chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Exactly one week later on 4/22 I started to develop hives (which I initially thought were mosquito bites). By today 4/24, I am positive they are hives and huge welts on my face and arms and torso, they itch; Half of my face is swollen; Exactly one week later on 4/22 I started to develop hives (which I initially thought were mosquito bites). By today 4/24, I am positive they are hives and huge welts on my face and arms and torso, they itch; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 32-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 15Apr2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included vortioxetine hydrobromide (TRINTELLIX); taken for unknown indication from an unknown date and unknown if ongoing. On 22Apr2021, exactly one week later, the patient started to develop hives (which she initially thought were mosquito bites). By today (at the time of this report, as reported) on 24Apr2021, she was positive that they were hives. She had huge welts on her face and arms and torso. They itch and half of her face was swollen. The events did not result in doctor or other healthcare professional office/clinic visit, 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 exactly one week later, the patient started to develop hives (which she initially thought were mosquito bites). By today (at the time of this report, as reported) on 24Apr2021, she was positive that they were hives. She had huge welts on her face and arms and torso. They itch and half of her face was swollen was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
16 YO REPORTS 5 MINUTES AFTER THE INJECTION HE DEVELOPED HEADACHE, JOINT PAIN, VISION CHANGES-DARKENING OF PERIPHERAL VISION AND SPOTS IN HIS VISION. HE REPORTED DYSPNEA AND PARENTS REPORTED SPEECH CHANGES. MOTHER GAVE ACTIVATED CHARCOAL, FISH OIL, TURMERIC AND EXCEDRIN, DID NOT RECEIVE BENADRYL. PARENTS WERE CONCERNED THIS WAS AN ANAPHYLACTIC REACTION. HE WAS EVALUATED IN ED WITH NO SYMPTOMS OF ANAPHYLAXIS. NO INDICATIONS OF NEED FOR EPINEPHRINE OR STEROID, UNLIKELY TO BE ANAPHYLAXIS. HE HAS A HISTORY OF MIGRAINE HEADACHES AND IT WAS THOUGHT TO BE A MIGRAINE, WHICH WAS TREATED IN THE ED WITH IBUPROFEN AND BENADRYL, LATER TREATED WITH ZOFRAN FOR NAUSEA. OBSERVED AND THEN SENT HOME FROM ED.
RASH, LOCAL REDNESS, BUMP, WHITISH BLISTER, SCAB, LOCAL ITCHING, MUSCLE ACHES, FEELING LOUSY, SEPTRA TABS GIVEN
My menstrual cycle has not stopped. I received my shot 16Sep2021. My period was due 17Sep2021 it came 20Sep2021 to this date 06Oct2021 I still have a period; My menstrual cycle has not stopped. I received my shot 16Sep2021. My period was due 17Sep2021 it came 20Sep2021 to this date 06Oct2021 I still have a period; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Sep2021 11:45 (Lot number: Ff2588) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "3 c sections" (unspecified if ongoing), notes: 3 c sections and a tubal ligation. No other medical problems. other medical history: None.; "tubal ligation" (unspecified if ongoing). There were no concomitant medications. The following information was reported: OLIGOMENORRHOEA (non-serious), MENSTRUAL DISORDER (non-serious) all with onset 20Sep2021, outcome "not recovered" and all described as "My menstrual cycle has not stopped. I received my shot 16Sep2021. My period was due 17Sep2021 it came 20Sep2021 to this date 06Oct2021 I still have a period". The event "my menstrual cycle has not stopped. i received my shot 16sep2021. my period was due 17sep2021 it came 20sep2021 to this date 06oct2021 i still have a period" and "my menstrual cycle has not stopped. i received my shot 16sep2021. my period was due 17sep2021 it came 20sep2021 to this date 06oct2021 i still have a period" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of oligomenorrhoea, menstrual disorder.  Additional information: No any other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Hours after vaccine area turn red red and indurated. Mom at home applied EPSON salt and cold compress. Now doing better before 24 hrs.
Patient described the swelling as a baseball size lump and difficulty moving arm. She reported to the pharmacy at 5:30pm to inquire how to treat. She had placed ice on the location for several hours. She is continuing with the ice and will try Tylenol to help with soreness.
I became very light headed and passed completely out. I do not remember anything leading up to this or while it was happening.  When I came too, I couldn't hear, had ringing in my ears, couldn't walk on my own, and my husband said I was very cold.  Two days later and i still have dizzy spells and extreme fatigue.
Stiffness and pain in back on head, left shoulder. Pain, tingling, numbness down left arm and into left hand. Pain has gotten worse over the past month. Now additionally experiencing bilateral pain in the right arm with tingling and numbness. Easy bruising, brittle nails, swelling of the limbs.
The next day post vax, the pt developed a fever and seizures. Taken to ER and dx with febrile seizures. Treated with Tylenol and Motrin.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: gave patient benadryl 25mg capsule and water. after 5 minutes, patient left
Dizzy and light headed same day as vaccine.  Next day strong strong intestinal cramps, nausea, continued  lightneaded, extreme joint aches, couldn't move left arm at all for all that day.  Most of these were decreased by late evening of the next day and pretty much resolved by the next morning except for the joint pain which steadily increased.  Seemed to move down body from shoulders, hips, knees, wrists, ankles.  I am normally a very active person, but could barely get up and down without extreme pain for the next three weeks, pain and weakness in knees and ankles.  Swelling and tenderness in both.  Has improved gradually since that first three weeks after the shot, but still not fully resolved, still some impairment that is totally not normal for me.  Hopefully this is not permanent.
Face numbing, mainly in cheek and eye area, eye twitching,  eyes very dry,  part of lip and chin.  it started off as becoming very tight, then the tingling.  it has been over 24 hours and still sum tingling in the check bone and chin area.
Severe pain & soreness in left arm where injection was given that extends upwards to the shoulder.
Left leg red swollen area size 2 inches diameter, warm to touch, no itching. Right leg 3 inch diameter swollen, warm, tender to touch, itching. Recommended Tylenol, Benadryl and ice packs.
Initial feeling of chills the evening of the vaccine. Overnight, stomach pain developed, followed by nausea, diarrhea and a sensation that felt like I needed to vomit. Pain subsided around 10 a.m. but feeling of extreme fatigue persisted all day. Slept most of the day.   Notably: after the first injection on 12/04/20, I also had a reaction - a different one. The right side of my face began stinging and itching - in the same area where I had a Shingles outbreak the previous July.
A non-serious spontaneous report of inadvertently given FLUMIST to a 51-year-old female patient was received from a registered nurse/health professional. Neither relevant medical history nor concomitant medications have been reported for this patient. On 08-Nov-2010, the patient received a dose of FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
Patients received expired doses; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received expired doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  Patient received second booster shot.  It was reported that there was incident because of miscommunication as a coworker told that there were some lot number whose expirations dates had been extended.   Treatment medications were not reported.
Pt received flu shot at 12pm, by 7 pm pt had red raised pruritic papules on chest and abdomen.  Progressed to neck and face by 9 pm associated with mild SOB, no wheezing.  No previous hx of allergic rxn to flu shot, no egg allergies. Symptoms resolved after cetirizine 10mg po. Also painful, warm, red swelling at injection site for 4 days.
23 yr old male sat on chair post Janssen vaccine and complained of light headedness approximately 1 minute afterward, patient called for assistance and onsite Paramedic (1) arrived by his side immediately. Patient became pale and clammy and as onsite Paramedic (2) approached patient sustained syncopal episode while seated on chair. Patient remained in seated position. Patient awoke and only recalled feeling "dizzy and lightheaded." Patient denied any medical history, allergies or medications. Patient denied shortness of breath, chest pain headache or pain. AOx4  EMS arrived. Care provided.
NONE EXPIRED COVID-19 GIVEN: EXPIRED 11/22/2022 GIVEN: 12-19-2022
The patient was given the Moderna Covid 19 Bivalent 6 months through 5 year vaccine as her first dose in the primary series, rather than the Moderna Covid 19 monovalent 6 months through 5 year vaccine. The patient has not had any adverse effects because of this, nor has she had any resulting symptoms. There was no treatment given because the patient presented no symptoms, and the patient is going to receive a dose of the primary series in 4 weeks, and further vaccination will be  determined at that time.
nurse gave three dose of Menactra to the patient, No AE; Initial information received on 28-Jul-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case involves a 17 years old female patient who received dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] on 04-Aug-2015, 29-Oct-2019 (lot number, expiry date and other dosing details not reported) and third dose, 0.5 mL, lot number: U658BA, expiry date: 20-Apr-2021 via an intramuscular route in the right deltoid on 28-Jul-2020 for prophylactic vaccination respectively.  The patient's medical history, past medical treatment, vaccination and family history were not provided. List of concomitant: none.  It was a case of an actual medication error case due to extra dose administered.  At the time of reporting, no adverse event was 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.
Patient reported to PCC on 4/4/18: Per RN Note: Left deltoid with blotchy reddened area to entire deltoid, site of injection raised, appearing like a bug bite. Denies any itching to site. Patient reports improvement to rash since appearing Monday 4/2/18 evening. He states that Monday night he had significant pain, making it difficult to sleep. Pain currently 1/10 he reports as tender.
Occasional accelerated heart rate; Swollen left axillary lymph node; Injection site warmth; Injection site itchiness; Injection site swelling; Injection site redness; Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Occasional accelerated heart rate), VACCINATION SITE WARMTH (Injection site warmth), VACCINATION SITE PAIN (Injection site soreness), VACCINATION SITE PRURITUS (Injection site itchiness) and VACCINATION SITE SWELLING (Injection site swelling) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (Injection site soreness). On 14-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warmth), VACCINATION SITE PRURITUS (Injection site itchiness), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (Injection site redness). On 15-Jan-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swollen left axillary lymph node). On 16-Jan-2021, the patient experienced HEART RATE INCREASED (Occasional accelerated heart rate). On 19-Jan-2021, HEART RATE INCREASED (Occasional accelerated heart rate), VACCINATION SITE WARMTH (Injection site warmth), VACCINATION SITE PAIN (Injection site soreness), VACCINATION SITE PRURITUS (Injection site itchiness), VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (Injection site redness) and VACCINATION SITE LYMPHADENOPATHY (Swollen left axillary lymph node) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information provided.
DIAGNOSED WITH COVID 10/3/2021; CARDIAC ARREST AND DIED 10/6/2021 FROM COVID COMPLICATIONS
Weakness in right hand; Numbness in right hand; Pain in the right arm in the brachial plexus; This case was reported by a physician via call center representative and described the occurrence of hands weakness of in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. In October 2020, 11 days after receiving Shingrix, the patient experienced hands weakness of, numbness in hand and neuralgia. On an unknown date, the outcome of the hands weakness of, numbness in hand and neuralgia were not recovered/not resolved.   It was unknown if the reporter considered the hands weakness of, numbness in hand and neuralgia to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix vaccine 3 weeks ago in the right arm. Caller reported 10 days ago, the patient reported weakness, numbness in the right hand and pain in the right arm in the brachial plexus. This was still ongoing currently. The reporter did not consent to follow up.
pt recvd vax; devel rash & fever on 23oct94;seen by MD 24oct94;prescribed meds;pt took meds x 4 days, did not help;PC to MD & he ref to hlth dept;to clinic 2nov94;rept taken & referred back to MD for tx of persistent rash;
Pt received flu vaccine. Has had it several times before. About 35 min after administration, returned to room where clinic was. c/o itching @ site. Has fine pink rash about 2" in diameter. A little fine pink rash vertically below on from lateral portion of arm about 1" to 3" area. No history of problems with vaccine. Contacted NOVARTIS, they do not make recommendations. Fits dx of localized response. Cold compress applied. No analysis needed. Standing order is Benadryl. Diphemhydrime hydro-chloride 25 mg available at employer. Pt decided to take some.
Coughing; Body Aches; Fever; Chills; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), PAIN (Body Aches), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headaches) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03IL20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient was diagnosed in last December with COVID) in December 2020. Concomitant products included SIMVASTATIN and LEVOTHYROXINE for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Coughing), PAIN (Body Aches), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headaches). At the time of the report, COUGH (Coughing), PAIN (Body Aches), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of these 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 these events, a causal relationship cannot be excluded.
SIDS death 7/1/04.  Nurse follow up on 10/05/04 states: "Focal chronic encephalitis."
Fatigue; sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and VACCINATION SITE PAIN (sore left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 22-Apr-2021, the patient experienced FATIGUE (Fatigue) and VACCINATION SITE PAIN (sore left arm). On 24-Apr-2021, FATIGUE (Fatigue) and VACCINATION SITE PAIN (sore left arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment details were provided.   This case was linked to MOD-2021-169299 (Patient Link).
Parent reports 1.5 x 2 inch hard area at inj site left leg area of hardness is at outer thigh and towards posterior.  Area is non tender and does not bother patient. Parents will monitor area and follow up if anything changes. Mom states that they are not overly concerned.
Began having chills, fever spiked up to 100.7, muscle aches and pain, headache, night sweats. These symptoms lasted approximately 36 hours. Felt lethargic and fatigue for approximately 48 hours after the vaccine. Also had some menstrual bleeding which was brief on 3/5/21, which was the date of the vaccine, and this was not expected. Alternated Tylenol and Ibuprofen after vaccine to help lower fever, and drank fluids.
Pain in arm for 2 days  24 hours after injunction full 24 hours of sleep. I went to sleep at normal time Tuesday night woke up at normal time Thursday morning. Same with Friday went to sleep normal time on Thursday woke up Saturday morning then Saturday night could not fall asleep at all.
This case was reported in a literature article and described the occurrence of anaphylaxis in a subject who received Meningococcal ACWY-CRM vaccine. The subject's past medical history included anaphylaxis (immediately following receipt of an unknown vaccine 6 years earlier). On an unknown date, an unknown time after receiving Meningococcal ACWY-CRM vaccine, the subject developed anaphylaxis. Serious criteria included GSK medically significant and other: Serious per reporter. The subject was treated with epinephrine. The outcome of anaphylaxis was unknown. It was unknown if the investigator considered the anaphylaxis to be related to Meningococcal ACWY-CRM vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of anaphylaxis in a patient of aged between 0-89 years of unspecified gender who was vaccinated with MENVEO (GlaxoSmithKline). The patient was a part of the study to provide additional information on post-licensure safety, reported to Vaccine Adverse Event Reporting System (VAERS) for subjects of any age receiving MENVEO during 1 January 2010 through 31 December 2015. The study utilized the data reported to a spontaneous reporting system- VAERS, the co-administered by the Centres for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA)-to summarize reports following immunization with MENVEO. The patient had a history of anaphylaxis immediately following receipt of an unknown vaccine 6 years earlier. No information on patient's family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received MENVEO (administration route and site unspecified; dosages unknown; batch number not provided). [In this study, out of 1380 reports, other vaccines were also given concomitantly with MENVEO. The most commonly co-administered vaccines varied depending upon age including pneumococcal (n=9) and MMR (n=8) in children less than 2 years of age, Tdap in children aged 2-10 years (32), Tdap (776) and HPV (608) in adolescents (aged 11-18 years), and Tdap in adults aged 19 and older (43)]. On an unspecified date, 24 hours or more after the vaccination, the patient developed anaphylaxis. The case met the definition of Brighton level 1. This case has been considered serious per reporter (In this study, reports are classified as serious or non-serious, using the definition for serious based on the Code of Regulations). The patient was treated with epinephrine. The outcome of the event was not reported. The authors did not comment on the relationship between the event of anaphylaxis and MENVEO. (VAERS personnel do not perform causality assessments regarding the relationship between a particular vaccine and a temporally-associated adverse event). The authors concluded that, "In our review of VAERS reports, findings of AEs were consistent with the data from pre licensure studies. Vaccine providers should continue to emphasize and adhere to proper administration of the vaccine." This is 1 of the 45 reported cases in the same literature article.
Once getting the shot, approximately 2 mins after receiving it I felt this heat wave come across my body and I passed out and was taken to the er, which they ran some tests and said I was fine, but the the next day I started feeling sick had chills and was dizzy when I stood up or walked around and felt that way for 5 days, I went yesterday to urgent care where they gave me a covid test and no awaiting test results