chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Knee arthritis; Injection site swelling; Knee pain; Fatigue; Fever; Injection site reaction; Knee injury; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE REACTION (Injection site reaction), JOINT INJURY (Knee injury), ARTHRITIS (Knee arthritis), INJECTION SITE SWELLING (Injection site swelling) and ARTHRALGIA (Knee pain) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ankylosing spondylitis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen,. In 2016, the patient experienced JOINT INJURY (Knee injury). On an unknown date, the patient experienced INJECTION SITE REACTION (Injection site reaction), ARTHRITIS (Knee arthritis), INJECTION SITE SWELLING (Injection site swelling), ARTHRALGIA (Knee pain), FATIGUE (Fatigue) and PYREXIA (Fever). At the time of the report, INJECTION SITE REACTION (Injection site reaction), ARTHRALGIA (Knee pain), FATIGUE (Fatigue) and PYREXIA (Fever) had resolved, JOINT INJURY (Knee injury) and ARTHRITIS (Knee arthritis) outcome was unknown and INJECTION SITE SWELLING (Injection site swelling) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: Elevated..         On unknown dates, the patient experienced fatigue, left knee arthritis, elevated cholesterol, fever, swelling at injection site and knee pain. In 2016, the patient experienced banging knee  with the door. on unknown dates, fatigue, fever and knee pain resolved. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: significant FU: updated events On 02-Mar-2022: Significant follow up appended: updated patient details, dose details and causality.
no additional AE; concomitant administration of PROQUAD and VARIVAX to a patient. Caller states patient was meant to receive MMRII and VARIVAX; This spontaneous report was received from a licensed practical nurse and refers to a 15-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 14-MAY-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, lot # S033952, expiration date 24-OCT-2021 and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml, lot # T013539, expiration date 17-OCT-2021 (dose number, vaccination site and route of administration were not provided for both) for prophylaxis, although the patient was meant to receive varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). No additional adverse events were reported.
Total body rash & swollen lips 7:00 AM 8/5/10 8:00 AM 8/5/10 Fingers swollen within 3 hrs.
The adverse effects were transmission of the shingles virus to my HUSBAND.  Two weeks after I receive the ZOSTAVAX vaccine my husband comes down with shingles.  We do not believe this was coincidence yet we were led to believe that the live virus would not be transmitted to another person.
Shoulder pain developed the day after the injection (similar to shot 1), however has not gone away.  It has now been 19 days post injection and shoulder pain appears not to be decreasing.
Attendee received first dose Pfizer vaccine at 11:31 in the left arm.  Lot# FK9896. Attendee was directed to observation area.   At 11:38 am - attendee was in observation sitting in a chair when he collapsed and fell from the chair to the ground and landed on his face.  .5 cm lac above left eyebrow and 1 cm lac on the bridge of the nose noted, both were moderately actively bleeding. Active acute severe nose bleed was occurring simultaneously. Attendee regained consciousness within <10 seconds and vomited clear fluid x 2. Attendee's skin was cool and clammy without pallor. Attendee's respirations were not tachypneic or dyspneic.  Attendee was not moved from his position on the floor.  Staff immediately went to work to stop the large amount of bleeding by applying pressure to stop the nose bleed.  Gauze with pressure was applied to bridge of the nose and eyebrow lacerations as well.  11:41 am - 911 was called.  Pressure was still being applied to stop the nose bleed which was still actively bleeding. From the moment the attendee aroused he was A&O x 3.  Breathing was normal, without any signs of anaphylaxis noted.    11:48 - EMS arrived and took over care of the attendee and took him out of the tent to the ambulance.    11:58 - Attendee refused transport and further EMS/site care and he exited the ambulance and sat on the curb, and made a phone call.  Vital signs were obtained from EMS, as they had been so busy trying to stop the bleeding that they did not have time to take his vital signs. EMS left the site.  HR:  97   BP:  121/83   RR:   16   O2Sat%:  98   Attendee sat across from the site on the curb, he did not want any further assistance from the site.  So the employee monitored him from the vaccine area, to make sure that he did not faint or start bleeding again.  All bleeding appeared to be stopped when he exited the ambulance.  11:45 am - attendee's wife arrived on the site and sat with her husband on the curb.   12:05 pm  Attendee's wife escorted the attendee away. Attendee did not have any reported/noted escalation of symptoms and was able to walk to his car independently with his wife.
Pt had flu-like symptoms with aching and fever from 8/27/01, late afternoon. He had a rash on Friday morning on 8/31/01 and turned into blisters with a splitting headache. On 9/4/01 was feeling some better. Rash had gone away and headache had improved. By 9/10/01, was back to normal. Dx: Lyme disease.
No additional AEs or PQC reported.; Caller reported expired dose of GARDASIL 9 was administered.; This spontaneous report has been received from a medical assistant, regarding a patient of unknow age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 09-AUG-2023, the patient was vaccinated with an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, at a dose of 0.5 milliliters intramuscularly in the deltoid (unspecified) as prophylaxis (lot number: 1780867, which was determined to be valid as syringe formulation, with an expiration date on 08-AUG-2023) (Expired product administered).  No additional adverse event was reported.
Nervous, Dizzy, anxious and difficulty breathing. Offered cold water and at 1710 felt normal again
Hive like rash on L hand evening after shot - lasted 2 hrs. The following morning could not walk forward - only backward for approx 1 hr. Resolved after a nap. No other neurologic signs or symptoms. Exam normal later in day.
Tingling of the lips, mouth without any weakness or muscle deficit or any after neurological deficit.   part 21.  only if symptoms persist.
Patient had increased respirations, SpO2 declined, 15 seconds of apnea, mottling to BLE, minimally responsive
shingles from trauma of hernia surgery; scabs on back and chest; Hernia; This case was reported by a consumer via call center representative and described the occurrence of shingles in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles, scab and hernia. The action taken with Shingrix was unknown. On an unknown date, the outcome of the shingles and hernia were unknown and the outcome of the scab was recovering/resolving.   It was unknown if the reporter considered the shingles, scab and hernia to be related to Shingrix.  Additional details were provided as follows: The reporter was the concerned patient. The age at vaccination was not reported. The patient received first dose of Shingrix (date unknown) and developed shingles (date unknown).  The reporter mentioned he developed shingles from the trauma of hernia surgery.  He developed scabs on his back and had a small scab on his chest.  He stated that he was 85 percent done with the scabs on his back, and it had not fully yet resolved. The patient denied consent to follow up.
Severe arm pain from elbow to shoulder, mild fever, diarrhea, headache, dizziness, nausea, low blood pressure. These effects were eliminated without any medication at 6hrs, the burning of the eyes intensified and reached its maximum 36 hours after the vaccine, 4 days later I continue with hypersensitivity in the skin of the face, especially in the eyelids. The sun burned my face in an exaggerated way, I was using sunscreen and without exposing myself to the rays directly
Pt admitted to hospital on 1/21. Tested positive for covid 2 weeks ago. Pt died on 1/22.
vaccination failure; mumps parotitis; This literature marketed report has been received from authors of published article. The incidence of parotitis and mumps in children was increasing nationwide. Retrospective chart reviews were conducted using ICD9/10-codes for parotitis and mumps from January 2007 to December 2017. Data on demographics, vaccination status, labs, management and disposition were collected. The patients had mumps immunoglobulin (IgM) and/or buccal swab for mumps reverse transcription polymerase chain reaction (RT-PCR) or viral culture to test mumps. 1017 parotitis cases were diagnosed, an upward trend in incidence occurred over time. Of the 1017 children with parotitis evaluated over the decade in the Healthcare emergency departments (EDs), 47 (4.6%) were tested for mumps and 9 (19%) of those tested were positive for mumps either by serology and/or PCR. Five of those cases were considered probable mumps and 4 were confirmed mumps. Of the 9 patients identified with probable or confirmed mumps, 7 (78%) were fully immunized, one was incompletely immunized (one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown)) and 1 child was unvaccinated. The most likely explanation for mumps cases in previously immunized persons may be secondary vaccine failure, or waning immunity.  This report referring to a 16 years old female patient. Information about concurrent condition, concomitant medication and medical history was not provided.  On unknown dates, the patient was vaccinated with two doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis (strength, dose detial, route, lot #, expiration date and anatomical location were not provided).   In 2017, the patient was tested RT-PCR at buccal. The results were postive for mumps at bilateral buccal. It was confirmed that the patient experienced mumps parotitis. On an unknown date, the patient experienced vaccination failure. The outcome of the events was unknown. The reporter considered the events to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown).   This is one of several reports received from the same literature.; Sender's Comments:  US-009507513-2011USA009173:
Rash on my neck; Mouth is hurting; Mouth hurts; Mouth started hurting at the night; Mouth is swollen; 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 received bnt162b2 (BNT162B2), administered in arm left, administration date 31Jul2021 (Lot number: FA7484) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: RASH (non-serious) with onset 31Jul2021 02:30, outcome "not recovered", described as "Rash on my neck"; ORAL PAIN (non-serious) with onset 31Jul2021 02:30, outcome "not recovered", described as "Mouth is hurting; Mouth hurts; Mouth started hurting at the night"; MOUTH SWELLING (non-serious) with onset 31Jul2021 02:30, outcome "not recovered", described as "Mouth is swollen". Therapeutic measures were not taken as a result of rash, oral pain, mouth swelling.  Additional information: The patient stated that she took the Pfizer vaccine yesterday, she had a rash on her neck, her mouth is hurting, her mouth is swollen. She stated that she did not receive any treatment, she just had an ice pack on it. The patient did not receive any other vaccine in four weeks.  Follow-Up (13Aug2021): Follow-up attempts are completed. No further information is expected.
PATIENT tested positive for COVID 3/16/21. Completed COVID vaccine series 1/28/21. Symptom onset 3/18/21.
Severe Headache, Fatigue, Low grade fever and hives on the inside of both arms
Very tired and Hive on the face first 30 hours. Then developed bad headache, itchy eyes, throat and ears, nasal congestion, body pain, tight chest, sneezing and lots of nasal drainage, bad cough. Very sick Sunday and Monday. Starting to feel a little better on Tuesday. Wednesday still a lot of nasal congestion and coughing.
This is a non-serious spontaneous case, initially received from a pharmacist on 29-Oct-2018, concerning a male patient of an unspecified age. On an unspecified date, the patient was administered FLUCELVAX QIVc [dose, route of administration, anatomical location, batch number and expiry date: not reported]. On an unspecified date after vaccination, the patient's arm started hurting. The outcome of the event was not reported at the time of this report. This case is linked to case 201805075 due to same reporter.
Information has been received from a pharmacist referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 13-JUN-2016, 0.65 ml of improperly stored ZOSTAVAX (lot # M001746, expiration date 07-APR-2017, subcutaneous) was administered. No adverse effects were noted. Additional information has been requested.
Red itchy rash on both arms and both legs- used anti itch creams- rash erupted two days ago 11 days after second vaccination shot
Within hours after receiving 2nd HPV, developed diffuse arm pain, from shoulder to wrist, involving entire arm. Later that evening with right leg pain (no injection in leg) aching in leg.
Pericarditis  Colchicine 0.6 mg times 2 /day Aspirin 325 mg 1st week 4x1/day 2nd week 3x1/day 3rd week 2x1/day 4th week 1x1/day Sharp, stabbing chest pain in the middle,left side of my chest. When I sit up and lean forward it eases the pain, but when lying down it worsens the pain.
patient broke out in red rash; had large swelling on top of right shoulder; This non-serious case was reported by a other health professional via sales rep and described the occurrence of red rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose approximately 6 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced red rash (Verbatim: patient broke out in red rash) and swollen joints (Verbatim: had large swelling on top of right shoulder). The outcome of the red rash and swollen joints were not reported.   It was unknown if the reporter considered the red rash and swollen joints to be related to Shingrix.   It was unknown if the company considered the red rash and swollen joints to be related to Shingrix.   Additional Information: GSK Receipt Date: 02-NOV-2023 After second Shingrix shot (administered approximately 6 months after the 1st), patient broke out in red rash all over front of body and had large swelling on top of right shoulder. The reporter did not agree to follow up from GlaxoSmithKline.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 09-MAY-2016 the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K016966, expiration date 10-MAY-2017, dose and route not reported). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 24, 8.7 and R; 9 and R. The storage criteria was (R). This is one of several reports received frmm the same source. Additional information has been requested.
Since my second shot of the vaccine, I have been experiencing chest pain. My chest feels tight and hurts a little bit. Any psychical  exertion causes the tightness and pain to increase a lot, like i'm being stabbed by a knife.  If I go on a walk, it gets really bad and I start to feel it in my throat and back. It subsides if I lay down or sit still for a while. It seems to be caused by movement and exertion. Also, my left toe is now partially numb. It is not fully numb, but feels like pins and needles when I touch it. This has been happening since I got the second shot I think.
swollen lymph nodes; Injection site pain; muscle pain/body aches; feeling unwell; This is a spontaneous report from a contactable Other Health Professional.  A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN6201), intramuscularly, on 20Feb2021 at 12:00 (at the age of 42-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included obesity, eustachian tube dysfunction. The patient is allergic to grass (fescue). Historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EN5318), intramuscularly, on 30Jan2021 at 12:00, intramuscularly in the right arm. The patient was not pregnant at the time of vaccination. The vaccine was administered at a workplace clinic.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were reported as "None." The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Feb2021 at 15:00 the patient experienced Injection site pain, muscle pain/body aches, feeling unwell, swollen lymph nodes. The patient did not receive any treatment for the events. The clinical outcomes of the events vaccination site pain, muscle pain/body aches, feeling unwell, swollen lymph nodes were reported as not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
This case was reported by a healthcare professional and described the occurrence of hives in a 4-month-old female subject who was vaccinated with INFANRIX (GlaxoSmithKline). The subject has a history of developing hives following administration of PEDIARIX at her two month visit. On 6 June 2011 at 13:30 the subject received unspecified dose of INFANRIX at 0.5 ml in the left leg. On 7 June 2011, 1 day after vaccination with INFANRIX, the subject experienced hives. The subject was treated with BENADRYL prior to vaccination with INFANRIX. At the time of reporting the event was resolved. The healthcare professional considered the event was probably related to vaccination with INFANRIX. For details regarding the event following administration of PEDIARIX at the subject's two months visit, refer to case number A0935245A.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 18-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported. It was stated that the date of refrigeration was 07 May 2021.
The pt developed extreme flu-like symptoms. Every muscle ached and couldn't move or get comfortable for 3 days. Fever with Tylenol was 101.5F, without ? Arm at sight of shot and the whole upper arm was swollen. Both shots were given in the same arm.
Pt had approx 1min episode of generalized tonic-clonic sz 2 days p/MMR vax given; Sz activity occurred during blood drawing; pt taken to ER where "vasovagal" episode dx by ER MD;
Patient received four vaccines at the same time. He passed out 2 minutes later and woke up crying with severe burning and numbness of fingers, paleness, weakness, and dizziness.
Symptoms began with hair loss two months after first shot, progressed to stomach problems, indigestion, bloating, menstrual irregularities, PMS Symtoms very bad, yeast infection, bladder infection, extreme fatigue, extreme headaches, muscle aches, foggy vision, foggy memory, inability to concentrate, depression, anxiety.  We are currently treating her for Systemic Candidias.  9/18/09 PCP medical records received DOS 10/2/06 to 6/27/08. Assessment: Cystitis. Irritable bowel syndrome alternating type. GERD. Patient presents with urinary urgency, dysuria, and frequency. Hypogastric tenderness. Nevus on shoulder. Dysplastic Nevus. Multiple benign nevi. Sinus infection, stomach ache, constipation, feeling run down, sore throat. UTI. Diarrhea. Ankle injury. Bloating. Dizziness, 'spacy', hair loss. Mucous in stool. Pelvic pain. LGSIL. Abnormal bowel movement pattern. Inflammation of colon.
patient had already received updated booster on 9/18/2022. No actual adverse event occured.
Round, itchy red rash in area of vaccination  1 week after vaccine. About the size of a baseball. Went away in less than 48 hours. No other symptoms