chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial and follow-up information has been received from a physician concerning an 18 year old female with a urinary tract infection at the time of vaccination and no allergies or drug reactions who on 28-MAR-2008 was vaccinated with a first dose of GARDASIL (lot# 659182/1757U) injection in the left arm at 10:00 AM. Concomitant therapy included BACTRIM for the urinary tract infection. After receiving the vaccine in the office and on the way home the patient developed diffuse rash. On 29-MAR-2008 the patient was seen by the physician and saw the patient at that time had markedly swollen lips and she had a diffuse maculopapular rash all over. Subsequently, on an unspecified date the patient recovered from the rash and swollen lips. No further information was provided. The reporter felt that maculopapular rash and swollen lips were considered to be an other medical event. Additional information has been requested.
Chest pain; Back Pain; nasty side effects; Body aches; Horrible headache; Chills; Fever (101.9); Tired; This spontaneous case was reported by a nurse and describes the occurrence of CHEST PAIN (Chest pain), BACK PAIN (Back Pain), VACCINATION COMPLICATION (nasty side effects), MYALGIA (Body aches) and HEADACHE (Horrible headache) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 006M204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history was reported). Concomitant products included ACICLOVIR SODIUM (ACYCLOVIR ABBOTT VIAL) and ALPRAZOLAM (XANAX) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced CHEST PAIN (Chest pain), BACK PAIN (Back Pain), VACCINATION COMPLICATION (nasty side effects), MYALGIA (Body aches), HEADACHE (Horrible headache), CHILLS (Chills), PYREXIA (Fever (101.9)) and FATIGUE (Tired). At the time of the report, CHEST PAIN (Chest pain), BACK PAIN (Back Pain), VACCINATION COMPLICATION (nasty side effects), MYALGIA (Body aches), HEADACHE (Horrible headache), CHILLS (Chills), PYREXIA (Fever (101.9)) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Paleness in the face, feeling chills, then hot. Dizziness. Body Aches.
Systemic: Abdominal Pain-Medium, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: Pt was looking pale 10 minutes after the injection. He looks to be in pain holding his stomach while hyperventilating. After another 5 minutes, he began to vomit and slowly recovered. He stated that his stomach was hurting. His heart rate is 90bpm.
She is walking like a cripple person; Pain is so intense in her hip area; Dull intense pain starting at injection siteof her left arm and radiates along the side of her body all the way to her ankle; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (She is walking like a cripple person), PAIN (Pain is so intense in her hip area) and MYALGIA (Dull intense pain starting at injection siteof her left arm and radiates along the side of her body all the way to her ankle) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included GABAPENTIN and DESMOPRESSIN for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced GAIT DISTURBANCE (She is walking like a cripple person), PAIN (Pain is so intense in her hip area) and MYALGIA (Dull intense pain starting at injection siteof her left arm and radiates along the side of her body all the way to her ankle). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, GAIT DISTURBANCE (She is walking like a cripple person), PAIN (Pain is so intense in her hip area) and MYALGIA (Dull intense pain starting at injection siteof her left arm and radiates along the side of her body all the way to her ankle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
BODY ACHES,FEVER, NAUSEA/VOMITTING AND SORE THROAT.
Patient states that within 2.5-3 hours after the shot on Tuesday 9/25/18, she experienced stiffness, aches, headache, and a fever of 102 F. She took TYLENOL and the fever was still 100 F on Thursday but decreased to 99.2 F on Friday. She is still achy, stiff, and has an upset stomach and other flu-like symptoms as of Friday 9/28/18.
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug allergies/reactions were not provided. On an unspecified date, the patient was vaccinated with improperly stored GARDASIL 9 lot#: N004798, expiration date: 31-OCT-2019 for prophylaxis (dose, frequency and route of administration were not reported). The administered dose of the vaccine experienced a temperature excursion of 32 degree Fahrenheit to 35 degree Fahrenheit for 6 hours. There were no adverse effects reported. There was no previous temperature excursion. Digital Data logger was involved. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA010758: US-009507513-1709USA010561.
No adverse effects reported; she inadvertently administered both VARIVAX and PROQUAD to a six year old patient.; This spontaneous report was received from a physician concerning a 6 years old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On 20-AUG-2019, the patient was vaccinated inadvertently (overdose) with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) and a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) both vaccines for prophylaxis (strength, dosage, frequency and route of administration, lot numbers and expiration dates were not reported). No adverse effects were reported.
patient got Menactra when they were supposed to get meningococcal B, no AE; Initial information received on 12-May-2021 regarding an unsolicited valid non-serious case from a pharmacist via Media Information (inquiry reference number 00598144).  This case involves a patient of unknown age and gender patient who got MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number U6521AB and expiration date not reported) when was supposed to get MENINGOCOCCAL VACCINE B not produced by Sanofi Pasteur (lot number U6521AB and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination on an unknown date (wrong product administered).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant mediation(s) and family history were not provided.   It was an actual medication error due to wrong vaccine administered (same day latency).  It was reported that registered pharmacist was calling to see if a Lot number provided matches the Menactra vaccine that had been given inappropriately. Checked her stock and the lot number did not match. This was given a few months back and the lots have changed. Caller said she was calling from overseas. She was asking to confirm if a certain lot (given here) was Menactra. Caller also stated that a physician noticed in a patient chart recently that this patient got Menactra when they were supposed to get meningococcal B. Caller also said that they were not sure if maybe the nurse who documented this typed in Menactra instead of meningococcal B by mistake. Caller said the lot number documented was U6521AB. Caller does not have any details on patient. She said this happened months ago. They are not even sure if this was an error. If Sanofi can confirm that the lot is not Menactra then it was probably typed wrong by nurse. No AE (adverse event) template done as caller does not have any details.    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.
Reference # 2000008268-1 is a spontaneous report by a registered nurse referring to a 22 year old female. The vaccinee is allergic to penicillin. Concomitant medications were not reported. On Feb 02, 2000 the vaccinee received her first IM right deltoid injection of engerix B. A few hours post vaccination she felt itchy without rash and her face was blotchy. No treatment was given. The most recent information received on March 08, 2000 reports the condition resolved.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 02-DEC-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Ulcer on the tip of my tongue.  I am not prone to ulcers tried many solutions and finally took lysine for two days and it went away.
The reason for my report coming so long after receiving my vaccine is because I continue to have the same reaction months later. I keep experiencing pain in my underarm and breast (left side). This happens every 2 weeks to a month apart. It can be so uncomfortable that I have to hold my breast to relieve some of the pain by removing some of the weight. I can?t sleep on my right side during this time. The pain can be anywhere from just a twinge of pain to where it is very uncomfortable.
Began stuttering shortly after immunizations, has continued 1 month later.  Has never stuttered before.
diagnosed with Covid-19; diagnosed with Covid-19; This is a spontaneous report from a non-contactable consumer (patient). A female patient of unspecified age received the first dose of BNT162B2 (COMIRNATY, batch/lot number and expiration date not provided), via an unspecified route of administration, on 23Aug2021, at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient stated that she received the first dose of the Pfizer Covid-19 vaccine on 23Aug2021 but did not received the second dose yet. Patient was diagnosed with Covid-19 back in Oct2021 and stated that she finishes up with quarantine today 05Nov2021. Patient was asking what she should do about getting a second dose of the Pfizer Covid-19 vaccine since she has just been diagnosed with Covid-19 after the first dose. The outcome of the events was recovered in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Father presented with pt to clinic on 3/4/15 stating that after pt received flu vaccine on 2/26/15 he began experiencing "flu like symptoms". He began with "cough" and "not feeling well." C/O having fever on and off since 2/28/15 and feeling shortness of breath at night and feels "something in his throat". Father took pt to ED on 3/3/15 and diagnosed with chest pain. Pt admitted to hospital 3/4/15 due to his complaints. F/U call to father/grandmother stated father did not take patient to hospital.
This spontaneous report was received from a healthcare worker refers to unknown number of patients with unknown demography. On an unknown date, the unknown number of patients was vaccinated with improperly stored ROTATEQ (dose, route and frequency were not reported). No adverse effect reported. No further information was provided. This case is linked to the case 1404USA010242 and 1404USA010659 (same reporter link). Additional information has been requested.
itchy; 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 PRURITUS (itchy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced PRURITUS (itchy). At the time of the report, PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
patient  experienced loss of consciousness last approximately 10 seconds, some shaking of arms noted last approximately 1-2 seconds. Patient regained consciousness with out intervention.  Given juice and monitored for additonal 20 minutes with no further reaction noted.
Patient 7 years old received a lower dose Pfizer (6 months to 4 years old ). By CDC guidelines patient have to be re-vaccinated with the correct dose. The patient was re-vaccinated with the age appropriate vaccine (PEDS) Pfizer (5 years through 11 years 11 months old) at 02:38pm and is doing well.
Moderna COVID- 19 Vaccine EUA: Patient received vaccine and had no immediate reaction. Patient feeling well without fevers, chills, shortness of breath, redness, or pain. Patient states eight days after vaccination felt a lump in left deltoid. It felt somewhat itchy and inflamed. Nine days after vaccination patient woke and arm was red and itchy: provider advised over the counter antihistamines and to closely monitor symptoms.
severe joint aches/ milder joint pain; I also have had nausea without vomiting.; I have also had sinus congestion without drainage; on 17Dec2020 02:30 PM/ second dose of BNT162B2 on 07Jan2021 08:15; This is a spontaneous report from a contactable other health professional (patient). A 28-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19), via an unspecified route of administration at right arm on 07Jan2021 08:15 at single dose for COVID-19 immunization. Medical history included chronic migraine and no known allergies. The historical vaccine included the first dose of BNT162B2 on 17Dec2020 02:30 PM at right arm for COVID-19 immunization and no notable adverse effects. Concomitant medication included ibuprofen; acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN MIGRAINE) and Vitafusion men's in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After the second dose, the patient have experienced severe joint aches the first night, and milder joint pain since. The patient also had had nausea without vomiting. I had also had sinus congestion without drainage, all after the second round. The events onset date was 08Jan2021 01:30. No treatment received for the adverse events.  The events outcome was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.  Information on the lot/batch number has been requested.
Approximately half hour after patient received MMR/IPV immunization, mom phoned office with complaint of periorbital swelling , bil. Pt in office , seen by MD approximately 1pm with same swelling noted. Epinephrine 0.2 ml SQ  given, Orapred 1tsp po x 1 given.
This spontaneous report as received from a medical assistant to a female patient of unknown age. The patient was vaccinated with PNEUMOVAX 23 and influenza virus vaccine (manufacturer unknown) (lot number, dose, route and injection site were not reported) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced allergic reactions to pneumonia and influenza vaccines brand names and manufacturers unspecified. Medical assistant reported that the patient described the reaction to the unspecified pneumonia vaccine as "quite severe." The outcome of was unknown at the time of report. It was unspecified if the patient seek medical attention. Additional information has been requested.
Pt was given influenza vaccine x2 within the same day. Approximately 2 hrs apart.
pain; lack of mobility in my right wrist and thumb; The symptoms matched exactly what I saw online for De Quervains syndrome; having joint pain throughout my body; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162b2 (Pfizer BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history included joint issue from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, about 24 hours after receiving the Covid vaccine, patient experienced pain and lack of mobility in right wrist and thumb. Patient did not tie it to the vaccine, but to a joint issue. The symptoms matched exactly what saw online for De Quervains syndrome. Patient followed the medical advice given, and pain subsided after about a week. As that pain started to go away, though, patient started to have joint pain throughout body, that lasted a few days, too. Now, almost 2 weeks to the day of receiving the vaccine, all the symptoms were completely gone, and patient was back to normal. Patient had no idea if it was a coincidence or not. The outcome of all the events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
after the patients got their shot, their immune system was off track; get sick all the time; after the patients got their shot, their immune system was off track; get sick all the time; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: IMMUNE SYSTEM DISORDER (non-serious), ILLNESS (non-serious), outcome "unknown" and all described as "after the patients got their shot, their immune system was off track; get sick all the time".  Additional information: The doctor mentioned the COVID vaccine and said she had three patients who had a bad immune system, she finally got the patients on track and states after the patients got their shot, their immune system was off track. The caller mentions the patients did have comorbidities, but the caller did not ask for any patient details. She believes that is a violation.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200402607 Same product and event, different patient; US-PFIZER INC-202200402704 Same product and event, different patient
since the day after receiving the vaccine patient has been experiencing heart palpitations, fever, chills, fatigue, sleep disturbances, and headache
FEVER; NAUSEA; TIREDNESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced fever. On 13-MAR-2021, the subject experienced nausea. On 13-MAR-2021, the subject experienced tiredness. Laboratory data included: Body temperature (NR: not provided) 102.6. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, nausea and tiredness was not reported. This report was non-serious.
big lump on the left side by her rib cage; muscles in her legs hurt every time she walks; It feels like a hurt rib cage; is sore to the touch; They feel weak; the muscles are tight; This spontaneous case was reported by a consumer and describes the occurrence of MASS (big lump on the left side by her rib cage), MYALGIA (muscles in her legs hurt every time she walks), MUSCULOSKELETAL CHEST PAIN (It feels like a hurt rib cage), PAIN IN EXTREMITY (is sore to the touch) and MUSCULAR WEAKNESS (They feel weak) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (product used for unknown indication).    On 22-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 MASS (big lump on the left side by her rib cage), MYALGIA (muscles in her legs hurt every time she walks), MUSCULOSKELETAL CHEST PAIN (It feels like a hurt rib cage), PAIN IN EXTREMITY (is sore to the touch), MUSCULAR WEAKNESS (They feel weak) and MUSCLE TIGHTNESS (the muscles are tight). The patient was treated with PARACETAMOL (TYLENOL) for Myalgia and Muscle tightness, at an unspecified dose and frequency and TROLAMINE SALICYLATE (ASPERCREME [TROLAMINE SALICYLATE]) for Myalgia and Pain, at an unspecified dose and frequency. At the time of the report, MASS (big lump on the left side by her rib cage), MYALGIA (muscles in her legs hurt every time she walks), MUSCULOSKELETAL CHEST PAIN (It feels like a hurt rib cage), PAIN IN EXTREMITY (is sore to the touch), MUSCULAR WEAKNESS (They feel weak) and MUSCLE TIGHTNESS (the muscles are tight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided