chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Felt lousy; Intense arm pain; Aches; Possible fever,; 2nd shot may have been compromised due to temperature issues; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a 58-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (1st dose was received on 15 June 2022 and she also had experienced pain and fever, kindly refer this case - US2023AMR018964) and Covid vaccine with an associated reaction of pain in extremity. Additional patient notes included Shingles does not run in her family.   On 24th October 2022, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling bad, pain in arm, pain, fever and incorrect storage of drug. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the feeling bad, pain in arm, pain, fever and incorrect storage of drug were unknown.   It was unknown if the reporter considered the feeling bad, pain in arm, pain and fever to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2023AMR018964   Additional Information: GSK Receipt Date: 03-FEB-2023 and 06-FEB-2023 Reporter's comments: The reporter had stated that, she had received two doses of the shingles vaccine. With both shots, she experienced significant side effects as intense arm pain, aches and a possible fever. The side effects for the second shot were a little worse than the first.  A month or so ago she was notified that her second shot might had been compromised due to temperature issues. They had advised her to take a third shot and were not interested in addressing her questions/concerns. She had asked, if it does the presence of virtually identical side effects indicated that there was a good chance, if the second shot was effective. She had asked, if it was it too late to take another shot.  She had asked that, was it safe to take a third shot and If she were to take it, then could she expect better, same or worse side effects. She said that, she never took her temperature to confirm if she had a fever, but she just felt lousy. She said the arm pain from Shingrix was not a big deal. She mentioned that she had experienced a sore arm when she had gotten a Covid vaccine. The reporter had consented to follow-up. Additional supportive information: This case was linked with US2023018204, which was reported by same reporter. The reporter was notified that her second shot might had been compromised due to temperature issues, which le to incorrect storage of vaccine.; Sender's Comments:  US-GSK-US2023AMR018964:Same reporter US-GSK-US2023018204:Same reporter
Deep itchiness unable to relieve via scratching beginning within minutes of vaccination and lasting for at least 5 days and resolved by taking TYLENOL. Over the last 2 days.
Pt vaccinated w/3 doses of Recombivax developed severe fatigue, malaise, arthralgia, myalgia, nausea, h/a;
covid positive on 7/7/22, prior to c-section delivery asymptomatic for covid
This spontaneous report was received from an office manager refers to multiple unspecified patients of unknown gender and age. Information regarding the patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapy were not provided. Reporter stated that on unknown dates, the patient may have been vaccinated with improperly stored doses of ROTATEQ (lot # L046320, expiry date: 29-SEP-2017; lot # L038536, expiry date: 19-AUG-2017. Reporter mentioned that the vaccine was exposed to 31.8 F for 62 hours. A data logger was used to record temperatures. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a physician via a field representative refers to a 18 year old female patient. Medical history and concurrent medications were not provided. On an unknown date the patient was vaccinated with GARDASIL 9. On an unknown date the patient experienced migraine and some redness and pain around the injection site. The outcome of the events was unknown. See case 1611USA000927 from the same reporter regarding the patient's 19 year old sister who experienced the same events. Additional information has been requested.
Lower backache; stomach cramps; headache; aching shoulders; fatigue; heartburn x 4 days.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a infant patient who received Hib (Hiberix) (batch number 242A7) for prophylaxis.   On 24-JAN-2023, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Shingle vaccine on yesterday, I am achy all over my body. It is constant. No pain. Started last night.  Worse No home treatment.  Headache started today.  Headache in fore of headache.pain level of  headache is 2-3, constant.Denies sob, chest pain or any other s/s at present.  Offered tylenol/NSAIDs
My skin turned red immediately after the injection.  The EMT Staff examined me and my pulse, temperature and blood pressure were normal.  After 45 minutes the redness abated and I came home,    1 March 2021 I came down with COVID symptoms with dizziness, blurry vision, redness, ringing in the ear and flu like symptoms of body aches.   Then the neuralgia in the dextral ulnar nerve increased and clawing started.  Then same happened on the sinistral ulnar nerve and Carpal tunnel in the other finders.  I feared going to sleep for fear of awaking with paralysis.  I drank vodka to calm myself down and Xanax to sleep (I know it is a dangerous combination).  2 March the red skin continues and when I awoke at 13:30 today I was still extreme and I called 911.  The EMS visited and determined my blood pressure and pulse were normal.  The dextral  ulnar nerve problems continue,
Slight fever, achy and stiff joints, difficulty regulating body temperature. Fairly significant fatigue. All my limbs felt like they each weighed 100 pounds.
Patient was vaccinated at our onsite clinic on 12MAR21 @ 0910.  Approximately 10 minutes after receiving the vaccine, she complained of a headache and an itchy throat.  She was evaluated by one of our registered nurses and given Benadryl 25 mg po.  She was monitored an additional 30 minutes.  At that time, she reported feeling better and denied worsening of itchy throat, mild headache continued.  She was instructed to follow up with our onsite nurse as needed.
Information has been received from a registered nurse concerning a 17-week-old patient who on 14-MAY-2007 was vaccinated with a first dose of Rotateq (Lot # 656389/0031U). No symptoms have been reported. No further information is available. There was no product quality complaint. Additional information has been requested. 08/31/07 This is in follow-up to report(s) previously submitted on 6/14/2007. Information has been received from a registered nurse concerning a 17-week-old patient with no pre-existing allergies, birth defects, or medical conditions who on 14-MAY-2007 was vaccinated PO with a first dose of ROTATEQ (Lot # 656386/0031U). There was no illness at the time of vaccination. Concomitant therapy that day included a second dose of DAPTACEL (Lot # C2628AA) administered IM, a second dose of IPOL (Lot # Z0548) administered IM, a second dose of ACTHIB (Lot # UE974AA) administered IM, and a second dose of PREVNAR (Lot # B08690C) administered IM. No symptoms have been reported. No further information is available. There was no product quality complaint. No additional information is expected.
tightness in neck, hives on buttocks; occurred 2 days p/2nd dose; 25FEB92 mailed request for addtl info; none returned; 6MAY92 2nd request for more info; none returned;
After both shots, the second on 1/27/21, I got a severe migraine within 2 hours that lasted 5 days. After day 5 the symptoms went away. During the time of the migraine I treated it with 2 doses of rizatriptan ODT per day.
Day 1 - 3 : Soreness & stiffness for 2.5 days following vaccination Day 4 -9 - no symptoms Day 10 - present: Rash near injection site, rash is warm to touch & itchy.  Soreness & slight swelling in the same area.
03/03/2021 in the evening after my shot, I felt completely fine up until the middle of the night. I woke up feeling pain from head to toe and thought that I was dying. Excruciating pain and got Advil. The morning after, I could not move my body because it was in such pain. I was shaking a lot as well and could not control it. This transpired for for a few days until I called my primary care. I was advised to drink a lot of water and Advil. The shaking got so bad that I couldn't write or feed myself. By around noon each day it was causing me a lot of pain. I drank a little bit of wine and it helped, it was odd because I do not regularly drink. During the summer time I was shaking and my daughter noticed this. I was then referred to physical therapy who then stated that I should get a referral to a neurologist after seeing my primary care again because cause of symptoms was still unknown. The symptoms were starting to decline and the neurologist believes that I may have been due to being given the second shot too soon. I am still shaky as it goes and my walking is still in need of physical therapy. I would say that I have about 60% improvement. I can now read a book again, paint, etc. however the symptoms are still there and impeded my quality of life. I normally would do 2 miles of walking in a park however, I cannot do this at the moment anymore. At the time I didn't think I could walk and I was simply shanking so hard for such a long time, which was noticeable to other people. Especially when I eat and I still need to do that now.
This case was reported by a healthcare professional and described the occurrence of a 63-year-old female subject not responding to therapy following vaccination with Engerix B for prophylaxis. Concurrent medical conditions included hypertension, lumbosacral disc disease, multiple sclerosis, optic neuropathy and osteoporosis. Concurrent medications included Altace, Zoloft, Calcium, Magnesium and Zinc. On November 1998, 9 April 1998 and 6 March 1998 the subject received 3rd dose, 2nd dose and 1st dose of Engerix B at 20 mcg to complete the three dose series. The subject was tested on 11 December 2006 and the titer was found to be negative. The subject had not responded to therapy with Engerix B given in 1998. At the time of reporting the event was unresolved.
Within 15 minutes after receiving the first vaccine shot I was I was lightheaded and had a metallic taste in my mouth. The metallic taste went away but I felt light headed until I fell asleep. At 2:00am  woke up with severe muscle aches all over my body. The next morning I woke up sweating, muscle aches, lightheaded, fatigue, and nauseated. I also had a headache but it was a different type of headache than I?ve ever had before, it felt like my eyes were going to pop so I decided to check my heart rate and blood pressure and both were high. My  blood pressure was 132/89, it is typically low (around 104/55). My heart rate was 109 and it?s typically in the 60?s or 70?s. I stayed with these symptoms until 04/17/2021. On 04/18/2021 I woke up for the first time since receiving the Covid-19 vaccine not sweating, hurting, and with a normal heart rate and blood pressure. As of today 04/25/2021 I am still dealing with fatigue.
Discharge Provider: DO Primary Care Provider: FNP Admission Date: 10/19/2022 Discharge Date: Oct 22, 2022  PRESENTING PROBLEM: Severe sepsis [A41.9, R65.20] Sepsis due to pneumonia [J18.9, A41.9] Community acquired pneumonia, unspecified laterality [J18.9] COVID-19 [U07.1]   HOSPITAL COURSE: Exceedingly pleasant 97 y/o community dwelling patient of Dr. was admitted on 10/19/2022 for bilateral community acquired pneumonia with associated severe sepsis.  The patient tested positive for COVID 19.  He had an elevated procalcitonin as well.  He was treated for both COVID 19 pneumonia and bacterial pneumonia.  He was unable to provide a sputum culture.  He improved with these treatments.  His sepsis resolved, and he had negative blood cultures.  He was deemed medically stable for discharge on 10/22/22.     He completed Remdesivir during this admission, as well as 4 days of Decadron.  He will not take Decadron after discharge, because he remained on RA during his admission and passed his home oxygen evaluation.     He was sent home on Ceftin 500 mg PO BID for 6 days and Doxycycline 100 mg PO BID x 6 days for a total time of 10 days of antibiotics for his pneumonia.  His WBC normalized.     The patient had history of a TURP and has mild LUT symptoms at home.  His UA was negative for infection.  His bladder scan was zero after he voided.  This is a stable comorbid issue requiring no medication.     The patient also had s/s of dysphagia related to GERD and was discharged home on Protonix 40 mg PO BID x 14 days followed by 40 mg daily for 30 days.  The patient should follow up with is PCP if this is unhelpful for possible EGD or UGI or further evaluation.     He is asked to follow up with is PCP for post-hospital follow up.
Initial information received on 22-Oct-2018 regarding an unsolicited valid serious case received from a physician. This case involves a 60 years old female patient who was administered one dose of TENIVAC, when she was meant to receive ADACEL and INFLUENZA VACCINE. The patient's past medical history, medical treatments, vaccinations and family history were not provided. On 22-Oct-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U5526AA via unknown route in the left deltoid. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. It was as actual medication error due to wrong drug administered. It was reported that no adverse reactions were found. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
I was light headed and body aches and fatigued. The body ache stopped the next day but I was still tired and little bit dizzy and a week later I had the worst feeling was really dizzy and tired and fatigued and pain in my body. I called my doctor and explained everything and they did the tests and thought I had vertigo and then they sent me to the ENT and they had me do the maneuver. It was not vertigo and then I got blood work done and everything was fine and then they felt like it might be related to the vaccine. I still have the dizziness and light headed. The doctors  recommend to try the Flonase and allergy medication.
Right upper arm with 10cm area observed to have erythema with nodular reactive mass to right deltoid; nontender.
feels nauseous.; This case was reported by a consumer via call center representative and described the occurrence of nausea in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced nausea. The action taken with Shingrix was unknown. On an unknown date, the outcome of the nausea was not recovered/not resolved.   It was unknown if the reporter considered the nausea to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The case was reported by patient. Patient received her first dose of Shingrix  few days ago. Patient states that she feel nauseous till the time of reporting. The reporter did not consent to follow-up.
rash developed on both forearms. Rosacia in face normal. no itching, no respiratory issues. Patient examined on upper body - no other rash found. Administered 25mg Benadryl, 40mg Pepcid AC - after 1 hr, rash gone. 51y/o male who stated he had a rash on Back and shortly after vaccination. No resp difficulties. No other complaints. No prior tx of allergic Rx Exam - 5% redness on post aspect of forearms No resp findings Plan- offered ED/urgent prefers to go home with observation Assessment - Mild Allergic Rxn-
Stroke; Graves' disease; AFIB; Shingles on her finger/underneath her nail; Shivers; Muscle pain; Felt sick to her stomach; Became very ill; Weakness; first dose of SHINGRIX about 5 years ago, and she has not yet received her second dose; This case was reported by a consumer via call center representative and described the occurrence of stroke in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the patient did not receive 2nd dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced stroke (serious criteria GSK medically significant), graves' disease (serious criteria GSK medically significant), atrial fibrillation (serious criteria GSK medically significant), shingles, shivers, muscle pain, upset stomach, illness, weakness and incomplete course of vaccination. On an unknown date, the outcome of the stroke, graves' disease, atrial fibrillation, shingles and incomplete course of vaccination were unknown and the outcome of the shivers, muscle pain, upset stomach, illness and weakness were recovered/resolved.   It was unknown if the reporter considered the stroke, graves' disease, atrial fibrillation, shingles, shivers, muscle pain, upset stomach, illness and weakness to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-Oct-2022 Reporter's comment: The reporter was the patient. The patient stated that she received her first dose of Shingrix about 5 years prior to the reporting, and she had not yet received her second dose. The patient stated she became very ill after receiving the first dose, which included shivers, muscle pain, weakness, and felt sick to her stomach. Since receiving her first dose of Shingrix, the patient had a stroke, graves' disease, diagnosed with atrial fibrillation, and had Shingles on her finger/underneath her nail. The reporter did not consent to follow-up. The patient did not wish to consent to follow up with Health-care professional. The patient did not wish to provide date of birth. This case was linked with case US2022148323, reported by the same reporter. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2022148323:Same reporter
Administered with vaccine that has been refrozen; A spontaneous report was received from a nurse concerning a 22-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered with vaccine that has been refrozen.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot: 025J20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 31 Dec 2020, the nurse reported she had been storing the mRNA-1273 vaccines at -20 degrees Celsius but discovered that prior to the vaccine administration facility receiving the vaccines on 24 Dec 2020, they had been stored at 38.2 degrees Fahrenheit at another facility. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered with vaccine that has been refrozen, was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 22 year old, female patient.  The patient's medical history is not provided.  The event occurred on 28 Dec 2020, when the patient was given the first dose of the mRNA-1273 (Lot: 025J20-2A). This report refers to a case of storage error where refrozen mRNA-1273 has been administered to the patient.
Vaccine was moved into the refrigerator on 10/28/22 and administered to the patient on 11/29/22; no adverse event; Moderna vaccine administered to patient after 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna vaccine administered to patient after 30 day use by date), PRODUCT STORAGE ERROR (Vaccine was moved into the refrigerator on 10/28/22 and administered to the patient on 11/29/22) and NO ADVERSE EVENT (no adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Nov-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna vaccine administered to patient after 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was moved into the refrigerator on 10/28/22 and administered to the patient on 11/29/22) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna vaccine administered to patient after 30 day use by date), PRODUCT STORAGE ERROR (Vaccine was moved into the refrigerator on 10/28/22 and administered to the patient on 11/29/22) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna vaccine administered to patient after 30 day use by date) and PRODUCT STORAGE ERROR (Vaccine was moved into the refrigerator on 10/28/22 and administered to the patient on 11/29/22).    No concomitant medications were reported. The vaccine was stored in the freezer upon receipt.  It was moved into the refrigerator on 10/28/22, giving it a beyond use date of 11/27/22.  The vaccine was administered to a patient on 11/29/22. The manufacturer date was reported as 3/11/22. No treatment medications were reported.
Continued soreness in arm.  Limited mobility due to pain.  Dr.-warm compresses IB.