chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 10 years old female patient who was vaccinated with 0.25ml dose, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Oct-2018, the patient received a dose of suspect FLUZONE QUADRIVALENT (lot number: UT6259JA) via intramuscular route in the right arm. It was an actual medication error due to vaccine underdose. 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 and Module VI of the 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.
L arm large redness, swelling, warmth, pain, requiring return appointment for concerns for infection.
one MA gave flu shot before doctor examined. Another MA gave Men B, Menveo, and another flu shot #2 same day
started to feel exteremely chilly; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (started to feel exteremely chilly) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced CHILLS (started to feel exteremely chilly). At the time of the report, CHILLS (started to feel exteremely chilly) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was taking concomitant medications (name not specified).  No treatment was received.
Pt. describes feeling weak, dizzy and near syncopal after first dose. Pt. states she started to feel this way 20 minutes post immunization but drove home anyay and continued to feel weak and couldn't sleep for one day.
A consumer reported that a male adult received Influenza Virus vaccine, Trivalent, Types A & B (1995-1996 formula) vaccine (date of immunization not identified). Subsequent to immunization he experienced paralysis and the patient died in connection with a flu vaccination. The consumer also reported that this individual experienced adverse events following immunization with smallpox in 1950. See Case ID HQ5610404DEC2002. This report was received from a department at a manufacturer. No additional information was available as of the date of this report.
Several minutes after receiving the Vaccine, I became flush and felt like I was not going to be able to breathe, however, it only lasted a minute or so and I was fine. The nurse had us stay for 30 minutes rather than the recommended 15 and I was fine and left.  Approximately 12 hours after receiving the Vaccine, the  left side of my lip/cheek (especially my upper cheek and corner of my mouth felt tingling and became numb. If I had to describe the feeling-It feels as though I've been to the dentist and had a shot of Novocain. 12 hours later my left arm felt/ feels tingly as well through the shoulder and through the underneath of my arm pit area.
Received Tdap 8/16/12 approximately 3:50 pm 8/17/12 approximately 8 am developed nausea, vomiting, headache, fever (101.3). No redness/rash at site.
Infant developed vomiting and diarrhea AM 3/23/00, then developed fever to 102 AM 3/24/06 with abdominal pain. Labs in ED showed sodium of 124. Subsequent urine culture positive for E Coli. She had ongoing need for sodium supplementation and evaluation by pediatric nephrologist.4/10/06 Received ER medical records which reveal patient experienced fever, nausea/vomiting, rhinorrhea & cough.  She was diagnosed with rotavirus and E coli febrile UTI she was hospitalized for dehydration, Hyponatremia, and febrile UTI.
No adverse effect; multiple patients were vaccinated with improperly stored VARIVAX; This spontaneous report was received from a medical assistant referred to a patient of an unknown age and gender. The patient's medical history and concomitant medications were not reported. On 08-MAY-2019, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)(lot # N020016 and expiry date 17-JUL-2019) and no adverse effects were reported(product storage error and no adverse event). Other suspect therapies included sterile diluent. There was a previous temperature excursion and the time frame and temperature was unknown. No PQC found.   This is one of several reports received from the same reporter.
Information has been received from a nurse practitioner concerning a 69 year old female patient who on 17-MAY-2011 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck). On 17-MAY-2011, after the vaccination, the patient immediately got a headache. The patient called the nurse practitioner two weeks later and went in to see her because she still had a headache, blurry vision, swollen glands and neck stiffness. Ultimately in July 2011 the patient was diagnosed with having polymyalgia rheumatica which was attributed to the ZOSTAVAX (Merck). Her condition was becoming subsequently worse until July 2011 when she got the diagnosis but she was getting better due to the high dose steroids she was prescribed for the diagnosis. A whole host of studies were performed with unspecified names and unspecified results. Therapy was reported as continued. The polymyalgia rheumatica was considered to be disabling and life threatening by the reporter. Additional information has been requested.
No additional AE reported; administered to the patient after the excursion occured; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.   On 23-JUN-2022, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter, lot #U029496, expiration date: 21-SEP-2023, administered (strength and route of administration were not provided) for prophylaxis (Product storage error).   On an unknown date, before the administration, the vaccine underwent temperature excursion at 7.7 Fahrenheit degrees (F) for 30 minutes. No previous temperature excursions were reported. No adverse events were reported (No adverse event).
Dizziness & HYPERtension Narrative: Employee received the second dose of the Pfizer vaccine and 5-10 minutes after administration he c/o dizziness/lightdeadedness and updated observation his bp was (1052am) 147/85 p 82 (temp. 98.0 (oral) room air sat 98%, employee had no history of HTN, denied cp,sob,pain anywhere. He was observed x 30 mins without resolution of symptoms but was not orthostatic nor had an unsteady gait. He was provided additional water to consume while here but had already drank a copious amount of water prior to vaccine appointment. The remainder of the vitals were (1101 sitting 147/85 p-74, 1102 standing 146/88 p 80, 1114 (sitting) p-73, 141/85, 1125-employee ambulated in the hallway unassisted and steady gait was noted c/o slight lightheaded denied headache and declined further evaluation to the emergency
4 days after shot I had sever fatigue and generally feeling bad  and stiffness, aches and sensation of weakness in hands and forearms. Also joint stiffness throughout body that moved around.   Also feeling of fatigue in hands and forearm muscles or tendons.   Urgent care and pcp have said it is likely vaccine because it?s in both sides and happened when vaccine.  PCP is running full testing for ra and arthritis type diseases.  4 weeks later still have weakness in forearm muscles or tendons with fatigue and generally feeling run down.
sore arm, started too get dizzy and unsteady about 5:00 pm on vaccination day. Thinking became off- brain fog. Tried to open house front door by clicking my car key unlock button a few times. Later when unloading the dishes that same night I couldn't remember where we store our pots. This is not typical at all. I woke up in the middle of the night with full body sweats but no fever or chills and a sore arm. My arm swelled up (not red at all) quite a bit that next day. Around 4 inches around the area of injection. I iced it a lot. About a week later, my arm started itching and got a small blotchy area or two. Nothing too bad. My lymph node under my armpit on same side as vax started to swell a lot. Around that same time I also got diarrhea for 2 days then it stopped abruptly. My arm still itches of and on and is sore.
Subacute thyroidits - painful thyroid, mild symptoms of hyperthyroidism. Slowly improving. At time of this report, approximately 9 weeks since onset of symptoms.
Dizzy spells; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy spells) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizzy spells). At the time of the report, DIZZINESS (Dizzy spells) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.  The patient enquired if having dizzy spells was a common side effect.
Prophylactic vaccination in bed, due to fear of needles and related syncope. Pt had no adverse reaction and further care by EMT was not needed.
On 11/15/00, the pt began swelling from shoulder blade around arm, down to bend of elbow.
weakness, shakey, tachycardia, chest pressure began 6 hours after vaccination.  no cardiac history, ischemic changes on ekg. IVF given, HR normalized, repeat ekg: resolution of ischemic changes.
This spontaneous case was received from a nurse regarding a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patient was vaccinated with first and second doses of GARDASIL 9 (dose, unit, lot#, expiration date and route were not reported). On unknown dates, the patient experienced Guillain-Barre Syndrome and respiratory infection and was admitted to hospital. The duration of hospitalization was unspecified. The outcome of the events was reported as recovered. The causality assessment of the events to the suspect therapy was not reported. No product quality complaint (PQC) was involved. Upon internal review, the events Guillain-Barre Syndrome and respiratory infection were determined to be medically significant.
Approx 30 hours pot inj. I started shivering uncontrollably, went to bed for the majority of 18 hours. Alternating between shivers and sweating. Vertigo and dizziness made getting to the bathroom extremely difficult. Headache and body aches too. Woke up at 4pm on Sat. 2/27.  The headache may also have been a caffeine withdrawal effect since I slept through all day Saturday without having any coffee.  I was not warned not to overexert myself but 7 hours before I fell sick I was pushing a 8hp. Snowblower through heavy melting snow. I tired quickly so i stopped after ~ 30 minutes.  Felt much better Sunday morning
(Within 24 hours) 1 day after Flu shot pt c/o flu like symptoms. Fever, aches, chills, sore throat - stated "full blown flu symptoms". Pt saw PCP & given a Z pack (Abx) - pt now recovering.
Approximately 20 minutes after inoculation, patient reported feeling extremely anxious, dizzy, nauseous and reported difficulty breathing. Pt was assessed and vitals obtained : BP 142/88, HR 133, SPO2 99%. Pt was AOX4, had clear and equal lung sounds, no swelling/obstruction of airway visible. Pt had small eczema rash on the inner elbow (she stated this was present the night prior) but no other skin issues/hives present. No discoloration, swelling, or other abnormalities present at injection sight. Pt was also assessed by RN (school nurse), Fire Department, and Personnel. Pt stated she believed these symptoms to be stress-induced and psychosomatic in nature. Pt was coached to slow her breathing and she called her mom on the phone for some comfort. Vitals at this time as follows : BP 112/76, HR 106, SPO2 99, BGL 86). Risks and benefits of transport explained to Pt, she refused transport and was picked up and taken home by family.
Stong back pain through entire back; headache; chills; fever; weakness; vomiting; pain in arm; swollen lymph nodes in armpit on side of vaccine; rash in injection area; Injection area that hurts; Injection area warm to the touch.; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191), via an unspecified route of administration in the left arm on 29May2021 at 09:45 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and hypothyroidism. The patient had a history of allergy to poultry, mucinex and red dye in food. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D) and collagen (MANUFACTURER UNKNOWN) all from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176), via an unspecified route of administration in the left arm on 08May2021 (at the age of 30-year-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29May2021, the patient experienced strong back pain through entire back, headache, chills, fever, weakness, vomiting, pain in arm, swollen lymph nodes in armpit on side of vaccine, rash in injection area that hurts and warm to the touch. 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. The clinical outcome of the events of strong back pain through entire back, headache, chills, fever, weakness, vomiting, pain in arm, swollen lymph nodes in armpit on side of vaccine, rash in injection area that hurts and warm to the touch were recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
Redness on her arm seems rather large about 5 inches around in circumference/ The entire area was red; arm was swollen like the size of a golf ball; It was sore; left arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm hurt), PERIPHERAL SWELLING (arm was swollen like the size of a golf ball), MYALGIA (It was sore) and VACCINATION SITE ERYTHEMA (Redness on her arm seems rather large about 5 inches around in circumference/ The entire area was red) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced PAIN IN EXTREMITY (left arm hurt) and MYALGIA (It was sore). On 23-Oct-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen like the size of a golf ball). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness on her arm seems rather large about 5 inches around in circumference/ The entire area was red). At the time of the report, PAIN IN EXTREMITY (left arm hurt), PERIPHERAL SWELLING (arm was swollen like the size of a golf ball) and MYALGIA (It was sore) outcome was unknown and VACCINATION SITE ERYTHEMA (Redness on her arm seems rather large about 5 inches around in circumference/ The entire area was red) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Oct-2021: Reporter information added. Patient information updated. Product information updated. Events were added.
PATIENT'S WIFE CAME TO PHARMACY AND REPORTED PATIENT EXPERIENCING ARM PAIN AND SIGNIFICANT PAIN WITH ARM MOVEMENT AROUND 3 DAYS AFTER GETTING VACCINE. SHE STATED THAT THE PATIENT WAS STILL EXPERIENCE MILD TENDERNESS/BRUISING FEELING AROUND THE INJECTION SITE APPROXIMATELY 6 WEEKS LATER UPON TOUCH. SHE DENIED VISIBLE REDNESS OR SWELLING AROUND THE INJECTION SITE. SHE DENIED ANY CONTACT WITH A MEDICAL PROFESSIONAL FOR FURTHER EVALUATION.
Pt is a 33 y/o who present to clinic for adverse reaction around the Jynneos vaccine site. He received IXIARO and Typhoid vaccine on right arm and Jynneos vaccine on left arm in preparation for Travel. He notes that he received the Monkeypox vaccine on 8/18/22 and developed an itchy rash on the right arm on 8/19/22  around the area he received the Jynneos vaccine along with burning sensation and chills. He went to ED. He received Cefadroxil and he developed hives on arm and face about 3 hours after the first dose. He had a fever of 100.0F with joint aches, chills on 8/19/2022 and lasted about 3 days. Denied vomiting, diarrhea, coughing, SOB, or loss of smell concerning for Covid.  He had one small speck of blood on toilet paper. Denies any other sick contacts. He took Benadryl last night for the reaction with the antibiotic. His hives resolved and had less itching where his monkeypox vaccine was. No symptoms noted on left arm. He note that he has a bruise around the area of the vaccination. Denies history of HIV, no diagnosis of eczema. Of note, he was diagnosed with COVID-19 on 22Jun22.
This spontaneous report as received from a other health professional refers to a 11 year old male patient with type 1 diabetes mellitus and prophylaxis. On 08-AUG-2017 the patient was vaccinated with GARDASIL 9, 0.5 ml, intramuscular for prophylaxis. Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and MENACTRA. Concomitant therapies included NOVOLOG)] and LEVEMIR. On 08-AUG-2017, the patient experienced syncope. The outcome of syncope was reported as recovered/resolved. Additional information is not expected.
balance is off, can't keep my balance; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (balance is off, can't keep my balance) in a patient of an unknown age and gender 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 BALANCE DISORDER (balance is off, can't keep my balance). At the time of the report, BALANCE DISORDER (balance is off, can't keep my balance) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.  patient's lab test data not reported.  No concomitant medication was reported. No treatment medication was reported.   Reporter did not allow further contact
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 16:00 as dose 4 (booster), single (Lot number: GJ5342) at the age of 53 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Latex allergy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300166767 same reporter/patient, different drug/AE;
pt recv vax 30OCT98 at 12:00PM at an office visit;4hr later when pt  was fed had a projectile vomiting event in which all the formula was expelled & later pt was cranky & did not sleep @ noc;constant crying & cold hands & feet;
Client complained of numbness in arm, SOB, throat closing per onsite party, medical rendered by ambulance service, client given a Benadryl, condition improved, client released to self and drove self from the waiting parking lot.
Sudden onset of hyporesponsivenes, went limp, jaw clenched shut, the episode lasted 5-10 minutes, followed by full recovery.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 14:00 as dose 5 (booster), single (Lot number: GH9694) at the age of 53 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Apr2021 at 14:00 as dose 1, single (Lot number: EW0162) at the age of 52 years, in left arm, on 12May2021 at 14:00 as dose 2, single (Lot number: Ew0179) at the age of 52 years, in left arm, on 17Nov2021 at 16:00 as dose 3 (booster), single (Lot number: FJ8757) at the age of 53 years, in left arm and on 30Mar2022 at 16:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 53 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received Paxlovid as COVID 19 treatment, from 15Dec2022 to 20Dec2022.