chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Approx 6 hrs p/DTP pt started a fever to 103(R) very fast, pt screaming continually; Mom stated pt had a jerky movement like having a sz;
Left shoulder has been sore; Can't raise arm over head; This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number L9F99, expiry date 10th October 2022) for prophylaxis.   On 28th December 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced shoulder pain and mobility decreased. On an unknown date, the outcome of the shoulder pain and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the shoulder pain and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix and since then her left shoulder had been sore and she could not raise her arm over her head. This event was ongoing at the time of report. The reporter did not consented to follow up.
I am a retired RN and based on information available to me, I requested the vaccine. Hx of chix pox and and shingles x5 over 10 years. After vaccination have had 5 outbreaks. Severe skin yeast infection and an onset of the auto immune disease, lichen planus. Believe due to vac.
PATIENT RECEIVED FIRST DOSE OF COVID VACCINE. WAS IN WAITING ROOM SITTING AFTER THE SHOT WAS GIVEN. AFTER A WHILE HE GOT UP TO LEAVE AND GO HOME. AFTER SEVERAL STEPS, HE PASSED OUT AND HIT THE GROUND. HE WAS ONLY OUT FOR SEVERAL SECONDS AND CONTINUED TO LAY ON THE GROUND. AFTER HE TRIED TO GET UP, HE BLACKED OUT AGAIN FOR SEVERAL SECONDS. WE CALLED 911 AND PARAMEDICS WERE ON THE SCENE SHORTLY. AFTER EXAMINATION AND PATIENT FELT BETTER, HE WAS CLEARED TO GO HOME.
Positive COVID-19 Test; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive COVID-19 Test) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive COVID-19 Test). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive COVID-19 Test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, COVID-19: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Patient has what feels like a knot or lump under her skin at the injection site on her right leg. She says that it itches.
On 10/24/2000, the patient broke out with chickenpox which gradually spread to 60-70 lesions distributed on both arms and legs and torso. The patient was afebrile and displayed normal activity. On 10/27/2000, the patient was seen by her physician, and treated for chicken pox. On 11/02/2000, the patient recovered. Additional information is not expected.
Pt complains of extreme pain, hot arm, redness at injection site and down arm. Got vaccine on a Friday and saw MD Monday to get steroid pack.
Muscle ache 3 hours after the vaccination, starting from lower extremities then moving to upper extremities. Then 3 hours later patient was shivering, but did not check if fever was present. Patient was concerned.
only has antibodies for mumps and rubella; first dose administered at 28 months and second at 3 years old; This spontaneous report was received from a male patient concerning to himself, a 4 years old patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On 08-NOV-2001, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route, lot#, expiration date and site of administration were not provided) as mandatory vaccination after moving to the country. He received the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) on 06-FEB-2004 (inappropriate schedule).   On an unknown date, the patient was tested for the antibodies for measles, mumps and rubella and discovered he only had antibodies for mumps and rubella. At the time of the report, the outcome of the event was not provided.  The causal relationship between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.
Swelling to lips, eyes, face, redness all over body. Hives all over body.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Hypotension-Mild, Additional Details: patient called and inform about rash happened on external upper body
Headache Extreme; fatigue; Pain at injection site; armpit and breast (all L) Ncek pain; armpit and breast (all L) Neck pain; armpit and breast (all L) Neck pain; This is a spontaneous report from a non-contactable Other HCP (patient).   A 40-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 19Jan2021 15:00 for an unspecified indication Covid-19 immunisation.  Medical history included irritable bowel syndrome (IBS), asthma, allergies to sulfa. Patient was not pregnant. The patient had not experienced Covid-19 prior vaccination. The patient's concomitant medications were not reported. No other vaccine was received in four weeks. On 20Jan2021 the patient experienced headache extreme, fatigue, pain at injection site, armpit and breast (all l) neck pain. No treatment received. COVID was not tested post vaccination. The outcome of events was recovering.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
On 3/9/2021 the patient presented at the ED for hypoglycemia. It was found that the patient had hypoglycemia due to an unintentional overdose of insulin. Reason for admission: hypoglycemia. Per EUA, hospitalizations are must be reported after recently receiving a vaccine. This hospitalization does not appear to be related to the vaccine.
Pt reported experiencing tingling on left side of face, arm, fingers leg and toes.  Tingling progressed to numbness on the fingers.
Systemic: SUPRACLAVICULAR LYMPH NODES; symptoms lasted 0 days
Pt complained of hives which manifested from her armpits to her hairline.  She stated these began within 24 hours of receiving vaccine.  She visited a walk-in clinic and received a steroid shot; the hives resolved shortly after the injection.
soreness at the injection site; fever; headache; nausea; felt like she had the flu for 2 days; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (for tolerance to the 1st dose refer case US2020029075).   In November 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site pain, influenza-like symptoms, fever, headache and nausea. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, fever, headache and nausea were resolved with sequelae and the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms, fever, headache and nausea to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and felt like she had the flu for 2 days, fever, headache, nausea, soreness at the injection site and was in bed for 10 straight hours.
Patient scheduled self for her second COVID vaccine at a POD that was only 19 days after her first Moderna dose, which was on 2/16/21. The patient received her dose before the IP RN was consulted. There were no significant side effects or adverse reactions noted or reported.
pt recvd Engerix-B 15JUL92 & had swelling & tingling rt side of face; seen by MD; blood samples taken; sx resolved;
sore, red, swollen, RUA; swelling extended to wrist by next day despite cold application;saw MD & given DPH; some flu-like sx, fever,
HIVES (NECK AND CHEST), VOMITING, DIARRHEA, NAUSEA
There are no adverse events. We are reporting because patient received the 4th dose of Moderna in less than 5 months from 3rd dose and he was not immunocompromised. Information was not completely disclosed by patient, hence the 4th dose was given.
Woke up the following morning (shot administered around 1pm) with malaise, fatigue, generalized body aches, headache, lethargy, inability to complete normal daily activities, diaphoresis. I need to take Ibuprofen every 4 hours x24 hours in order to function. The symptoms improved the following day, but I still required several doses of Ibuprofen that day. I am now 5 days out and still experiencing fatigue.
Pain at injection site (expected); pain in shoulder and neck on right side. Just over 24 hours later, area above right collar bone (same side as injection in right arm) was swollen and very tender to touch. I had pain when tilting my head to the right or shrugging right shoulder. Lymph node (presumably) bulged when shrugging shoulder. Pain and swelling lasted 3-4 days.
swelling on right side of face and pain, arms, thigh, stomach, legs, and feet just on the right side
Inconsolable crying following vaccines (3) 1-1 1/2 hours. The pt was reexamined (within 2 hrs) physical exam was essentially unremarkable except crying and large erythematous macular rashes at inj sites. Somewhat better after Motrin. 8/21 follow up call, he was fine.
only received the diluent and not the lyophilized powder portion with no reported adverse event; Initial information received on 06-Nov-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2023SA343804, 2023SA343809 and 2023SA345528.  This case involves 15 months old male patient who only received the diluent and not the lyophilized powder portion for HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel) for Immunisation and Hepatitis A Vaccine (Hepatitis A) for Immunisation.  On 26-Oct-2023, the patient received a standard dose 4 of suspect HIB (PRP/T) vaccine Powder and solvent for solution for injection at a dose of 0.5 ml total (lot UK007AB, expiry date- 31-DEC-2024) via intramuscular route in the right thigh for Immunization.  On 26-Oct-2023, the patient only received the diluent and not the lyophilized powder portion with no reported adverse event (single component of a two-component product administered) (latency- same day) following the administration of HIB (PRP/T) vaccine.  Reportedly, Pharmacist reported that four patients received a dose of ACTHIB. However, one patient only received the diluent and not the lyophilized powder portion. They noticed there was one extra powder vial left but they are unsure which patient only received the diluent. Should they revaccinate all or should they do serologic testing prior to re-administering? Treatment: The caller was not aware of any adverse reactions, treatment.  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 the 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.
Clots in her lung and legs; Arm sore; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (Clots in her lung and legs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (Arm sore). On 13-Mar-2021, the patient experienced THROMBOSIS (Clots in her lung and legs) (seriousness criterion medically significant). The patient was treated with APIXABAN (ELIQUIS) at a dose of 5 mg twice a day. At the time of the report, THROMBOSIS (Clots in her lung and legs) outcome was unknown and PAIN IN EXTREMITY (Arm sore) had resolved.            No concomitant medications were provided.  On 13-Mar-2021 the patient was in hospital with clots in her lung and legs. The patient also mentioned that other people had clots.  Company comment This case concerns a female patient of unknown age with no relevant medical history, who experienced the serious unexpected events of thrombosis and a non-serious event. The event thrombosis (AESI) occurred approximately 1 month and 14 days after the second dose of mRNA-1273. The rechallenge is not applicable because the AEs occurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the serious unexpected events of thrombosis and a non-serious event. The event thrombosis (AESI) occurred approximately 1 month and 14 days after the second dose of mRNA-1273. The rechallenge is not applicable because the AEs occurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
A few days after receiving my second vaccine shot I lost my hearing. it was mostly in my right ear .  Went to Dr he gave me Afrin for 3 nights, flonaze during day and claritin.  After one week no improvement.  Went back and was given predzone for 10 days and went for a hearing test.  Test showed way below normal both ears.  Now have an appointment with an ENT specialist next week.  Ears seem to build up with pressure and noise and cause lightheadedness.
Case number PHEH2014US010189 is an initial spontaneous report from the pharmacist received on 16 May 2014 with a follow up report received on 20 Jun 2014. This report refers to a 17 year old female patient. She was vaccinated with MENVEO (batch number: A13059) on 23 May 2014 at 12:00 hour. It was reported that the Men A lyophilized component was inadvertently reconstituted with sterile diluent that comes with MMR vaccination instead of Men CYW liquid conjugate. No adverse event reported following this medication error (wrong solution used in drug reconstitution). Follow up report received on 20 Jun 2014: Changed patient gender (male to female), update patient demographics (date of birth, height and weight), changed vaccination date (from 16 May 2014 to 23 May 2014) and batch number (M13059 to A13059).
Systemic: syncope-Mild, Additional Details: bp recorded immediately 117/62 pulse 82; after 15 min 123/76 pulse 60, after 30 min 130/79 pulse 69
The morning following the vaccination (10/20/2021) soreness, redness, and swelling around injection site was noticed. Despite usage of antihistamines, pain killers, and cold compresses, vaccination site continues to grow and swell. The site is hard, red, and hot to the touch. Swelling has now extended into the shoulder and is limiting mobility. If reaction continues to worsen instead of improve, treatment will be sought at the one week mark (10/26/2021).
Patient states lips swollen and tongue numb and legs weakened approximately five minutes after flu vaccine administered. On advice of nurse went to ER given generic pepcid AC and prescribed for pepcid AC. When brand name pepcid AC taken, allergic reaction exacerbated. Went back to ER and give presciption for generic pepcid AC.
On the second day of vaccine I had a terrible headache & nausea, 3rd day till today I have been having severe dizziness & hear racing & palpitations along with nausea.
On 2/22/2021 episode of metrorrhagia starting at 11pm and lasting 60-90 minutes with golf ball-sized clots.  Patient then went to bed and slept through the remainder of the night uneventfully. Prior to this episode LMP was 2/10/2021, and next menstrual cycle started on 3/10/2021 as expected.
Dehydrated; Itchy; Long 4-inch rash, it was itchy; Fainted; sick, like she had a high fever; A spontaneous report was received from a consumer , who was a 73-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fainting (syncope), sick like had a high fever (illness), long 4-inch rash (rash), itchy (pruritis), and dehydrated (dehydration).    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 29 Jan 2021, the patient received her first of the two planned vaccine doses of mRNA-1273 (Batch number: 012M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 26 Feb 202, the patient received her second of the two planned vaccine doses of mRNA-1273 (Batch number: 014M20A), intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 27 Feb 2021 the patient was sick, like she had a high fever..  Reportedly, her temperature was not taken.  She was unable to eat or drink and she fainted. It was reported that she was not aware that she fainted until the next day when her husband told her. The following Monday, she was informed by the doctor that she was dehydrated.   On 28 Feb 2021, the patient developed a long 4-inch rash, that was itchy, but resolved in a week. It was reported that this reoccurs every now and then and feels itchy. Treatment information was not provided.    The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events, fainting, sick like had a high fever, long 4-inch rash, itchy, and dehydrated, were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
her left arm was a little bit sore after she got the COVID-19 Vaccine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/Lot number was not reported),via an unspecified route of administration, administered in the left arm on 12Mar2021 08:40 (at the age of 61 years-old) as single dose for covid-19 immunization. Medical history included tinnitus from Nov2020 and would get headaches, she had anxiety, panic attacks and insomnia. She had high blood pressure; last visit to her doctor was in Jan2021 and her EKG was fine, and her blood pressure was down. She said her doctor wanted to wean her off of her old blood pressure medicine before starting any new medication). She also had AFib (atrial fibrillation), left ventricular muscle thickening and enlarged right atrium. She reported that she was getting herself a new heart doctor and neurologist. She was also sick in Mar2020, and the doctor was not sure if she had the COVID-19 Virus. She said she quarantined for 16 days, and then found out she was negative for the COVID-19. She said after that, she couldn't leave her house without having extreme anxiety and panic attacks. She said her blood pressure would reach 200 during those times. The patient's concomitant medications were not reported.  The patient received her first dose on 12Mar2021 and had no symptoms, except that her left arm was a little bit sore after she got the COVID-19 Vaccine. She said the soreness started late in the afternoon, or early evening. She said her left arm soreness maybe lasted through to the next day, and the left arm soreness was only for a day. The outcome of event was recovered. The event did not require visit to an emergency room or a physician's office.  Information about lot/batch number has been requested.
Discharge Provider: MD Primary Care Provider: DO Admission Date: 5/11/2022 Discharge Date: May 12, 2022  PRESENTING PROBLEM: AKI (acute kidney injury)  COVID  COVID-19    HOSPITAL COURSE: For details of the patient's presentation please see my colleague's history and physical.   1. COVID-19 acute infection in a patient who received a full Maxine course without the 1st posterior shot in October 2021 -not hypoxemic but did present with weakness and confusion -he received 6 mg of Decadron in the emergency department and a dose today. -the patient has had resolution of his confusion, he is up he had all of his practice and did well with therapy.  He desires on discharge and will go home with his wife changed and with self-care.  I had a conversation with GI and via phone at the patient's bedside and both the patient and his wife are in agreement with home discharge today.  His oxygen saturation is 99% on room air   2. Acute kidney injury due to prerenal azotemia resolving with fluid administration I would continue keeping his urine is clear and colorless.   3. Elevated D-dimer and CRP consistent with a diagnosis of COVID-19.-should his symptoms worsen or he becomes hypoxemic he would be a candidate to come back for admission.