chrisvoncsefalvay/vaers-outcomes huggingface dataset:
9/14-Patient was seen on 9/10 for discomfort to her left deltoid area where she received her 3rd HPV vaccine. She was advised at that visit to apply heat, Naproxen 250 mg bid was prescribed and encouraged to perform gentle ROM (as she was keeping arm straight and hesitant to use). She reports although better than 9/10 visit; she still experiences some pain if she quickly raises her affected LUE. Denies any weakness/paresthesias to affected LUE. She is right hand dominant. Referred to Specialist; 9/21 student who received her 3rd HPV vaccine into the L deltoid 3 weeks ago. She notes that the next day that the pain involved a broad area on the L lateral arm (not just at the injection site). Says the pain is moderate. Has been taking Naproxen, which helps. No neck pain. The past week, has had a little pain in the L upper trap area which she attributes to compensation for the shoulder pain. Denies paresthesia. No prior shoulder problem; X-ray Ordered; 9/23 PT reports increased pain/decrease in mobility. MRI ordered.
This spontaneous report as received from a Medical assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 06-FEB-2018, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (expiration date 22-JAN-2018) (dose, route and lot number were not reported) for prophylaxis.
Developed fever and chills around 6pm on day of vaccination. Severe febrile reaction. Developed respiratory distress and became unresponsive. Transported to ED where O2 sat'n on room air was 45%. Intubated and transferred to ICU. Extubated on 2/24/21 and transferred to telemetry floor with nasal cannula. Ultimately stable on room air. Treated for pulmonary edema, cardiogenic shock and acute on chronic CHF. Resolved and  back to baseline by 3/4 when she was discharged.
REACTIONS SEVERE ENOUGH TO WARRANT REPORTING; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced reactions severe enough to warrant reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of reactions severe enough to warrant reporting was not reported. This report was non-serious.
Chronic tinnitus (component of Meniere's syndrome) and some vertigo, worse after 2nd vaccine. Severe enough to require bed rest and sleep. Increased diazepam, meclizine but little help. I am not sure the vaccine made tinnitus worse, but I do think it was a trigger. I am still experiencing tinnitus. I am in the process of trying to use Effexor (getting ENT team involved.)
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. No concurrent conditions, medical history and drug allergies reported. On 18-JUN-2015 the patients were vaccinated with improperly stored PROQUAD (Merck) (lot number K020747 and expiry date 30-APR-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The action taken with the therapy with PROQUAD (Merck) was unknown. The outcome of the events to the therapy with PROQUAD (Merck) was unknown. The relatedness of the events to the therapy with PROQUAD (Merck) was unknown. There was no product quality issue reported. This is one of the many reports from the same source. Additional information has been requested.
on 4/29/2018 Patient began suffering syptons including full body Uticaria , Gate imbalance , Left side weaknessand brain mri studies postive for white matter patches that were subsequently diagnosed as ADEM (acute disseminated encephalomyelitis to the currnt date patient countinues to suffer from the abouve injuries
Patient had a history of non-aggressive breast cancer that was successfully treated in 2016. In  early 2021 patient had received 2 doses of Pfizer vaccine after that her health progressively got worse.  CT scan showed non-treatable metastatic cancer in her lungs, bones and liver. Patient died a month later.
My healthy daughter began showing signs of a headache 3 weeks after the shot. For the last month she has had several trips to the ER, is now on 17 medications with migraine and high blood pressure that is unresolved. Today she is at the Neurologist with a series of 3 days of outpatient IVs to try and decrease her pain. She has been on bed rest for over a month and is not able to participate in daily activities or soccer.
The patient experienced a red mark at the injection site the day after administration and it progressively increased over 12 days to form the approximation of a circle. It is red and painful at the time of reporting.
This case was reported by a physician via call center representative and described the occurrence of injection site cellulitis in a 65-year-old female patient who received 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 injection site cellulitis. The patient was treated with antibiotics nos (Antibiotic (Drug Name Unknown)). On an unknown date, the outcome of the injection site cellulitis was unknown. It was unknown if the reporter considered the injection site cellulitis to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the reporter on behalf of the patient. The age at vaccination was not reported, but the patient was 65 years old at the time of reporting. The patient experienced cellulitis at the injection site and had to receive antibiotics. Patient went to the emergency room for the reaction. It was reported that the patient called her to report the event but she has not physically seen the patient. No additional details were available. This is one of the three cases reported by the same reporter.
Rash around site, bruising around site Reported "tightness" around the "heart area" but wasn't sure it was vaccine related.
Pt c/o arm received vaccine in (L) felt "wobbly-like Jello" and (L) side of face felt "tingly". Pt states she had hot flash and it was already hot inside building and she got nervous. States "I know I'm nervous because I can feel it in my stomach." No rash, no breathing probs, no other symptoms.
Kinrix administrared to 4 month old baby; Kinrix was administrated when Pentacel was intended to be given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 09-NOV-2023) for prophylaxis.   On 20-JUN-2023, the patient received Kinrix. On 20-JUN-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix administrared to 4 month old baby) and wrong vaccine administered (Verbatim: Kinrix was administrated when Pentacel was intended to be given). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were 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: GSK receipt date: 21-Jun-2023 The Kinrix was administrated to patient 4 month age when Pentacel was intended to be given, which led to wrong vaccine administered and inappropriate age at vaccine administration. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
Pt has a T 104 (R) for 2 days. Called PMD & instructed to give suppository APAP. Fever would go down then go right back up.
puffy around injection point; itchy and puffy around injection point; muscle aches; very tired; very sleepy; no appetite; so cold and could not get warm with a little fever; vertigo; This is a spontaneous report from a contactable consumer. This 75-year-old female consumer (patient) reported that:  A 75-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received BNT162b2 (PFIZER_BIONTECH COVID-19 mRNA VACCINE, solution for injection; Lot number: EN6200; expiration date: unknown), via unspecified route in right arm on 16Feb2021 at 16:30 (Patient was 75-years-old at the time of vaccination) as a 2ND DOSE SINGLE for covid-19 immunization. The patient's medical history included mitral valve prolapse, glaucoma, allergies to Lisinopril and penicillin. The patient's concomitant medication included centrum, CoQ10 100mg, diclofenac gel, lumigan, pre. The patient received first dose of BNT162b2 (Lot: EL9265) on right arm, on 26Jan2021, 5:00 pm. The patient do not have COVID-19 prior to vaccination. Since vaccination, the patient was not tested for COVID. On 17Feb2021 at 16:00, the patient experienced muscle aches, so cold and could not get warm with a little fever, no appetite, itchy and puffy around injection point, very tired and very sleepy - not as bad as after first shot. These symptoms started the day after the shot and was fine the following day. 4 days after the shot, the patient experienced vertigo and patient was not sure whether it is related. The patient not received any treatment. The outcome of the events were recovered on 2021.
Patient was nervous prior to the injection. When injection occurred. Patient because lightheaded immediately, Patient stated she felt like she was going to pass out. Patient stated she feels hot. Patient pale in color. Patient remains alert and oriented at all times. Patient stated she has felt like this after a previous blood draw. Patient assisted to a supine position. Legs elevated. Patient stated she felt better immediately after lying down. When event occurred, BP was 76/33. After patient recovered BP up to 112/72. Event lasted approximately 30 minutes. Afterwards patient ambulating without difficulty. Patient alert and oriented. Patient stated she felt completely better.  Encouraged patient to drink lots of water. Had patient to contact family for transportation home.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (My arm, where the vaccine was, is red), VACCINATION SITE SWELLING (My arm, where the vaccine was, is swollen) and VACCINATION SITE PRURITUS (My arm, where the vaccine was, is itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (My arm, where the vaccine was, is red), VACCINATION SITE SWELLING (My arm, where the vaccine was, is swollen) and VACCINATION SITE PRURITUS (My arm, where the vaccine was, is itchy). At the time of the report, VACCINATION SITE ERYTHEMA (My arm, where the vaccine was, is red), VACCINATION SITE SWELLING (My arm, where the vaccine was, is swollen) and VACCINATION SITE PRURITUS (My arm, where the vaccine was, is itchy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No relevant concomitant medications were reported. No treatment information was provided.
Itching & rash ? elevated blood pressure. Tx: IV BENADRYL 50mg, PEPCID 20 mg IV Rx: Methylprednisolone 4mg usp Qt. 2l BENADRYL 50 mg Q 4 hrs prn.
hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 94-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2022 at 17:00 as dose 2, single (Batch/Lot number: unknown) at the age of 94 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension Cardiac" (unspecified if ongoing), notes: Hypertension Cardiac; "allergy" (unspecified if ongoing), notes: Known allergies:None. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization, reaction(s): "hives". The following information was reported: URTICARIA (non-serious) with onset 19Jan2022, outcome "not recovered", described as "hives". The event "hives" required physician office visit. Therapeutic measures were taken as a result of urticaria.  Additional Information:Reporting for my 94 year old mother. After first vaccine she started having hives. For 2 years she has dealt with this issue. Treated and seen by multiple doctors. Phototherapy was used as well as medications.No any other vaccine in four weeks.Patient received Other medications in two weeks.No any covid prior vaccination and No any covid tested post vaccination  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300124954 same patient/event and different drug dose;
Starting around 9/8/21, Pt legs began to "feel funny".  He slept for 15 hours on 9/9/21.  On 9/10/21, he was unable to walk and was hyporeflexic and unable to feel pain in his lower extremities.
Breakthrough Covid + male presents to the ED with general malaise about 10 days ago and that over the past 2 days he has had a HA associated with N/V, unrelieved by taking tylenol around the clock. Pt states his sister tested positive for COVID-19 a few days ago and he was recently in contact with her.
pt stated presented to ED with edema of R. arm and severe pain bilateral arms. Pt further stated severe chest pain. Was told by Dr at ER that the two vaccines administered in same arm caused MI 12/07/22. Pt scheduled for stress stess Monday. Pt states at home and stable currently with no further complaints. Will call to f/u tomorrow on pt condition
10 cm erythematous patch of skin surrounding vaccine site with swelling. Temperature to 101.  Resolved over 12 hours.
Itchy; Rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE RASH (Rash) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included Acid reflux (esophageal).    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE RASH (Rash). At the time of the report, VACCINATION SITE PRURITUS (Itchy) and VACCINATION SITE RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant included acid reflux medication. No treatment provided
When I when I caught the virus in July 22 it was great unexplainable hip pain that sent me to to the hospital.  The technician decided to do a chest X-ray and fount pneumonia. She did a test and it came up positive. Somehow the virus aggravated the hips.  Tonight that pain is back in the right hip but not as severe.  It is different from the past bursitis.  It is like when I caught the virus.
Moderna administered when patient reported that his first dose was Moderna, and intake personnel wrote "M" at top of sheet indicating this was to be a Moderna vaccine.   Personnel then filled in info at the bottom of intake form that first dose was Pfizer, administered at another location.   Nurse (myself) did not verify by seeing at the bottom of intake form that first dose had been Pfizer.  Patient was notified and voiced understanding.
Bad Joint pain fingers; This is a spontaneous report from a non-contactable consumer, the patient. A non-pregnant female patient of an unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 25May2021 at 15:00 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28May2021, the patient experienced bad Joint pain fingers, never had pain before. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event bad Joint pain fingers was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
fatigue,headache ,feels warm ,no feverheadache improving headache ,not weak ,no numbness
minor soreness at injection site within 3 hours, frequent sneezing Day 2-something I seldom do, minor itching at injection site-Day 3
This spontaneous report was received from a respiratory therapist referring to an patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not provided. On 19-DEC-2016, the patient was vaccinated once with an expired dose of RECOMBIVAX HB intramuscular injection (dose reported as: 1 ml intramuscularly, lot number L001456, expiration date 22-OCT-2016) for prophylaxis. (Strength was not provided). No adverse effects were noted.  Additional information has been requested.
Fatigue; Abnormal body temperature for more than one week. 99.5 F.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 21Apr2021 00:45 (Batch/Lot number: unknown) at the age of 24 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 22Apr2021, outcome "not recovered", described as "Fatigue"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 22Apr2021, outcome "not recovered", described as "Abnormal body temperature for more than one week. 99.5 F.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue, body temperature abnormal.  Additional information: no other vaccine in four weeks was received, no COVID prior vaccination, it was unknown if patient was tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Menactra and Ipol was exposed at 27.7F for 15 minutes in October 2019/no AE; Initial information received on 24-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 13 years old male patient who received  0.5 ml IPV (VERO) [IPOL] which was exposed at 27.7F for 15 minutes/no AE (product storage error) on 23-Aug-2019 for prophylactic vaccination via intramuscular route at the left deltoid [batch number P1E701M and expiry date 09-Nov-2019] It was also reported that MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] was also exposed at 27.7F for 15 minutes (product storage error).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE (MENINGOCOCCAL VACCINE) for Immunisation; HPV VACCINE (HPV VACCINE) for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP).  It was of actual medication error case product storage error temperature too low.  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.  Information on the batch number was requested for Menactra.
Very bad body aches literally my whole body feet, head , back, arms, (everywhere). 102.6(F) fever. Light headed/ dizzy
Mother reported intermittent fever (at 1550 on 7/27/16 fever was 99.2 degrees F) and states that he generally runs low fevers. Vomiting x1 episode.
The evening of the injection, the injection area on the left upper arm was red, slightly raised and very sore. The erythema was approximately 3" long and 3/4" wide and felt hot to the touch. Stayed like this for 5 days. As of 01/09/2001, the area is no longer sore and the red strip is very slight but still visible on her arm. Additional correspondence received on 02/15/2001 reported that the patient recovered from this experience. It was requested on 02/12/2001 to send a copy of this report to MD. No further information was provided from correspondence returned on 03/08/2001.
This case was reported by a nurse via sales rep and described the occurrence of cellulitis in a adult female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant), pain, tenderness, erythema, feeling hot and swelling. On an unknown date, the outcome of the cellulitis, pain, tenderness, erythema, feeling hot and swelling were unknown. It was unknown if the reporter considered the cellulitis, pain, tenderness, erythema, feeling hot and swelling to be related to Shingrix. Additional information was reported as follows: The age at vaccination can be 56 or 57 years. The patient experienced pain, tenderness to touch  which as diagnosed as cellulitis of approximately 3 into 5 inches size with redness, hot to touch and raised in the area of cellulitis.
Mild headache, muscle aches, nausea, low grade fever, explosive diarrhea for about 2 hours.
Patient called and stated that about 1/2 to 1 inch below the site of the injection she has a lime to lemon size lump. She stated the lump is not painful or warm to the touch and it doesn't bother her, but it is pinkish red in color. She was going to maybe take some ibuprofen for the swelling and see if that helped. If it wasn't decreased in size tomorrow she may ask her physician if there is anything she needs to do. She stated it wasn't bothering her at all.