chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a patient was administered DIPTHERIA and TETANUS (DT) vaccine which was expired/No AE; patient was supposed to receive Adacel but received a DIPTHERIA and TETANUS (DT) standard dose accidently/No AE; Initial information was received on 11-Sep-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 27-years-old female patient who received a 0.5mL dose of an expired DIPHTHERIA-25/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE lot C5511AA, expiry date 30-Aug-20 via intramuscular route in the left deltoid for prophylactic vaccination on 04-Sep-2020 accidently instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Human papilloma virus (HPV) VACCINE for prophylactic vaccination on 04-Sep-2020.  It was case of an actual medication error due to wrong vaccine administered and expired vaccine used (latency seven days).  Nurse states the non-pregnant consumer was supposed to receive Adacel but received an expired  DIPHTHERIA TETANUS [DT] standard dose.  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.
This spontaneous report was received from a registered nurse (R.N.) refers to multiple unspecified number of patients of unspecified age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored RECOMBIVAX HB (Lot # J006027 and expiry date: 16-DEC-2015; lot # J014855 and expiry date: 16-APR-2016; lot # K007263 and expiry date: 09-JUN-2016) (dose, site and route of administration was not reported). No adverse effects were reported. The outcome of the reported events was unknown. No product quality complaint (PQC) was filed. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
DTaP, IPV, MMR, varicella given 3pm.  Immediate puffiness of eyes/face area with hives starting & c/o itching.  No resp distress noted.  BENADRYL 25mg IM given IM Lt arm.  Pt 40#.  Sent via ambulance to hospital.
14MAR92 body aches, fever, dec in appetite tx w/APAP; t104.4; 17MAR92 @ MD t101.3 fever, otherwise healthy; no rash; dx adverse rxn to MMR; DTP? Roseola?;
Hives and swelling, went to the school nurse and was given Benadryl and released from school.
bleeding or spotting per vagina; Cramps; extremely swollen lymph node in the groin; lack of sleep; joint pains; fever; Tender to touch; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (bleeding or spotting per vagina), MUSCLE SPASMS (Cramps), LYMPHADENOPATHY (extremely swollen lymph node in the groin), INSOMNIA (lack of sleep) and ARTHRALGIA (joint pains) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced VAGINAL HAEMORRHAGE (bleeding or spotting per vagina), MUSCLE SPASMS (Cramps), LYMPHADENOPATHY (extremely swollen lymph node in the groin), INSOMNIA (lack of sleep), ARTHRALGIA (joint pains), PYREXIA (fever) and PAIN OF SKIN (Tender to touch). At the time of the report, VAGINAL HAEMORRHAGE (bleeding or spotting per vagina), MUSCLE SPASMS (Cramps), LYMPHADENOPATHY (extremely swollen lymph node in the groin), INSOMNIA (lack of sleep), ARTHRALGIA (joint pains), PYREXIA (fever) and PAIN OF SKIN (Tender to touch) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable No Relevant concomitant medications was reported.  Treatment information included Excedrin medication.   This case was linked to US-MODERNATX, INC.-MOD-2021-104140 (E2B Linked Report). This case was linked to MOD-2021-104140 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-104140:For first dose
Upon arriving at the facility for a COVID booster clinic I was told that Pt needed her 2nd Moderna vaccine. There was only 1 shot documented in the facility's ER. Upon filling out the patient's card (the card could not be located when I started the clinic; it was brought to me towards the end of the clinic), I realized she had already received her 2nd dose on 08/24/2021. Because the patient does not qualify as immunocompromised, giving the 0.5ml of Moderna 2 months after her second shot was an error.
This spontaneous report was received from a medical assistant and refers to a currently 65 year old female patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. In APR-2017, the patient was vaccinated with a proper stored dose of PNEUMOVAX 23 lot umber reported as R048403 and expiration date 18-APR-2018 (dose and route were not reported) "recommended for her age". On an unknown date, the patient experienced swelling at the injection site, after two weeks she was recovered from the event. The causal relationship between the event and PNEUMOVAX 23 was not reported.
Severe Chills, body aches, insomnia, sore arm.  24 hours in duration.  No treatment.  No reaction to vaccines one and two and the first booster.
Information regarding PREVNAR was received from a healthcare professional regarding a healthcare professional who cut her finger as a result of the syringe breaking at the finger grip while administering the vaccine. The patient received a dose on an unspecified date. Relevant medical history was not provided. Concomitant medications were not reported. A healthcare professional cut her finger as a result of the syringe breaking at the finger grip while administering the vaccine. No additional information was available at the time of this report. The plant has reviewed all investigations associated with this batch from a manufacturing and techinical perspective and investigations were appropriately clsoed and addressed prior to batch release. No quality issues were identified in review of batch records, release test records or inspection of retained samples. Retained samples meet the product description and the product. No product was returned for examination.
Cellulitis (R) upper extremity. Lesions - lateral aspect of (R) upper arm warm and erythematous. Rednes of area approx 25 cm/mg/12-15 cm wide. No induration. No tenderness. Cephalexin 500 mgm caps QID (5 days) BENADRYL 25 mgm 1/2 q 6 hours PRN itch.
9/29/19 Back of upper left arm started feeling itchy off and on. Thought it was a mosquito bite. 10/1/19 Site felt like it was burning a little and slightly swollen. Noticed there was a red rash an inch below injection site.  The rash  got bigger over the next few days and 5 blisters appeared. One of the blisters was larger.  It felt like I was being pinched at that spot.  10/7/19 Rash is almost gone. The blisters are now just red spots. No itchiness. A little soreness to touch.
Before going to bed on 2/11/21 I noticed I had a red raised bump at the injection site that was tender. On the morning of 2/12/21, I awoke feeling achy and lethargic, almost like a hang-over from drinking. As I started to move around and do tasks for my morning I started to get an intense headache, fevers avg. 103+, and began napping intermittently from noon until 5 PM. I still felt achy, but didn?t take anything besides water and ate dark chocolate to help with my headache.  The redness on my arm continued to spread and ache. I went to bed at 9 PM mostly with body aches and my fevers remained consistently around 103. I woke hourly between midnight and 8 AM on 2/13 and around 3:30 AM I noticed my body aches had gone away. My fevers remained and my headache continued to intensify. When I got out of bed around 8 AM I tried to watch TV and cried when the volume turned on since the noise was too harsh for my head. I couldn?t do sounds the rest of the day and had intensifying headaches and neck pain throughout the day. I lost all color in my face and was able to move around but felt miserable. I tried eating my first meal since 2/11, chicken noodle soup and felt nauseous afterwards. I went to bed around 9 PM and slept in 3 hour increments drinking water and sips of Coke Zero each time I woke up. At 6:30 AM on 2/14 I was so fed up with feeling miserable I decided to take 3 Advil 200 mg liquid gels and slept soundly from 6:30 AM-11:30 AM. I awoke feeling refreshed and mostly better. I hadn?t been eating so I tried an orange and felt good enough to do work for a few hours until I felt neck pain and tension around my temples again around 2:30 PM. I took 2 Tylenol 500 mg gel caps and left my house for the first time since 2/11 around 5 PM. The outing went well, but around 9:30 I could Feel pain coming on again so I took 1 200 mg Advil and got ready for bed. The redness on my arm has grown rather large so I drew boarders around it to see if it continues to spread. It is still bright red and tender. I didn?t sleep very soundly but am still feeling intermittent headaches and have to keep up with my nsaid/ Tylenol pain relief to function.
Febrile illness 3-6 days prior to onset of ataxia. Hepatitis A vaccine 2 days prior to onset of ataxia. Cerebellar ataxia with headache and vomiting 3/14/05. Decadron for 5 days. Improved about 3/19; ongoing. Able to ambulate independently 3.22 with minor ataxia. Follow up on 06/30/05: Please contact primary medical doctor. I have not reassessed.
Gave both FLUAD and PNEUMOVAX 23 in left arm muscle deltoid and it swelled and was red.
This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a adult male patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. The reporter considered the pain in arm to be possibly related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient was administered SHINGRIX on an unknown arm. The nurse reported that one of their patients received the SHINGRIX vaccine at a pharmacy and reported to the nurse that after he received the SHINGRIX vaccine, he experienced arm soreness that resolved in a couple of days. The reporter had limited information at the time of the call and stated that she might call back in to provide additional details.
warm vaccine area; Shoulder discomfort; a red blotch on arm near the vaccine area; I have also had pain in the corresponding wrist; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm vaccine area), MUSCULOSKELETAL DISCOMFORT (Shoulder discomfort), VACCINATION SITE ERYTHEMA (a red blotch on arm near the vaccine area) and ARTHRALGIA (I have also had pain in the corresponding wrist) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-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 VACCINATION SITE WARMTH (warm vaccine area), MUSCULOSKELETAL DISCOMFORT (Shoulder discomfort), VACCINATION SITE ERYTHEMA (a red blotch on arm near the vaccine area) and ARTHRALGIA (I have also had pain in the corresponding wrist). At the time of the report, VACCINATION SITE WARMTH (warm vaccine area), MUSCULOSKELETAL DISCOMFORT (Shoulder discomfort), VACCINATION SITE ERYTHEMA (a red blotch on arm near the vaccine area) and ARTHRALGIA (I have also had pain in the corresponding wrist) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Chills; Tiredness; Headache; Muscle pain; Fever; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received an unknown dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0172) via an unspecified route of administration in the left arm on an unknown date in 2021 (at the age of 62-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma from an unknown date. Concomitant medications included salbutamol (ALBUTEROL) and fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), both for unknown indications from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  On 12Apr2021, the patient underwent nasal swab test  and the result was negative. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Apr2021 at 15:45, the patient experienced chills, tiredness, headache, fever and muscle pain. The clinical outcome of the events of  chills, tiredness, headache, fever and muscle pain was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from an office manager/medical assistant refers to an unknown number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies were reported. Since 03-DEC-2014 doses of GARDASIL, which underwent supported temperature excursions, have been administered to unknown number of patients for vaccination (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). No adverse effects were reproted. No concomitant therapies were reported. This is one of several reports received from the same reproter. Additional information has been requested.
Pain and swelling in deltoid where vaccination was administered which began at 3 am (>12 hours after administration). Pain occurs with movement and extends down to elbow and forearm, around scapula. Patient also indicates slight numbing sensation in forearm.
9/9 - 4P - Muscle sore and tingling in upper arm where shot was administered;  9/10 - 2p - Tingling radiated over and down arm; thought it was neurology acting up; took Gabapentin but did not help. 9/10 - 9/14 - Blood pressure 171/101 - thought from IVIG treatment for CLL;  chills, sweats, achey, lethargy, lightheaded, went to bed.  9/14 - 9/21- Temp 100.-102  during night 4p to 4a ;  seemed better during day.  Didn't eat for three days.
pt was nervous about getting vax; p/vax pt walked out into main waiting room, sat down, & was observed to shake like having a sz; shaking lasted approx 10sec or less; became tearful & upset, c/o pain @ inject site, dizziness, h/a;
A non-serious report of administration of expired FLUMIST was received from a health care professional concerning a 19-year-old male.  The patient's medical history and concomitant medications were not reported.  On 06-Oct-2008, the patient was given FLUMIST via nasal administration by an immunization health technician.  The vaccine was found to be expired when a nurse in the same clinic noted that the lot # of the administered FLUMIST (expiration date 24-Mar-2008) was different from the lot # of the other supply of FLUMIST with expiration date of 25-Dec-2008.  The expired lot of FLUMIST was given to 17 adult individuals including this patient.  The reporter stated that prior to being informed by the immunization clinic, the expired lot of FLUMIST was already suspended for use by their office and that suspended lot is collected by a contracted company for disposal.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Additional information received on 07-Nov-2008:  Follow-up call to reporter revealed that no adverse events have occurred to date.
inner ear issues; Ringing of the ears; stuffiness; I feel I don't hear as well in my left ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Apr2021 09:30 (Lot number: ER8737) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Seasonal outdoor allergies" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; ALEVE. Vaccination history included: Bnt162b2 (product = COVID 19, brand = Pfizer,, lot number = ER8737,, lot unknown = False,, administration date = 02Apr2021,, administration time = 10:15 AM,, dose number = 1,, vaccine location = Left arm), administration date: 02Apr2021, when the patient was 55 years old, for Covid-19 Immunisation. The following information was reported: INNER EAR DISORDER (non-serious) with onset 24Apr2021, outcome "not recovered", described as "inner ear issues"; TINNITUS (non-serious) with onset 24Apr2021, outcome "not recovered", described as "Ringing of the ears"; EAR DISCOMFORT (non-serious) with onset 24Apr2021, outcome "not recovered", described as "stuffiness"; HYPOACUSIS (non-serious) with onset 24Apr2021, outcome "not recovered", described as "I feel I don't hear as well in my left ear". Therapeutic measures were not taken as a result of inner ear disorder, tinnitus, ear discomfort, hypoacusis. Additional information: Adverse event: Patient was on her 5th consistent day after vaccination with inner ear issues. Ringing of the ears, stuffiness. She felt she don't hear as well in her left ear. other vaccine same date details: other vaccine same date vaccine date: 23Apr2021. If other vaccine in four weeks: No. Other medications in two weeks: Rosuvstatin (cholesterol), Aleve. If Covid prior vaccination: No. If Covid tested post vaccination: No.   No follow-up attempts are possible. No further information is expected.
Headache, lethargy,fever, stuffy nose, sore throat, cough developed fourth day with chest tightness. Required doctor visit.  She Is still sick a week later. I believe the shot gave her covid and I hope it doesn?t turn into myocarditis or death
Injection Site Pain, Tiredness and Exhaustion (Slept a lot), Headache, Muscle Pain Later Chills 2nd Night ... Night Sweats
Client called office on 1/26/18 at 5:50 PM stating a few days after receiving flu vaccine she began to experience flu like symptoms along with a hot, tingly sensation down arm that radiated into shoulder and neck. Per client she took ibuprofen and saw her Doctor on 1/22/2018. Client was awaiting influenza test results done at PCP. Follow up call with client on 2/2/2018 - client states she wake up with a numb, tingly cold arm this morning but that has since gone away. Client states she had the worst headache of her life for 2 weeks and is now experiencing temple pain. Per client PCP diagnosed her with a sinus infection and her influenza test results were negative. Client inquiring about vaccine ingredient list along with common allergens to ingredients. Client referred to CDC website for information.
Vomiting and black diarrhea began evening of vaccination and continued for 2 days & chills but no temperature. Friday 4/29/11 "still feels sick", states "can't move" due to joints hurt and muscle ache. Was evaluated by Dr. Ordered LOMOTIL, PHENERGAN & encouraged fluids. Spoke to parent on Monday 5/2/11, patient is feeling well again.
On Sept. 7, 2004, I cut my hand and was advised by the health unit at work that, since it had been so long since my last tetanus shot, I should get one. So I received a TD booster. Immediately after the shot, there was some soreness in the arm that was injected, but I knew this was normal. Except for feeling run down, I didn't really notice anything else until Sept 30th. On that day, I was kneeling on the floor taking a photo and found that I could not get up. It was like my legs had just stopped working. While my husband lifted me up on one side, I pulled hard on a fence with my other hand and finally got to my feet. My legs felt wobbly and weak, but I dismissed it and thought I was coming down with the flu. About a week after the first incident, I tried running across the street and I almost pitched forward on my face because my legs would not move with me. At that point, I knew that there was a problem. I called the health unit that had given me the shot, but the nurse that answered the phone said she didn't know what I was talking about and had never heard of any side effects from the tetanus booster. So I decided to wait a while longer to see if the symptoms would subside.  They have not. Since receiving the shot, I have tried to go about my normal routine, but the muscles in my legs have grown stiff and weak. My legs ache constantly, especially when I am walking or trying to get up out of a chair. And walking up stairs has become almost impossible. The pain and weakness has also affected my neck, arms and shoulders. My hands shake, sometimes very badly, while at other times just slightly. I feel exhausted most of the time and sometimes I have a low grade fever or a headache.
Per hospital records- on 4/2/19 patient was found at home by mother unconscious in crib with cyanosis, then called EMS C/O apneic episode. Another hospital note states mother found patient "gasping for air" then she called 911. Once EMS arrived, CPR was performed. Patient was taken to ER, arrived in ER at 1949 for cardiac arrest. Per mother last PO intake was 1500 that day. Patient became apenic then was intubated and admitted to PICU. On 4/11/19 patient was transferred to main campus for ECMO.
Information has been received from a nurse practitioner concerning a 19 year old female who on 08-Jan-2009 was vaccinated with the first dose of GARDASIL lot number 661766 /0652X, 0.5ml, intramuscularly into the right deltoid. The patient also received her second dose of Hepatitis A virus vaccine. Other concomitant therapy included YAZ. It was reported that on 08-Jan-2009 in the evening, the patient developed numbness and tingling in her legs from the knees down. The patient stated to the nurse practitioner that the discomfort has gotten worse every day and when she laid down she developed numbness and discomfort starting at her sacrum and continuing down her legs. The nurse practitioner also mentioned that the patient was having difficulty urinating. The nurse practitioner reported that the patient had not sustained any injury. At the time of the report, the patient had not recovered. On 13-Jan-2008, the patient was seen in the office. Additional information has been requested.  3/3/09 Received vaccine record & GYN records of 1/8-1/13/2009. FINAL DX: none provided. Records reveal patent in good health on 1/8.  RTC 1/13 w/dysuria & hesitancy x 3 days and legs tingling/numbness since 1/8.  Referred to PCP.  Calls to patient after 1/13 not returned.  3/24/09 Received additional GYN records of 2/26/09. Patient returned to clinic for hormon implantation birth control.