chrisvoncsefalvay/vaers-outcomes huggingface dataset:
immed onset of myalgias 2hrs p/vax;severe pain of large muscle groups;paresthesias in feet & legs starting approx 24OCT;gait is diff;some incoordination in hands;dx GBS
Pt recvd vax 31JUL92 & 31JUL92 approx 20 mins following vax pt exp tingling over the lateral aspect of lt cheek inc w/pressure; presented to ER & MD felt that pt devel trigeminal neuralgia poss due to vax; No further details were provided;
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 29-SEP-2015, the patient was vaccinated with an improperly stored dose of MMRII (lot # L003855 exp date 05-FEB-2017) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Muscle weakness, partial paralysis. Fatigue, high blood pressure, Guillain-Barre syndrome. 10/21/09 Hospital and ED records received DOS 9/17/09 to 9/19/09. Assessment: Malignant hypertension. Diabetes mellitus, new onset. Patient presented with generalized weakness, more to his left side. BP 236/145 Heart rate 90. 11/12/09 Medical records received for date 9/19/09 DX: HTN. Assessment: no c/o SOB. pt. d/c home 12/22/09 Duplicate ED/ Hospital records received for DOS 9/17/09-09/19/09.  12/22/09  PCP Medical records received for DOS 11/20/09. Pt. presents with h/o continued fatigue but improved strength; is able to walk, but needs to stop and rest frequently. Assessment:  recovering from Guillain-Barre syndrome; hypertension    12/22/09 Neurology consult records for DOS 10/01/09.  Pt. gives h/o inability to walk up flight of stairs due to fatigue one day after getting flu shot. Drove himself to ED and was hospitalized for hypertension management .  Did not have neurology consult or nerve conduction studies in hospital. Symptoms of weakness gradually improving.  Assessment: polyneuropathy
pt recv vax 23OCT96 & 48hr p/vax pt devel a blotchy rash on head, neck, buttocks & back;pt was treated w/DPH & sx resolved;
Received ZOSTAVAX on 10-3-11 2:00pm - went home later started having Rt leg - Rt arm decreased function. Rt side face droopy - speech slight slurred. Reported events on 10-6-11 at 3:30pm. Sent to personal Dr. to rule out stroke.
A report received from a healthcare professional on 02Dec02, concerning an unk number of vaccinees of less than 4 years of age who were inadvertently administered Fluvirin. On unk dates, an unk number of vaccinees of less than 4 years of age were inadvertently administered Fluvirin. There was insufficient information to determine the reporter's causality assessment.
On 12/29/2022 had a slight cough and runny nose.  I also have more frequent diarrhea. I had no treatment or outcomes. I also caught the flu right after for a week.
usual right arm soreness, then settled in right wrist area tingling, pain, weakness, and itchy type feeling in wrist
Patient explained that about 3 days after receiving the Zostavax, her arm was very swollen and very red around the administration site.  She showed photos on her cell phone 9/22/16.  Patient said no other problems or complications occurred and that the problem completely cleared up.
Body aches; This is a spontaneous report from a contactable consumer, the patient. A 56-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL9261, expiration date: not reported) via an unspecified route of administration on 16Feb2021 (at the age of 56-years-old) as dose 2, single for COVID-19 immunization and ademetionine (SAM-E), unspecified route of administration, started in 2021 two weeks after her second dose, lot number and dose were not reported for supplementation therapy. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not test for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EL3302), via unspecified route of administration on 26Jan2021 (at the age of 56-years-old), as a single dose for COVID-19 immunization. On an unspecified date after second dose in 2021 the patient experienced body aches. The patient had reported that it was not a serious adverse event, but in the interest of helping to collect data on impact of the vaccine the patient wanted to share it. About two weeks after her second dose she started a supplement, SAMe. She found that she immediately had significant body aches, not dissimilar from having the flu. The patient assumed that something had taken place at the cellular level related to the interaction of SAMe and the vaccine. The clinical outcome of the event body aches was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient received first Pfizer vaccination at 0800, and 10 minutes later began to experience facial flushing and a scratchy throat. Her BP was moderately increased, and no swelling or evidence of narrowed airways was found upon assessment. She was kept for increased monitoring for 45 minutes, during which time she reported that she felt dizziness as well. BP went down to normal levels, and this patient reported feeling much better after 30 minutes. She was instructed to call EMS with any signs of anaphylaxis and to talk to her provider before getting her 2nd dose.
Patient was admitted for acute metabolic encephalopathy , UTI, right lobar PE, Gram-negative bacteremia with altered mentation last known status was 2-3 weeks ago. Pt was boderline febrile. Tachypnic with a cough.  He tested positive for COVID-19 without any acute pulmonary process. Patient was treated for acute toxic metabolic encephalopathy.  His toxic metabolic encephalopathy was likely secondary to a complicated urinary tract infection in combination with a pulmonary embolism.  Additionally patient was found to have dehydration.  With regard to his urinary tract infection, use found to have E coli which grew on a urine culture.  Additionally found to have Roseomonas which grew on blood culture.  Infectious Disease consulted. Ultimately patient was treated with ceftriaxone and transitioned to ciprofloxacin for which he must complete doses on outpatient basis.  Patient was initially treated with heparin drip for pulmonary embolism and then transitioned to Eliquis.  Patient to finish Eliquis for total of 11 weeks.   He was eventually discharged in stable conditions.
Patient's wife called on 10-13-2020 stating patient received the pneumonia vaccine and since then, he has a large lump with  pain radiating to his back and other arm that is getting worse day by day since he received the vaccine.
patient came into clinic today to receive second dose of moderna primary series. upon looking in patient received pfizer primary dose on 08/18/2021 at pharmacy. she received Moderna 1/25/2022 as a full dose. patient was under the impression that she needed her second primary dose of moderna today. I did not give patient a covid vaccine at all. Contacted public health to ask how the patient should proceed with her booster in six months. Public health is unsure what should be done at this time. The nurse did state that she should have received both her primary doses as the same brand which I agreed.
Fever, joint point, body aches, chest pain.  Typical, low risk pregnancy. Due date August 8th
Reaction at site of injection. 12.5 cm redness on (L) upper arm. Firm, warm, tender, itchy. Cannot exclude infection.
This spontaneous case, initially received on 05-Nov-2018 reported by a pharmacist and concerns a 12-year-old, female adolescent patient. The patient had no medical history. The patient did not receive any concomitant medications. On 03-Nov-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 252681 and expiry date: 30-Jun-2019]. On the same day, 5 minutes after vaccination, the patient fainted and had a skull injury. On the same day, the patient was taken to hospital and was diagnosed with cracked skull, concussion, impaired hearing on left ear and temporal bone fracture with 5 sutures (reported as stitches). The same day (03-Nov-2018), the patient had recovered from all the events. On 04-Nov-2018, at 08:00 PM, the patient had discharged from the hospital. The reporter assessed this case as serious (hospitalization).
Case number PHEH2015US026240, is an initial spontaneous report received from a nurse on 10 Dec 2015. This report refers to a 40 year old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: 174273) at a dose of 0.5 ml intramuscular on 04 Dec 2015. On 07 Dec 2015, the patient developed hand tingling, stiffness in upper back/neck and pain in the same side as injection, felt of being locked up in jaw. The outcome of the events was reported as condition unchanged. The seriousness of the events was reported as non serious and causality was not reported. Following an internal review done on 05 Feb 2016 for data received 10 Dec 2015: Suspect drug coding changed from seasonal influenza vaccine to FLUCELVAX.
itchy/painful welt patch about 3 inches in circumference around injection site.  delayed onset, appeared about 5 or so days after the first vaccine.  had typical soreness for about three days, but this patch came after the soreness had disappeared.  I have read from the news stories that this is referred to as "COVID Arm" and it appeared to be similar to the picture featured in the article
Within hours of hep A vaccine, she was really sleepy, fever, altered mental status urinary incontinence.
I was diagnosed with COVID-19 yesterday, December 17; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I was diagnosed with COVID-19 yesterday, December 17) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 17-Dec-2021, the patient experienced COVID-19 (I was diagnosed with COVID-19 yesterday, December 17). At the time of the report, COVID-19 (I was diagnosed with COVID-19 yesterday, December 17) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in. Company comment: This spontaneous case concerns a patient of unspecified age and gender, with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 that occurred on an unknown date in context to third dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was unknown. Ongoing pandemic remains a confounder for the event COVID-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.; Sender's Comments: This spontaneous case concerns a patient of unspecified age and gender, with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 that occurred on an unknown date in context to third dose of mRNA-1273 vaccine. The Clinical course, Concomitant medication and treatment details were not provided, and the event outcome was unknown. Ongoing pandemic remains a confounder for the event COVID-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed as per medical judgement and available information.
Fussy x 4 days.  OTC Tylenol, Motrin.
Stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), administration date 10Apr2021 (Batch/Lot number: unknown) 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 (First dose covid-19 vaccine), for Covid-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset May2021, outcome "unknown", described as "Stroke".  Clinical course: The caller is calling in regards to the Covid vaccine. She explains she took the first shot and then had the second one on 10Apr2021. Exactly, 28 days later, she  had a stroke. She is calling to ask if she needs to get the booster shot? The caller declines to complete a report at this time, stating she is seeking advice on whether or not to get the booster or not. She states she will call back and give her information at a later time, but she is concerned on whether she should get the booster as soon as possible. She clarifies further she is willing to give the information but not right now. She wants to find out if she should receive the booster or not. The caller states on Pfizer's website it says if anyone has had a severe reaction to the Moderna or Pfizer vaccine, any person should not get further vaccines, so she is assuming its recommending her to not get the booster?  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Vaccine given high on left arm.  Immediately could feel problem in upper arm, shoulder, back and into neck.  Had 3 days of fever also.  After 2 weeks, went to Chiropractor and Dr about problem with muscles.  The dr sent me to a physical therapist which helped but I also had to see chiropractor.   Still seeing them presently.
Patient received Adacel and Prevnar 13 in left arm on 4/22/19.  ( she also received Twinrix and Shingrix in the right arm).  Patient returned today on 4/29/19 and her left arm is red and hot to the touch.  It is red at the injection site and the redness progresses down her arm.  It does not progress below the elbow.  She stated her arm was sore the evening after receiving the vaccinations and warm to the touch.  She stated during the first night, "a blister came up and oozed a little".  She did have a small sore on her arm and she said that was were the blister was, but the blister/sore location was NOT the site of either injection.  Her  arm was red in this location, as well as in the deltoid muscle region.  The patient stated the redness did not start until about 3 days after receiving the vaccinations.  She said the redness has not gotten worse, but it has not gotten better.  She stated her arm does not hurt, but it does itch.
A few days after vaccination distortion of taste and smell of certain products (eggs, some dairy) became clear. They started having distinctive metallic smell and taste, which makes impossible eating these foods. Experiments with different types of mentioned products and cooking methods didn't not result in a different perception of their taste and smell. Second dose administration didn't change the reaction, and this distortion is still ongoing and not fading away.
Information has been received from a medical assistant referring to multiple patients of unknown age and gender. The patients' medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # M006139, expiration date 13-MAY-2017; lot # M006141, expiration date 28-MAY-2017; dose not reported) orally. The doses of vaccine were improperly stored at 60 degree Fahrenheit for 25 minutes. Data logger was not involved. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
A week later, I was also tested positive for COVID; Immediate reactions from the shot / Almost flu-like symptoms; Immediate reactions from the shot / I felt extremely ill; Immediate reactions from the shot / I was tired; Immediate reactions from the shot / Had muscle aches; Immediate reactions from the shot / It completely wiped me out; This case was reported by a consumer via call center representative and described the occurrence of covid-19 in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included open heart surgery, local swelling (had a small area of bump before) and shingles (Family History) (had family history of getting shingles).   On 18th September 2020, the patient received the 1st dose of Shingrix. On 18th September 2020, 3 hrs after receiving Shingrix, the patient experienced covid-19, influenza-like symptoms, unwell, tiredness, muscle pain and feels awful. On an unknown date, the outcome of the covid-19 was unknown and the outcome of the influenza-like symptoms, unwell, tiredness, muscle pain and feels awful were recovered/resolved.   It was unknown if the reporter considered the covid-19, influenza-like symptoms, unwell, tiredness, muscle pain and feels awful to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient for himself. The patient was taking blood thinner (unspecified).  The patient had small area of bumps before, and that's why his doctor recommended to get the shingles shot.  The patient received 1st dose of Shingrix at the pharmacy on his left deltoid and after 2 to 3 hours, he felt extremely ill, was tired, had muscle aches, and almost flu-like symptoms. It completely wiped him out.  The patient had immediate reactions from the shot, and he reached out to his county health department and the lady there suggested the patient to get himself tested for COVID. The patient stated that his symptoms were getting worst by following Wednesday. The patient went to the urgent care and a week later, he was tested positive for COVID. The patient also mentioned that he was unsure whether the side effects came from Shingrix or a combination of Shingrix and COVID positive. The patient mentioned that he never reacted to the vaccines before, and recently had 2 doses of Pfizer COVID vaccines, but no side effects. The patient stated that he had the ability to bare the side effects, but this just wiped him out. The patient would not like to get his 2nd dose of Shingrix until he feels ready. The adverse effects that he experienced had been resolved. The patient stated that the reason he wanted inform GlaxoSmithKline about his side effects was incase if someone goes through similar issue as his. The reporter did not have the following information about 1st dose of Shingrix lot number and expiration date, dose, and route of administration. The reporter gave consent to follow up with healthcare professional, however he did not have an exact address, phone number, email address, or a fax number to healthcare professional.  The patient consented to follow up.
Left arm red, swollen at sight of injection reports swelling under left arm since 5-20-09.  6 X 8 cm area; redness, heat to LUE @ injection site; pocket of pitting edema left axilla
Pt C/O Bright redness to site, warm to touch, states very painful, and some swelling to site.
SEVERE STOMACH CRAMPING/SEVERE LIKE MENSTRUAL CRAMPING OR STOMACH VIRUS; HAD NO FEVER BUT WAS WARM THAN WAS COLD; CONSTANT SINUS DRAINAGE; FLU LIKE SYMPTOMS/SORE THROAT/CHILLS/TIREDNESS/MUSCLE PAIN/HEADACHE; KNEES WERE HURTING; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's past medical history included: thyroid gland removed, and concurrent conditions included: immunocompromised. The patient experienced drug allergy when treated with prednisone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced severe stomach cramping/severe like menstrual cramping or stomach virus. On MAR-2021, the patient experienced had no fever but was warm than was cold. On MAR-2021, the patient experienced constant sinus drainage. On MAR-2021, the patient experienced flu like symptoms/sore throat/chills/tiredness/muscle pain/headache. On MAR-2021, the patient experienced knees were hurting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe stomach cramping/severe like menstrual cramping or stomach virus, had no fever but was warm than was cold, constant sinus drainage, flu like symptoms/sore throat/chills/tiredness/muscle pain/headache, and knees were hurting. This report was non-serious.
Patient was administered an expired dose of vaccine. The vial that had been punctured approximately 48 hours prior and maintained in the refrigerator during the interim period. Patient was advised of the situation and Modera drug information specialist was contacted for further guidance in the matter. Pharmacy is awaiting this guidance and will advise the patient
Feel like vomiting; Aching joints; Headache; I feel like a truck ran over; discomfort; This non-serious case was reported by a consumer and described the occurrence of nausea in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis and TETANUS VACCINE for prophylaxis.   Concomitant products included LEVOTHYROXINE.   On 08-APR-2023, the patient received Shingrix, PNEUMONIA VACCINE and TETANUS VACCINE. On 09-APR-2023, 1 days after receiving Shingrix, the patient experienced nausea (Verbatim: Feel like vomiting), joint pain (Verbatim: Aching joints) and headache (Verbatim: Headache). In APR-2023, the patient experienced feeling bad (Verbatim: I feel like a truck ran over) and discomfort (Verbatim: discomfort). The outcome of the nausea, joint pain, headache, feeling bad and discomfort were not resolved.   It was unknown if the reporter considered the nausea, joint pain, headache, feeling bad and discomfort to be related to Shingrix.     It was unknown if the company considered the nausea, joint pain, headache, feeling bad and discomfort to be related to Shingrix.   Additional Information: GSK receipt date: 07-APR-2023 The reporter reported that patient had Shingrix and pneumonia and tetanus all at the same time. The patient felt like a truck ran over. The patient is wondered whether to take Advil for discomfort. The patient experienced feel like vomiting, Aching joints, headache, feeling bad and discomfort. The reporter consent to follow up.
Starting approx. 8/16/21 I experience nausea after eating.  Pepto bismol tablets helped calm my stomach.  After a few weeks, I went to the doctor and he prescribed famotidine 20mg 2/day and sucralfate 1 g tablet 4 times/day.  The medicine seemed to help a little, but not much.  Pepto bismol tablets helped the most.  I had an ultrasound of my abdomen on October 20; results showed no abnormalities.  Around 11/1/21 my symptoms lessened and went away.  I have an appt with a specialist on Nov 15.  I do not think this is related to the vaccine as these symptoms have happened in the past but they did not last as long as this occurence.