chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Muscle aches; Fever 100-99 degrees; Resting heart rate is usually in the 60's but is now in mid to high 80-'s; This non-serious case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included atrial fibrillation. Concomitant products included metoprolol and apixaban (Eliquis).   On 07-MAY-2023, the patient received the 2nd dose of Shingrix (intramuscular, left arm). On 08-MAY-2023, 1 days after receiving Shingrix, the patient experienced muscle pain (Verbatim: Muscle aches), fever (Verbatim: Fever 100-99 degrees) and heart rate increased (Verbatim: Resting heart rate is usually in the 60's but is now in mid to high 80-'s). The patient was treated with ibuprofen (Advil). The outcome of the muscle pain, fever and heart rate increased were not resolved.   It was unknown if the reporter considered the muscle pain, fever and heart rate increased to be related to Shingrix.     It was unknown if the company considered the muscle pain, fever and heart rate increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-MAY-2023 The patient received 2nd dose of Shingrix. The reporter stated that the next day of vaccination, he woke up with muscle aches, fever of 100 now went to 99 degrees (been taking ADVIL).  Reporter also mentioned that his resting heart rate was usually in the 60's but was now in mid to high 80's. The reporter consented to follow up.
pt recv vax NOV96 & devel an inj site rxn w/redness, swelling & itching;the affected area is about the size of a BP cuff (4" x 10");this case was reported by a MD;
I started vomiting about 20 minutes after I received the vaccination.  That continued on and off for the next 24 hours.  The indigestion has continued since then and has not stopped.  I also still have pain in my arm where the injection was given and general muscle soreness throughout my body..  This includes my back and the site of my old back injury.  This has made walking painful at times.
DIZZINESS; PAIN UNDER THE LEFT ARM; This spontaneous report received from a patient 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, and batch number were not reported) dose was not reported, administered on 26-MAR-2021 on left arm 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 dizziness, and pain under the left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness and pain under the left arm was not reported. This report was non-serious.
Patient presented to receive an influenza vaccination.  The vaccinator documented giving her a COVID vaccination of Moderna Lot 3030342, exp 3/25/2024.  Patient received a copy for her records and later questioned what she received.  The vaccinator is unsure if her documentation is incorrect, or if she gave an incorrect vaccine.  Patient contacted public health department and we were made aware of this on the evening of 10/3/2023.
Dizzy; diarrhea; headache; vomiting; fatigue; fever; chills; body aches; muscle aches; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 42-years-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3249), via an unspecified route of administration (at the age of 42-years), administered in arm left on 30Jan2021 at 08:30 as dose 1, single for COVID-19 immunization. Medical history included seizures, asthma, ptsd from an unknown date and unknown if ongoing. There were no concomitant medications. Patient did not have covid prior vaccination. The patient have known allergies. The patient did not received any other vaccine in four weeks. On 30Jan2021 at 10:00, the patient experienced dizzy, diarrhea, headache, vomiting, fatigue, fever, chills, body aches and muscle aches. The treatment was received for all the adverse events. The adverse events resulted in physician office visit. The patient underwent lab tests and procedures which included Covid-19 test: negative Nasal Swab on 03Feb2021. The clinical outcome for the events was reported as recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Moderna COVID-19 Vaccine EUA  Very sore arm on night of injection (couldn't sleep though night) Nausea/ vomiting Fatigue Day 2-3 extreme dizziness All resolved by 4th day after shot
A large open wound on shin of leg; This spontaneous case was reported by a consumer and describes the occurrence of WOUND (A large open wound on shin of leg) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WOUND (A large open wound on shin of leg). At the time of the report, WOUND (A large open wound on shin of leg) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. The patient did not receive any treatment. Action taken with mRNA-1273 in response to the event was not applicable
Patient was admitted to the hospital on 09/27/2021. Patient tested COVID positive on 10/08/2021 after cough initiated. He was placed in isolation, On 10/11/2021 CXR was suggestive of infiltrates and became very symptomatic on 10/12/2021 requiring oxygen treatment. Treatment was started on Decadron and remdesevir. On 10/14/2021,  baricitinib was added; on 10/16/2021 his pneumonia worsened and theres was small to moderate effusion; Vancomycin and zosyn IV were added as well. It was noted that he had anasarca and treated with lasix which didn't help his respiratory status. On 10/18/2021, CXR showed continued opacities and RT lung atelectasis; 10/19/2021 he was coughing uncontrollably. Palliative care was recommended and patient transferred to hospice on 10/21/2021 and passed away on 10/22/2021.
administered only the liquid component of Menveo  without the powder; administered only the liquid component of Menveo  without the powder; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA466A, expiry date 31st October 2022) for prophylaxis.   On 22nd July 2021, the patient received Menveo. On 22nd July 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: Age at vaccination was not reported. Physician reported that they inadvertently administered only the liquid component of Menveo without the powder to a patient today (day of reporting), which led to  inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consented to follow up.
Sore arm from the 1st dose. 2nd dose: Tiredness, body aches, nauseas, fever, body shivers, hard to breath, sore arm and weak (lasted about 24 hours).
Patient received FLUARIX flu shot that is indicated for patients 3 years - 64 years. No signs, symptoms, adverse reactions noted. No treatment required.
Client received first COVID vaccine on 11/05/2021.  Client complained of fast heart rate and chest discomfort 5 days post vaccination, lasting 2 days.  Client was seen by pediatrician, had EKG and blood labs and told all within normal range.  Client has history of Kawasaki Disease and 3 coronary artery aneurysms @ 4 months of age, client's mother reports she was "cured".  No chronic medical conditions, no allergies.
This spontaneous report as received from a mother reporting on her 5 year old son. On an unknown date, the patient was vaccinated with M-M-R II (dose, route, lot # not provided). On an unknown date, 4 weeks after vaccination, the patient started having repeated, unspecified time duration of deep breathing when he was at rest. Moreover he was experiencing unspecified time duration of being agitated. The patient did not seek medical attention. The outcome of the events and suspect product was not specified. Additional information has been requested.
Epigastric pain. Gradual increase not relieved by TUMS or over the counter medication. I personally recognized the symptoms of a previous infection before felt the same to me, uncomfortable. Went to the doctor and got an EKG, blood work, and stool sample that indicated the infection, H pylori. At the time, stopped taking doxycycline and acyclovir. Also, gave me a T-dap at the time, 7/21/2021, 3 antibiotics and one other medication were given (Flagyl, Omeprazole, Amoxicillin, & Clarithromycin).  14 days for all medications. Feel a lot better and doing better, effective.
- Developed dry cough and cold-like symptoms  on 11 Feb 2023; tested neg by two Ag tests performed simultaneously.  - Awoke feeling worse, i.e. body aches, temp of 100.2, and excessive tiredness. Tested positive on 12 Feb by Ag test. Called physician's office; described systems & test results to on call doc and requested that Paxlovid be prescribed. He agreed. I started taking Paxlovid with the evening dose on 12 Feb.   - Temp normal 14 Feb.   - Symptoms fully resolved on 19 Feb. Tested neg by two Ag tests performed simultaneously.   - Returned to 20 Feb  - As of 07 April, no recurrence
Seizure (tonic/clonic) with fever approximately 8 hours after vaccination. Underwent full workup in ER. Received ceftriaxone x 1.
This spontaneous report was received from a nurse and refers to a 7 months old patient. No medical history, concurrent conditions or concomitant therapies were reported. On 24-SEP-2015, the patient was inadvertently administered with a first dose in the vaccine series of ROTATEQ orally (lot #, dose and anatomical location were not provided), when the patient was 34 weeks of age. No adverse effects were reported. Additional information has been requested.
I received the flu shot at 4 p.m. on wednesday, sept. 30.  I was ill at 3 a.m. with a severe stomach ache.  By afternoon on the 1st of oct., it then turned into full body aches, 100 degree fever, headache, and chills. At 6 a.m. on Oct. 2 the fever broke, and I was left with a headache, and body aches
allergic reaction, mild swelling of throat and tongue, roof of mouth itch. Started about 20 mins after injection. Sat in chair for 20 mins with no relief. Went home and took some Benadryl. Same allergic reaction (just mild) compared to latex/bananas, knew what to do.
I tested positive for COVID-19 on 8/23/2022. I had extreme high blood pressure had a terrible headache. I didn't think I had COVID at the time. I also had terrible congestion. I didn't have diarrhea, or any other symptoms. I received the infusion on 8/24/22, and it made me feel better within a day or two. They prescribed hydralazine, 2 times a day to bring down my blood pressure, and they recommended TYLENOL for the headaches.
had a sore arm; severe headache; dizziness; feeling like he can't get oxygen; achy all over; dry cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  An 11- year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date 07Dec2021 16:00 (Batch/Lot number: unknown) at the age of 11 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (1st Dose, Unknown Manufacturer.), for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Dec2021, outcome "unknown", described as "had a sore arm"; HEADACHE (non-serious) with onset 08Dec2021, outcome "unknown", described as "severe headache"; DIZZINESS (non-serious) with onset 08Dec2021, outcome "unknown", described as "dizziness"; DYSPNOEA (non-serious) with onset 08Dec2021, outcome "recovered", described as "feeling like he can't get oxygen"; PAIN (non-serious) with onset 08Dec2021, outcome "unknown", described as "achy all over"; COUGH (non-serious) with onset 08Dec2021, outcome "unknown", described as "dry cough". Therapeutic measures were taken as a result of pain in extremity, headache.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sore arm first three days . Headache first morning after.   Almost two weeks later soreness in arm returned.  Red rash circling the vaccine area. Still experiencing symptoms after  6 days
This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients "over 14 years of age" received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this female (age unknown) were reported to be  1) 16-AUG-2016 and 2) 23-DEC-2016. [These dates were as reported. Further clarification of dates is needed.]  No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
Approximately a few days after my 2nd booster (Dose 4) I experienced the following symptoms: Hip pain (Left hip). I called a doctor for consultation and was prescribed with a muscle relaxant and prednisone. It marginally helped with my condition but not as much. As of today 04/27/22 I still have the same symptoms but have not fully recovered.
2 days after receiving the flu shot, I was told my daughter (35 weeks gestation) was dead. I delivered her a day later (October 18)- the OB guessed she had died 3 days earlier, the day I had gotten the flu shot.
I was given the shot and the doc returned to the room in about ten min and I was in hives all over my body and was light headed. She then gave me a steroid shot and I then went home in about twenty min and I then took Benadryl. I still have hives but am feeling better.
The day after , around 12:55 pm I felt like I had electricity running through my arms and cheeks.  I wasn?t at home so I just went inside where it was air conditioned and sat down.  Drank some cold water. Symptoms lasted almost 2 hours .  I felt ok after that.
Patient received a Pneumovax 23 and her injection site swelled and required antibiotics.
pain in upper arm; coldness in extremeties; soreness; Achiness; Low grade Fever; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Feb-2021 and was forwarded to Moderna on 23-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in upper arm), PERIPHERAL COLDNESS (coldness in extremeties), PAIN (soreness), PAIN (Achiness) and PYREXIA (Low grade Fever) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in upper arm), PERIPHERAL COLDNESS (coldness in extremeties), PAIN (soreness), PAIN (Achiness), PYREXIA (Low grade Fever) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (pain in upper arm), PERIPHERAL COLDNESS (coldness in extremeties), PAIN (soreness), PAIN (Achiness), PYREXIA (Low grade Fever) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
About an hour after I received vaccination, I began feeling very nauseous. I then vomited three times. The nausea improved, but my equilibrium felt off for the rest of the night. Since the day of vaccination I have had involuntary muscle spasms that started the day after I received the vaccine and have not yet subsided.
pt started w/high pitch schrill cry & just couldn't quiet pt about 6PM; when breathing became irregular took to ER;
She stated that her arm was sore.  She said that she did not feel good.  Also said she slept rotten last night.  But is feeling better today.
Nauseous the afternoon of my shot. The following day I threw up ALL DAY (dry heaves, etc.).  I also had the worst headache I ever had. Also, weak.  No fever. This all lasted the entire day, Saturday. On Sunday, I was able to eat soup. However, I lost 2 pounds as a result of being sick!
This spontaneous non valid report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On an unknown date, the patient was vaccinated with improperly stored dose of PROQUAD lot # reported as N019282, expiration date 09-JAN-2019 and VARIVAX lot # N021581, expiration date 09-AUG-2019 (for both strength, dose number, route and anatomical location were not provided). The vaccines were reconstituted with properly stored sterile diluent (MERCK). Administered dose of PROQUAD and VARIVAX experienced the temperature excursion of -9 Celsius degrees to 8 Celsius degrees (also reported as 7.3 Celsius degrees) for 1 hour and 9 minutes. There were no previous excursions reported. The digital data logger was involved. No adverse effects were reported. Upon receipt of follow-up information it was determined that this case is now valid because the patient identifier was received. Follow up information has been received from a nurse on 12-JUN-2018 and refers to a 4-year-old patient. On 24-JAN-2018, the patient was vaccinated with improperly stored dose of PROQUAD lot # N019828 (previously reported as N019282) and VARIVAX. This is one of six reports received from the same reporter. Albumin status for measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live, for lot # N019828 has been verified as recombinant human albumin (rHA). Sender's Comments: US-009507513-1806USA007938: US-009507513-1806USA007939: US-009507513-1806USA007940: US-009507513-1801USA006139: US-009507513-1806USA007937.
Outbursts, Much Sleepier/lethargic, Sleeping longer periods, Jittery, Lack of appetite for solid foods, Periods of Crying for no reason in the floor, Fussiness, Screaming, Irritable, Severely Uncomfortable, Diarrhea for 2 days, Throwing things.
Aside from the typical Flu-like symptoms, very high fever, sore arm, etc.  Heart palpitations and shortness of breath began two days following the second dose of the vaccine.  My heart was racing and I was trying to catch my breath.  It was very intense for 2 days and has since subsided.
Fever around 101-102 with measles like rash. The rash started January 12th. Rash mainly on stomach, knees, neck and nose.
RUNNY NOSE, WATERY EYES ~2 HRS. AFTER SHOTS INCREASED HR AND BREATHING ~ 9 HRS. AFTER SHOTS LUMP SHOWED 24 + HOURS LATER. WENT TO E/R TUESDAY NIGHT -GIVEN BENADRYL.
Pain, swelling, erythema on left deltoid about 24 hours after immunization with DTaP. Positive low grade fever; 7cmx7cm swelling with induration.
concerns regarding sx's of "clammy, waves of hot flashes, night sweats, achy and no appetite". She has low grade fever of 99.6.
Syncope about 5 minutes after vaccination. Patient regained consciousness in a few seconds and appeared to be fine. EMS was called, evaluated patient, mother declined transport to hospital.
3 days after my 2nd Pfizer covid vaccine shot, I developed a rash on my leg while I got the shot in the arm.   The next 3 days the rash spread to my groin and lower back and went to urgent care.  2 different doctors examined me and both said I have Covid vaccine induced shingles.  It is painful and I have no knowledge of having chicken pox before.
Sore left arm; Nerve pain; Itching; shingles; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm), HERPES ZOSTER (shingles), NEURALGIA (Nerve pain) and PRURITUS (Itching) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, High cholesterol, Type 2 diabetes mellitus and Allergy to antibiotic. Concomitant products included METFORMIN, ATORVASTATIN, TELMISARTAN, ASPIRIN [ACETYLSALICYLIC ACID] and CARVEDILOL (COREG) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced HERPES ZOSTER (shingles). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore left arm), NEURALGIA (Nerve pain) and PRURITUS (Itching). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency; GABAPENTIN for Nerve pain, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Sore left arm), NEURALGIA (Nerve pain) and PRURITUS (Itching) outcome was unknown and HERPES ZOSTER (shingles) had not resolved. Not Provided          Treatment details include antiviral  drug as per his dermatologist. .   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Significant follow up
I tested positive for COVID-19 on 3/15/23. I had a scratchy throat, cough, congestion, and nasal drip, I just thought that I had a cold. I contacted my doctor and they insisted on me taking a COVID-19 test. They said they wouldn't be able to treat me without taking it, so I did. I got a call yesterday that it was positive. I was prescribed montelukast and promethazine. I am still dealing with my symptoms at this time.
Woke up in morning ~14d following my 2nd Pfizer COVID vaccine with fairly significant bilateral tinnitus. I am an otherwise healthy 32 y/o male with no relevant PMH and never with tinnitus prior to this. It continues to persist for 2 days. No other relevant sx to report. Seemed worthy of reporting given the likely timing of my peak antibody response at the 14d mark and general vaccine monitoring concerns of cross reactive antibody responses.
Severe muscle pain/stiffness in right side mid back, right thigh, right arm.