chrisvoncsefalvay/vaers-outcomes huggingface dataset:
neck pain; neck stiffness / upper back stiffness; upper back pain; hand pain, finger pain; hand and finger numbness; soreness in her sternum; decreased neck mobility; clavicle burning sensation; soreness at her clavicle; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 13th October 2020, 1 days after receiving Shingrix, the patient experienced neck pain, stiff neck, back pain, pain in fingers, numbness in hand, sternal pain, mobility decreased, burning sensation and bone pain. The patient was treated with naproxen (Aleve) and lidocaine (Lidocaine Patch). On an unknown date, the outcome of the neck pain, stiff neck, back pain, pain in fingers, numbness in hand, sternal pain, mobility decreased, burning sensation and bone pain were recovering/resolving.   It was unknown if the reporter considered the neck pain, stiff neck, back pain, pain in fingers, numbness in hand, sternal pain, mobility decreased, burning sensation and bone pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that one day after receiving 1st dose of Shingrix, she experienced neck pain, neck stiffness, upper back pain, upper back stiffness, hand pain, finger pain, hand and finger numbness, soreness at her clavicle and soreness in her sternum.  The patient had been using Alleve and lidocaine patches, and at time of report events were slightly improving. The reporter did not consent to follow up.
Chills; Headache; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Body ache) 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 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Body ache). At the time of the report, CHILLS (Chills), HEADACHE (Headache) and MYALGIA (Body ache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Approximately 5 hours after my son, 6 weeks old at the time, had his wellness visit and all his vaccines, he started to sleep very heavily, he was unresponsive, he woke to projectile vomit and it was highly unusual, he was burning up with a fever (the fever was below the offices recommended rate at when you would bring him to the emergency room), he was having projectile diarrhea. He was obviously having severe reactions to the vaccines, I didn't know it until I asked fellow mothers who have gone through this same experience. I called the emergency line at approximately midnight, nearly 10 hours after the vaccines, at this point he was not waking up without me forcefully waking him so he wouldn't fall into a deep sleep, at times he would not wake up even to me saying his name and gently nudging him and patting his back, etc, he is an exclusively breast fed baby that has ALWAYS nursed on demand, he has ALWAYS woke every 2 hours to nurse, this is how I knew immediately that something was very, very wrong during the first 5 to 10 hrs, when I got through to the emergency doctor on the emergency line, she shrugged off all my concerns, she told me THIS WAS NORMAL, she said I was a "first time mom" and that I was over reacting and panicking for no reason etc, I told her this is not normal and I know my son's patterns, behavior, and his routine. She told me to give him Tylenol which is known to cause more extreme and adverse side effects after vaccines. I told her it didn't seem right, she told me to do it and he would be fine, I did not give him Tylenol because his immune sytem would not be able to fight the fever or clear the new toxins present if I gave him that dose of Tylenol as she suggested. They still have that recording and I will ask them to pull that recording if need be, to prove that this doctor dismissed these huge issues, she downplayed his adverse reactions to the vaccines, she mocked me, then proceeded to tell me she's "been doing this for 40+ years" that she knows what she's talking about, etc.. I did not bring my son to the E.R., I nursed him and I stayed away the entire week, I did not sleep, because I knew if I slept that my son would not wake back up ever again, he was very close to death after these vaccines, it took a full week for him to slowly come back to normal, he would not look us in the eyes like he did prior to the vaccines, he was groggy and zombie like, he was sluggish and unresponsive, he would do blood curdling screams towards the end of the week, as if he was in pain, my poor son went through more than any child should endure at the young age of 6 weeks, it's sad our family went through this and my son endured this after we knew that this seemed wrong.
The vaccination given was the DTap + Polio - unsure of the manufacturer. This was to be the final shot in the series. Approximately 48 hours after injection, the injection site became red and raised. The diameter of the affected area was approximately 4". Additionally, the patient's hand developed what appeared to be large hives across the fingers and knuckles with an additional inflamed area on the right forearm, approximately 1" in diameter. The hives did not itch or hurt but the fingers and knuckles appeared red and swollen. The affected area was warm to the touch. Symptoms continued for 9 days, until oral BENADRYL was administered over the course of 48 hours. The inflammation resolved as of day 12, however the red patches have turned brown and the skin has begun to peel.
Within 5 hours of the YF vaccine on 5-9-02, pt experienced blurry peripheral vision.  Pt later went on to experience insomnia, dizziness, heart racing upon exertion, and bliateral limb weakness noted by ID doctor on 5-31-02.
Case number PHEH2014US022006, is an initial spontaneous report from a pharmacist received on 31 OCT 2014. This report refers to a 51-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUCELVAX (batch number: 161281) subcutaneously on 31 OCT 2014. No adverse event reported. No further information provided.
Initial information received on 28-Jan-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 24 years old female patient who was received vaccine ADACEL lot number U6141AB (Expiry date 15-Dec-2020) via intramuscular route in the left arm on 27-Jan-2019, while she was pregnant. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was case of vaccine exposure during pregnancy. The patient was 24 months pregnant when she received vaccine. It was reported that no adverse reaction was experienced. Pregnancy outcome was unknown at the time of report. List of documents held by sender- none.
Pressure under the left eye, headache (day 1) diarrhea/loose stoole daily for 2 weeks
Swelling, hotness and itchiness at the injection site appeared 8 days after the injection. The swollen bump is about one inch in diameter.  Discoloration (redness) is minimal but yes, present.
This is a spontaneous case, reported by other non-health professional (consumer) on 22-Oct-2018, concerns a female patient of unspecified age. The patient's current condition included egg allergy. It was reported that, the patient had a bad egg-allergy, she could not eat cooked egg, but only in small amounts (for e.g. she could not eat angel cake or cheese cake because it had too much egg in it and if she ate egg that was barely cooked her throat stared to close). On 29-Dec-2017, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 195244 and expiry date: 30-Jun-2018]. On the same day, after vaccination, the patient developed flu-like symptoms which included sickness and body aches. Additionally, the patient experienced localized swelling. It was reported that, the patient's symptoms were not severe. The patient believed that, these were the normal adverse reactions from the vaccine rather than the egg allergy. On 31-Dec-2017, the patient had recovered from the events flu like symptoms and localized swelling. The reporter assessed this case as non-serious and considered the causality of the events as related to the suspect vaccine. Follow-up report received on 05-Nov-2018: The suspect product was changed from 'INN Flu Vaccine Seasonal' to 'FLUCELVAX QIV'. Added vaccination date as 29-Dec-2017, batch number as 195244 and expiry date as 30-Jun-2018 in the product tab. The new events 'localized swelling' and 'body aches' were added in event tab. The onset date of the event 'flu symptoms' was updated as 29-Dec-2017. The narrative was amended accordingly. Follow-up received from the reporter on 27-Nov-2018: The case was downgraded from serious to non-serious. The reporter confirmed that, she experienced flu like symptoms and onset date of the event was 29-Dec-2017. The LLT for the event flu symptoms was changed to flu-like symptoms. The narrative was amended accordingly.
I HAD THE VACCINE WITH NO ILL EFFECTS, ACTUALLY DIDN'T FEEL THE INJECTION AT TIME OF ADMINISTRATION. I AWOKE AT 2AM IN SEVERE PAIN FROM MY ENTIRE RIGHT ARM, MY HAND WAS STIFF ALSO, THE PAIN SPREAD TO MY RIGHT CHEST AND RIBS. THE FOLLOWING DAY I DEVELOPED A FEVER OF 100 DEGREES AND MY SPINAL COLUMN WAS PAINFUL. I TOOK TYLENOL FOR TWO DAYS, DEVELOPED UPPER RESPIRATORY COUGH AND HARSH FREQUENT SNEEZING WITH  COPIOUS AMOUNTS OF CLEAR PHLEGM.  I ALSO HAD A HEADACHE AND HAD TO MISS WORK ON 1/20/21. MY SYMPTOMS TAPERED AWAY THE FOLLOWING EVENING AROUND MIDNIGHT. THE ENTIRE COURSE OF SYMPTOMS WAS FROM 1/20 AT 2 AM UNTIL MIDNIGHT ON 1/22. SINCE THAT TIME I HAVE FELT WEAKER AND CHILLS OCCASIONALLY WITH NO FEVER.
fever, headache, chills, body aches--alternating tylenol and Ibuprofen, rest, staying hydrated   x 2 days
Rt. arm sore and range of motion was linited. Arm was throbbing.
Approximately 45?60 minutes after being given the injection my heart started to race,  I became very SOB  and I felt as if I might pass out while driving my car. I pulled over and called 911. Few minutes later I canceled squad because I was feeling much better. Started driving again and the same type episode happened again, I drove approximately three minutes to the fire house that I was close to. Was there approximately an hour being monitored before having my dgt drive me to near by ER.. I had four of these episodes in approximately an hour and a half time. During each time the symptoms became less intense,  My heart rate while having one of these episodes at the fire house went go up into the 120s and my blood pressure elevated to the 200s over 100?s. This is all very abnormal for me.  I have not told many people about my experience because I do not want to deter others from getting the vaccine. My primary reason for reporting this is because I want guidance regarding getting my next dose. I am a nurse, I work for hospice and really want to receive my second dose. Just would like  guidance. I have read that side effects increase with second dose. Other than the initial effects of the dose I?ve had no other adverse side effects. Any guidance you can give me would be greatly appreciated.
My arm became very hot later in the night and then my face got really hot and when I woke up my face was swollen like I had a mild reaction
After the Vaccine. On the third date, April 13th 2:15pm  my left side hand and leg feel numbness. On April 14th, my right side hand starts numbness. I went to see doctor on April 15th, Dr took blood works and schedule a CT scan on April 20th. On April 21st my left side hand and leg feel more numbness than before.  I took a  Tylenol at 9:35pm on April 21st.  And When I wake up this morning which is April 22rd my right side head feel pain and I feel I can't walk straight.  Then I took another Tylenol at 9:35 am on April 22nd.  My head is painful and I feel dizzy.
Sick; This spontaneous case was received on 24-Oct-2020 from other non-health professional via Agency (reference number: SEQW20-04206) and concerned a female patient of unreported age. At the time of initial report, the patient was 73 years old.  The patient's medical history and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified, dose, anatomical location, route of administration and indication: not reported). The batch number was not reported.  On the same day, the patient was vaccinated with non-company co-suspect shingles vaccine (varicella zoster vaccine rge (cho), dose, anatomical location, route of administration and indication: not reported). The batch number was not reported.  On an unknown date, unknown amount of time after receiving vaccines, the patient became sick.  On an unknown date, four weeks after the onset, the patient recovered from the event.  The reporter did not provide causality assessment.  This case is linked to the case 202005444 (same patient).  Company comment: The event of 'sickness' is considered as related to influenza virus vaccine polyvalent.; Sender's Comments: The event of 'sickness' is considered as related to influenza virus vaccine polyvalent.
Initial information received on 09-Aug-2018 regarding an unsolicited valid non-serious case received from Physician. This case involves a 16 years old male patient received vaccine MENACTRA. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication not reported. On 09-Aug-2018, the patient received a Booster dose of suspect Meningococcal A-C-Y-W135 (D Conj) Vaccine, lot U6016AA (expiry date: Oct 9 2019) via unknown route in left deltoid. It was a case of actual medication error due to product storage error. MENACTRA was ordered from pharmacy and administered after delayed delivery over 24 hours. The products have been too long in transit. 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.
Hearing loss and a clogged, stuffed feeling in the left ear.  Significant level of tinnitus in the left ear.  It came on suddenly in the evening 3 days after receiving the vaccine.  Saw an ENT the following morning (April 12, 2021) who cleared the ears of wax and performed a hearing test.  Diagnosed 50% loss of hearing in the left ear.  No fluid in the ear or any explanation readily available.  He diagnosed sudden sensorineural hearing loss.   He prescribed Prednisone, Valtrex and N-Acetyl_L-Cysteine to begin immediately.  He referred patient to a specialist who patient saw on 4/16/21 at 4pm.  Doctor performed another hearing test that confirmed hearing loss and tinnitus in the left ear.  The test showed perhaps slight improvement in hearing but not in level of tinnitus. Doctor injected steroids directly behind patient's left eardrum during the visit and Patient is scheduled for follow up injections on 4/23/21 and 4/30/21.   patient was directed to continue taking all the medications prescribed by doctor on 4/12/21 (prednisone, valtrex and N-Aceyle-L-Cystine)  Patient is scheduled for an MRI of his internal auditory canals on 4/21/2021 which was  ordered by doctor.
Patient presents for pre-syncope and then subsequent development of chest pain. She was in therapy when she had to use the restroom. She was urinating and having a BM when she suddenly felt extremely lightheaded as though she were about to lose consciousness. She did not thankfully lose consciousness, but rather rapidly developed chest pain after this event. She was brought to ED for evaluation. COVID screen in ED is positive. She was infected with COVID in November, 2020. She has since had a negative COVID screen. She is now positive again >90 days after first positive test, thus this will be treated as a new COVID infection. Place in negative pressure room. I am inclined to begin. Remdesivir as patient is always at high risk for progression to severe disease.  11/11/2020 positive COVID-19 2/13/2021 negative COVID-19 3/29/2021 positive COVID
Hospitalized 2/1/22-2/5/22 cough, dizziness, headache, diarrhea, tightness in chest, sore throat, chills, epigastric pain, hypoxia, PNA,  respiratory failure, decreased appetite, SOB
This spontaneous report was received from a registered nurse refers to a 68 year old patient (gender unknown). On 20-APR-2010 the patient was vaccinated with dose 1 of ZOSTAVAX 0.65 ml, subcutaneously (lot# 665513/0146Z, expiry: 21-APR-2011). On 15-NOV-2014, the patient was inadvertently vaccinated with second dose of ZOSTAVAX (administration details not specified) at the pharmacy. No adverse effects reported. No medical attention sought. Additional information has been requested.
Fatigue, muscle joint pain, dizziness, memory loss, black outs, chest pain with activity, shortness of breath, small red blisters on skin that pop and bleed. Symptoms have come and gone over the past 8 years. The fatigue and muscle, joint pain are the most common reocurrences. I have been to many doctors over the past 8 years without anyone being able to help.
8 days post vaccination I developed a localized reaction at the injection site. The area was erythematous, warm to the touch, and swollen. It is not painful, no drainage or other symptoms of infection. I went to my PCP who said it looked like a localized reaction to vaccine. She suggested ice to reduce swelling and Benadryl and Motrin as needed. She prescribed me cephalexin 500 mg if symptoms do not improve or worsen.
Temperature excursion and administered to patient; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 41-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43JH7, expiry date 23rd November 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th April 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 13th April 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was 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: 14-Apr-2022 Reporter's comments: The healthcare professional reported that Boostrix had undergone a temperature excursion and the vaccine was administered to the patient on the same day. The patient had not experienced any adverse events.  The reporter was with provided telephone number for Medical Information for future reference. The reporter disconnected call whilst transferring to Medical Information. Additional Supportive Information: The patient received Boostrix which undergone temperature excursion, which led to incorrect storage of drug. This was 1 of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022065217:Same reporter. US-GLAXOSMITHKLINE-US2022065218:Same reporter. US-GLAXOSMITHKLINE-US2022065221:Same reporter.
Her husband has been having issues with tiredness and redness after the vaccine; Her husband has been having issues with tiredness and redness after the vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ERYTHEMA (Her husband has been having issues with tiredness and redness after the vaccine) and FATIGUE (Her husband has been having issues with tiredness and redness after the vaccine) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Her husband has been having issues with tiredness and redness after the vaccine) and FATIGUE (Her husband has been having issues with tiredness and redness after the vaccine). At the time of the report, ERYTHEMA (Her husband has been having issues with tiredness and redness after the vaccine) and FATIGUE (Her husband has been having issues with tiredness and redness after the vaccine) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Dosage text reported as unknown. No treatment information was reported.   Reporter did not allow further contact
There were periods of fussiness, uncomfortableness, changes in behavior leading up to Sunday, September 5, 2021, at 4:00pm when he refused any more milk and spit up every couple hours into the next morning, along with periodic pain and crying, until fully throwing up the next morning Monday, September 6, 2021 at 6:00 am. Went to change his diaper and discovered mucus-like, bloody diarrhea. Rushed him to the emergency room and there he underwent various tests including, blood test, ultrasound, and X-ray. After testing it was concluded the symptoms were the result of intussusception. We were then rushed by ambulance and admitted to hospital. First an air enema was attempted and unsuccessful as the blockage was too severe. Surgeon went in laparoscopically to untangle intestines and discovered intestines lost blood flow and cells were damaged and that portion needed to be removed.
This spontaneous report as received from a now 77 year old female physician refers to herself. The patient's medical history included sleep apnea, heart failure, history of tuberculosis, the patient had a history of agitation and vomiting after amiodarone use, also had a history of blindness for 4 hours after nitroglycerin (manufacturer unknown) use. Approximately in March 2007 ("7 years ago") the patient was vaccinated with a dose of VARIVAX (merck), lot#, expiration date, dose not reported, intramuscular. Concomitant therapies included CARDIZEM, COUMADIN and ATACAND. On an unknown date after vaccination, the patient developed fever of 102F, and also redness and a little bit of pain at the site of VARIVAX (merck) injection. She recovered 3-4 days later. The patient had 3 separate strokes between about "2-5 years ago". The patient was hospitalized each time. The patient was still recovering from these strokes. Blood tests were performed and no results were provided. Upon internal review, strokes was considered as medically significant. The patient had a history of blindness for 4 hours while on prior therapy with nitroglycerin (manufacturer unknown) (captured in MARRS #1403USA009381). Additional information is not expected.