chrisvoncsefalvay/vaers-outcomes huggingface dataset:
When I try to get up everything is spinning; Throwing up; Fever; Body ache; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (When I try to get up everything is spinning), PYREXIA (Fever), MYALGIA (Body ache), CHILLS (Chills) and HEADACHE (Headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A. and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced PYREXIA (Fever), MYALGIA (Body ache), CHILLS (Chills) and HEADACHE (Headache). On 08-Apr-2021, the patient experienced VOMITING (Throwing up). On 09-Apr-2021, the patient experienced DIZZINESS (When I try to get up everything is spinning). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, DIZZINESS (When I try to get up everything is spinning), PYREXIA (Fever), MYALGIA (Body ache), CHILLS (Chills), HEADACHE (Headache) and VOMITING (Throwing up) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medication not provided.
This spontaneous report as received from a Nurse refers to an unspecified number of patients of unknown ages and genders. Pertinent medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown dates the patients were vaccinated with improperly stored dose of RECOMBIVAX HB lot number M001578 expiration date 21-NOV-2018. Dose, the patient's frequency, anatomical location and route of administration were not provided. Temperature: 32.9 Fahrenheit degrees, time: 5 hours. Digital data logger was involved, no previous exposures and no product quality complain involved. No other suspect medications or concomitant therapies were reported. No adverse effects were reported. This is one of four reports received from the same reporter. Additional information has been requested.
Large area of redness, spreading around inner thigh and almost to the back of thigh. Swollen and warm to the touch.
In the evening of the same day of second dose vaccination the patient began to feel hot and sweat. Patient reported after going to sleep she woke up between 0000 and 0300 of 5/6/2021 with a fever, chills, and diaphoresis. Since that time the patient has further developed diffused rash and hives over chest and neck. Patient recorded her highest temperature as being 103.2 early this morning. The patient has only taken acetaminophen for her fever at time of reporting.
I got the vaccine at 4:00 on Oct 4. Overnight I had chills and extreme tiredness. I was so exhausted I mostly slept for 36 hours. I  was unballanced. I was afraid I would fall if I walked anywhere. My brain was  not working. I use the computer every day and I didn't know how. I couldn't open a new window or change from large caps to small. it is 48 hours now and it is better but not over. Also, my eyesight is affected.
Employee received flu vaccine on 10/8/13 about 3-4 PM into left deltoid and then that night began experiencing left deltoid muscle ache that traveled down to elbow anteriorly. ALEVE relieves discomfort. Hand grasps equal/strong - some limitation with range of motion but minimal.
No additional AEs or PQC reported; vaccine administered after temperature excursion; This spontaneous report was received from a registered nurse, referring to a patient of unknown gender and age. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 31-JAN-2022, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (formulation prefilled syringe, lot # U010534 with expiration date: 31-OCT-2022, 0.5 milliliter, strength unknown), intramuscularly for prophylaxis after temperature excursion (product storage error). No additional information provided.   Administered dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) experienced the temperature excursion below 49. 1 Fahrenheit degrees (F) for 5 hours and 9 minutes; 56.3F for 14 hours and 7 minutes; 49.6F for 35 hour and 9 minutes. There was no previous temperature excursions reported.
I started having shortness of breath and chest pain and  had pre-syncope. Then, in February I went to see a cardiologist and I was hospitalized because my symptoms were getting so bad. I also have ringing in my ears that has gotten really bad.
Lump near my collar bone/ swollen lymph node; Lump is painful to touch; This is a spontaneous report from a non-contactable consumer (patient herself). A 45-years-old not-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: el3247) via an unspecified route of administration, administered in arm left on 27Jan2021 at 08:15 as 1ST DOSE, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Medical history included prediabetic and lymphedema in right foot. No allergies to medications, food, or other products were reported. Concomitant medications included daily multivitamin. On 02Feb2021 at 08:30 AM, six days after receiving the Covid-19 vaccine, she developed a lump near her collar bone. Lump was painful to touch. She reached out to her doctor, but they were unavailable due to a snow storm in our area. She believed it was a swollen lymph node. Patient has not been tested for COVID-19 since the vaccination. It was unknown if the patient received treatment for the adverse event. The case was considered as non-serious as per reporter. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Cellulitis approximately 2 inches below the injection site -- First appearance about the size of a quarter, red, hard, hot and tender to the touch.  Involved area expanded over the next 24 hours. Resolved within 48 hours.
This is a spontaneous report from a non-contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 07May2021 10:00 (lot number and expiration date not reported) at the age of 27 years old, as 2ND DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. Historical vaccination included first dose of BNT162B2 for COVID-19 immunization on an unspecified date (anatomical location: right arm). The patient fainted approximately 29 hrs after receiving dose on an unspecified date with outcome of recovered. 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. Since the vaccination, the patient has not been tested for COVID-19. No treatment was given for the event. No follow-up attempts are possible; information on the lot/batch number cannot be obtained.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "Allergy: Coconut" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (start date24Oct2023, stop date28Oct2023).  The information on the batch/lot number for [Comirnaty (2023-2024 Formula] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300357525 same reporter/patient, different drug/event;
Information has been received from a nurse referring to a 3 month old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, current condition and concomitant medication were not provided. On 05-SEP-2018, the patient was inadvertently administered GARDASIL 9 (dose, frequency and routewere unknown; lot # N035957; expiration date 10-OCT-2020 ) for prophylaxis(Inappropriate age at vaccine administration). No adverse effects reported.
I started having arthralgic knee pains starting about 5-7 days after vaccination. Knee pains limited my mobility, I was in a lot of pain, exacerbated by walking or physical activity. I needed antiinflammatory drugs for almost 3 wks. Pains are improved now after 4 wks of vaccination, more off and on, rather than constant at this time.
cried all day & had temp of 100;fine as of 25AUG95;
Expired vaccine given to patient/expired dose administered to patient; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient/expired dose administered to patient) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient/expired dose administered to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient/expired dose administered to patient) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported.  No treatment information was reported.  There are no adverse events reported for the patient.   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Follow-up received includes significant information.
This case was reported by a physician, via a GSK representative, and described the occurrence of not responding to therapy or decreased therapeutic response in 24 subjects of unspecified age and gender who were vaccinated with ENGERIX B (GlaxoSmithKline). On unspecified dates the subjects received doses of ENGERIX B (details unknown) or hepatitis B vaccines. On unknown dates after completion of the vaccination series with ENGERIX B or hepatitis B vaccine, the subjects experienced not responding to therapy or decreased therapeutic response. Some of the subjects were re-vaccinated. The physician reported that 24 subjects had titers drawn after completion of the vaccine series. The titer results for the subjects were low or showed no immunity at all. Not all of the subjects received ENGERIX B, but they did receive some hepatitis B vaccination. Follow-up received on 24 August 2010: The subjects were aged between 10-19 years. The physician reported that their labwork came back with no immune response and there was no further information available.
7 hours after vaccination- chills headache and low grade fever  24 hours after headache low grade fever and dizziness  Dizziness persists 4 days after vaccination
Pt reported morning after vaccination with a large portion of upper arm visibly swollen, red, and hot to the touch. Part of the arm was exceptionally swollen half a cm higher than the rest (from axial region down to elbow). Pt denies other reactions to vaccinations, medications, or food.   Pt saw urgent care for a dosage of steroid pack.
Headache, Myalgia, Arthralgia, Fever, injection site pain/arm pain, swelling at injection site, fatigue, chills Narrative:  Other Relevant History:
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 26-MAY-2016 the patient was vaccinated with ZOSTAVAX, 1 DF, (route and lot# unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 22-JUL-2016, the patient was treated by a Nurse Practitioner at a Family Medicine Practice for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles, with cellulitis due to zoster infections. The patient has been prescribed valacyclovir and cephalexin for management of his painful shingles and subsequent dermal infections. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Upon internal review cellulitis was considered to be a medically significant event.   Additional information has been requested.
This spontaneous report as received from an office manager and nurse practitioner, regarding multiple unspecified patients (age and gender not provided). Patient's pertinent medical history, drug reactions/allergies were not provided. On an unknown date, multiple unspecified patients received doses of PROQUAD (route, lot number and expiration date were not provided) that were stored improperly. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Red area 2 inches long and 5 inches wide on left arm. Area also warm to touch. Pt came to office area, was measured and was instructed to give Benadryl and apply cold wash cloth to red area.
Site: Itching at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chest Tightness / Heaviness / Pain-Severe, Additional Details: pt had vaccine rxn about 20 min after receiving moderna. itching then swelling, then hives, asked for epi I called 911, Watched pt but she went pale and said had difficulty breathing. gave epinepherine 30 mins after vaccine. ambulance came and took her to hospital.
48 y o male with h/o RLE DVT associated with a right achiles  tendon rupture (that has not yet been repaired) involving the right post tibial  and right peroneal veins. RLE DVT 2 months after moderna vaccine Dec 2021, but had Janssen vaccine also in 2021. pt requested that ADR be entered esp for the Jansseen vaccine
I had a skin reaction after both the first and second injection; Has the vaccine had a reported side effect of long-lasting abdominal pain? / starting at the time of the second injection, stomach pain; This case was reported by a consumer and described the occurrence of skin reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of skin reaction (received 1 st dose on an unknown date, and experienced skin reaction, refer case US2020AMR065886).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced skin reaction and stomach pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the skin reaction and stomach pain were unknown.   It was unknown if the reporter considered the skin reaction and stomach pain to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient had reported side effect of long-lasting abdominal pain and skin reaction.
Information has been received from a physician concerning a 9 year old male patient who in 2003 was vaccinated with a second dose of MMR II (Merck), initially reported as mumps virus vaccine live (Merck).  On approximately 22-MAY-2008 the patient developed parotitis on one side which was inflamed.  Unspecified medical attention was sought.  Laboratory testing showed serum IgG antibodies elevated at 1.9, IgG negative at < 0.8; and amylase elevated at 3, 450.  It was also reported that there was no known exposure to patients with mumps.  At the time of the report the patient's status was unknown.  Additional information has been requested.
fever; chills; headache; body aches; This is a spontaneous report from a contactable consumer or other non-health care professional. A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient got first Pfizer vaccine in morning and was told by the person giving her the vaccine, she should not take any Tylenol. Reporter states she took a Tylenol earlier that morning, around 8:30. Now she was worried about the effectiveness of the vaccine she received and asked whether it was ok to take Tylenol. The patient experienced fever, chills, headache, and body aches on an unspecified date. Reporter was asking if she should assume if she was not getting symptoms after the vaccine it was not working on her and whether everyone have some side effects after the vaccine. What about the variants that are showing up, whether the Pfizer vaccine work on those also. The outcome of the events was unknown. Information on Lot/Batch number has been requested.   Follow-up attempts are completed. No further information is expected.
FOCAL MOTOR SEIZURE HYPOTENSION 2/9/2023  &  1/17/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Within 30 minutes of receiving vaccine, complained of dry mouth and difficulty in swallowing.  Alert, oriented.  Color pink; skin warm and dry; VS within normal range.  Denies shortness of breath; no overt swelling.   After few minutes, c/o burning in chest.   Benedryl 25 mg tab x2 given with water.  Able to swallow, but stated it was difficult to do so.  Interacting and conversing with EMTs.
swollen lymph nodes under the left arm; Initial information received on 09-Oct-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 55 years old female patient who experienced swollen lymph nodes under the left arm after receiving Influenza Quadrivalent Recombinant Vaccine [Flublok Qiv].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 06-Oct-2023, the patient received 0.5 ml of suspect Influenza Quadrivalent Recombinant Vaccine (Frequency: once, Strength: Standard) (lot number: U8058BA) (with an unknown expiry date) via intramuscular route in the left deltoid for immunization.  On an unknown date, the patient developed swollen lymph nodes under the left arm (lymphadenopathy) (unknown latency).  It was reported, Call received from pharmacist reporting a patient who received a dose of FLUBLOK QIV, on Friday, 06OCT2023, called to report she is experiencing swollen lymph nodes under the left arm. Patient called pharmacy today, 09OCT2023, stating that she noticed the swollen lymph nodes after she exercised, denies any other symptoms.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (swollen lymph nodes under the left arm).  At time of reporting, the outcome was Not Recovered / Not Resolved for the event swollen lymph nodes under the left arm.
Large boil/nose formed inside right roof of mouth very painful and full of puss.  The dentist could only drain 1/2 of it.  I do have pictures if needed.
My arm was sore, my throat was itching, like something stocked in the  back of my throat, I used a lamp, and it was a white spot, it gets bigger every time. I called my dentist because I had an issue with my teeth and she saw my throat it was recommended for me a doctor, I have an appointment for next week.
Mom stated she cried immediately after shots, then "collapsed" - very sleepy and unresponsive ?? awake later, cried inconsolably for 4-5 hrs. Then limp again. Poor eye contact for 3 days. Right eye deviated in > 48 hrs.
Sore arm (ended approx 72 hours after vaccination)  Red, itchy arm, began 8 days after vaccination