chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was supposed to receive Fluzone Quadrivalent, but instead the nurse accidentally administered Tubersol, no AE; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional.  This case involves a 55 years old female patient who was supposed to receive vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] but instead the nurse accidentally administered TUBERCULIN TEST [TUBERSOL] (lot C5563AB, Exp. Date 14-Mar-2021) via intramuscular route in left deltoid, on 14-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to wrong vaccine administered.  At the time of reporting, no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive  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.
Dizziness and light headed, with confusion, fatiuge, with head ache. Very severe just after injection. 3 days post vaccine and still feeling dizziness and headache with mild fatigue. Symptoms are similar to a hang over. The symptoms are slightly better than the day of vaccination but still exsist. Symptoms do seem to come and go and are not constant. Little relief is given by tylenol.
patient did not have adverse reaction.  Patient had not received primary series before Pfizer Bivalent was given 10/20/22.
Arm hurt a little bit; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt a little bit) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt a little bit). At the time of the report, PAIN IN EXTREMITY (Arm hurt a little bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-035688 (Patient Link).
H1N1 vaccination on 1-22-10 - on 1-23-10 "woke up with bright red sore above lip painful then spread over entire face", - in clusters on left side of face.
Aching, swelling, redness (not rash). No treatment tried. Noticed 10-29-2012 on awakening. Sweating, headache. Patient went to hospital; turns out she also has a viral infection.
Extreme fatigue, dizziness, blurred vision, very low blood pressure, hot and cold flashes, disoriented
EUA Pfizer-BioNTech vaccine reaction Patient fainted after receiving vaccination. Medical alert team RRT called , patient escorted to ED for observation. She lost consciousness for a period of less than 1 minute.
Tested positive for COVID-19; Bilateral COVID-induced pneumonia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570).  A 69-year-old female patient received BNT162B2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "Tested positive for COVID-19"; COVID-19 PNEUMONIA (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "Bilateral COVID-induced pneumonia". The patient was hospitalized for drug ineffective, COVID-19 pneumonia (start date: 16Oct2021). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2021) positive. Clinical course: The consumer (patient's child) reported that the patient received 2 doses of the Pfizer COVID-19 vaccine. Unfortunately, she tested positive for COVID-19 and was admitted to the hospital on 16Oct2021. She was diagnosed with bilateral COVID-induced pneumonia. Doctors speculated that the patient did not have a response to the Pfizer vaccine since she was the worst case in a vaccinated adult they have seen. She had scheduled her booster. The consumer mentioned that the patient has "6-12 months left".  The lot number for BNT162B2 was not provided and will be requested during follow up.
Vaccines given 5-6-13. Fever 5-7-13, up to 103.3. Nausea, vomited 5-7-13 AM, and c/o headache. Also had diarrhea 5-6-13 evening.
fatigue; arm soreness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, manufacturer unknown), for covid 19 immunisation. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "fatigue"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I began with chills 9 hours after receiving the vaccine, which then transitioned to severe shaking all night. Temp was 102 at the highest, severe headache( worst ever) for 3 days. The next day I had difficulty walking and had to lean on the wall to ambulate due to lower extremity weakness which lasted 2 days and spinal pain.  I missed 3 days of work due to the illness after the 2nd covid vaccine.   12/23/21 After the 1st Pfizer vaccine Lot # CJ 1685, I began with chills 6 hours later and felt like I had brain fog the whole next day, just didn't feel right.
Approximately six days following the first vaccine, I started having pain in my armpit area. The lymphnode did not necessarily appear swollen, but it was painful to the touch for three to four days. Approximately nine days following the vaccine, I developed a rash on my arm where the vaccine was administered (it looked red and blotchy), and it was warm to the touch. The rash is still present, and it has been eleven days since my initial vaccine.
Swollen and painful lymph-nodes in the right breast and arm pit. Pain level of 5/10  mostly a constant dull ache with an occasional sharp 10/10 pain.
On 07/24/02 developed red, swollen, warm around area of shot. Pt was seen 07/25/02 treated for local reactoin, treat with hot packs given Augmentin if worsens.
temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209:
Pt reports redness, swelling, induration, and pain in (R) upper arm, approx 4-5 in x 2.5 inch reddened area, also fever. No hives, no itching, no throat/facial swelling. Pt took BENADRYL.
general myalgia;multiple joint pain;chills;pt has been taking Ibuprofen for pain;
Mouth Sores/Lesions on the Left side of mouth, Sore left side of face, Warm to touch left side of face, left jaw sore,  Whiteish colored tongue, swollen left side of face. Started 2/3 days prior to 2nd Moderna shot
Five days after receiving the Pfizer vaccine, I had a sudden onset of neck & shoulder pain on my left side, radiating up into my left ear & across my chest.  My chest was tight.  It hurt in my neck and shoulder and chest to take a deep breath.  Shortly after, I felt jittery inside & started getting chills.  The backs of my legs were quaking against the chair and I got really cold.  My blood pressure went up to 149/78.  I also had one bout of diarrhea.
Pain, swelling from left shoulder to elbow, redness, warm to touch at vaccination site, dime size hive like rash
I received the vaccine @ 3:26p on 1/7/21 by 9:30p I was dealing with itchiness. I woke up on 1/8 w/soreness & rash around the injection site & on the left arm. By  6p I had a rash on both arms, back & on my right knee. By midnight I developed a rash on my r foot & belly area.  It's 1/13 & I have been taking Benadryl on & off since 1/8 @ 2am. The rash comes and goes on different parts of my body. My physician is now ordering a low dose of prednisone that I will start taking today, 1/13.
Presented to ED with significant exacerbation of fibromyalgia symptoms severe GI discomfort (3 days after Covid vaccine). She states that her pain feels similar to when she was admitted in December 2020 for diverticulitis. She denies urinary symptoms and hematochezia. She has been taking generic Bentyl with minimal relief to her symptoms. She took an Oxycodone this morning with moderate relief to her symptoms. Patient admitted. Urinalysis shows obvious infection.  There is some squamous cell contamination. Bicarbonate was 15. Pregnancy test was positive and her quantitative hCG is 16 which is negative.  CBC did not have leukocytosis or thrombocytopenia.  She has baseline, chronic anemia with a hemoglobin of 10.9.  CT imaging of the abdomen pelvis was performed without contrast secondary to renal dysfunction.  She does have what appears to be early diverticulitis. Patient started on Invanz which will be continued. Gentle fluid, diet as tolerated, as needed antiemetic, as needed analgesic and antipyretic. Added Xifaxan 550 mg BID x 3 weeks to discharge regimen. General surgery was consulted given this is pt's 3rd bout of diverticulitis in less than a year.  At this time, they recommended ABX mgt and referral to AMC with a GI surgeon given her complex status with the kidney transplant and CKD.  GI was also consulted at pt's request.  Rec 3 weeks of rifaxamin in addition to whatever standard diverticulitis treatment.  Pharmacy reviewed pt's allergy list and thought moxifloxacin 400 mg daily would be sufficient (it also has anaerobic coverage).
Had severe headache and body aches for 3 days, fever over 100. Nauseated for 24 hours. Tylenol only relieved pain for a single hour after taking. Switched to ibuprofen on day three and got relief for up to 2 hours. Symptoms were gone on fourth day.
Patients believes the shingles vaccine caused her face to swell thereby reactivating her trigeminal neuralgia. By the following week the severe pain in cheek had subsided to a "toothache".
headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and PYREXIA (fever) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M201) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced HEADACHE (headache) and PYREXIA (fever). The patient was treated with ACETAMINOPHEN at a dose of UNK dosage form. At the time of the report, HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient does not take concomitant medication.
Patient seen in clinic for first dose of Moderna covid-19 vaccine. Moderna 0.5ml IM administered into left deltoid by vaccinator RN at 0910. Patient with history of pruritic reactions and anaphylaxis. Patient instructed to wait 30 min post injection for observation. At 0930 she reported to this RN torso and upper extremity pruritis and redness, without hives; and feeling of warmth over ears and torso. Benadryl 50 mg PO and cetirizine 10mg PO administered with 8oz water at 0932.  Patient able to ambulate to wheel chair and reclined. Three sets of VS obtained all WNL. At 0947 she reported that pruritis was spreading to lower extremities and new onset of headache and two emerging hives to right wrist. Patient drank another 8oz water and continued to rest in reclining chair. At 1020 she noted an overall improvement in symptoms and there were no hives present. She was feeling well on discharge, up and walking about clinic. She was instructed to pick up Benadryl from site pharmacy and repeat dose in 4 hours. Discharged to home at 1045.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 20th June 2018, the patient received the 2nd dose of SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth and injection site lump. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site lump were unknown. It was unknown if the reporter considered the injection site erythema, injection site warmth and injection site lump to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter who was a pharmacist administered the SHINGRIX to the patient in an unknown deltoid. The pharmacist stated that, the patient had a possible injection site reaction and requested to be transferred to GlaxoSmithKline's Medical Information team to discuss her inquiry of whether or not the reported reaction could be considered an injection site reaction since it was located about 4 inches down from the site of the injection on the patient's deltoid. The pharmacist described the reaction as red and warm. The patient still wore a Band-Aid at the injection site and told the reporter that, she felt a lump there. Due to time constraints, the reporter was not able to complete the form. No further details were provided due to time constraints. The reported agreed to be contacted for further details.
Severe and excruciating cramping in my left leg that I have thrombosis in.  The last time I had this is when a clot developed again and hematologist then put me in warfarin(was in Xeralto previously)
c/o difficulty breathing; seen in ER told infected sinus; ? if related to vax; drain sinus, hard cough, pain in chest;
experiencing recurring migraines.; experiencing recurring migraines and sensitivity to light.; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0150) via an unspecified route of administration in the left arm on 31Mar2021 at 13:30(at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history were reported as none. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 11:30, the patient experienced recurring migraines and sensitivity to light. The patient did not receive any treatment for the reported events. The clinical outcome of the events recurring migraines and sensitivity to light were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Admitted to hosp on 26OCT90 died on 26OCT90; MI w/cardiac arrest.
Skin irritation on face, head, and eyelids consisting of dry, scaly, itchy patches. Eyelids red, itchy and swollen (mostly right eye).  Scaly and itchiness progressed to scalp. The issues began 5 days after the first dose, and progressed to much worse about 6-7 days after the 2nd dose.  I had the same issues occur after being diagnosed with COVID in mid-September 2020, and that is why I'm connecting this immune response to the vaccine.  During the two (plus)  months I had these issues after COVID, the only real relief occurred while temporarily taking a steroid.
2 weeks after the first Vaccine the patient had a seizure, then 7 days after the second vaccine the patient had another seizure. The patient has never had a history of seizures. now being worked at at the Hospital and has not had any issues since
Tachycardia and hypertension, cold and clammy within 4-6 hours of receiving 2nd COVID vaccine dose, was seen in ER, treated and released.  Reports feeling weak and achy for next 2 days
Pt. given GARDASIL on 5-17-11 (L) Deltoid, 24 hrs later pt. stated throat started to swell, pain & rash at pain site. Pt. advised to take BENADRYL 50mg by Dr. & if sx. persisted to go to ER. No more GARDASIL inj. to be given to pt.
As of June 23, 2016 (L) arm pain starting in area of injection progressive pain to reach shoulder, elbow (L) arm (L) hand and (R) too, paresthesia lips on and off no change by stopping meloxicam.
Reporter indicated that several patients were non-converters p/recvd Hep B vax; pt recvd 3 doses of Engerix-B & did not convert; recvd booster dose & titer results are not known;
Severe headache and severe fatigue.  Large knot from injection site to crook of my arm,  So very sore I could not lift my arm,  I could lay on arm with no pain,  but to touch it and push was extremely painful.  My voice was just about gone..excessively low and crackly,  but no throat pain!
headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A.) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced HEADACHE (headache) and PYREXIA (fever). 13-Mar-2021, the patient experienced CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            Action taken with suspect mrna-1273 COVID-19 vaccine was not applicable.  No concomitant medications reported by investigator.
Patient was supposed to receive his second monovalent Pfizer vaccine. He was given the Bivalent Pfizer vaccine instead.
7/25/21: Patient presented to ED with SOB and cough.  The cough is productive of white colored sputum associated with SOB with exertion. Pt noted fever today. Diagnosed with COVID-19 pneumonia. Note: patient has a history of receiving the Pfizer COVID-19 vaccine in Feb/Mar 2021.  7/28/21: patient discharged
flush; nausea (noxious); Could not keep anything down; soreness; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (flush), PAIN (soreness), NAUSEA (nausea (noxious)) and VOMITING (Could not keep anything down) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN (soreness). On 13-Jan-2021, the patient experienced FLUSHING (flush), NAUSEA (nausea (noxious)) and VOMITING (Could not keep anything down). At the time of the report, FLUSHING (flush), PAIN (soreness) and VOMITING (Could not keep anything down) outcome was unknown and NAUSEA (nausea (noxious)) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Body temperature: 97.8 Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment was received.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
terrible pain that would surge from low level to unbearable over 5 days (headache, eye pain, neck and shoulders, lower back, throat), sensitivity to light, dizziness, ringing in hears
Information has been received from a registered nurse referring to a 27 year old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On an unknown date in September 2016, the patient was vaccinated with GARDASIL 9 (lot # M004116, expiration date 12-OCT-2017; dose and route were unknown) at 27 years of age (drug administered to patient of inappropriate age). No adverse effects were reported. Additional information has been requested.
Patient received Shingrix 50 mcg injection on 5/2/2019 on the left arm. Patient then felt a small nodule in her left arm. Due to the pain, she could not move her left arm backwards. In August 2019, patient started physical therapy to help with the movement of left arm. The physical therapy lasted for 6 weeks. Up till today, patient still does not have full range of motion of her left arm. She decided not to have the second dose of the Shingrix vaccine.
Abdominal pain, chills, n/v, dark urine, elevated LFT's, Bilirubin in urine. Patient currently admitted to hospital
Patient developed a fever of 102.5 and lethargy. She slept most of the day on 5/12, 5/13 and part of the day on 5/14.