chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started November 2020 - Says my head is HOT. please put some water on my forehead. (Started Nov 12th 2020 - happens every day) he feels better after putting some water on his forehead. Issue Continues.  December 2020 - Biting Nails. He never bit his nails before this. Issue continues  December 2020 - High Emotions over every little thing. Issue Continues. December 2020 - Passing gas multiple times a day - Frequency is increasing. He probably passed gas once in 3 months. a sudden change. Issue Continues.   January 2021 - Eczema (starts with dryness on skin) on face, back of the knees, back of the ears. He has had some itchiness in the back in last 2 years but this is way beyond anything - ever. Issue Continues  January 2021 - Complaints of headache 3-4 times a week, he complains of a headache that lasts 2-3 minutes. If I massage his head, it goes away. this issue has subsided since Mid April.   February 2021 - Vomiting - Stomach is very sensitive now, He has vomited 6 times in February and March. this has subsided since.  February 2021 - Pee in pants every day. this never really happened before. it may have happened once in 6 months before. a drastic change. Issue Continues.  February 2021 - Sneezing in the morning specially (started mid-Feb 2021 Every day) Multiple sneezes for a couple of hours. Issue continues.   March 2021 - Stuffy Nose - this issue used happen 1-2 times a year, when he would get sick. Nothing like this before. Issue continues.   March/April 2021 - More Eczema issues appearing on face. Issue continues.
This spontaneous report as received from a registered nurse and refers to a 4 month old male patient. The patient's concurrent condition included weight gain poor. Medical history and concomitant therapies were not provided. On 27-SEP-2017, the patient was vaccinated with the first dose of ROTATEQ orally (strength, dose, frequency were not provided, lot # N009964, expiration date 22-NOV-2018) for prophylaxis. On 01-OCT-2017, 5 days after onset of therapy the patient experienced diarrhoea (three times), vomiting, infantile spitting up and decreased appetite. The patient recovered from diarrhoea on the same day and from infantile spitting up and decreased appetite on 02-OCT-2017. The outcome from decreased appetite was not provided. Prescription drug treatment for the experience was not required, no lab tests were done. The patient had no illness at time of vaccination. The causality between the events and ROTATEQ was not reported.
itching on genital area with in 1 hr after getting vaccine of mumps. Then broke out with red bumpy rash, not hives, on back, back of neck and genital area.
Vaccine administration error. No adverse outcome reported. On 1/13/22 Patient was inadvertently administered Trumenba (MenB) instead of Bexsero (MenB).  Patient had received Bexsero as the first dose on 12/9/21.  Error was discovered after patient left. Patient was contacted and appointment scheduled to be vaccinated with 2nd dose of Bexsero.   Received 2nd dose of Bexsero on 2/25/22.
Itchy rashes all over my body; This is a spontaneous report from a contactable healthcare professional, the patient. A 39-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 25Mar2021 at 10:45 as a single dose for COVID-19 immunisation. The patient has not reported any other health issues. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021, the patient experienced itchy rashes all over body. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event itchy rashes all over the body was recovering at the time of this report. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Apr2021 at 12:15 (at the age of 39-year-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in an 89-year-old female patient 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.
Case number PHEH2014US022453, is an initial spontaneous report from  a nurse received on 07 Nov 2014. This report refers to a 13 years old male patient. Medical history and concomitant medications were not reported. He was inadvertently vaccinated with FLUCELVAX (batch number: 013011A) intramuscularly on 07 Nov 2014. No adverse event was reported following this medication error (inappropriate age at vaccine administration).
Patient received 2 doses of COVID-19 vaccine.  On 4/21/21 developed body aches, headache, cough, and nasal congestion.  Tested positive for COVID.
Immediate onset of tachycardia and flushing, resolved after 5 minutes. 30-min delayed onset of metallic taste in the mouth, resolved after 2 hours. 8-hours delayed onset of 8/10 arm pain and 8/10 fatigue, arm pain resolved after 4 days, fatigue improved after 3 days but has bet to resolve. 24-hours delayed onset of circular erythema around the injection site, approximately 6' in diameter, resolved after 9 days.
15min p/vax exp lightheadedness, chest felt heavy & throat tight;BP became higher epi given & sent by amb to hosp ER;given antihistamine & pred & sent home, tightness gone;told allerg & not to have again;
Inbound call from nurse reporting product quality issue with 3 broken VAXNEUVANCE syringes. All affected products were from the same lot and in the same tray. Caller is willing to send pictures and was provided e-mail for pictures. Products are; No adverse event; This spontaneous report was received from a nurse and refers to an unknown patient (age and gender was not provided). The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  The nurse reported that three total syringes of  pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) 0.5 milliliter injection, unk, lots #W027250, with expiration date: 09-JUL-2024, administered for prophylaxis (route of administration was not provided), wereaffected. One was broken at the luer lock attachment. the luer lock attachment has completely broken away from the barrel and the vaccine has leaked out. the other two syringes have crushed barrels  For this complaint the nurse reported a total of 3 broken syringes, 2 broken finger flanges and 1 broken hub/tip. Site received 4 syringes, 3 have broken finger flanges and 1 has a broken finger flange and a broken hub/tip.  It was also confirmed that there were 4 total pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) syringes that were broken and all 4 of those were sent back. The nurse also reported that all 4 vaccines were damaged like that when they received them. None of the damage occurred during shipment back. No additional information provided.  This case was considered non-valid due to lack of patient identifiers.
Fever; chills; Muscle soreness; Sore arm; Swollen lymph gland on right side (size of orange half).; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Sep2021 14:15 (Lot number: 30145B7) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Second dose, No reactions for 1 & 2), for COVID-19 immunization, reaction(s): "No reactions for 1 & 2"; Bnt162b2 (First dose, No reactions for 1 & 2), for COVID-19 immunization, reaction(s): "No reactions for 1 & 2". The following information was reported: PYREXIA (non-serious) with onset 29Sep2021, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 29Sep2021, outcome "recovering", described as "chills"; MYALGIA (non-serious) with onset 29Sep2021, outcome "recovering", described as "Muscle soreness"; PAIN IN EXTREMITY (non-serious) with onset 29Sep2021, outcome "recovering", described as "Sore arm"; LYMPHADENOPATHY (non-serious) with onset 29Sep2021, outcome "recovering", described as "Swollen lymph gland on right side (size of orange half).". Therapeutic measures were not taken as a result of pyrexia, chills, myalgia, pain in extremity, lymphadenopathy.  Clinical Information:The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination,the patient was not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
"COVID arm" with large lump, redness, swelling, pain and itching at the injection site about one day following the booster dose.
Heart fluttering, or palpitations, shortness of breath and acute fatigue.  Symptoms lasted 3 days initially, then I went to the urgent care.  Urgent care recommended I go to the ER.  Attending physicians recommended follow-on consultation with a cardiologist.
Pt had fecal incontinence the night of the vaccine. He continued to have both urine and at times fecal incontinence.He also developed some ticks and OCD symptoms. He became increasingly quiet and withdrawn since the vaccine. 2 months after the vaccine he would space out and at times could not recall his name or address. We are now into the 5th month of him not being himself.
Reaction started with cough and increase phlegm in throat and quickly progressed to swollen throat, dry tongue, unquenchable thirst, shakiness, weakness, ears feeling full, headache, increased blood pressure and increased pulse. Called personal physician who recommended going to the Emergency Department. Took one 25-mg benedryl and went to ED where physician confirmed allergic reaction to the vaccine and administered 20 mg prednisone and pepcid. Symptoms improved over two-hour observation and was released. Continued 20 mg prednisone, pepcid (twice daily) and benedryl (every 6 hrs) daily for 4 days, followed by Allegra and Zyrtec once daily each until 4/13/21. Swollen throat, dry tongue, excess thirst, shakiness, weakness, ears full, headache, and increased heart rate/palpitations persist 7 days post-vaccination. Had in-person visit with primary care physician on 4/13/2021 who recommended Nasocort twice daily for two weeks for fluid behind ears and antihistamine once daily for 5 additional days, and will refer to local allergist for work-up.
Migraine-like headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine-like headache) and NAUSEA (Nausea) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced MIGRAINE (Migraine-like headache) and NAUSEA (Nausea). On 09-Mar-2021, MIGRAINE (Migraine-like headache) and NAUSEA (Nausea) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       patient uses concomitant medications that includes High Blood Pressure Medication. Treatment includes Pain Reliever.   This case was linked to US-MODERNATX, INC.-MOD-2021-077943 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077943:CROSS LINKED WITH DOSE 2
Pt started making hiccup noise whole body was jerking around; Eyes were open; Stopped breathing-threw up twice; Ambulance took to Hosp-screamed & screamed;
This spontaneous report was received from a physician via company representatives referring to a patient of an unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 16-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (Vls 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, the PNEUMOVAX had a temperature excursion for 40 and 72 hours, the lowest recorded temperature was 28F (-2.222 Celsius) and the highest was 47F (8.333 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
approx 1/3 of pts treated w/Engerix-B failed to respond or had borderline titer level produced p/3rd dose; 60 to 70 employees have been treated to date;
July 22nd at the covid vaccine clinic Moderna was administered to a 17 year old. Person in billing was working on getting patient checked in and had VAR on hand. RN called patient over for administration of vaccine before check in process was complete. VAR was handed to nurse who was documenting after the administration of vaccines. At this time it was noted the VAR was signed by patient and patient was 17 years old. Nurse at clinic was notified and she states verbal consent from parents. Nurse at clinic will sign with telephone consent and resend to staff. Patient remained with nurse for 15 minutes with no reaction. Health department was notified. Instruction to monitor for same side effects as any other vaccine. May administer Moderna vaccine for second dose. This information was forwarded to nurse at Job corps. Will notify parents and VAER report completed.
Patient fainted. The person with him got my attention very shortly after he got the vaccine. He fell down and hit his head, and ended up in a sitting position. He became conscious and with the help of a stander-by, we were able to gently lower him into a laying position. He felt fine after laying down for a while and got some water. There was no redness around the injection site nor any other indications of an allergic reaction. The 911 operator asked if he wanted someone to come and check on him, but he declined this. After a while he got up and sat in a chair for several minutes, and then they left.
Within minutes of receiving my booster I became dizzy and felt as I was about to lose consciousness, I also felt heart palpitations. I was not anxious about the shot, as I work for a health system, and this was just another thing I had to do in my busy day. The symptoms were very sudden and intense. I was taken by a nurse for observation. I was able to calm down within minutes. Throughout the day following my booster I felt heart palpitations coming and going. After 4 days I had another episode of feeling as I was about to pass out. I went to the ER and nothing significant was found. I was asked to wear a Holter monitor for 48hours, only benign PVCs were found. A week following the vaccine, I gradually started feeling numbness on the left side of my body, beginning with face, then hand, and leg. I was ordered a brain MRI where nothing abnormal was found. It has been two months after my vaccine, and I still feel numbness on the left side of my body, sometimes more intense, sometimes less. Occasionally I feel dizziness, however not as intense as directly after the vaccine.  I feel fatigued and anxious. Anxiety is directly related to the intensity of my symptoms. As of right now, there is no plan of action to my symptoms. Physicians who were able to see me, believe these are side effects of the vaccine which with time they hope will resolve. I am concerned as it has been two months and still having significant intensity of numbness.
Information has been received from a county health registered nurse concerning a 7 year old male who on 10-MAY-2001 was vaccinated with VARIVAX (Oka/Merck).  On 30-MAR-2007 the patient developed varicella < 50 lesions.  The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation.  An immunization clinic was conducted in the school where students received a second dose of VARIVAX (Oka/Merck).  This is one of 28 reports received from the same source.  No further information is available.
Patient fully vaccinate as of 2/2021, currently admitted for COVID-19 in hospital.
received vaccine on 2/11/2021, stopped eating on 2/18/2021,  expired on 03/06/2021
Very high fever over 102 up to 103.6 for 3 and a half days.
Awakened with fever of 100.2 (not small, considering I'm usually running a 97.0 body temp). Dizziness. Half baseball size lump on right arm, very red, swollen, painful, achy, stiff. Had this for two whole days and nights. Caused me to have a small infarction of the retina, raising my C Reactive Protein Levels to 4.5 and raising my white blood count.
A red, rough spot on my forehead appeared. I applied first aid cream and nothing happened so I applied Purell. It is no longer red but is still rough to the touch. Iff, when I take the second shot, I shall know that it is due to the vax.  Never had this before.
frozen dose of Menactra administered; Initial information received on 01-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an 18 years old female patient who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and reported that frozen dose of Menactra administered.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 20-Jun-2019, the patient received a dose of suspect 0.5 ml MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U6455CC and expiry date: 15-Nov-2020 via intramuscular route in the left deltoid.  It was a case of actual medication error due to product preparation issue.  It was unknown if the patient had any adverse 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 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.  List of documents held by sender: none.
Med Error. Today we were administering the second dose of vaccine to our employees. I am the sole person responsible for setting up the dose. I diluted the vaccine with 0.8 of normal saline rather than the 1.8 cc.
localized redness, swelling, heat; tenderness more than a normal inj;area hard to touch
This spontaneous report was received from a medical assistant regarding unknown patients of unknown age and gender. No pertinent medical history and drug reactions or allergies were reported. On an unknown dates, the unknown patients were vaccinated with improperly stored doses of M-M-R II (lot # L037356 and expiry date 30-SEP-2017) (dose, frequency and route were unknown). No concomitant medications were reported. On unspecified dates the vaccine was exposed to temperature excursions of 1 celsius for 176 hours and 9 celsius for 32 hours. There were no prior excursions and a data logger was not used. No adverse effects were reported. No product quality complaint (PQC) was filed. This is one of the three reports received from the same reporter. Additional information has been requested.
Patient came to pharmacy two days after receiving vaccine with large red, swollen, warm, hardened area surrounding the injection site. The skin was warm to the touch and was a medium red in color. The circle around injection site was approximately 6-7 inches in diameter and hardened. Patient still had feeling in his lower arm and hand, and there was no pain in moving the arm. Only painful to the touch. Instructed to take OTC benadryl and ice area. If no improvement in a couple days, contact MD.
This RN administered the wrong seasonal influenza vaccine to patient. Pt experienced no adverse effects from administration.
This is a spontaneous report from a contactable pharmacist. An elderly patient of an unspecified gender received the PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient developed a large nodule on the arm and blood came out. The clinical outcome of the events, large nodule on the arm and blood came out, was unknown. The batch/lot numbers for the vaccine, pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), were not provided and will be requested during follow up.
Delayed localized reaction with erythema and induration of soft tissue 16 x9cm in size. Will tx with cold compresses, antihistamines, and abx for potential cellulitis
Dizziness, lightheadedness BP: 133/83 Pulse: 64 o2-98% 15 minutes later  BP: 118/68 Pulse: 70 Patient stated she had lightbreakfast and skip lunch.  Snacks and water given vitals checked after 15 minutes . Patient felt better and went home.   #21 - went home
body rash; had bumps all over; This is a spontaneous report from a contactable consumer (patient reporting for self). A 62-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 25Jul2021 at 12:00 (noon) as DOSE 1, SINGLE (at the age of 62-years-old) for covid-19 immunization. Medical history included vegetarian from an unknown date (She has been a vegetarian for 42 years). There were no concomitant medications. Patient did not take prior vaccination within 4 weeks. She got her first dose of the Pfizer COVID 19 vaccine. She has had a body rash since. She didn't know exactly when the rash started because it wasn't really itchy. She noticed it probably a week later. She had bumps all over. It went back in forth between improving and worsening both occurred on an unknown date in 2021. She wanted to know if rash had been reported in vegetarians, had bumps all over. Patient was wondering if there was something in the vaccine with extra protein that would cause a reaction in a vegetarian. She didn't have a prescribing doctor. Patient was scared for the second one because she didn't know if this was a reaction. She hasn't had any skin problems or rashes in her life and was pretty healthy. Events were not resulted in visiting of emergency or physician office. The outcome of the events was not recovered.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.