chrisvoncsefalvay/vaers-outcomes huggingface dataset:
an 11 years old  patient who received a dose of Adacel and Menactra which had a temperature excursion below zero/No AE; Initial information received and additional information received on 10-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer (office staff).  This case is linked to cases 2019SA255155, 2019SA255195 and 2019SA254282 (same reporter).  This case involves a 11 years old male patient who received a 0.5 ml first dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6214AA, expiry date: 14-Mar-2021 via intramuscular route in the left arm on 12-Jul-2019 and 0.5 ml first dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot U6365AA, expiry date: 24-Sep-2020 via intramuscular route in the right arm on 12-Jul-2019 which had a temperature excursion.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage.  At the time of reporting, adverse event was not reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Red, swollen, "bumpy", warm area where vaccines given, 10x6 cm splotchy erythema on (L) thigh with 2cm area of bruising without induration no difficulty using legs.
chills; achy joints; This is a spontaneous report from a contactable consumer reporting for himself. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chills and achy joints on Dec2020 with outcome of recovering. Patient was still experiencing the symptoms but was feeling better. The patient wanted to know how long symptoms typically last after vaccination.  Information about Lot/batch no has been requested.
Starting at about 10:30 PM I had severe full body muscle contractions from my jaw down my legs.  My husband described it as "bouncing all over the bed".  After 2 hours I took two Tylenol PM tablets and symptoms subsided about 20 minutes after taking the pills.  The following day I had severe head and body aches (I assume from eh muscle spasms)
Weakness, facial swelling, chest tightness Narrative: Facial swelling resolved after taking diphenhydramine.
Dose administered after more than 30 days in refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 30 days in refrigerator) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 30 days in refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 30 days in refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not reported.  Treatment information was not reported.   This case was linked to MOD-2021-267672 (Patient Link).
covid booster; sore arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administration date 04Oct2021 (Batch/Lot number: unknown) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU taken for immunisation. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer: Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 04Oct2021, outcome "unknown", described as "covid booster"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm".  Additional information: The event lasted for an about 4 days. It was reported that She was calling regarding a possible side effect from the covid booster. Her and her mother also had a flu shot at the same time. The caller is 75 years old and she is a retired RN. This is the report for the caller herself. Reports at the beginning they both had sore arms and that was not a big deal, lasted about 4 days. She is not worried about herself and declined to complete a report. Unable to clarify details provided or gather additional information.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Case PHEH2016US024662 is an initial spontaneous report received from medical assistant on 22 Sep 2016. This report refers to the unknown demographics patient. Past medical history and concomitant medication was not reported. The patient was vaccinated with expired FLUVIRIN (batch number: not reported, expiry date: Jun 2016) at a dose of 0.5 ml single dose intramuscular on 19 Sep 2016. No adverse event was reported following this medication error.
Reason for Admission: stone and UTI.  Brief Summary of Hospital Stay: (Include Significant Findings and Invasive Procedures) was admitted for hydration and antibiotics due to strongly recurrent UTI in setting of urolithiasis and need for remove all stone debris.  She underwent removal of residual stone debris  Hospital Course: No notes on file uncomplicated  Issues Requiring Follow Up: (Who, what, when, and how communicated?) stent removal and stone analysis.
11:24AM Patient complained of dizziness. Blood pressure 121/56 and HR of 68. Discharged patient  at 12:45PM with  no  dizziness. -As described on Post Vaccination observation sheet.
Information has been received from a nurse concerning her 11 year old daughter who on unspecified dates was vaccinated with the first and second doses of GARDASIL.  The patient developed an injection site reaction after the second dose of GARDASIL.  The patient reported pain at the injection site and swelling at the site and down the arm.  Ice was applied and the next morning the patient awoke with body aches and the injection site had the appearance of an inverted nipple.  Medical attention was sought in the office.  Patient outcome was recovered.  At time of reporting the patient had not received the third dose of the vaccine.  No product quality complaint was involved.  Additional information has been requested.
arm soreness starting seven or eight hours after injection; Pregnant at the time of vaccination?: Yes; Pregnant at the time of vaccination?: Yes; Pregnant at the time of vaccination?: Yes; This is a spontaneous report from a contactable consumer (patient). This consume reported information for both mother and fetus/baby. This is a mother report. A 39-year-old female patient received bnt162b2 (lot number: EJ1685), intramuscularly at left arm, on 22Dec2020 11:00 at single dose for COVID-19 immunization. Medical history included asthma, migraines from an unknown date. The patient is pregnant at the time of vaccination. The patient date of LMP is 09Oct2020. The mother was 10 weeks pregnant at the onset of the event. The mother was due to deliver on 16Jul2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). The patient experienced arm soreness starting seven or eight hours after injection on 22Dec2020 21:00. The event was reported as non-serious. No treatment received. The outcome of the event was recovering.
It first started with flu like symptoms. That lasted through the weekend and seemed to go away. Over the past 3 months, it has felt like my hormones have been up and down, a period for about 1 1/2 months, migraines (which I haven't had in the past), extreme, sharp pelvic pain, constipation, and lethargy. My doctors have done hormone testing, ultrasounds, exams and all they have concluded (or could for lack of information) is that I must have endometriosis. I tried progesterone for a week and had extremely unfavorable issues, very heavy flow, menstrual pain......and now I feel better. It feels like the effects of the shot are literally wearing off in my body. I've started to feel like myself again. No pelvic pain, no body aches. It's like the shot ran its course. Worse 3 months of my life! I had to stop allergy shots due to them making me extremely ill all the time. Now I'm fine and just continue with Zyrtec. I've been told it might have to do with my redhead gene, but I don't have all he answers for that. I know certain pain meds, like morphine, don't even effect me.
Pt experienced redness, induration, soreness and warmth at site of the injection. Had a fever of 102F and was given Tylenol and didn't decrease with one dose. Given 800mg Motrin and reduced fever to 101F on 12/18/00. Had nausea, vomiting which subsided. Had aches, headache and slight itching.
The evening I received the seasonal Flu vaccine, I experienced the usual muscle aches and soreness at the injection site. Then around 10pm I started experiencing nausea which went from unpleasant to severe in minutes. Around 12am the nausea became so bad I vomited several times. This continued all night with me getting up every 45mins to an hour to vomit. As a result of not being able to keep fluids down, I became dehydrated and experienced chills and shaking. The nausea finally subsided around 10am but I still had to stay in bed all day because I was so weak and had to miss a day of work.
After 1st Dose: Extreme fatigue, shortness of breath, extreme anxiety, anxiety attack, palpitations, heart pounding, heart flutter, extreme sweating, severe chest pains, insomnia, fainting upon standing, dizziness, blurred vision, nausea, vomiting, lasting for 8-10 weeks. After 2nd Dose: Peripheral Neuropathy,
he still got Covid; he still got Covid; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 74-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetic" (unspecified if ongoing); "high stress" (unspecified if ongoing); "cortisol being high" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "he still got Covid". The patient underwent the following laboratory tests and procedures: Blood cortisol: High; Blood glucose: High; Oxygen saturation: 94 %; SARS-CoV-2 antibody test: greater than 250; SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 17Sep2023.  Clinical course: He developed general muscle ache, weakness and sore throat. When he took a test it was so black line which means that he has a high viral load. He has a CGM (continuous glucose monitor) and insulin pump, and even though he's not really eating anything, due to the high stress and cortisol being high, his blood sugar is high.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccines BNT162B2 in this patient cannot be completely excluded.
Same day post vax, the pt developed pain in right arm pit radiating through to right breast. Later that night, the pt developed pain at the injection site as well. On 10/13, the pt developed a fever of 103, body aches, pain at site, and red patch at injection site, and weakness. Pt seen by physician and treated with prednisone and antibiotics. 11/3/00 client states she has not had any further treatment. Dr. visits, etc. since 10/13 and 16/16 visits. States R delt has 1 1/2" knot and still a "little" tender.
pain on both arms; Warm on both arms, thorax and abdomen warm; 38 C of fever; Chills; Muscular pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on both arms), FEELING HOT (Warm on both arms, thorax and abdomen warm), PYREXIA (38 C of fever), CHILLS (Chills) and MYALGIA (Muscular pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (fatigue, hair loose, join and muscular pain, diarrhea intermittent) in March 2020. Concurrent medical conditions included Asthma. Concomitant products included MULTIVITAMINS [VITAMINS NOS] and STEROIDS for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain on both arms), FEELING HOT (Warm on both arms, thorax and abdomen warm), PYREXIA (38 C of fever), CHILLS (Chills), MYALGIA (Muscular pain) and ARTHRALGIA (Joint pain). The patient was treated with CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) for Adverse event, at a dose of UNK dosage form. On 05-Feb-2021, PAIN IN EXTREMITY (pain on both arms), CHILLS (Chills), MYALGIA (Muscular pain) and ARTHRALGIA (Joint pain) outcome was unknown and FEELING HOT (Warm on both arms, thorax and abdomen warm) and PYREXIA (38 C of fever) had resolved. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Body temperature: 38 (High) 38°C  fever.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-006536 (Patient Link).
The patient was given a booster dose (0.25 mL Moderna) as a third dose rather than an additional dose (0.5 mL Moderna). The patient did not report any adverse reactions, but stated that her oncologist recommended that she receive an additional dose as that was what should have been administered due to her health conditions/being severely immunocompromised.
p/vax pt exp pain at inj site; then severe pain lt arm; dec rom lt shoulder;
pt recvd vax & s/s of reaction on 22MAR93 started w/lt upper arm swelling, warm to touch, chills & fever starting on 18MAR93; AM following vax 17MAR93AM;
First started having runny nose and sneezing on 02/10/2012. On 02/11/2012 had temp of 100.2. On 02/14/2012 had hives all over body. Took her to doctors and was told to give her Benadryl for reaction. Patient received flu vaccine and Prevnar on 02/08/2012 and had reaction to flu vaccine.
10 days after my 1st shot I started having a period and I'm Menopausal I haven't had a period in 18 years. Called my PCP he had me schedule a pap  with Dr for May 18, 2021 pap was normal, Dr scheduled me for a Vaginal Ultrasound  May 20, 2021 and it showed abnormal thickening of the endometrium with internal heterogeneous echogenic foci and cystic appearing components. The findings are nonspecific and my reflect endometrial hyperplasia. Dr scheduled me for an Endometrial Biopsy May 27, 2021 and it also was normal. I was referred to and OBGYN and I saw Dr on August 10, 2021 and I'm scheduled for surgery September 7, 2021, they go in vaginally with a camera and light and do a D&C an this is an outpatient procedure at Hospital.  I have since seeing Dr had ANOTHER Period lasting 6 days it started August 11, 2021 and I also came down with what they thought was Covid on August 11, 2021 but Covid test on August 13, 2021 was negative
Intussusception 6 d after rotavirus, Hep B, IPV, DTaP, Hib, PCV13. Surgical intervention required.
soreness in right armpit that intensified and radiated into the breast, down the ribs, and deep in the armpit. It specifically felt like it was coming from a knot -- I assume a swollen lymph node reacting. It decreased intensity after 2 days and went away after 4 days. I did not seek care for it, but wanted to report it as it was different than what I had heard were common side effects. I just received the Pfizer booster and had the same tenderness in the armpit, but much less severe.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies of medical history provided. On 17-MAY-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot# L033693, expiration date 31-MAY-2017, dose was not reported, orally). No adverse events were reported and there was no previous temperature excursion. The data logger was involved. Temperature was 21.1 degrees Fahrenheit for 2 hours and 5 minutes, 33.4 degrees Fahrenheit for 6 hours and 5 minutes and 31 degrees Fahrenheit for 3 hours and 30 minutes. This is one of several reports received from the same reporter. Additional information has been requested.
Rash on arms, legs, face, trunk - consistent with hives- given antihistamines,  developed within 24 hours of 2nd dose
At 9 month well visit, patient was given an extra dose of HIB and PCv13 vaccine. That afternoon, he began vomiting. The next morning, vomiting con't and explosive diarrhea began. By the afternoon, he was refusing solids and liquids and had dropped 1 lb in body weight. Was admitted into the hospital for dehydration on 08/06/2010 approx. 09:30 PM. He remained in the hospital until 8/11/10.
No patients experienced symptoms.; Impropertly stored doses of varivax were administered; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 02-JUN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck)(VARIVAX), subcutaneous (dose and frequency were not provided; Lot number reported as S032357 has been verified to be valid; expiration date reported and validated as 14-OCT-2021) for prophylaxis. The vaccine was reconstituted using a properly stored sterile diluent (MERCK STERILE DILUENT).  The vaccine underwent a temperature excursion of -17.2 Fahrenheit for a period of 14 hours and 2 minutes. The vaccine did not underwent a previous temperature excursion. The excursion was called by a digital data logger. The nurse reported that the patient did not experience any adverse event.  This is one of several reports received from the same source; Sender's Comments:  US-009507513-2006USA001641: US-009507513-2006USA001819: US-009507513-2006USA001817: US-009507513-2006USA001816: US-009507513-2006USA001818:
First pregnancy, vaccinated at 26 weeks. Estimate Delivery Date is November 15th. Experiencing tingling in the right arm, and extreme nerve pain in the left leg, hip, buttox, ankle, and foot. The pain began today around 24 hours after the vaccine and got progressively worse but did not experience this prior to the vaccine. It hurts to stand or walk and feels like a stabbing pain and like my left leg and skin is on fire.
Patient with history of 2 COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "78 year old male with a history of cerebral amyloid angiopathy complicated by two intracranial hemorrhage events, CAD, hyperlipidemia, and hypertension who presented to Facility on 12/29/22 with facial droop and gait instability. Upon arrival to the hospital he was noted to be febrile and tachycardic. He did test positive for COVID-19. Stroke work-up was quickly initiated. Initial CT did not demonstrate any acute intracranial hemorrhage and follow-up MRI was positive for only chronic findings. Remainder of work-up was unremarkable. It is hypothesized that the presenting symptoms were more related to the acute viral illness compared to an acute intracranial abnormality. He was monitored for a couple days, and by the time of discharge he was at his physical and mental baseline according to family.    He was noted to be in atrial fibrillation on arrival to the hospital and periodically had a rapid ventricular rate. Unable to anticoagulate due to prior brain bleeds, he will be sent home with metoprolol for rate control.  "
This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (pulsating tinnitus, stating she can hear her pulse in her head), CHILLS (having chills) and HEADACHE (headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 16-Feb-2021, the patient experienced TINNITUS (pulsating tinnitus, stating she can hear her pulse in her head) and CHILLS (having chills). On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with Tylenol at an unspecified dose and frequency. At the time of the report, TINNITUS (pulsating tinnitus, stating she can hear her pulse in her head), CHILLS (having chills) and HEADACHE (headache) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication include colonoscopy prep.  Action taken with mRNA-1273 in response to the event was not applicable.
Non Stop crying, seems to be in pain, lethargic, decreased appetite, refusing to walk.
Nasal drainage, body aches (days later), right sided throat pain 2-3 days later, which resolved.  Short of breath with activity. Now feeling fatigued. Ongoing dypsnea.
This spontaneous report as received from a Licensed Nurse Practitioner refers to a patient of unknown gender and unknown age. On 21-MAY-2014, the patient was vaccinated with a dose of VARIVAX, subcutaneous (lot/batch number, expiration date, strength, dose number and indication not reported). It was reported that the patient received VARIVAX in error. No known adverse effects were reported. Additional information has been requested.