chrisvoncsefalvay/vaers-outcomes huggingface dataset:
already administered fluzone high dose not suitable for use with no reported adverse event; Initial information received on 21-Sep-2021 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient who already administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] dose not suitable for use [expired product administered].   The patient medical history, medical treatment(s), vaccination(s), concomitant medication, and family history were not provided.   On 21-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ759AB and expiry date: not reported] via an unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to expired product administered [Latency: on the same].   It was reported "Pharmacist reports that they received a shipment of FLUZONE HIGH DOSE today; states he received a call from Sanofi and was told that his products were supposed to be delivered yesterday, and since they were delivered today his products are not suitable for use. Pharmacist states they had already administered this FLUZONE HIGH DOSE to 2 patients before they received the call from Sanofi. Pharmacist states he does not have complete information for an AE/safety report at this time, states he has to speak to the other pharmacists to determine exactly what happened".  No other vaccines were reported.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.  At the time of report no adverse event was 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 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.
Individual had onset of ipsilateral hand/finger pain the day following the immunization which has persisted until now.  Discomfort is worse in the morning upon awakening.  No hyperemia or swelling other than some swelling over the distal ulna with some discomfort/paresthesias into the fifth digit.
Ringing/Buzzing in her head like a Machine; Intense Headaches; Vomiting; A spontaneous report was received from a nurse who was a, female patient who experienced ringing/buzzing in her head, intense headaches and vomiting.  The patient's medical history was not provided. No concomitant medications were reported.  On 02 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. Within minutes of receiving the vaccine, the patient experienced ringing/buzzing in her head, intense headaches and vomiting. The patient stated that she did not report the symptoms to the healthcare professionals providing the vaccine to avoid causing a scene. The patient tried some topical ointment/gel (pennsaid) to get the ringing to stop that was used for plantar fasciitis. However, the off-label medication did not help.  On 04 Jan 2021, the patient went to the emergency room (ER). The patient was treated with dextroamphetamine, toradol, fluids and ondansetron for the events.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome for the events, ringing/buzzing in her head, intense headaches and vomiting was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report as received from a pharmacist refers to a 17 year old patient of unknown gender. The patient's pertinent medical history were not reported. On an unknown date, the patient was vaccinated with the first 0.5 ml dose of RECOMBIVAX HB (route of administration, lot number and expiration date were not reported). A month later, on an unknown date, the patient was vaccinated with the second 1.0 ml dose of RECOMBIVAX HB. Concomitant therapies were not reported. No adverse effect were reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Information has been reported in a CDC slide titled as "Safety of PNEUMOVAX 23 in the Vaccine Adverse Reporting System (VAERS)". This spontaneous prospective pregnancy report as received from a registered nurse (RN) in Centers for Disease Control and Prevention (CDC) concerning a female patient of unknown age, 6 of the six patients who experienced cellulitis. On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) was not known. On an unknown date the patient was administered with a dose of PNEUMOVAX 23 (lot#, dose and route were unspecified) during pregnancy. On an unknown date the patient experienced cellulitis. The outcome of cellulitis was unknown. The pregnancy outcome was unknown. This is one of the 18 reports (PNEUMOVAX 23 administered during pregnancy) that received from the same source. Additional information has been requested.
joint pain is remaining; This case was reported by a consumer and described the occurrence of joint pain in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of lymphadenopathy (1st dose was received on 21st July 2020 and the patient experienced lymphadenopathy (see case US2020AMR252432)).   On 30th September 2020, the patient received the 2nd dose of Shingrix. In 2020, less than 3 months after receiving Shingrix, the patient experienced joint pain. On an unknown date, the outcome of the joint pain was not recovered/not resolved.   It was unknown if the reporter considered the joint pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for himself. After vaccination, the patient experienced joint pain.  The patient clarified that he did experience joint pain and not muscle pain. It seemed to be getting better, but it had not resolved.  The joint pain was remaining; it had been going on for a couple of months before the date of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR252432:Same patient
Employee received Moderna booster vaccine (0.25 mL) 12/17/21 at 1010.  On 12/18/21 in the afternoon, employee experienced a "beet red" itching and burning rash involving the trunk of her body only, both front and back.  No vesicles, but states it felt like one congruent hive on her back.  States left arm injection site was red and swollen, the size of a baseball.  She took 50mg Benadryl po and went to bed.  Awoken with residual rash Sunday am, 12/19/21, but it resolved throughout day.  There is some residual redness at injection site today, see photo, but no rash apparent upon exam by Employee Health nurse 12/20/21 at 0830.
This is a spontaneous report from a contactable consumer or other non hcp. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19, Formulation: Solution for injection, Batch/Lot Number: unknown; Expiration Date: unknown) via an unspecified route of administration on an unspecified date as a SINGLE DOSE for COVID-19 immunization. The patient medical history was and concomitant medications were not reported. The patient experienced just chills for a little bit the night on an unspecified date. The outcome of the event was unknown. Information about lot/ batch number has been requested.
Narrative: COVID infection following COVID vaccine series 03 19, Pfizer,  dose #1 04/09, Pfizer, dose #2 11/26 CXR impression: No acute findings in the  chest 12/24 pt admit ED, cc: BODY ACHES, NASAL CONGESTION, dx:  VIRAL SYNDROME LOS: 1 day 12/24 SARS-COV-2 Variant Sequencing:  pending 12/24 COVID swab, result: detected 01/02 COVID swab, result: detected  01/04 COVID swab, result: detected 12/23 pt cc: chills, cough, fever, rhinorrhea  exposure: unknown 12/29 clinically resolved 01/07 COVID-19 MONITOR  PANEL: pending
Rash on lip; Rash on face, rash on left eye lids, rash on nose; Chills; High Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHEILITIS (Rash on lip), RASH (Rash on face, rash on left eye lids, rash on nose), CHILLS (Chills), PYREXIA (High Fever) and HEADACHE (Headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Herpes simplex.    On 06-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (High Fever) and HEADACHE (Headache). On 07-Feb-2021, the patient experienced CHEILITIS (Rash on lip) and RASH (Rash on face, rash on left eye lids, rash on nose). At the time of the report, CHEILITIS (Rash on lip), RASH (Rash on face, rash on left eye lids, rash on nose), CHILLS (Chills), PYREXIA (High Fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Feb-2021, Body temperature: high (High) High Fever.     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.
On 8/24/05 rash on upper body. 8/29/05 pimple like spots around injection spot, also some papules, vesicles, back of neck, scrotum, near g tube site, rubbing arm, 6 seizures during the night, 1 in office. Diastat given, seen in office but still in reactive state.
Incorrect diluent dosage. Instead of 1.8ml of sterile water, 0.9ml of sterile water was used to dilute Pfizer vaccine. 0.3 ml was given to 3 patients.
This spontaneous report was received from a registered pharmacist refers to a patient of unknown age and gender. On 09-OCT-2013 the patient was inadvertently vaccinated with ZOSTAVAX (lot # J002777, expiration date 07-JUN-2014) intramuscularly. No adverse effects reported. Additional information has been requested. Follow up information has been received from registered pharmacist concerning to a 69 year old female patient. None medical conditions, none current conditions or drug allergies and no illness at the time of vaccination. The patient had an historical drug of pneumonia vaccination. On 09-OCT-2013 AM, the patient was vaccinated with a first dose (also reported as previous doses 1) of ZOSTAVAX 0.65ml in the right deltoid area at 5/8 subcutaneous, lot # J002777, expiration date 07-JUN-2014. Diluent (unspecified) 0.7ml, lot#J004088 expiration date 31-AUG-2015 (also reported as 15-AUG-2013). Concomitant therapies included FLUVIRIN. In 2013, the patient experienced soreness. The pharmacist reported that the patient felt that the shot was given inappropriately; she said it should have been given under arm area, subcutaneous. The pharmacist said that she or he give it subcutaneous in the deltoid are with 5/8". The pharmacist massaged area well at referred to massaging deep in the muscle. She inferred this to get intramuscular shot, the patient said to the pharmacist that she or he gave her IM but the pharmacist did not. The pharmacist referred to massage as deep to help with soreness. The patient did not seek medical attention. The outcome of soreness was unknown. Additional information is not expected.
terrible itching on my neck, arms, hands (the inside is worse) legs and feet; muscle pain effects my entire left side in the manner of stiffing and pain; muscle pain effects my entire left side in the manner of stiffing and pain; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EN6203 and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 27Mar2021 08:45 (at the age of 34-year-old), as dose 2, single for COVID-19 immunisation in hospital. Medical history included PCOS (Polycystic ovarian syndrome), GERD (gastrooesophageal reflux disease), IBS (irritable bowel syndrome), asthma, depression, allergies to kiwi, pineapple, oranges, bananas, dogs, cats, and latex. Concomitant medications included multivitamins [vitamins NOS] and birth control pill. The patient previously took norco, dilaudid, zofran [ondansetron and acetaminophen and experienced allergy. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EM 9809 and expiry date not reported), via an unspecified route of administration, administered in Arm Left on 03Mar2021 (at the age of 34-year-old), as dose 1, single for COVID-19 immunisation in hospital and experienced extreme itching on neck. Patient had no other vaccines in four weeks. Patient had no COVID prior vaccinations. Patient was not tested for COVID post vaccination. On 27Mar2021, the patient received second dose of the Pfizer vaccine and since the second dose was administered, at 08:45 the patient had terrible itching on neck, arms, hands (the inside was worse), legs and feet. The muscle pain effects entire left side in the manner of stiffing and pain. The patient visited physician office on 29Mar2021 as the itching had become worse over the past few days and informed primary care doctor. The patient was treated with over-the-counter medication. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Dtap 12/07/99, developed raised reddened area at injection site the following day.  12/9/99, Injection site tender, and warm.  12/10/99, reddened area larger than on 12/9/99, but doing ok.  Pt was home from school today.
One day after receiving vaccines, mother notice that the child's "whole body shook" for 7-10 seconds, while being breast fed. Mother said his name, but said child didn't respond. His eyes were closed while shaking, He was ok after that incident. No other incidents have happened since then.
The event was: He got .25 mg for his first dose (5-31-22)instead of the .5mg. Stated he had a strong reaction. "laid up for a few days" Today (6-28-22) he got .5 mg as his true first dose. Called our health Department, they stated his first dose is invalid and we informed him that he would need to come back and get another .5 mg dose.
Panic/anxiety attack around 10-15 minutes following administration of the vaccine.  Patient asked for family member to come pick her up and cried a lot.  When family member couldn't pick her up she asked us to call 911.  She walked out with them, presumably transported.
On 5/22/07 rec'd vaccine. On 5/24/07 when at work and mixing cappuccino from powder (powder became aerosolized) Pt started with hives and SOB. Seen in ES and rec'd Benadryl. Pt told by allergist had "small allergy to nuts" of skin testing at cappuccino powder has nuts.
She has been dizzy and exhausted and it has lasted for about 7 weeks so far. She is also having headaches.
Minor pain at site of shot on arm right after shot.  Minor tongue swelling following night.  5 days following first shot, experienced sudden flash and onset of severe imbalance.  Went to bed 3/3/21 and experienced profuse sweating, dizziness, imbalance and nausea.  Slept for 30 hours,  Upon waking, symptoms continued, along with fatigue and loss of appetite for additional 2 days.  About 10 days after first shot, nausea disappeared and appetite returned, with gradual improvement in other symptoms.  Continued experiencing mild fatigue, mental fogginess, dizziness and imbalance 6 weeks after first shot and 2 weeks after second shot, with these symptoms gradually improving and mostly gone as of date of this form.
Extreme fatigue; Dose 3 (Booster); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 17 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Dec2021 14:30 (Lot number: FE3594) at the age of 17 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ADVIL [IBUPROFEN]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 14Apr2021, when the patient was 16 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 24Mar2021, when the patient was 16 years old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 15Dec2021 07:00, outcome "recovering", described as "Extreme fatigue"; IMMUNISATION (non-serious) with onset 14Dec2021 14:30, outcome "unknown", described as "Dose 3 (Booster)". Therapeutic measures were not taken as a result of fatigue. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination: Advil. Reported event was extreme fatigue. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. Follow-up attempts are completed. No further information is expected.
Began to have hives on thighs, back, stomach the evening after vaccines. Started giving BENADRYL. Hives spread to trunk and face. Eyes swollen in morning 2 days after vaccines. Seen in office 8/13/10. Given Rx for Hydroxyzine 10mg/5ml 1 tsp Q6h PRN.
unable to eat; unable to stand; muscles are in pain; unable to smell; no appetite; diarrhea; cold chills; cold chills; fever; she has in bed since Thursday; tenderness on the site/soreness to her arm on the site; This is a spontaneous report from a contactable consumer (patient's daughter). A 71-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown) via unknown route of administration on 27Apr2021, dose 1, single (age at vaccination: 71 years) for Covid-19 immunisation. Relevant medical history was none. The concomitant medications were not reported. Consumer reported that her mother took the vaccine last Tuesday on 27Apr2021 and afterwards experienced soreness to her arm and tenderness on the site but she has in bed since Thursday on 29Apr2021. She has been sick with all the symptoms that they list. Adds she unable to eat, unable to stand, all of her muscles are in pain, she unable to smell; she has no appetite; she has diarrhea; cold chills and fevers. Consumer states she is trying to take care of her. Adds her mother was sore and tender at first but then on Thursday all the other symptoms started and they are getting worse. Adds Thursday her mother could not move and she is not getting better. Her mother was healthy before getting the shot. She is on no medications and has no health concerns. The outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
10-year-old female received 12 to 17 year old dose of Pfizer vaccine (0.3mL).
Patient was admitted to the ER with shortness of breath. She tested positive for COVID-19 on 9/02/21.
Shot administered at 310pm. Pt called at 515pm stating arm was in severe pain & she "could not lift it". She said the actual injection hurt her & didn't fell like a typical shot.
was 4°F warmer at the site of rash; cherry red rash; rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (was 4°F warmer at the site of rash), RASH ERYTHEMATOUS (cherry red rash) and VACCINATION SITE RASH (rash at the injection site) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE WARMTH (was 4°F warmer at the site of rash), RASH ERYTHEMATOUS (cherry red rash) and VACCINATION SITE RASH (rash at the injection site). On 05-Apr-2021, VACCINATION SITE WARMTH (was 4°F warmer at the site of rash), RASH ERYTHEMATOUS (cherry red rash) and VACCINATION SITE RASH (rash at the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment drug information was not given.
pt recv vax 26JAN94 & 8AUG96 pt devel parotiditis;lab eval indicated that pt had no mumps titer, low rubella titer & high rubeola titer;
Full body tremor started around 10pm and stopped around 10:40pm 4 days after vaccine date. Anxiety and low grade fever lasted for a week and a half. Body ache on lower back and legs as well as itching, rash, and swelling on the vaccine site started 7 days after the vaccine. The symptoms lasted about 5 days.
Itchiness and hives appeared first on my back the evening of the shot. Took Benadryl. Next day, itchiness was worse and all over. Hives on neck, back, stomach, legs, ears, scalp, and arms. Hives are hot to the touch. Taking benedyrl twice a day but hives keep appearing new places. Lips became swollen Tuesday evening, and began breaking out on my face Tuesday during the day.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were not reported. On 25-JAn-2016, the patient was vaccinated with an improperly stored PNEUMOVAX 23 10 PK, lot # L002310, expiration date 08-JUL-2016, at a dose of 0.5 ml, (route and anatomical location of administration were unspecified). The vaccine underwent a total temperature excursion, of 24 hours. The highest recorded temperature was 47 Fahrenheit degrees (8.33333333 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". No adverse effects were reported. No product quality complaint (PQC) as involved. This is one of several reports received from the same reporter. Additional information has been requested.