chrisvoncsefalvay/vaers-outcomes huggingface dataset:
present to ED due to generalized fatigue.  Patient is disabled at baseline due to his prior neurologic injury and is cared for by his wife at home.  Patient's wife reports the patient is becoming less responsive at home and is having difficulty with his ADLs.  Patient is significantly weak and is sleeping most of the day.  Patient's wife reports that he has been developing a cough over the last 4-5 days which is nonproductive as well as some nonbloody diarrhea for the past 2 days.  Patient's wife denies any blood in the stool or any other significant changes. Patient's daughter recently tested positive for COVID and was last around patient about 7 days ago.  Patient has been afebrile at home.  Patient has not been eating or drinking over the last 24 hours.  Patient is afebrile on arrival, normal vital signs, mild hypertension.  Patient does appear to be significantly fatigued with a GCS of 13 patient will wake up and follow commands when prompted.  Patient appears mildly volume depleted.  Laboratory results demonstrated no significant abnormalities.  Patient's COVID test is positive.  ER gave IV fluids, IV Toradol, IV Zofran, oral Tylenol with minimal relief of symptoms.  Patient is debilitated at baseline and patient's wife is concerned about his worsening status at home.  Patient continues to saturate well on room air but is able to tolerate by mouth. Patient denies palpitations, chest pain, shortness of breath, decreased UOP or diarrhea. Patient admitted to hospital medicine for medical management in setting of COVID-19 infection, decreased PO intake and generalized weakness.  Hospital course:  Acute COVID-19 infection complicated by acute respiratory failure O2 saturation <94% on room air, required oxygen briefly meets criteria for dexamethasone and remdisivir. Started both 8/9  Continue supportive care with tylenol as needed  Discharge Disposition/Condition Disposition: Home Condition: Stable (s/sx potential problems absent or manageable)
Pfizer bivalent SDV received on 2/3/23. Patient received vaccine on 2/6/23. On 2/9/23 clinic received notification that the product is bad due to temperature excursion. Vaccine was being delivered during bad weather/ice storm. Spoke with Pfizer Medical Information and told to follow CDC guidelines for revaccination. Revaccination due immediately. Parent of patient contacted with this information.
Information has been received from a Registered Pharmacist concerning a 3 year old child who on unspecified date was vaccinated with a dose of PNEUMOVAX 23 accidently instead of the flu vaccine. The wrong vial was grabbed, medical error. The patient was not experiencing any known symptoms. Additional information has been requested.
This spontaneous report as received from a certified medical assistant refers to multiple unspecified patients of unknown ages and genders who on an unknown dates were vaccinated with improperly stored dose of VARIVAX (Merck) (dose, lot #, expiration date and route were not reported). No adverse effects were reported. It was unknown if the patients sought medical attention. This is one of several reports from the same source. Additional information is not expected because the physician cannot be contact.
General joint pain in days following initial dose. Has persisted specifically in left hip since first injection, going on two months. Ran 20-25 miles per week prior to vaccine. Can no longer run due to hip pain.
Initial unsolicited report received from the literature on 21-FEB-2018. The following is verbatim from the article: Abstract: Reports of myocarditis and pericarditis following smallpox vaccination in adults suggested a need to assess inflammatory cardiac disease risk among adults who receive live viral vaccinations. From 1996 through 2007, among 416,629 vaccinated adults in the Vaccine Safety Datalink, we identified one probable pericarditis case and no cases of myocarditis in the 42 days following a live viral vaccination. Our self-controlled risk interval analysis found that, based on one case identified during the risk interval and 10 cases during the control interval, there is no increased risk of myopericarditis in the 42 days following vaccination (IRR, 0.57; 95% CI, 0.07, 4.51). Our study suggests that the occurrence of myopericarditis following live viral vaccination is rare with an estimated incidence of 0.24 per 100,000 vaccinated, which is not higher than the background rate and is much lower than the incidence rates reported following smallpox vaccination. This case involves a patient (age and gender unknown) who was vaccinated with a dose of YELLOW FEVER VACCINE, INFLUENZA VACCINE, TD vaccine and MENINGOCOCCAL VACCINE, POLIOMYELITIS VACCINE (INACTIVATED) and HEPATITIS A VACCINE (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown dates for all vaccines. Patient's medical history was not reported. Concomitant medications were not reported. On an unknown date, 42 days post vaccinations, patient developed probable pericarditis. Lab tests and corrective treatment were not reported. Outcome of the event was not reported. Upon internal review, the company decided to consider the event serious because of important medical event: probable pericarditis. Documents held by sender: none. Sender's Comments: Time to onset was compatible. No information regarding product name, lot number, medical history and condition at the time of vaccination was not reported. Patient received multiple vaccines. There is a possibility of underlying infection that pre dates vaccinations. Lab tests confirming the diagnosis and ruling out alternate etiologies must be provided. Due to vaccination with multiple products the role of one vaccine cannot be assessed.
a lot of chest pain; blurry vision; shortness of breath; though she was going to die; got really really cold; pain on the chest and radiating to the neck, down the arm got worse after the vaccine; Palpitations; does not want to take the second dose./ first dose of the Moderna COVID-19 vaccine on 13Jan2021; decrease in taste; brain fog; swelling of the lymph nodes under the arm and the breast; got really really hard chills; body aches; severe headaches; nausea; extreme fatigue; feverish; This spontaneous case was reported by a nurse and describes the occurrence of CHEST PAIN (a lot of chest pain), VISION BLURRED (blurry vision), DYSPNEA (shortness of breath), FEELING ABNORMAL (though she was going to die) and NASOPHARYNGITIS (got really really cold) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (a lot of chest pain), VISION BLURRED (blurry vision), DYSPNEA (shortness of breath), FEELING ABNORMAL (though she was going to die), NASOPHARYNGITIS (got really really cold), CONDITION AGGRAVATED (pain on the chest and radiating to the neck, down the arm got worse after the vaccine), PALPITATIONS (Palpitations), PRODUCT DOSE OMISSION ISSUE (does not want to take the second dose./ first dose of the Moderna COVID-19 vaccine on 13Jan2021), TASTE DISORDER (decrease in taste), FEELING ABNORMAL (brain fog), LYMPHADENOPATHY (swelling of the lymph nodes under the arm and the breast), CHILLS (got really really hard chills), MYALGIA (body aches), HEADACHE (severe headaches), NAUSEA (nausea), FATIGUE (extreme fatigue) and PYREXIA (feverish). At the time of the report, CHEST PAIN (a lot of chest pain), VISION BLURRED (blurry vision), DYSPNEA (shortness of breath), FEELING ABNORMAL (though she was going to die), NASOPHARYNGITIS (got really really cold), CONDITION AGGRAVATED (pain on the chest and radiating to the neck, down the arm got worse after the vaccine), PALPITATIONS (Palpitations), PRODUCT DOSE OMISSION ISSUE (does not want to take the second dose./ first dose of the Moderna COVID-19 vaccine on 13Jan2021), TASTE DISORDER (decrease in taste), FEELING ABNORMAL (brain fog), LYMPHADENOPATHY (swelling of the lymph nodes under the arm and the breast), CHILLS (got really really hard chills), MYALGIA (body aches), HEADACHE (severe headaches), NAUSEA (nausea), FATIGUE (extreme fatigue) and PYREXIA (feverish) 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.   no concomitant medicication was reported no treatment drug was reported   Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: Significant FU received on 07 Sep 2021 includes. New events are added Feeling abnormal, taste disorder, fatigue, pyrexia.
Information has been received from a nurse practitioner concerning a female who on an unspecified date was vaccinated with the first dose of GARDASIL (lot # was not available). Per nurse practitioner, the patient passed out and had a small seizure for 30 seconds after receiving the first dose of GARDASIL about 2 weeks ago. To date, patient only received the first dose of GARDASIL. No further information provided. It was reported that hepatitis B virus vaccine (unspecified) and TB test on the day that the patient is supposed to get the second dose of GARDASIL but the patient refused to receive the second dose. Upon internal review, "small seizure" was determined to be an other important medical event. Additional information has been requested.
Myalgia, right leg, upper portion, pain centered ~ 6 inches below hip and radiating up/down along the muscle. Received shots on Tuesday afternoon (12/07).  That day, worked out as usual (cardio, wallyball).  Went to bed feeling great. Woke up Wednesday morning (12/08) with pain in the right leg that made it difficult to get out of bed, stand, sit, etc. Pain continued at same level for three days. Went to sleep Friday night (12/10) with the pain. Woke up Saturday morning (12/11) and noted that pain had mostly disappeared.
injection site reaction (redness, swelling) --- still has it,  apply cold compress / ice and monitor
Administered 2 liquid components of Menveo; Administered 2 liquid components of Menveo; This case was reported by a nurse via call center representative and described the occurrence of inappropriate reconstitution technique in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA762A, expiry date 30th November 2023) for prophylaxis.   On 14th November 2022, the patient received Menveo. On 14th November 2022, unknown after receiving Menveo, the patient experienced inappropriate reconstitution technique and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate reconstitution technique and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-Nov-2022 Reporter's Comments  Nurse reports that a staff member inadvertently administered 2 liquid components of Menveo vaccine instead of 1 liquid reconstituted with 1 powder vial.   At the time of reporting, the dose had not been repeated. Additional Supportive Information: the patient inadvertently administered 2 liquid components of mennveo vaccine instead of 1 liquid reconstituted with 1 powder vial, which led inappropriate preparation of medication and inappropriate dose of vaccine.
mom states had a rxn to last shot APAP given a/vax but still ran fever >104;pt cried nonstop for over 2hr;had a knot fifty cent size & big as a golf ball on rt leg;it was red, hard, swollen up;taken to & treated @ hosp;
Rippling effect down her neck; Pain in her upper shoulder; This spontaneous case was reported by a consumer and describes the occurrence of RIPPLING MUSCLE DISEASE (Rippling effect down her neck) and ARTHRALGIA (Pain in her upper shoulder) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 060F22A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Flu shot . Past adverse reactions to the above products included No adverse event with Flu shot .    On 14-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced RIPPLING MUSCLE DISEASE (Rippling effect down her neck) and ARTHRALGIA (Pain in her upper shoulder). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency; NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RIPPLING MUSCLE DISEASE (Rippling effect down her neck) and ARTHRALGIA (Pain in her upper shoulder) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient had received 5 doses of the Moderna COVID-19 vaccines on: Dose 1: 20JAN2021, lot number 012120A Dose 2: 17FEB2021, lot number 016M20A Dose 3: 1NOV2021, lot number 939904 Dose 4: 12MAY2022, lot number 004M211A. Following the first dose of the vaccine she noticed a rippling effect down her neck and onto her shoulder without pain. That did not occur with doses 2-4 however it had returned following dose 5.  That rippling effect was now associated with pain in her upper shoulder which had continued since April. Initially she had been taking Aleve and Tylenol for her symptoms which seemed to not help. She stopped using these medications and was instead using ice 2 times daily on her shoulder to help with the pain. Currently she takes some Aleve before she goes to sleep to help with the pain. She spoke with her HCP who seemed unfazed by her symtpoms. Because that had persisted so long, they agreed to schedule an MRI for October.   This case was linked to US-MODERNATX, INC.-MOD-2023-737042 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737042:Same patient (Dose 5)
This case was reported by a pharmacist via sales representative and described the occurrence of injection site blisters in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On 11 November 2013 the subject received unspecified dose of FLULAVAL (unknown details). On 11 November 2013, immediately after vaccination with FLULAVAL, the subject experienced injection site blisters (described as "blistering"). At the time of reporting the outcome of the event was unknown. The pharmacist reported other cases with FLULAVAL. See cases A1052878A and A1052877A for details.
In January I was given the first two doses of the COVID-19 Pfizer vaccine, and in May I started with irregular menstrual periods. In November I am given the 3rd Pfizer Dose at Pharmacy and I start with palpitations.
Breakthrough bleeding 4 month postpartum three days after the second Covid dose. Followed by anxiety and decrease milk supply. Milk supply better after a couple weeks. Anxiety still happening. No more bleeding
Woke up early the next morning and head felt like it was going to explode. Felt very weak, lots of fatigue, achy, fever, pain at the back of the neck. Site of injection was hard, red and lumpy. Has noticed extreme tiredness since then that has not resolved. Went to ER because it felt like she had COVID again. Determined her antibodies were low. Vision affected after pink eye which turned into a virus. Was given Valacyclovir.
L arm SQ where PPV23 was administered became painful, hot, red, raised, arm was very painful to move. Pt showed photos of raised red weal extending from just above elbow to the middle of back of upper L arm. Resolving slowly. Pt reports used ice on/off some for relief.
4 hours after administration of noticed his face had become numb and his lip was not "moving as it should."  Rt side of face was affected, His blood pressure was elevated at 160/110 at noon.  Only other symptom was his arm hurt "alittle."  States symptoms are improving and minimal over the weekend.  He has noticed them getting  worse when he needs to talk alot or with his mask rubbing on his face.   Does report his BP has remained elevated and he continues to check each day.  Today was 120/95.   Does report drinking alot of coffee.
Currently pregnant and due June 19, 2021.  Experiencing: pain at injection site, body aches, lethargy, low-grade fever
Approximately 4 days after receiving the booster, the soles of my feet became intensely itchy, so intense that I was awakened from sleep. There was no rash or anything visible at the time, and the itchiness subsided. The following days, I would have intense itchiness at random places on my body, but again there was no rash or anything visible. 9 days after receiving the booster, my back broke out in a rash which was unbearably itchy. I took Xyxal and applied Benedryl cream to the rash which helped somewhat. The following day, I began getting hives on my ribs and armpit area, in addition to the rash that was on my back, which spread to my neck. Every day since then, I have had hives and the rash appearing in different places on my body - mainly on my truck (back, neck, ribs, abdomen, and around my bra line). Today I had the itchy rash appear on the backs of my hands. Taking Xyxal daily in addition to applying Benedryl cream to the rash and hives relieves most of the itchiness and fades the rash and hives somewhat, but as soon as the medication wears off, the rash, hives, and itchiness return. I have also noticed the rash and hives are the most red/angry following my shower.
Patient was given the first dose of shingrix on 02/18/19 lot# JE45P and the 2nd on 5/9/19.  Pt started having pain in her LUQ on 5/28/19, she came the clinic on 6/5/19 for the pain.  She had labs and CT scan of her abd, all were normal.  Pt then came back to the clinic on 6/10 with pain around her L rib cage and was told to try aleve  2 bid and ice.  Pt called back on 6/17/19 with buring, tingling pain the the same LUQ, she was given valcyclovir  1gm TID for 7 days with some lidocaine patches.  Pt is still having the pain as of today 10/24/2019.  She was diagnosed with shingles.
Common side effects began within a couple of hours - headache, muscle/joint pain - 24 hours later the rash appeared from neck to upper legs
Syringe injected into deltoid nurse thought needle broke.  Patient complained of pain at site.  Site red, ambulance called and patient taken to emergency room. Health notified.
Initial report was received on 30 March 2011 from a consumer who is also the patient's parent.  A 23 year-old male patient (24 years-old at the time of the report) had received in November 2009 an intramuscular deltoid injection of H1N1, lot number UP019AA (exact site and date of administration not reported) and one to two days later, experienced horrible injection site pain ("like nerve pain"), trouble standing, joint pain, he was tired and debilitated.  He appeared to be sad and complained of terrible headaches and pain in the eyes with sensitivity to light.  The patient began to have "seizures" with reported shaking that started at the injection site arm and moved to the other extremities.  Diagnostic tests included a CT scan, MRI and blood test all were reported to be normal.  He was evaluated by a neurologist.  The patient was diagnosed with chronic fatigue.  Treatment medications and concomitant medications were not reported.  The patient has a history of Down's syndrome, mitral valve regurgitation and had open heart surgery twice once at the age of five months and last in 1999.  Adverse events following prior vaccinations and illness at the time of vaccination were denied.  No further information was available at the time of the report.  The patient's outcome was reported as not recovered.  Documents held by sender: none.
Dizzy; trouble speaking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; SPEECH DISORDER (non-serious), outcome "unknown", described as "trouble speaking".  Additional Information: Caller says he called about the corrupt COVID vaccine, his own mom is dizzy and having trouble speaking etc and they didnt make it a liability, and if she dies he is coming after (withheld), his mom was healthy, she was fine.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.   Follow-up (19Jan2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
productive cough; feeling completely sick; Diagnosed with Covid-19; Fever; nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Diagnosed with Covid-19), PRODUCTIVE COUGH (productive cough), MALAISE (feeling completely sick), PYREXIA (Fever) and NAUSEA (nausea) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced PYREXIA (Fever) and NAUSEA (nausea). On 07-Apr-2021, the patient experienced COVID-19 (Diagnosed with Covid-19). On 09-Apr-2021, the patient experienced PRODUCTIVE COUGH (productive cough) and MALAISE (feeling completely sick). The patient was treated with ALBUTEROL [SALBUTAMOL] on 09-Apr-2021 for Adverse event, at an unspecified dose and frequency; DOXYCYCLINE on 09-Apr-2021 for Adverse event, at an unspecified dose and frequency and PREDNISONE on 09-Apr-2021 for Adverse event, at an unspecified dose and frequency. On 11-Apr-2021, PRODUCTIVE COUGH (productive cough), MALAISE (feeling completely sick), PYREXIA (Fever) and NAUSEA (nausea) had resolved. At the time of the report, COVID-19 (Diagnosed with Covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment also included benzo-something (09-Apr-2021).
Swelling, itching, tightness, erythema that has spread down the arm bordered by rash. Approximate measurement of red zone is 10cm by 8 cm and continues to spread around the arm. Day 2 of reaction worse than day 1.
Rash, bruising, petechiae, nosebleed, bleeding gums, ITP.
1/29/20 - After vaccine stomach ache, headache, muscle weakness  2/5/20 - After vaccine stomach ache, nausea, vomiting, headache, muscle weakness.
Developed redness, swelling, itching on (R) anterior thigh just distal to injection site.