chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported for the patient; administration of one dose of an improperly stored vaccine// Temperature: (58.5 F); administration of one dose of an improperly stored vaccine/ Temperature: (58.5 F)/ possible malfunction of the Data Logger; This spontaneous report has been received from an office manager concerning one patient of unknown age and gender.  The patient's past drug and pertinent medical history, as well as the concomitant medications, were not provided.   On 06-NOV-2019, the patient was vaccinated with one improperly stored dose of 0.5 milliliters (ml) of Hepatitis A Vaccine, Inactivated (VAQTA) as prophylaxis (lot number S009943, expiry date 26-JUL-2020); number of administered dose and frequency of vaccination scheme, route and anatomical location of vaccination were not reported.   The Hepatitis A Vaccine, Inactivated (VAQTA) underwent a temperature excursion of 58.5 degrees Fahrenheit (°F) for a time frame of 10 minutes, as recorded by the data logger. However; the office manager reported a possible malfunction of the data logger (circumstance or information capable of leading to medication error and product storage error). There were not any previous temperature excursions. No adverse effects were reported for the patient.
Case number PHEH2014US010666 is a combined initial spontaneous report from a nurse received on 22 May 2014 and a follow-up received on 27 May 2014 with a follow-up received on 27 Jun 2014. This report refers to an 18-year-old female patient. She received only the Men CYW-135 liquid conjugate component of MENVEO (batch number: X13051) into right deltoid on 25 Apr 2014 at 11:30. It was reported that the past vaccination with MENVEO which was given on 24 Jan 2008 was well tolerated. No adverse reaction has been reported following this medication error (inappropriate preparation of medication). Follow-up received on 27 Jun 2014: Site of vaccination, past vaccination, patient's demographics and reporter details were updated.
This case was reported by a health professional to a sales representative and described the occurrence of multiple sclerosis in an adult female patient who received hepatitis B vaccine recombinant (Engerix-B). On an unspecified date in 2002, the patient received the first dose of Engerix-B. Approximately two years following the administration of Engerix-B., on an unspecified date in 2004, the patient developed multiple sclerosis. The outcome of the event was not reported. The health professional considered the multiple sclerosis to probably be related to vaccination with Engerix-B. Multiple sclerosis was assesses as medically serious by manufacturer (OMIC).
Shortly after receiving PNEUMOVAX  (on left arm) soreness developed. 24 hours after receiving PNEUMOVAX (on left arm) & FLUARIX (one right arm): fatigue, loss of appetite, headache developed, body aches developed and worsened as time progressed, tightness in chest cavity, sudden chills throughout sleep, hives developed around where PNEUMOVAX was received and arm extremely sore with very limited movement ability due to pain. 48 hours after receiving PNEUMOVAX and FLUARIX: fatigue, loss of appetite, headache, body aches, tightness in chest cavity, hives stayed around where PNEUMOVAX was received and arm extremely sore with very limited movement ability due to pain. Hives felt hard and warm to touch. 72 hours after receiving PNEUMOVAX and FLUARIX: fatigue, hives persisted and arm extremely sore with very limited movement ability due to pain. Ibuprofen was taken the first 72 hours. Heat pad had only accelerated hives and soreness. Symptoms continuing
This spontaneous report was received from a licensed practical nurse concerning an unknown  number of patients of unknown age. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with a dose of PROQUAD (dose, dose number, lot number, expiration date and route were not reported) that was improperly stored. No adverse effects reported. Co-suspect and concomitant therapies were not reported. This is one (1) of two (2) reports from the same source. Additional information has been requested.
Four days after first Pfizer dose, experienced onset of atrial fibrillation, a new condition. Since then frequent episodes of AF despite flecainide 100mg BID without signs of resolution. Second dose Feb 22, arrhythmia continues. MD feels that inflammatory action of vaccine may have caused or triggered onset.
Lump in the collarbone area; Red rash going down the to the armpit; Red circle the size of a quarter and raised; Red circle raised; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red circle the size of a quarter and raised), SWELLING (Red circle raised), SKIN MASS (Lump in the collarbone area) and RASH ERYTHEMATOUS (Red rash going down the to the armpit) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced ERYTHEMA (Red circle the size of a quarter and raised) and SWELLING (Red circle raised). On 19-Nov-2021, the patient experienced SKIN MASS (Lump in the collarbone area) and RASH ERYTHEMATOUS (Red rash going down the to the armpit). At the time of the report, ERYTHEMA (Red circle the size of a quarter and raised), SWELLING (Red circle raised), SKIN MASS (Lump in the collarbone area) and RASH ERYTHEMATOUS (Red rash going down the to the armpit) outcome was unknown.            Concomitant information was not provided.   No treatment was received.   Reporter states that she completed the Moderna primary series prior to receiving her booster.   Reporter did not allow further contact
Improperly stored administered PROQUAD vaccine; This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, drug reactions/allergies were not reported.   On 03-NOV-2020, the patient was administrated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) (lot # T016990, expiration date: 11-NOV-2021) (strength, dose number, route and site of administration were not reported) for prophylaxis (product storage error).   The vaccine was exposed to a temperature range between -14 Celsius degrees to -10 Celsius degrees (-13.8 Celsius degrees) for 36 minutes; -14 Celsius degrees to -10 Celsius degrees (-13.4 Celsius degrees) for 42 minutes. The cumulative time frame was 4 hours and 32 minutes. There was an previous temperature excursion. Digital data logger was involved.
Was fine after my injection however next morning I got the normal side effects like sore arm runny nose and headache. However the headache has lasted five consecutive days, I find it hard to swallow and get hot and cold sweats. I don?t believe I was told symptoms could last more than 2 days and I?m in pain constantly
Moderately severe tonic/clonic seizure of approximately 60 second duration observed by nursing staff at approximately 7:00am on 2/3/21.  Patient was awake sitting at the dining table.  Patient has no previous history of seizures. The only immediate treatment was continued observation, with no further seizures noticed to date.  Patient visited his PCP later that day for follow-up, no treatment advised.
spiked a fever of 101.3; spiked a fever of 101.3 which cause a 20 minute seizure; spiked a fever of 101.3 which cause a 20 minute seizure; headache; This is a spontaneous report from a contactable consumer reported for himself. A 33-years-old male patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration at right arm on 25Jan2021 11:00 at single dose for COVID-19 immunization. Medical history included seizure disorder and other neurological issues, allergy to latex. Concomitant medication included levothyroxine sodium (SYNTHROID), fluoxetine hydrochloride (PROZAC), omeprazole, lacosamide (VIMPAT), lamotrigine (LAMOTRIGINE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included 1st dose of BNT162B2 (lot number: EK9231) on 04Jan2021 12:00 PM at left arm for COVID-19 immunization when he was 32-years-old. The patient had a headache throughout the following day and evening on 26Jan2021.  On 27Jan2021 spiked a fever of 101.3 which cause a 20 minute seizure. He was hospitalized for 2 days. Events resulted in emergency room/department or urgent care, hospitalization. Treatment was received for the adverse event in hospital. The events outcome was recovering. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. The report was reported as serious with seriousness criteria-caused hospitalization.
Left deltoid red, swollen and tender. Area warm to touch. Area of redness and swelling 50mm in size. Still has knot on the arm.
sWELLING AND REDNESS ON RIGHT THIGH,LATERAL ASPECT MEASURING 55cm X 70cm.
(L) arm with 2x4 cm induration/erythema with warmth and tenderness. 2-3 small scabs in area (scratching). Cellulitis-likely from skin flora through injection or scratch marks. Treatment: Keflex 250/5 2tsp TID x 10 days, Motrin PRN, compresses. F/up if worsening.
Patient is extremely sore, can not lift arm. Pain at level 10. Persistent fever and headache.
hospitalized at her local hospital 7/26/2021, transferred to hospital on 8/1/2021, currently hospitalized
Adverse reaction began 2 days after injection.  Patient had a migraine (first time for her) and full body hives and urticaria
Pt reported dizziness and chest discomfort. Pt medications she was taking are Linsinopril, Zocor and Synthroid. Pt requested MMR/VZV/Td or Tdap to fullfill requierments for a green card.
Site: Pain at Injection Site-Medium, Additional Details: Patient came in on 4/28/2023, claiming that the Shingrix(shingles vaccine) given on 8/8/2022, has caused her much pain, and is still bothering her.
Patient developed nausea, headache, vomiting, and lower extremity numbness within 10-15 minutes after vaccine administration. Initial BP was 190 systolic.  Patient was given Aspirin and Oxygen . She was transferred to the emergency department for management of acute stroke. TPA was administered and she is in ICU.
This spontaneous report as received from a medical assistant refers to a 1 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 24-JUN-2014 the patient was vaccinated with first dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J005010, expiry date: 23-OCT-2015) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, , 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA01304 (same reporter link).
Itchy spots on face, belly, back, arms, about < 20 developed to blisters.
Pt received primary smallpox vaccine (SPV) in left arm on 18 MAY. She also received anthrax (2) vaccine on the same day in her right arm. She denies significant local reactions at vaccination sites. Reports SPV site progressed to a pustule and is now scabbed. On 25 March, post-vaccine day (PVD) 7, patient reports left supraclavicular adenopathy and mild burning type pain at SPV site, with muscle aches and malaise the following day. No fever or chills. Patient self treated with MOTRIN 400 mg and rest with some improvement of symptoms. On PVD 9, 28 may, patient developed nausea, vomiting and diarrhea. She was unable to keep food down and sought evaluation. She was diagnosed with "food poisoning" and was prescribed ZOFRAN and Pepto Bismol, which she did not take. She was placed on bed rest x 24 hours and by 30 May, she was able to tolerate fluids. She reports increased sleep over a 48 hour period, but no persistent fatigue. On 30 May, PVD 12, patient noted pain, first in her right ankle and later in her left ankle. She resumed taking MOTRIN 400 mg which did not relieve the pain. Pain described as "aching" joint pain with pain intensity level of 10/10 at onset, using pain scale of 0 (=no pain) to 10 (=worst pain ever experienced). Patient denies redness, warmth, or swelling of joints. She denies numbness/tingling and weakness. Joint pain increased with AROM/ By evening of 30 May, patient was experiencing pain in her shoulders, knees (R>L), ankles, wrists (R>L), and lower back/hips.
First Rotavirus/ RVS vaccine was ordered for patient at age of four months and was given. No adverse effect noted to patient.
Red, warm, swollen below injection site reported. Instructed to apply indirect ice & Ibuprofen or TYLENOL q 6 hrs. When seen again 8/12 new red spots along left anterior/upper thigh. Redness/swelling significantly reduced at time of appt.
Tingling sensation throughout body; Fever; Dizzy; Fatigue; Aches; This is a spontaneous report from a contactable other healthcare professional, the patient. A 71-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6208) via an unspecified route of administration in the right arm on 21Mar2021 at 09:15 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included vestibular neuronitis, hypertension and temporomandibular joint disorder (TMD). Concomitant medications included clonazepam (MANUFACTURER UNKNOWN), duloxetine (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN); all from an unknown date and for an unknown indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6200) via an unspecified route of administration in the right arm on an unspecified date at 10:00, as a single dose for COVID-19 immunisation. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021 at 18:00, the patient experienced fever, dizzy, fatigue, tingling sensation throughout body and aches. The events resulted in doctor or other healthcare professional office/clinic visit. The patient contacted neurologist as a part of treatment for the reported events. The clinical outcome of the events fever, dizzy, fatigue, tingling sensation throughout body and aches were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
I didn't really have any symptoms, but my husband was positive, so I tested after having sneezing. The next day I went and tested at a local pharmacy, and I was positive for COVID-19. I treated the symptoms at home, and I did recover within 2 weeks or so.
Patient reported to clinic to receive 2nd dose of Pfizer Covid vaccine but had completed the consent form for the Pediatric Pfizer covid vaccine. We didn't verify the age as being too old to receive the pediatric dose until after the fact.
My husband received the vaccinations while standing was asked how he was feeling he said ok was then sent to the hallway of the emergency room so I could receive my vaccinations. The nurse said that we had to wait for 15 min. to be watched for any reactions.  My husband was not monitored for the 15 min. When he went into the hallway he said the last thing he remember was a warm fuzzy feeling. My husband then passed out and landed flat on his back in the hallway. As a result of his fall he has a fractured skull, brain bleeding and swelling.  He was admitted to the hospital and sent to ICU. At the present time he is home but still is in pain, has no appetite, nausea, no sense of smell and is still not himself.  8/31/09 Received hospital medical records of 8/20-8/21/2009. FINAL DX: subarachnoid/subdural bleed Records reveal patient experienced fall, head injury & headache immediately after receiving vaccine.  Neurosurg consult done.  Tx w/steroids.  Remained stable & d/c to home. ICD-9 codes for DC 401.9, 780.2, 401.9
Observed for 30 minutes  BP 113/74   Sat O2 99  HR 70's No EKG changes and with mild PVCs
About 2-3 minutes after injection, while patient was waiting in the lobby, Mother reports patient was not feeling well and asked for a wet paper towel for her neck and forehead. When I returned from getting her a wet paper towel patient became pale and passed out for 1-2 seconds while sitting in the chair in the lobby. Mother was holding daughter so that she did not slip out of the chair. No injury at this time.  Patient became alert quickly, patient reports she felt a little sick.  Mother reports this is the first time she has passed out after any vaccine. When talking with the patient she reports that she was nervous about the shot. Patient also reports that she only ate banana today and nothing else. Water given to patient, instructed to take small sips. At 3:40 when back out to check on patient, she reports that she feels better. Discussed with mother that I will file a VAERS report and they will call to follow up with the her and the patient. 3:43 HR taken at 68 bpm, regular, RR 18, breathing clear and unlabored, patient no longer pale, radial pulses strong.  Patient reports that she does feel better and mother reports she will take her to get something to eat. Discussed with mother to continue to monitor patient and if she has any other signs of difficulty breathing or not acting like herself to take her straight to the ER. Mother in agreement and verbalizes understanding.
She felt very dizzy; had diarrhea; Body Pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (She felt very dizzy), DIARRHOEA (had diarrhea), PAIN (Body Pain) and CHILLS (Chills) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced DIZZINESS (She felt very dizzy), DIARRHOEA (had diarrhea), PAIN (Body Pain) and CHILLS (Chills). On 04-Mar-2021, DIZZINESS (She felt very dizzy) and DIARRHOEA (had diarrhea) had resolved. At the time of the report, PAIN (Body Pain) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. No treatment was reported.
Patient received full series of Pfizer COVID vaccine in 2/2021. Came into pharmacy asking for Moderna COVID shot. Asked patient if they had ever received a COVID shot to which she replied no. Administered Moderna COVID shot on 8/25/2021. When entering shot into system saw they had previously received Pfizer series and our policy is not to mix manufacturer's unless it is absolutely necessary.
has a Bladder surgery 23Mar; This case has been considered invalid as the AE was unspecified. This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a male patient that: Is the Reporter a Healthcare Professional (HCP): Unknown Occupation/Specialty: UNKNOWN Is the reporter the prescribing HCP: UNKNOWN. Is the reporter's contact information available to you or a sub-contracted party: Yes. Verbatim and Event Description: No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. Below is the verbatim report. Consumer husband Received first covid vaccine on the 27Feb- Also has a Bladder surgery 23Mar- Second dose is the 20th- Can it be extended until after surgery- if so how long- Clarified it was scheduled before first dose- Transferred after 1 min- faxed possible AE. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 32-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported. No concomitant medication was reported.
This non-serious initial spontaneous case was received on 15-Sep-2017 from other health professional and concerns a female patient of unspecified age. On an unspecified date, the patient was administered with FLUAD (TIV) (dose, route of administration, anatomical location, batch number, expiry date was not reported). On an unspecified date, 2 days after administration of FLUAD, the patient was out of character and was with depression with out of sorts. The outcome of the events was not reported.