chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 01-FEB-2017 and on 02-FEB-2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX (lot number M032649 and expiration date 11-NOV-2018, dose and route were not reported) for prophylaxis. The temperature exposure was more than 8 Celsius degrees but less than 25 Celsius degrees for 2 hours and 23 minutes. There was not previous excursions or data logger involved. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested. This is one of the several reports received from the same source. Sender's Comments: US-009507513-1702USA001003:Original Case : 1702USA001003; US-009507513-1702USA003522:Original Case : 1702USA001003; US-009507513-1702USA003520:Original Case : 1702USA001003; US-009507513-1702USA003521:Original Case : 1702USA001003.
This spontaneous report was received from a medical assistant referring to 12 unspecified patients (age and gender unknown). No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified dates, the patients were vaccinated with improperly stored doses (incorrect product storage) of injectable VARIVAX (lot# M035140, expiration date 03-AUG-2018) (strength, dose, frequency, route of administration and anatomical location were not reported). The vaccine doses were exposed to a temperature excursion greater than 5 and less than 14 degrees Fahrenheit (also reported as ">-15 but <-10 degrees Celsius") for 1 hour and 40 minutes and 2 hours in two different time frames; digital data logger was involved. No adverse effects were reported. There was not product quality complain (PQC) reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA000959.
-Vaccine given 3 days beyond use-by date of 12/31/21 (in error). Thaw date 11/30/21. -Manufacturer contacted who recommending re-vaccination as no viability data available for the vaccine beyond 32 days from the thaw date. -Child's father informed who will bring child in for re-vaccination to Medical Center -New policies adopted at Medical Center to improve tracking of the vaccine's use-by date
On 2/28/01, post vax, a hard, raised lump appeared immediately on right leg; also noted a red area approx. 1/4 wide which appeared on left leg. Spoke to mom on 2/29/01 and child is afebrile and moving both legs WNL and "raised" areas remain with no redness or warmth.
febrile 101 per head thermometer 3 1/2hr post vax, irritability, vomiting, soreness, erythema to both legs;above sx resolved 5NOV97 2PM APAP was used for fever;no other tx;
No adverse event; Patient received expired dose of Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066K21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: J&J Vaccine (Dose number: 2LOT number:unknown), J&J Vaccine (Dose number : 1 and LOT number:unknown). Past adverse reactions to the above products included No adverse reaction with J&J Vaccine and J&J Vaccine.    On 26-Jul-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of Moderna COVID-19 vaccine).    No concomitant medications were reported.  It was reported that the vial had not undergone any temperature excursions.  No treatment medications were reported.
Mother of patient reported he received an MMR vaccine 12/04 in San Diego, CA.  For the next 4 months he continued to have spells of generalized rash associated with fever occurring every couple of weeks with complete resolution in between.  The problem was completely disappeared by about April 2005.
Narrative: Symptoms:  Diarrhea, NauseaVomiting, GastricBleeding & HYPERtension Treatment:  ONDANSETRON 4 MG PRN
She says that the only side effect was body aches for her daughter and a little headache; She says that the only side effect was body aches for her daughter and a little headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A 22 year-old 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: Bnt162b2 (Dose 1, Single), for COVID-19 immunization. The following information was reported: PAIN (non-serious), HEADACHE (non-serious), outcome "unknown" and all described as "She says that the only side effect was body aches for her daughter and a little headache". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021416620 same reporter/ product, different patient.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. In February 2016 (reported as starting on or after 14-FEB-2016), the patients were vaccinated with the improperly stored doses of VARIVAX (Merck) (lot # L032391, expiration date 28-AUG-2017; dose and route of administration were not reported). No adverse effects were reported. The vaccines were stored in -14 degrees of Celsius for 12 hours and 45 minutes and in -14 degrees of Celsius for 17 hours on unknown dates. This is one of several reports received from the same reporter. Additional information has been requested.
an allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of ALLERGY TO VACCINE (an allergic reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (an allergic reaction). At the time of the report, ALLERGY TO VACCINE (an allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   No treatment details were reported.   Reporter did not allow further contact
pt recv vax 26MAR97 & on 23DEC97 in the morning, pt devel chickenpox;had pimples on all extremities, abd & on back;approx 20 vesicular lesion w/erythematous borders;aveeno for itching;
throat closed up; she could not talk; severe allergic reaction; left ear was on fire; knees were red; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (throat closed up) and SPEECH DISORDER (she could not talk) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced THROAT TIGHTNESS (throat closed up) (seriousness criterion medically significant), SPEECH DISORDER (she could not talk) (seriousness criterion medically significant), HYPERSENSITIVITY (severe allergic reaction), EAR DISCOMFORT (left ear was on fire) and ERYTHEMA (knees were red). On 19-Feb-2021, THROAT TIGHTNESS (throat closed up), SPEECH DISORDER (she could not talk), HYPERSENSITIVITY (severe allergic reaction), EAR DISCOMFORT (left ear was on fire) and ERYTHEMA (knees were red) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I had a cough, chest congestion, sore throat, and runny nose. Previously in the month on 07DEC2022 I had had bronchitis and an upper respiratory infection. Then when I got COVID-19 the mucous and cough became worse. I went to the emergency room where they did a chest X-Ray which was normal. They also gave me a breathing treatment with albuterol. I was given PAXLOVID and after about 2 1/2 days I felt better. After about 5 days I tested negative for COVID-19.
DTaP left arm. Red/swollen 9cmx9cm. Benadryl and Tylenol.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 23-MAR-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
Pt began to feel faint in observation area after vaccine.  Transported via w/c to observation bay after brief loss of consciousness.  Mother present. BP 109/68, HR 58, RR 16 -- > 101/69, 64, 16.  Pt reports feeling much better.  Pt stable and released from the vaccination site.
Redness & swelling, warmth at injection site. Treatment: observation & BENADRYL.
Rash. ....Started different areas of my body. Stinging, burning. On my face, neck arms and back, also on my legs. Comes and goes. Constant for several months now.   Treated with cortisone creams and finally prednisone and hydroxyzineHCL itching is tolerable now but rash still appearing'
currently having a hard time getting around; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (currently having a hard time getting around) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (currently having a hard time getting around). At the time of the report, VACCINATION COMPLICATION (currently having a hard time getting around) outcome was unknown.            No concomitant medications reported by reporter. No treatment medications provided by the reporter.   Reporter did not allow further contact
extreme cold internally, head ache and tremors within 10 or 15 mins.  Sat for 20 more minutes, then walked to parking garage.  Breathing became labored as I walked the block to car - no one was around.  Pulled off mask and sat in car - it subsided in 15 minutes.   Body temp was 94.5 remainder of the day.  96.5 today.  Awoke nauseated, headache, left foot and hand pain and very sore left arm.  Nausea stopped about 3:00 pm, when body tremors started again.  Cold all day with no energy
Obvious redness, swelling, and warmth of affected area of left upper outer arm. Flinches from pain upon touch, rates pain at this time about 1-2. Area measures about 3.5"" x 3.5" round edges. Scabbed area of injection site. Antibiotics ordered 11-03-2016.
No AE reported; expired dose of MMR II; This spontaneous report was received from the office manager referring to a 5-year-old patient. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported     On 26-MAY-2021 , the patient was vaccinated with a expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) lot # S015427,expiry day 20-MAY-2021, 0.5 milliliter, intramuscular for prophylaxis; No other adverse event was reported.
Weakness; Fever; Chills; Headache; Sore arm; A spontaneous report was received from a healthcare professional concerning a couple of patients who received Moderna's COVID-19 Vaccine and experienced fever, chills, weakness, headache, and sore arm.  The patients' medical history was not provided. Concomitant product use was not provided by the reporter.  On 23 Dec 2020, prior to the onset of the symptoms, the patients received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date in Dec 2020, a couple of patients developed side effects such as fever, chills, weakness, headache, and sore arm. Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, fever, chills, weakness, headache, and sore arm were unknown.  The reporter assessed the events, fever, chills, weakness, headache, and sore arm, as related to study drug.; Reporter's Comments: This case concerns a subject, who experienced a non-serious expected event of pyrexia, chills, headache and injection site discomfort, and a non-serious unexpected event of asthenia. The event occurred approximately 1 day after the first dose of mRNA-1273 administration. A very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pain, swelling in right arm starting evening of vaccination continuing for 3 days. No hives or redness. Patient took BENADRYL and noticed improvement in swelling. Complete resolution in 3 days.
Significant heart palpitaions in otherwise healthy individual. (11 months postpartum). Symptoms persisted 5 days after vaccination.  Administration of the shot occurred in incorrect position, posterior area of arm muscle, leading to tigling and numbness in fingers and hand.
Vaccine expired 1/25/2020 and was administered 1/29/2020.
I have had wringing in my ears for about a year and when I got the vaccine about 2 or 3 days later my ringing became substantially worse. It used to be at about a 2 out of 10 but now it is like a 7 or 8 out of 10. My hearing has also become super sensitive. So sensitive to the point where talking with someone at medium volume hurts my ears.  So sensitive that daily things that used to be no problem are now unbearable loud.
Case number PHEH2011US07069 is an initial spontaneous report received from a pharmacist on 12 Oct 2011 with the follow up received from a nurse on 16 Nov 2011. This case refers to a 11-year-old male patient. He was vaccinated with MENVEO (batch number: A10058) at a dose of 0.5ml intramuscularly into his right deltoid on 10 Oct 2011. On the same day he was also vaccinated with BOOSTRIX (other manufacturer, batch number: AC528074AA) at a dose of 0.5ml intramuscularly. On 11 Oct 2011, he developed cellulitis at the injection site (6x8 inches area). He required treatment with steroids. The outcome of the event was reported as recovered. Follow up information received from a nurse on 16 Nov 2011: Updated patient details (previously reported as multiple patients), suspect vaccine, adverse event experienced by the patient, treatment received and the outcome.
nurse took a vial and the vial shattered in her hand having the vaccine to spill on the hand, no AE; nurse took a vial and the vial shattered in her hand having the vaccine to spill on the hand, no AE; Initial information received on 19-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 47 years old female patient who was exposed to the vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U6543AB,exp. Date: 23-Feb-2021 on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to accidental exposure to product and exposure via skin contact. It was reported that nurse took a vial from a carton and the vial shattered in her hand having the vaccine to spill on her hand.  At the time of reporting, 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 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.  List of documents held by sender: none.
Dizzy, it comes and goes, Feels dizzy when moves head; Sweating; Had incontrollable vomiting; felt nauseas; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy, it comes and goes, Feels dizzy when moves head), HYPERHIDROSIS (Sweating), VOMITING (Had incontrollable vomiting) and NAUSEA (felt nauseas) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack in 2007 and Surgery (for Heart attack) in 2007. Concurrent medical conditions included Anxiety and Pollen allergy. Concomitant products included CITALOPRAM, LISINOPRIL, ATORVASTATIN, CLONAZEPAM and METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET) for an unknown indication.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced DIZZINESS (Dizzy, it comes and goes, Feels dizzy when moves head), HYPERHIDROSIS (Sweating), VOMITING (Had incontrollable vomiting) and NAUSEA (felt nauseas). At the time of the report, DIZZINESS (Dizzy, it comes and goes, Feels dizzy when moves head), HYPERHIDROSIS (Sweating), VOMITING (Had incontrollable vomiting) and NAUSEA (felt nauseas) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Update event outcome in events tab., Sender's comment in analysis tab updated.
No adverse reaction was reported.  It was discovered on 6/1/2022 while checking inventory that Pediarix was documented as given, but Vaxelis was actually administered.  Baby received 2 doses of Hib in error. Mother/guardian of child was telephone on 6/1/2022, at number provided in patient's record, but message "not accepting calls" was received.  Her voice mail box was full, so no message was left.
Pt had an episode of rapid breathing starting 5 hours post vax. It lasted approx 30 minutes then he returned to normal breathing without any medical treatment. Later in the evening 3 hives appeared 1 on forehead, 1 on cheek and 1 on pts neck. They were gone by morning.
Fever, chills, night sweats, muscle aches, joint aches all started approximately 14 hours after the vaccine (2100, 1/17,2021) and continued for approximately 6 hours (0300). Joint and muscle aches and pains however continued for approximately 24 hours (until 2100, 1/18/2021). Treatment was acetaminophen 1000mg q6-8h with little to no relief of symptoms.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided. On 29-NOV-2018 the patient received improperly stored dose of PNEUMOVAX 23 (dose and route were unknown; lot # R022754, expiration date 12-JUL-2019)and ROTATEQ (dose, batch/lot number and expiration date were not provided)orally, both for prophylaxis(Product storage error). The administered doses experienced a temperature excursion ranged from 47 Fahrenheit to 77 Fahrenheit for 24 hours. No previous excursions were reported. The temperature excursions were not detected by a data logger. No adverse effects were reported.
Patient received expired pfizer, expiration date in fridge was 3/26/22, no adverse effects per patient.
12 or so hours after vaccine I began to feel like I had Covid again. Since then I?ve had a feeling of being flushed and my skin feels like it is hot to the touch. I have sporadic nite sweats. I?ve also had another variant of Covid recently that?s resulting in nightly night sweats