the event was unknown at the time of report. Information about the lot/batch number has been requested.
A week or so after first dose, observed a lot of muscle pain in my shoulders, upper back, neck, and head I attributed it to stress and hard work. I used muscle creams and percussion massager to try to alleviate the pain. I was also fatigued. It wasn't until July 8th that I noticed that the lymph node on the left side of my neck near my collar bone was very swollen (once I pointed it out, people could see it). That was the cause of my pain. My husband and I took a very short hike, less that half mile, but included many stairs and some uphill and downhill traversing. On Saturday July 10th, I was extremely fatigued, and my lower left hip ached. I used muscle creams to try to alleviate that pain. On Thursday July 15th,
Soon after immunization was administered pt's arm swelled at injection site. redness and swelling. pt did not complain of any pain. I called RN into exam room to examine site. Ice pack was placed on site to help with swelling, vitals were rechecked and pt was monitored by myself and RN until provider came into exam room. Pt complained of lightheadedness/feeling faint and sob. prior to injection pt complained of anxiety that was addressed in office visit wtih provider.
5/23/22: sore throat, repetitive coughing, onset of mild diarrhea, chills, loss of appetite, hypotension from dehydration - no apparent fever, no SOB.  After taking one day of Paxlovid pills on 5/26 , my symptoms were significantly diminished the following morning on 5/27. Today 5/31 I feel I have recovered.    I did three home  antigen tests between 5/23 and 5/26 and each was positive.
Administered more than 30 days after 11-Jan-2022 are not in accordance with the EUA; Patient was administered expired Moderna vaccine accidentaly; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered expired Moderna vaccine accidentaly) and PRODUCT STORAGE ERROR (Administered more than 30 days after 11-Jan-2022 are not in accordance with the EUA) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 008C21A and 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered expired Moderna vaccine accidentaly). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered more than 30 days after 11-Jan-2022 are not in accordance with the EUA). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered expired Moderna vaccine accidentaly) and PRODUCT STORAGE ERROR (Administered more than 30 days after 11-Jan-2022 are not in accordance with the EUA) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. Patient received first booster dose on 09 May 2022.   Vials were refrigerated on 11-Jan-2022 and did not undergo any temperature excursion. No patient had reported any adverse event.  No treatment medication was reported by reporter.
Dizziness & Headache Narrative:  reported that day after the injection woke up with a massive headache and was dizzy. the dizziness lasted half of the day. spent the day in bed.
Severe headaches for over 12 consecutive days, brain pressure, dizziness, debilitating  brain fog. These adverse effects are disabling me as they prevent me from working and functioning normally.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Apr2021 at 11:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 30Apr2021 at 15:00 as dose 2, single (Lot number: EW0173), in left arm and on 14Dec2021 at 16:00 as dose 3 (booster), single (Lot number: FH8030) at the age of 62 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: VITAMIN D3, start date: 17Feb2020; OMEGA-3 [OMEGA-3 NOS], start date: 17Feb2020; LIPOSOMAL VITAMIN C, start date: 17Feb2020; ADREN ALL, start date: Jan2019; BONE UP, start date: Jan2017. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 01Sep2022 at 06:00, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Sep2022) Positive, notes: Rebound symptoms and Covid-positive test 7 days after completion of Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti viral treatment with Paxlovid was started on 19Aug2022 and stopped on 24Aug2022. No known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received vaccine at 0822, patient was in observation area and was about to leave. Patient told observer (RN), that she has chest pain/tightness and a headache at 0850. RN had her sit down and since the chest tightness/pain was intermittent, RN called the ED at 0854. ED RN came and escorted patient to the ED.