chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received DAPTACEL instead of ADACEL with no reported AE; 11 year patient received DAPTACEL instead of ADACEL with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from the pharmacist via Medical Information (Reference number- 00805147) and transmitted to Sanofi on 08-Oct-2021.    This case involves a 11-year-old male patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] [(wrong product administered) and (product administered to patient of inappropriate age)].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) and VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]) for prophylactic vaccination.  On 20-Sep-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (Suspension for injection, lot number: C5743AA, expiry date unknown) via intramuscular route in the left deltoid instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date not reported) for prophylactic vaccination.  It was case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency: same day).  It was reported "patient received DAPTACEL instead of ADACEL patient was 11 years old".  At the time of this 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 the 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.
pt awoke shaking & crying; mom picked up pt very hot-not responding to voice but contd shaking x 1-2mins; noted lt thigh swelling lt vax site; t40.3 R
At 1:30 AM in the morning I woke up with a fever of 102°F. I was able to go back to bed. Around 6:30 or 7 AM I woke up again and experienced extreme head pain, arm pain, and abdominal pain. The arm pain was so intense that I could feel gravity pulling on it. I got out of bed to take my dog outside. However, I only went 5 feet before starting to lose consciousness. I was able to make it to the floor in time and waited out the pain and for my blood pressure to rise. Eventually I crawled back to bed. I have a history of losing consciousness due to pain because of a hypersensitive vagal nerve. The sensitivity requires me to have atropine whenever I am under general anesthesia in surgery in order to keep my heart working. The combination of extreme pain in the areas of my head, arm, and abdomen caused my body to start shutting down. I noticed that my abdomen was distended and hard. I was unable to move in bed due to the movement causing syncope episodes. I was also unable to reach my phone or get up to get water as a way to increase my blood pressure. I live alone and had no support. I was able to call my mother through a smart device. My mother was able to contact my sister and she made it over to my house in the afternoon. I had not been able to leave or move in my bed since the early morning. The pain was so intense that I did not want anyone to move me or touch me. In hindsight, I probably should have called an ambulance but again I did not want to be touched or to lose all consciousness.  My sister was able to provide me with water and Tylenol. By the late evening, I was able to move around in bed but was unable to lay on my stomach or side due to my pain. The next morning my head pain had reduced, my arm pain was worse, and my abdominal pain was the same. I completed a telehealth doctor visit and was prescribed pain medication for the swelling and inflammation of my pancreas and intestines. By later that evening I was able to walk a little bit without extreme fluctuations in my blood pressure. My pancreas and intestines continue to be inflamed and hurt for a month. I plan to visit my G.I. doctor before I receive a booster and create a plan for a systemic inflammation that largely attacks my already irritated organs.
vaccine site swelling, redness , warmth; slight improvement w/ swelling. possible due to administration technique?
Fever, chills, vomiting, tingling in hands and feet, soreness at site, body aches, dizziness
Pt called 911 for shortness of breath The following is the paramedic narrative patient found at home, sitting on floor. alert, speaking. Patient with sob, saying she can not breath , states it came on suddenly about a half hour ago and pt has not been feeling ill prior to this. No trauma, no pains or other complaints.  pt went unconscious then into pea cardiac arrest, witnessed. Laid pt down and check for heart beat and breathing, became pulseless and apneic Initial treatment CPR, IV, BVM. Family states no medical history other than anemia.  no drug use, no respiratory or cardiac issues.  Pt was given J and J covid 19 vaccine recently.  Pt also just returned from a trip and noted to not have gone diving.    2 epinephrine IV given on scene with no change to heart rhythm.  Pt loaded into the ambulance and cpr continued while transporting.  pt with copious amounts of vomit, suction enroute to ed.  Pt w/o shockable rhythm throughout transport.  Continue cpr and bvm via king airway , cap at 9. unable to get capnography higher.  no change in heart rhythm. while enroute to er.  At ED pt did get pulses back however it was reported that pt loss pulses and was pronounced
Probably vasovagal syncope. Pt was in line checking out groceries and passed out. Came to immediately, paramedics checked him over, BP/pulse normal. Pt left under his own power.
numbness in left arm/ gets very numb while driving/ left foot also gets numb/ numbness weaker in left arm; tingling in left arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in left arm/ gets very numb while driving/ left foot also gets numb/ numbness weaker in left arm) and INJECTION SITE PARAESTHESIA (tingling in left arm) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 022C21A) for COVID-19 vaccination.     The Medical history was not reported by the reporter.  Concomitant products included IRBESARTAN and BUPROPION for an unknown indication.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness in left arm/ gets very numb while driving/ left foot also gets numb/ numbness weaker in left arm) and INJECTION SITE PARAESTHESIA (tingling in left arm). At the time of the report, HYPOAESTHESIA (numbness in left arm/ gets very numb while driving/ left foot also gets numb/ numbness weaker in left arm) and INJECTION SITE PARAESTHESIA (tingling in left arm) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported
Information has been received from a registered nurse concerning an 8 year old white male who on 15-MAY-2007 when he was 12 months old was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. In May 2007 the patient experienced breakthrough chicken pox with 2 dozen lesions on his torso and 3 dozen lesions on his head. Unspecified medical attention was sought. Unspecified medical attention was sought. He was treated with calamine (+) camphor (+) diphenhydramine hydrochloride (CALADRYL) and calamine (+) camphor (+) pramoxine hydrochloride (AVEENO) baths. It was reported that his lesions healed. No diagnostic laboratory tests were undertaken. No product quality complaint was involved. This is one of several reports received from the same source. It was reported that the patient's sister WAES 0709USA03914 experienced a similar event following vaccination with varicella virus live (Oka/Merck). Additional information has been received from the registered nurse who stated that the patient's other called in office on 18-MAY-2007 and stated that the patient had red dots on abdomen and back and were spreading up to face. The spots were reported as itchy. No further information is expected.
ataxia, falling repeatedly 10/20/2009 hospital records from 10/11-10/13/2009. Patient with c/o's fever and ataxic gait. Tx: dx studies and labs, IV ABX.  DC DX Acute Cerebellar Ataxia. F/up with PCP and Neurologist.
The office had a power outage that required us to move the vaccines to another location. Unfortunately, it was determined by the Department of Health and the vaccine manufacturer that the vaccine was believed to be non-viable after this move. No adverse event has been reported.
arm soreness; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program. A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunization. Medical history included allergies- there's a whole list of things she couldn't take; carried an epi pen for years. Concomitant medication included cetirizine hydrochloride (ZYRTEC) to avoid allergies. The patient had the 1st dose yesterday and she's feeling good. She had no side effects except for a little bit of arm soreness on Jan2021. Her doctor told her to take Tylenol for arm soreness, but another woman told me not to take Tylenol, but the patient didn't need it anyway (unknown if treatment was received). Her doctor was giving her Zyrtec to avoid allergies because there's a whole list of things she couldn't take and have carried an epi pen for years. She took Zyrtec before having the vaccine and would take another before the second dose. Would this make the vaccine less effective? Her appointment was 16Jan2021 and she have already scheduled for 08Feb2021. Do they give you a timetable? What was the timing of the 2nd dose of vaccine? The outcome of the event was unknown.  Information on the lot/batch number has been requested.
3 day after FLUMIST developed severe (R) otalgia. Seen 5th day post vaccine found large bulla (R) TM without any Sx of a URI.
patient got one dose of 4-valent GARDASIL at age 18 and then did not complete the series. The patient now wants to complete the series at age 29.; No adverse event; This spontaneous report was received from a pharmacist and refers to a unknown gender 29-year-old patient.  The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On an unknown date in 2011, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, dose and route of administration were not provided).  The reported stated that the patient got one dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) at age of 18-year-old and then did not complete the series. The caller reported that the patient wanted to complete the series at the age of 29-year-old (reported as now) (inappropriate schedule of product administration). The caller did not provide any further information. No adverse event was reported.
Fatigue, waves of sleepiness, weakness, itching at site of injection, nausea, headache, body ache, hot and cold flashes, soreness, fuzzy head, fever is unknown due to Tylenol and motrin for aches.
a nurse at the doctor's office said her grandmother had this with her first vaccine in the same area of her chest; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization.The patient medical history was not reported.The patient's concomitant medications were not reported. Reporter states a week after the vaccine the patient started feeling bad. On an unspecified date the patient experienced a nurse at the doctor's office said her grandmother had this with her first vaccine in the same area of her chest . States the doctor ordered a chest x-ray today because he heard wheezing, she has no energy and all that. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Overnight after receiving my 2nd dose of the Pfizer COVID-19 vaccine, I experienced significant swelling, tenderness, and pain in the lymph nodes under my left armpit at the injection site, extending through the left side of my chest and side (ribcage). The swelling reduced in size and pain over the span of about 10 days, but there is still noticeable swelling and discomfort in the lymph nodes around my left armpit now longer than 6 weeks from the time of the injection.
Hard raised lump at injection site 4-5 cm in diameter; red, itchy rash around injection site 8-10 cm in diameter. Began 2 days after vaccination, worsened for 1-2 days, began to subside on day 5, still present on day 6 but continuing to resolve. Cortisone cream helped the itching, no other treatment provided.
In the early morning of 4/7/2021, after receiving the 2nd dose of Pfizer COVID 19 vaccine on 4/5/2021, around 6:00 am, I started to experience severe chills with uncontrollable shaking. I had experienced mild chills and a sore arm starting around 8:00 pm of 4/6/2021. With the chills intensifying, I attempted to take acetaminophen to reduce fever, but began to vomit and experience uncontrolled diarrhea, both continued for several hours. My fever was over 103 and continued to be that high until approximately 8:00 pm on 4/8/2021 when it was registering between 101.8 to 102.8 through 4/9/2021.  On 4/10/2021 the fever started to register between 99.9 and 101.8 and I also began to notice a blistering rash on my torso. 4/8/2021 through 4/10/2021 I was also showing signs of dehydration - dark yellow and cloudy urine. By 4/11/2021 my temperature was registering near normal, spiking to 99.9 at times. I was able to take acetaminophen and also took Benadryl for the itchy rash. It is 4/13/2021, I still have some of the rash remaining, temperature is normal and urine has become clear. I did not seek medical treatment because I never felt that my symptoms were life threatening, however the reaction was more than I had expected and am concerned that this may have been an allergic reaction.
tightness in upper chest; chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (tightness in upper chest) and CHEST PAIN (chest pain) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST DISCOMFORT (tightness in upper chest) and CHEST PAIN (chest pain). At the time of the report, CHEST DISCOMFORT (tightness in upper chest) and CHEST PAIN (chest pain) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-186664 (Patient Link).
Mom reports left thigh was swollen and red and sit worse in spite of her giving him Tylenol and applying cold compresses as instructed. Saw physician on 8/7/00. He told mom he was trying to develop cellulitis. Prescribed Zithromax and Diproline cream. Problem is resolving but not completely gone.
Relapsing of CIDP; Relapsing of CIDP; This is a spontaneous report from a contactable consumer (reported for himself). A 57-years-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EP7534) administered in left arm via an unknown route of administration on 06Apr2021 at 10:00am as SINGLE DOSE for covid-19 immunization. Medical history included chronic inflammatory demyelinating polyradiculoneuropathy. The patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6208) administered in left arm via an unknown route of administration, on 18Mar2021 at 10:00am as SINGLE DOSE for covid-19 immunization and experienced no adverse event. Concomitant medications received within 2 weeks of vaccination included Atorvastatin (LIPITOR), Levothyroxine sodium (LEVOTHYROXINE SODIUM), Cetirizine hydrochloride (ZYRTEC ALLERGY). On 15Apr2021, the patient experienced relapsing of CIDP (chronic inflammatory demyelinating polyradiculoneuropathy) and Disease recurrence. The patient received treatment for the event as  IVIG. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior vaccination, the patient was not diagnosed with covid-19 and not tested for covid post vaccination. Patient had no allergy. Device Date was 12May2021. The outcome of the event was not recovered.  Information about batch number/lot number was available. Further information has been requested.
Day following vaccine pt developed hives (full body), blisters, swelling of eyes, seen by PCP on 10/3/16 and prescribed a course of prednisone. Symptoms started 9/30/16, seen in EHS 10/5/2016.
Patient complained of red rash wrapping around administration area on the arm and down the arm to the forearm and up the arm past the shoulder. Patient states after 4 days the pain and redness is beginning to dissipate.
Hypertension, BP 214 mmHg systolic 11/12/2009 VA MR for 11/6/2009, patient with hx of controlled HTN, reporting  increased HTN post vaccine . BP> 210, given clonidine with good results in office, advised to stay on current HTN meds, has a BP device to monitor blood pressure. and instructed in low Na diet.
at 12:55 pm  "enormous hot flash", became diaphoretic, chest tightness, immediate need to have BM, "uneasy" feeling.  Waited 40 minutes, then went to ED. No meds given. 1 Liter IV fluids given. VS monitored and within "normal" range. Cardiac enzymes  and other labs drawn and within normal range. Released to self after 2 hours. Returned to work next morning.
Flu like symptoms; Chills; Fatigue; Headache; Nausea; Achiness/soreness; Dry mouth; This is a spontaneous report from a contactable consumer (patient). A 57-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL3247, Expiry date: not reported), via an unspecified route of administration in left arm on 10Feb2021 14:00 (at age of 57-years-old) as dose 2, single for covid-19 immunisation. Medical history included lyme disease and allergy to Sulfa drugs. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. It was unknown if prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL33247, Expiration Date: Not reported), via an unspecified route of administration in left arm on 20Jan2021 (at age of 57-years-old) as dose 1, single dose for covid-19 immunisation. On 10Feb2021 at 16:00, the patient experienced flu like symptoms, chills, fatigue, headache, nausea, achiness, soreness and dry mouth. No therapeutic measures were taken. The outcome of the events was not recovered.   Follow-up attempts completed. No further information expected.
Extremely painful right upper arm starting 6 hours after vaccine lasting 5 days.  Ongoing fatigue ever since vaccine.  Did not have fatigue previously.  Interferes with job performance.  Nap every weekend multiple times, and sometimes as soon as I come home from work.  Going to bed about 1.5 hours earlier than usual and wake up exhausted.
Information has been received from a physician concerning a cluster of cases in approximately 6-7 boys in one classroom who were approximately 17 years old who on unspecified dates had received 2 doses of MMR II (doses, durations and lot numbers were not reported). The physician reported that he had done some laboratory work to confirm the diagnosis of mumps in a few children. He indicated that he did not find any children who were Immunoglobulin M (IgM) positive for mumps, but most were immunoglobulin G (IgG) positive. The physician said that most children had parotid gland swelling. At the time of the report, the patients' statuses were unknown. The physician also mentioned that he was seeing a fair number of mumps in his community and that there were "a lot" of cases in similar religious communities. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. This is one of several reports from the same source. Additional information had been requested.
Patient has temperature the day after the vaccine (1/23/2021), then felt better. On Monday developed chest pain and palpitations. Admitted to hospital.
Patient brought in by ambulance after cardiac arrest witnessed by patient's wife at 4/19/21 1:37AM. Per ED, the wife reports he had complained of feeling weak over the last few days without clear reason, then this morning patient had episode of emesis after which he told wife to call 911 and then suddenly became unresponsive.    In ED was intubated, started on hypothermia protocol,  Patient sedated on Propofol and started on a heparin drip, clopidogrel, aspirin and empiric antibiotics for aspiration Pneumonia
Pfizer-BioNTech COVID-19 Vaccine EUA 1. Pain at the injection site - 2 days 2. Tiredness - 2 days The severity level decreased the third day after the second dose.
This spontaneous report as received from a other professional refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with GARDASIL, (lot number and expiry date unknown) (dosing regimen and frequency unknown) 0.5 ml, intramuscular that was exposed to a lowest temperature of 33F between 04-MAR-2014-07-MAR-2014 for a total time of 1 hour was administered. No adverse event was reported. No product quality issue was reported. This case is linked to case number 1403USA012476 via same reporter link. Additional information has been requested.