chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna vial was punctured 21 times instead of 20 and a patient got the 21st dose.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Moderna vial was punctured 21 times instead of 20 and a patient got the 21st dose.) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 012M20A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Moderna vial was punctured 21 times instead of 20 and a patient got the 21st dose.). On 08-Dec-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (Moderna vial was punctured 21 times instead of 20 and a patient got the 21st dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient had no reaction during the 15 minutes they remained ate the facility.  No concomitant medications were reported. No treatment medications were reported.
Caller reported a temperature excursion in which PROQUAD was administered to patient(s); No additional AE.; This spontaneous report as received from a physician refers to unspecified number of patients of unknown age and gender.  The patients' concurrent conditions, medical history and concomitant medications were not provided.      On an unknown date, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccines live(PROQUAD) lot # T016990 with expiration date of 11-NOV-2021, 1 (units not provided) dose/frequency, for prophylaxis (route of administration was not provided). The vaccines were exposed to temperature of 14°F to 46°F (41°F) for 30 minutes. The vaccines had previous temperature excursion of 14°F to 46°F (22F) for 3 hour 30 minutes 0 seconds. This was called because of a data logger. Caller unable to provided any further details. No additional AE. No PQC.
Redness, swelling and warmth at injection site. Low grade fever and axillary lymphadenopathy within 24 hrs of vaccine & continued x 1 wk treated with po prednisone & naproxen.
pentacel was administered to a patient after the expiration date, with no reported adverse event; Initial information received on 01-Feb-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an unknown age and gender patient and it was reported that Diphtheria, tetanus, AC pertussis, IPV AND HIB vaccine [Pentacel] (VERO) was administered to a patient after the expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On 01-Feb-2023, the patient received an unknown dose of suspect Diphtheria, tetanus, AC pertussis, IPV AND HIB vaccine (lot UJ640AAA, Expiry date: 28-Jan-2023) (with unknown formulation, strength, route and at unknown administration site) for immunization.  On 01-Feb-2023, reporter reported that pentacel was administered to a patient after the expiration date, with no reported adverse event (expired product administered) (latency: same day).  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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.
C/O chest tightness, pain in both feet, pain (cramping in calves( visual disturbances, weakness, headache, heavy feeling in his chest, pain in 1+ knee, back pain.
Same day symptoms -General Health "not feeling well" malaise; sick to stomach; bright RED rash >face, neck & chest 48 hours post vaccination; elevated temperature (not measured/no oral thermometer; has taken Ibuprofen 200mg 4 doses no effect; worried about TV report that males are experiencing heart attack & related cardiac events.
This non-serious initial spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult, male patient of unspecified age. This refers to 14 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in a cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Took tylenol before vaccination, has swollen lymph nodes supra clavicular, no pain at the site. This has happened with previous vaccinations.
The next day after the second vaccine, developed extreme fatigue and body aches, lasting 5 days.
Pain at injection site, tingling on left side of face, slight feeling of left lip swelling (but didn't swell). On 4.16.21 sore left arm, entire body fatigued.
Swelling (very hard), red upper arm around injection site (from elbow to shoulder) uncomfortable, but not painful or itchy, swelling and redness lasted at least 96 hrs.
Breakthrough case admission after 4 vaccines  Pfizer 3/1/2 Lot# EN6207;  Pfizer 4/1/21 Lot# ER8737;  Pfizer 11/1/21 Lot# FD0809;  Pfizer 5/19/22 Lot# FK9893
marked swelling and redness at injection site, quite warm, extending ~ 4 cm. centered around L arm upper area, at site of varivax
On 7/19/21 Patient went to urgent care for an unrelieved nagging cough with congestion. He was diagnosed with bronchitis prior. He was then tested for Covid-19, results-Positive. Patient received vaccinations for Pfizer on 1/14/21 first dose and 2/4/21 second dose. At that time he lived at assisted living with his wife who passed away from Covid-19 infection in the memory care unit. According to Patient's family, he tested positive for Covid-19 in November 2020 and December 2020. Here's a time line I put together below. November 2020-Positive Covid test December 2020-Positive Covid test 1/14/21-First Dose Pfizer 2/4/21-Second Dose Pfizer July, 19 2021-Positive Covid test. Was diagnosed with Bronchitis within the same month
Low grade fever; chills; muscle aches; soreness in arm of injection site; fatigue; headache; Dose number: 3; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 31Dec2021 09:00 (Lot number: 33130BA) at the age of 28 years as dose 3 (booster) , single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0170, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 01May2021, when the patient was 27 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0151, Location of injection: Arm Right), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 31Dec2021 09:00, outcome "unknown", described as "Dose number: 3"; PYREXIA (non-serious) with onset 31Dec2021 22:30, outcome "recovered", described as "Low grade fever"; CHILLS (non-serious) with onset 31Dec2021 22:30, outcome "recovered", described as "chills"; MYALGIA (non-serious) with onset 31Dec2021 22:30, outcome "recovered", described as "muscle aches"; VACCINATION SITE PAIN (non-serious) with onset 31Dec2021 22:30, outcome "recovered", described as "soreness in arm of injection site"; FATIGUE (non-serious) with onset 31Dec2021 22:30, outcome "recovered", described as "fatigue"; HEADACHE (non-serious) with onset 31Dec2021 22:30, outcome "recovered", described as "headache". Therapeutic measures were not taken as a result of pyrexia, chills, myalgia, vaccination site pain, fatigue, headache. Additional information The patient was diagnosed with COVID-19 prior to vaccination.  The patient had not been tested for COVID-19 since the vaccination.   No follow-up attempts are possible. No further information is expected.
INFLAMMATION that lead to the following DIAGNOSES: Diastolic Dysfunction, Parotitis, Cardiac Sarcoidosis, Pulmonary Inflammation,  SYMPTONS: Dizziness, faster heart rate, chest discomfort, pulse visible in neck, fluid overload, swelling in ankles/legs/feet, nasal congestion, pains (especially upper torso, mid back and neck TREATMENT: Mycophenolate 1000 mg 2/day, Metoprolol, Lasix OUTCOME(S): To be determined.  PET Scan will be repeated in six month. Regular monitoring ongoing.
Patient was in the act of receiving seven vaccines when he fainted. He was supported to the floor where he quickly recovered. After the fact, he revealed that he had not eaten that day.
PROQUAD underwent a temperature excursion and was administered; This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. On 11-JUN-2021, the patient was vaccinated with a dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # T036562 exp date 26-APR-2022) rHA (dose and route not reported) that underwent a temperature excursion. Previous temperature of excursion was 6°F to 14°F (14F) for 2 hours, 14°F to 46°F (45.5F) 1 hour and 30 minutes and 6°F t o14°F (14.4F) for 2 hours.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2106USA006064: US-009507513-2106USA006458: US-009507513-2106USA006459: US-009507513-2106USA006460: US-009507513-2106USA006461: US-009507513-2106USA006462: US-009507513-2106USA006463: US-009507513-2106USA006464: US-009507513-2106USA006465: US-009507513-2106USA006466: US-009507513-2106USA006467: US-009507513-2106USA006468: US-009507513-2106USA006469: US-009507513-2106USA006470: US-009507513-2106USA006471: US-009507513-2106USA006472: US-009507513-2106USA006473: US-009507513-2106USA006474: US-009507513-2106USA006475: US-009507513-2106USA006476: US-009507513-2106USA006477: US-009507513-2106USA006478: US-009507513-2106USA006479: US-009507513-2106USA006480: US-009507513-2106USA006481: US-009507513-2106USA006482: US-009507513-2106USA006483: US-009507513-2106USA006484: US-009507513-2106USA006485: US-009507513-2106USA006486: US-009507513-2106USA006488: US-009507513-2106USA006489: US-009507513-2106USA006490: US-009507513-2106USA006491: US-009507513-2106USA006492: US-009507513-2106USA006493: US-009507513-2106USA006494: US-009507513-2106USA006495: US-009507513-2106USA006496: US-009507513-2106USA006497: US-009507513-2106USA006498:
Patient wasn't feeling well after the shot.  He said he had a couple episode where he spaced out.  He mentioned afterwards that he doesn't do well with immunization shots. He was sweating and seemed dehydrated.  We gave him water and to monitor.  Fire dept came and asked if he requires urgent care and he said no.  He felt better afterwards.
W/in 6 hrs p/HIB/DTP/OPV, pt exp urticaria @ inject site which later devel into generalized urticaria; also had fever 100.6; recovered; @ 6mos pt was referred to allergist; scratch testing for DTP/OPV was neg;
Information has been received from a pharmacist concerning a 62 year old female with no known allergies and a history of shingles who on 16-JUN-2006 was vaccinated SC with a dose of varicella-zoster virus vaccine live.  There was no concomitant medication.  On 18-JUN-2006, two days after vaccination, the patient developed a swollen tongue.  The patient reported that when she woke up in the morning her tongue was swollen and she even had teeth impression on her tongue.  The patient was scheduled to see her doctor on 28-JUN-2006 since she was still experiencing the problem.  She had no problems breathing and eating.  As of 28-JUN-2006, it was reported that the patient was recovering.  No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/10/2006. Additional information from the pharmacist indicated that the patient's condition has resolved and the patient is fine. The physician's office called the pharmacist to report that the patient's swollen tongue was not due to ZOSTAVAX (Oka/Merck) but due to the patient's new toothpaste. No further information is available.
Complained of fever of 103-104 degrees, had chills, generalized body aching, headache, nausea for 24-36 hours after onset of body aches and chills, auditory hallucinations. Took EXCEDRIN for headache and Ibuprofen for aches and pains.
He has stayed in bed most of the time since yesterday at 2 pm; Very little appetite; Fever (99.5-100.5); Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (He has stayed in bed most of the time since yesterday at 2 pm), DECREASED APPETITE (Very little appetite), PYREXIA (Fever (99.5-100.5)) and MYALGIA (Muscle ache) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042120A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION COMPLICATION (He has stayed in bed most of the time since yesterday at 2 pm), DECREASED APPETITE (Very little appetite), PYREXIA (Fever (99.5-100.5)) and MYALGIA (Muscle ache). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of UNK dosage form. At the time of the report, VACCINATION COMPLICATION (He has stayed in bed most of the time since yesterday at 2 pm), DECREASED APPETITE (Very little appetite), PYREXIA (Fever (99.5-100.5)) and MYALGIA (Muscle ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Body temperature: 99.5-100.5 (High) 99.5-100.5. On 24-Feb-2021, Body temperature: 99.5 (High) in the morning.         Concomitant medication was not included.  The patient took Tylenol which helped a little bit but it was not a game changer.
I have previously reported pain in my right finger after obtaining the vaccine.  I have also started having sharp pains in the middle of my chest. It first started last week when I was bending over to empty the washing machine, I bent over 3 times and each time I had a sharp pain in my chest.    Earlier this week, I had the same pain in my chest when laying in bed on my side and my right finger began to hurt.   I have just done a few searches online and have found information regarding the vaccine and rheumatoid arthritis and how this can cause heart inflammation.
Patient with 2 doses of Moderna COVID vaccine, last dose 02/11/21, who admitted with COVID complications.  Provider d/c note:  "HPI: Pt presents to ER from home (lives alone). She has been cough for some time now, after she was exposed to her brother (admitted) with COVID. She has been having some fever, chills. She has been very weak and last night she collapsed while attempting to go to the restroom. She had a difficult time getting back up. No head injury. Cough has been dry. No CP. No V,N,D> no abdo pain. She has been vaccinated but has not had her booster due to memory issues from the initial vaccines. She has a son here but is not in touch with him and has 2 other children in Florida. She does not have any help at home. Attempts were made to ambulate her but she was weak.  She is on RA, CXR neg. Labs unremarkable.  She is being admitted under Obs, PT, OT eval. "
Tachycardia event the night of Feb. 27 Pulse rate of 200 beats per minute lasting approx 3 hours duration beginning at 11:30 pm accompanied by mild nausea and an overwhelming feeling of anxiety.  I was awakened from a sound sleep by this event.
Pt received second COVID vaccination at 11:01, pt observed for mandatory 15 minutes, after the observation period (around 30 mins after vaccination), pt c/o narrowing of airway, "lump" in throat, and tingling lips. Pt was assessed by physician and nurse. Pt compared her symptoms to her symptoms when she has shellfish (pt has active shellfish allergy). Due to pt sxs not improving, EMS was activated and epinephrine auto injection pen was administered (at 11:40). Vitals were obtained and WNL, pt was a&oX4, airway non-obstructed. EMS arrived to facility around 11:50 and transported pt to local ED. Pt returned to facility later in the day to schedule f/u appt from ED, pt stated sxs resolved prior to leaving ED and was feeling much better.
Congestion, fatigue, cough, these were all moderately severe and lasted for 3 days. I took PAXLOVID.
Information has been received from a pharmacist via company representative referring to a female patient of unknown age (a pharmacist). There was no medical history or concurrent condition reported) intramuscularly (incorrect route of drug administration). There was no concomitant mediation reported. The patient developed a severe unspecified rash around the injection site on an unspecified date in August 2015. The pharmacist stated that the rash from the injection site "had gone up to the patient's arm onto her chest". The patient told the pharmacist that it was not vesicular however it was red, swollen and painful. The patient also stated that she had a bad headache and had flu like symptoms on unspecified dates. At the time of the report, the outcome of the events was reported as not recovered.  Additional information has been requested.
a 49y.o. year old  female with a h/o HTN, SVT and breast cancer on chemotherapy (last administered 10/4) presented on 10/9 secondary to palpitations with lightheadedness.  She also admits to intermittent LLQ abd pain since Thur 10/7 with associated low grade fever to 100.2. She admits to nausea and decreased appetite which she relates to recent chemo. +chronic rhinorrhea. No sore throat, HA, shortness of breath, diarrhea, anosmia and change in taste. SVT to 227 on admission requiring adenosine. CTAP with short segment diverticulitis. No known sick contacts, however has had several recent urgent care visits within last 2 weeks.   Symptom onset 10/7 Tested positive: 10/9 Vaccinated with Pfizer 6/25/21, 7/16/21
Intense itching-especially of scalp-2:00 profuse diaphoresis-2:05; SOB 2:07; 2:10 shallow breathing, no radial pulse, declining LOC;
pt recv vax 23JAN97 & APR97 pt devel chickenpox consisting of greater than 50 lesions;pt recovered;
Patient recieved first dose of Pfizer vaccine in left arm. Patient fainted immediately after administration. Patient was hot to the touch and sweating. Brought patient water and placed cool compress on back of neck. Seat with patient as he recovered.
About a week after shot 1 I started to feel very fatigued and run down.  I was able to function but got tired easily.  On May15, I received shot 2 and my fatigue got worse.  I started to get tremors and shakes in my hands and arms.  Legs felt weak, its difficult to hold my arms up at times.  I felt hyper, yet weak.  Unable to stay asleep.  On June 6 I took a hot shower and barely made it out before collapsing.  I went to the emergency room .
The next morning after receiving the vaccine the injection site was red, swollen and painful to touch.  Today (three days after receiving the vaccine) woke up and the redness has spread to another spot on my arm and itches and still painful to touch.
had day 0 dose / missed day / 3 dose / came today for day 7 / This is for post exposure; This case was reported by a other health professional via licensee and described the occurrence of drug dose administration interval too long in a 35-year-old female patient who received Rabies NVS (RabAvert) (batch number ARBA651A, expiry date unknown) for prophylaxis.   Co-suspect products included rabies vaccine needle device (Rabavert Needle Device) injection needle for prophylaxis and rabies vaccine pre-filled syringe device (Rabavert Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included Rabies NVS (RabAvert).   On an unknown date, the patient received the 2nd dose of RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device. On an unknown date, unknown after receiving RabAvert, Rabavert Needle Device and Rabavert Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The patient received 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule. The pharmacy student verified that patient had day 0 dose and missed day number 3 dose and went for day 7.  The vaccination was for post exposure.
Headache, Arthralgia,  FATIGUE, CHILLS, PAIN INJ SITE Narrative:
Red ring around the injection measures 2 inches in diameter warm to touch and itchy began 6 days post injection. Treatment: steroid cream.  Outcome: Improving did not interfere with ADLs continue to work.
Information has been received from a pharmacist concerning a male who was hospitalized and had a splenectomy due to trauma in early April 2001. On April 07, 2001, he received the 1st dose of Pneumococcal vaccine 23 polyvalent, 2nd dose on an unspecified date before 05/04/01, the patient's oxygen saturation levels began to decrease and he was placed on a ventilator. Additional info has been requested. After the fourth dose, the pt developed a rash on his upper body and at the same time his oxygen saturation levels began to decrease. he was transferred to the intensive care unit and was placed on a ventilator. The pharmacist felt that it was unknown if the rash was associated with the excessive number of doses of pneumococcal vaccine as an overdose an allergic reaction or if it was coincidental that it occurred after the fourth dose. On 05/17/2001, th ept remained hospitalized and it was unknown if the pt was still on the ventilator. Additional info has been requested.