chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received 1st dose not the 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received first dose in 2017 or in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 20-Feb-2023 Reporter's comment: The reporter did not provided information about first Shingrix dose (lot number/expiration date/ date of administration). The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination. As it was not clearly whether the patient received the first dose in 2017 or in 2019, therefore in worst approach case was kept valid and further clarification request was raised.
Reports and intermittent pain that has persisted since the day after vaccination. Pain is located at the anterior right shoulder and in the lateral shoulder just inferior to the acromion.  The pain will come and go with movement and resolves with heat. He denies specifically and visible swelling, redness or fever.
tired all day; headache that came and went; chills; fever; 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 FATIGUE (tired all day), HEADACHE (headache that came and went), CHILLS (chills) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced FATIGUE (tired all day), HEADACHE (headache that came and went), CHILLS (chills) and PYREXIA (fever). At the time of the report, FATIGUE (tired all day) and HEADACHE (headache that came and went) had not resolved and CHILLS (chills) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 99.5.
Information has been received from a physician concerning a 14 year old female who on 22-DEC-2006 was vaccinated with a first dose of Gardasil (lot# unknown) injection. In February 2007, the patient came to the office complaining of abdominal pain, vomiting, nausea. Medical attention was sought. The physician sent the patient to the emergency room because she felt abdominal tenderness. At the hospital, the patient had a computed axial tomography (CT scan) but no results were reported. On an unspecified date 2 days after the emergency room visit, the patient reported diarrhea. The outcome of the event was not reported. On 14-MAR-2007 the patient received a second dose of Gardasil. In May 2007, the patient reported she experience backpain, tingling in the fingers and felt lightheaded. On an unspecified date the patient had a pelvic ultrasound and a stool culture but no results were reported. On 12-JUL-2007 the patient received a third dose of Gardasil. On 24-JUL-2007 the patient experienced stomach pain but no diarrhea or fever. The patient stated that she has had stomach pain on and off since February. The physician referred the patient to a GI specialist. At the time of reporting the patient has not recovered. No additional information was provided. Additional information has been requested.
13, 14, and 18 year old patients were given 0.3mL of Orange Cap as their first primary dose; correct dose, wrong strength, gave 0.3cc of 5-11yo vaccine; Depression; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  An 18-year-old patient received BNT162b2 (BNT162B2), on 25May2022 at 12:00 as dose 1, 0.3 ml single (Lot number: FL8095) at the age of 18 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Migraine", start date: 18Sep2017 (ongoing); "Unequal leg length", start date: 21Sep2004 (ongoing); "Eczema", start date: 07Nov2006 (ongoing). There were no concomitant medications. The following information was reported: DEPRESSION (non-serious) with onset 25May2022, outcome "not recovered"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 25May2022 at 12:00, outcome "unknown", described as "13, 14, and 18 year old patients were given 0.3mL of Orange Cap as their first primary dose"; ACCIDENTAL UNDERDOSE (non-serious) with onset 25May2022 at 12:00, outcome "unknown", described as "correct dose, wrong strength, gave 0.3cc of 5-11yo vaccine".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (27Jun2022): New information received from a contactable Nurse reported for the patient in response to HCP letter sent via follow-up letter which included updated information: At risk classification has been deleted. Reporter details updated, new reporter added added. Patient name updated. Patient age at vaccination added. RMH 'Migraine, Unequal leg length and Eczema' added. Start date, time, lot number, route of administration and anatomical location of suspect added. Vaccine facility name, address, city, state, type, phone number and Vaccine Administered at Military Facility added. Event onset date and time added for ' Inappropriate age at vaccine administration and Accidental under dose'. New events (Accidental under dose and Depression) added. Concomitant therapy captured as None.  Additional Information: Type of medication error reported as Dispensing issue with stage of medication error: Correct dose, wrong strength, gave 0.3 cc of 5-11 yo vaccine. Contributing factors to the medication error include Vials and clipboards placed on small table in medical room side by side. 12+ always kept to left on 5-11 yo on right. On 25May2022 clipboards were reversed on this (word illegible) drew up the wrong medicine. The medication error affected the patient or consumer with clinical consequences with reported outcome that patient needed to return the next day for a full dose of 0.3 cc, 12+ year old vaccine per guidelines. Medical room reconfigured 50 vials now in separate areas with separate tables; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200766227 same reporter/drug/event, different patient;
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (lot#, expiry date, dose, route of administration and anatomical location were not reported). On an unknown date, the patient experienced loss of appetite and weight loss. The outcome of events was unknown. The relatedness between the events and GARDASIL 9 was not reported. Additional information has been requested.
Swelling of lymph nodes under right arm (in arm pit), Fever Blister (aka Cold Sore), Headache.  Took 2 Tylenol twice in 24 hours.  Headache has gone, fever blister has grown, lymph nodes have decreased in swelling but are still painful and swollen.
pt recv vax & T104-105 rx w/APAP;evening temp went to 107.2 & mom reports child had febrile sz;seen in ER & hosp;dx OM & febrile sz;
The patient received her second dose of the SHINGRIX vaccine on 9/7/18. Then early in the morning on 9/8/18 the patient went to the hospital. The patient had a fever, felt weak, felt nauseous, had two large stools, was very cold, and had frequent urination. The hospital believed her symptoms were due to the SHINGRIX vaccine. She had no injection site reaction. They gave her IV fluids and she stayed for 4 or 5 hours. Then they discharged her. Later that day she felt better.
Ont 10/7/10 at approximately 8 pm,caregiver of patient (with the patient right by her) reported that patient has been experiencing headaches, bone pain and weakness since receiving the flushot on 10/3/19. It has not gotten better or worse and she is still feeling weak. I told her if her symptoms do not improve by tomorrow, to report to an urgent care of primary doctor.
First really noticed increased aching of arm near injection site about 5 hours after the injection, which was evening. Awoke the next morning with bad headache, feeling tired, with a lack of appetite. Increasingly got occasional chills, as the day went on. Suspected fever (which I haven't had in probably over a decade), and took my temperature in mid-afternoon, which was about 24 hours after I'd gotten the vaccine: 101 degrees. I then read of the possible side-effects. Slept and rested the rest of the day, but I basically "lost" a day. Totally fine the next day, except for residual bit of ache at the injection site. Not looking forward to the recommended 2nd injection in a few months.
Patient came into received her  second dose of Pfizer vaccine and was given Moderna in error. Pt has not reported any adverse reaction. This report is for reference only at this time.
Rash with vesicles over trunk and face, and fever Tm 103F x 2-3d
Face Swelling; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 24Mar2021 at 23:15 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, diabetes, hypertension, depression, obesity, sleep apnoea, arthritis, glaucoma, psoriasis and rosacea. The patient was allergic to penicillin and sulphadrugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), aripiprazole (ABILIFY), venlafaxine hydrochloride (EFFEXOR), atorvastatin calcium (LIPITOR) and irbesartan (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 08:00, the patient experienced face swelling. The adverse event resulted in doctor or other healthcare professional office or clinical visit. The patient was treated with BENADRYL for face swelling. The clinical outcome of the swelling face was resolved on an unspecified date in Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a medical assistant refers to a 15-month-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 26-OCT-2016, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # M025867 with expiry date on 24-MAY-2018; dose and route of administration were not reported) for prophylaxis. The administered dose experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1610USA010748: US-009507513-1701USA000675: US-009507513-1701USA000676: US-009507513-1701USA000677: US-009507513-1701USA000678: US-009507513-1610USA004609: US-009507513-1701USA000680: US-009507513-1701USA000681: US-009507513-1701USA000682: US-009507513-1701USA000683: US-009507513-1701USA000684: US-009507513-1701USA000685: US-009507513-1701USA000686: US-009507513-1701USA000687: US-009507513-1701USA000688: US-009507513-1701USA000689: US-009507513-1701USA000690: US-009507513-1701USA000691: US-009507513-1701USA000692: US-009507513-1701USA000693: US-009507513-1701USA000694: US-009507513-1701USA000695: US-009507513-1701USA000696: US-009507513-1701USA000697: US-009507513-1701USA000698: US-009507513-1701USA000699: US-009507513-1701USA000700.
Pharmacist states they gave full doses for boosters instead of half doses.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Pharmacist states they gave full doses for boosters instead of half doses.) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Pharmacist states they gave full doses for boosters instead of half doses.). On 25-Oct-2021, ACCIDENTAL OVERDOSE (Pharmacist states they gave full doses for boosters instead of half doses.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patients were given 0.5 milliliter as booster dose instead of 0.25 milliliter. Concomitant medications were not provided. Treatment information is not provided.
This case was reported by a healthcare professional and described the occurrence of hives on neck in a 41-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline), FLULAVAL. The subject's medical history included two c-sections and removal of gallbladder. Concurrent medications included Multivitamins (Vitamins). On 3 August 2011 at 16:00 the subject received 1st dose of ENGERIX B (1 ml, unknown route, left arm). One to two hours after vaccination with ENGERIX B, the subject experienced hives on the front of her neck. No other events were noted. After the next vaccination with ENGERIX B the event recurred. On 5 October 2011 at 10:00 the subject received 2nd dose of ENGERIX B (1 ml, unknown route, right arm). On 5 October 2011 the subject also received a dose of FLULAVAL (details unknown). It was not specified whether the 2nd of ENGERIX B was administered at the same time as FLULAVAL. On 5 October 2011, 1 to 2 hours after vaccination with ENGERIX B, and less than one day after vaccination with FLULAVAL, the subject experienced hives. On 6 October 2011, reported as 1 to 2 days after vaccination with FLULAVAL and ENGERIX B, the subject experienced heart palpitations, swelling of scalp (left side) and instability ("unsteadiness"). At the time of reporting the hives were resolved and the other events were unresolved. The healthcare professional considered the events were probably related to vaccination with ENGERIX B and FLULAVAL. Follow-up information was received from the healthcare professional on 08 November 2011: all vaccines were administered intramuscularly. FLULAVAL was given as 0.5cc dose in the left arm. Biopsy was not performed. The events resolved on an unspecified date.
No adverse event occurred. Noted 9/8/16 that client inadvertently received Proquad and Varicella vaccine in seperate arms instead of MMR and Varicella seperately.
Whole arm swollen, red itchy, mobility. Neck immobilized. Severe pain.
Patient began feeling lip numbness shortly after receiving the vaccine.  Patient reported feeling tightness in throat that felt like muscle tightening, not airway compromise.  Refused IM epinephrine.  Patient awake, alert, mild symptoms.  Patient given water and is resting.   0704 HR 70, oxygen saturation per pulse oximetry 95%, BP 130/70.  0712 BP110/80, pulse 80, 0732 BP 116/74 and 25 mg Benadryl given.  At 0830 lip tingling and throat symptoms have resolved. Patient report lips feel cool, but all other symptoms have resolved.
Received first vaccine on 2/17/21, had left arm soreness and swelling the next day which continued to get worse. Went to urgent care on 2/22/21 diagnosed with vaccine reaction.
Sedation, Myalgia, Tachycardia, arm soreness, body pain, chills and shaking Narrative:  History of prolonged COVID infection diagnosed on 11/23/20 - complications included pericarditis and lung changes and required 5 weeks away from work. COVID treated with monoclonal antibody therapy. Last CT completed prior to vaccination showed resolution of symptoms. Received first dose of vaccine 1/7/21. Arm soreness noted that day which increased in severity as day progressed. Awoke at 2 am on 1/8/21 with pain throughout body. Additional symptoms included tachycardia, chills, shaking and fatigue. Sought care at the local emergency department. Treated with OTC naproxen and famotidine and referred to Cardiology for evaluation of tachycardia.
FEVER, COUGH, LOSS OF TASTE/SMELL, RN, CONGESTION, CHILLS, HA, FATIGUE
Blistery, weeping sores on left hand after each dose, worse after the second dose.  Evolved into cellulitis
dry cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (dry cough) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) 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) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced COUGH (dry cough). The patient was treated with AZITHROMYCIN (Z-PAK) at an unspecified dose and frequency. At the time of the report, COUGH (dry cough) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, Chest X-ray: normal (normal) Normal. On 19-Feb-2021, Oxygen saturation: normal (normal) normal. On 22-Feb-2021, Oxygen saturation: 89-92 (Low) decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: F/U received on 28 APR 2021, reporter email ID updated.
Tested positive for Covid; A spontaneous report was received from a Consumer concerning a 55-years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history includes obesity and diabetes.  Concomitant medications were not reported.  On 31st Dec 2020, prior to the onset of events the patient received their first dose of mRNA-1273 (batch/ lot # 011L20A) for prophylaxis of COVID-19 infection.  On 7th JAN 2021 the patient was exposed to someone with COVID -19 and tested positive for Covid on 13th JAN 2021.  Laboratory details was not provided.  Treatment was not provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was considered as Unknown.
no adverse effects reported; patient inadvertently received an expired dose of MMR II on 02.10.19; This spontaneous report was received from a medical lab technician (who is also office manager) and refers to a patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not reported.  On 02-OCT-2019, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) recombinant human albumin (rHA), lot # N023150, expiration date 24-AUG-2019 (exact dose, route and site of administration were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent. No adverse effects were reported.
Patient experienced a sore arm, then on the morning of October 21, 2018 he noticed a rash. He went to be seen in emergency room/ immediate care. He was diagnosed with cellulitis and was started on IV antibiotics for 5 hours and four bags of fluids. He, also, experienced diabetic ketoacidosis, and lactate levels were high. After a lab re-check and some hospital stay, he was discharged and scheduled for a follow-up.
throwing up; headaches are so bad; so much pain; chest hurts; burning sensations throughout her body; arm, chest, head are on fire; can't eat, can't do anything, and can't move; does not feel good; This is a spontaneous report from a contactable consumer (patient).  A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unknown route of administration on 14Sep2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not feel good, had chest hurts, burning sensations throughout the body, arm, chest and head are on fire, can't eat, can't do anything, and can't move, headaches are so bad on an unknown date in Sep2021 and throwing up on 14Sep2021. Consumer was in a hurry because she was in so much pain, and she wanted to know what she should do about the side effects that she is experiencing. The clinical outcome for throwing up was not recovered and outcome for the other events was unknown.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Symptoms: High Fever (103-104), Sore Throat, Coughing, Body Aches including Head and Stomach, Sneezing, Vomiting. Treatment: Tamiflu medicine (OSELTAMIVIR).
This case was reported by a healthcare professional and described the occurrence of sneezing in a 61-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included aortic valve disease and sulfa allergy. There were no concurrent medications. On 11 October 2011 at 13:30 the subject received a dose of FLUARIX in the left arm. On 12 October 2011, 1 day after vaccination with FLUARIX, the subject experienced sneezing. On 22 October 2011, 11 days after vaccination with FLUARIX, the subject developed chills, a sore throat, body pain, cough, nausea, vomiting, headache and eye pain. The healthcare professional considered the events were disabling. At the time of reporting, sneezing and body pain were improved and chills and sore throat were resolved. According to the reporter, all four of these events were probably related to vaccination with FLUARIX. The outcome and FLUARIX attribution of cough, nausea, vomiting, headache and eye pain were not known, although a note was made that these symptoms lasted several days. It was indicated that a coworker who did not receive the FLUARIX vaccination, but had been exposed to the subject had not gotten sick; therefore, this subject believes her reactions were not a contagious illness, but rather a reaction to the vaccine. Two additional subject experienced events following vaccination with FLUARIX. Linked cases are A0951452A and A0951453A.
11 am 8/31/09 vaccines administered.  Fatigue & listlessness ensued & increased within few hours.  Late that day & into night vomiting & headache 2 am 9/1/09 temp rose to 103 degrees.  11AM still fatigued, temp 99, anorexic.  9/2/09 SX abated.
Felt like wind burn or sun burn.  Very painful 1mm in diameter.  "Sores" in the hairline on left side of face.  Then on the side of her face beside her nose several slightly larger. "Started as a bump red, then blister and then scabbed over.  Reports that this was very painful.  The process lasted about one week.  Client still has sores on the cheek area.
Narrative:  Per Immunization Registry information, patient received two different COVID-19 vaccines (Pfizer 3/25 and Moderna 4/22). There were both administered outside the facility. Detected by nursing staff on review of vaccine registry. Unknown if patient had any adverse reaction to vaccine as these were not administered on site.