chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10/14/2022 I was on a cruise and wore the mask and  I started to feel a starchy throat and the next day I woke up with a really bad sore throat with excruciating pain. I had bad headache and body aches. I saw the doctor on the cruise on 10/15/2023 got tested negative. Couple of hours later I tested myself and was positive. I was quarantined for 5 days and I still did not feel well until a month. The doctor did not give me any medications and got cough medication and Tylenol.
receive vaccine after temperature excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT STORAGE ERROR (receive vaccine after temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (receive vaccine after temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (receive vaccine after temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reports stated that every 12 hours there is a spike in the temperature where they store the vaccines reach a highest of 14.8 degrees Celsius, excursion does not last longer than 5 minutes. This also occurs when they are re-stalking the vaccines from the freezer to the fridge. He was unable to provide the lot numbers or patient information for those who had received the vaccines after these excursions.
Muscle ache; Back pain; Joint pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on 15Mar2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated, on an unspecified date in Mar2021, had muscle ache, back pain, and joint pain. Patient wants to know if this was normal and was it okay to use an antihistamine after the vaccine, was that safe. Outcome of all events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Erythema nodosum,muscle aches, bone pain , arthritis. During the last 9 years I have no energy, bone, muscle  aches, bruising. Feeling of tireness. At the time of administration in 1994 AN immunologist was following my situation but I was never taken seriously  because HBV vaccine is considered safe Need to contact the hospital for more information
Right thigh became red, swollen, hardened, hot to the touch and extremely itchy.
Pt is 39 y/o female. Pt is casual RN for ED. Pt received COVID-19 vaccination here on the 23rd of December. Pt began feeling weak on the 17th of January. On the 18, Pt began experiencing numbness and tingling in hands and feet. Pt has been seen at facility and her PCP prior to coming to ED. Pt PCP called me and told me she is concerned that the Pt might have Guillain Barre syndrome and referred her here. Pt now c/o numbness and tingling from feet to mid abdomen and numbness/tingling up entire arm. IV was established and labs drawn, CT Head normal. Pt to IR for LP for definitive Dx of Guillain Berre. Pt admitted to room 202. Director of ED notified.
Tremors in right hand after muscle spasm in right leg at holiday dinner.  Sister witnessed tremor which has continued off and on.   On Dec 11th, my tooth came out of my mouth  in the morning right after getting up.
My left ear is swelled shut. I have never had any type of ear problems. I was prescribed ear drops for a possible bacterial infection on Friday morning however nothing is currently working. I have a follow up appointment 4/21 @ 8am.
Information has been received from a nurse concerning a 19 year old female with a allergy to amoxicillin and a history of vaginal surgical repair from blunt trauma who on 11-May-2007 was vaccinated "into a vein" instead of intramuscularly in the left arm with the 1st 0.5 ml dose of Gardasil (lot #656617/0384U).  The mother and patient claimed that they saw blood back into the syringe after the 1st dosage was given.  On 06-Jul-2007, the patient was vaccinated intramuscularly in the right arm with a 0.5ml 2nd dose of Gardasil (lot #657868/0523U).  Concomitant therapy included ethinyl estradiol/norgestimate (Ortho Tri-Cyclen LO).  The nurse stated, post vaccination, the patient became woozy (unspecified which dose) and was told to lay down until she felt better.  Mother stated that the patient does not do well with needles.  The patient received unspecified medical attention and recovered on 11-May-2007.  Additional information has been requested.
The pt experienced possible hives on face. Treated with Benadryl and went away. The pt also experienced a fever of 101. On 10/30/00 5 days post vax, the hives returned. The pt was referred to an allergy clinic.
This spontaneous report as received from a registered nurse refers to a 10 week old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 11-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025194, expiry date: 22-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Shortly after receiving vaccinations patient's eyes rolled back became pale and began seizure like activity. Patient was evaluated by provider. Vitals stable. Seizure like activity lasted approx. 30-45 seconds.
diarrhea; headache; tired; felt nauseas; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), HEADACHE (headache), FATIGUE (tired) and NAUSEA (felt nauseas) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 immunisation.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2011, the patient experienced NAUSEA (felt nauseas). On 10-Mar-2021, the patient experienced HEADACHE (headache) and FATIGUE (tired). On 11-Mar-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea), HEADACHE (headache), FATIGUE (tired) and NAUSEA (felt nauseas) outcome was unknown.  Action taken with mRNA-1273 in response to the event was unknown.  No treatment details are provided.
Left ventricular enlargement, ejection fraction dropped from 55% from previous testing  to 27%
parent complained of pt inability to weight-bare on lt leg d/to inj;pt limping-area on lt thigh sl redness w/sl swelling;instructed parent to put ice on area&take APAP as needed&directed;
Believes the Pfizer shot constipated her; She is shaking all of the time now; hives were not severe and she had worse; appears to be a red spot in the middle of the hives; experiencing hives on her left wrist and arm; This is a spontaneous report from a contactable consumer (Patient). A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 14Feb2021 (at the age of 68-years) as single dosefor COVID-19 immunisation. Medical history included gout (hasn't had an attack in 8 months and when she has a flare-up, she is crippled and out of commission), blood pressure high, blood uric acid abnormal, arthritis and tried face creams and gets hives. Concomitant medication included allopurinol taken for blood uric acid down; colchicine for gout but has not taken in 8 months. On 15Feb2021 (one day after vaccination), patient experienced hives on her left wrist and arm which was the injection, and other two hives on the outside of the hand. One hive was on the inside her wrist. Patient took Benadryl and the original hives went away. However yesterday (unspecified date), another batch of three hives appeared on the inside of the wrist on the injection arm. Patient stated that Benadryl constipates her if she takes too much. Can't stay on Benadryl for too long. Believes the Pfizer shot constipated her on unspecified date. Patient was making herself sick over this. Her nerves are shot between the new variants and not knowing a lot about the vaccine. She is shaking all of the time now. Patient had tried Voltaren and got severe hives and was using it on the left side of her body and saw hives on the left side of her face and throughout her head. Hives were 100 times worse than the hives she has at the time of report. Patient just took a Benadryl and the hives have calmed down. One hive was very puffy. There appears to be a red spot in the middle of the hives. Patient thought hives were from a cuff watch that she wears. However, she was looking at it and now doesn't think the hives are from her watch. Therapeutic measures were taken as a result of hives included Benadryl HC1-25mg tablets (UPC: 312547171366), two tablets a day and Voltaren. Patient stated that doctor recommended her to get the COVID-19 Vaccine. Patient wanted to know if she can take the second dose of the vaccine. The outcome of the event hives was not recovered, while for other events, it was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient is a 82 y.o. female with multiple medical problems including history of pulmonary hypertension, hypertension, fibromyalgia, left knee osteoarthritis status post recent left TKA with development of postoperative hypoxia requiring home oxygen therapy who presented from home on 5/20/2023 with complaints of increasing shortness of breath and noted dyspnea at home; found to be COVID-19 positive. She was noted to be Hypoxic requiring O2 therapy. Per current COVID guidelines, she was started on Decadron along with IV Remdesivir. CT imaging showed no evidence of consolidative changes.  Throughout hospitalization her breathing improved and she is currently not requiring oxygen therapy during the day. PT/OT did follow along and recommending HHC at DC, however pt declined as she is already set up with OP therapy and she wishes for this to continue  Acute on chronic respiratory failure with hypoxia COVID-19 Infection - Presented with: cough, congestion and mild sputum production - Symptom onset: 5/13/2023 - Positive COVID-19: 5/20/2023 at Facility ED - Vaccination status: Vaccinated x4 with Pfizer - CT Chest on admission showed no evidence of consolidative changes - Oxygen status: initially required 1 to 2 L nasal cannula ATC (baseline wears 1-2L nocturnal); currently on RA during the day  - Decadron: Yes. Expected end date 5/30/2023 - Remdesivir: initiated while inpatient - last dose 5/24 - DVT prophylaxis: ASA - Serial COVID labs ordered: No - Case Management/Social Services consulted: No
She developed rashes on right and left side of neck & upper left cheek of face.  The rashes lasted about for 1 week. It was itchy, however, she did not take any medications. The rashes were gone she feels good today.
PAIN IN STOMACH; MIGRAINE; LEGS HURT; This spontaneous report received from a patient concerned a 50 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included lupus, and pre-menopausal. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced pain in stomach, migraine, and legs hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in stomach, migraine and legs hurt was not reported. This report was non-serious.
Vial was opened at 9:02am on 11/22/2021 and the injection was given to patient on 11/23/2021 at 11:14am/ Patient had no Adverse reactions
Headache, Arthralgia, SkinRash, NauseaVomiting, large welt at site 4 inches post injection day 1, post injection day 2 is 6 inches in diameter Narrative:
This case was reported by a nurse and described the occurrence of crying in a 2 month old male pt who received Pediarix. In "the morning" of 3/23/05, the pt received the 1st dose of Pediarix in the left thigh (lot AC21A013AX). In the morning of 3/23/05, the pt also received injections of ActHib and Prevnar. The sites of injections for ActHib and Prevnar were not provided. "At 1:00 PM" on 3/23/05, the pt "started crying". At 3:00 PM, on 3/23/05, the pt was seen at a physician's office and "was still crying". It was also reported that at the physician's office at 3:00 PM on 3/23/05, the pt "had local tenderness". The site of local tenderness was not provided. The pt was treated with acetaminophen (Tylenol). The events resolved on 3/24/05. The nurse considered the events to possibly be related to vaccination with Pediarix.
he caller reports she started getting her GARDASIL 9 vaccination in 2019, however, she never got the third dose of the vaccination due to being unable to see her provider when COVID-19 emerged.; No further information was provided. No additional AE was reported. No PQC was reported.; This spontaneous report was received from a consumer of unknown age concerning herself. The patient's concomitant therapies, pertinent medical history, and drug reactions/allergies were not reported.  On an unknown date in 2019, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, lot #, and expiration date were not reported) for prophylaxis. However, she never got the third dose of the vaccination due to being unable to see her provider when Coronavirus Disease 2019 (COVID-19) emerged (inappropriate schedule of product administration). The patient would turn to be 45 years old on 07-FEB-2023, and she was wanting to know if she needed to start the vaccination schedule over again. No further information was provided. No additional adverse event (AE) was reported.
HAVE HAD A COUGH AND A GREAT DEAL OF CHEST CONGESTION/EXCESSIVE MUCOUS PRODUCTION FOR THE SINCE LATE JANUARY/EARLY FEBRUARY
Headaches- breaks in-between with increased intensity. Went down the side of my head to my neck-very severe. One spot of my head will hurt for a few minutes. This happens in random spots. The headaches get better when I don't move around. Trouble communicating or saying words, forgetting conversation, recalling words, trouble thing, and roaring rushing sounds in my ears. I think I am getting better taking Excedrin. Herbal remedy is helping me feel better with Hyland's Migraine Headache Relief.
Bone were hurting throughout entire body. Very weak and complaining of a severe headache. Patient has never complained w/prior flu vaccinations.
According to parents the baby was found not breathing in bed. Taken to ER. Died before reaching the ER.
Patient reports he experienced severe chills on the night of 11/12/2012 (the day of vaccine administration) b/w hours of 9:30PM-11:00PM period. He states, he had 3 episodes of chills, that resolved when he covered himself. Pt also took TYLENOL, no symptoms in the morning.
Very red and bruised arm at injection site; Very red and bruised arm at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Feb2021 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT) and levothyroxine (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. On 01Mar2021, the patient had very red and bruised arm at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very red and bruised arm at injection site were recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
VACCINE ADMINISTRATION ERROR DUE TO AGE. NO EVENT IN CLINIC OR FOLLOW UP
Around the middle of May 2021,  I started to notice rapid heart beat.  I do not have a history of cardiac issues and this is the 1st time I  have ever had an episode of A-fib.  I decided to go to the ER. They did an EKG and blood pressure.  I was admitted and stayed for 4 days.   I had a cardiac catherization.  I was then transferred to another hospital  to be evaluated  for another surgery.  They wanted to do a coronary bypass surgery.  Instead, I was discharged with medication and surgery was not recommended at the time. I did follow up  with cardiology and my condition is severe so I will either have to get a stent or do a by pass surgery.  I am waiting for this and in the process of deciding what to do.
Patient started with weakness, dizziness. Progressed to inability to move, in and out of consciousness. Hard time breathing with heavy weight on chest. Throat swelling & closing so couldn't swallow and breath. Husband took patient to ER. IV Benadryl and fluids. Does not believe had epinephrine.
This spontaneous report as received from a healthcare student refers to a currently 65 year old male patient. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (route, lot # and expiration date were not provided). On an unknown date, a couple of years ago, the patient experienced an anaphylactic reaction. It was unknown if the patient sought medical attention. The outcome of the anaphylactic reaction was unknown. Additional information is not expected.
Information has been received from a pharmacy intern referring to two unspecified patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On 12-OCT-2016, the patients were administered doses of PNEUMOVAX 23 syringes (lot number M020521 with expiration date 17-NOV-2017; dose was unknown) intramuscularly for pneumonia vaccination. On an unspecified date in October 2016, after administration, the patients experienced "redness, and swelling from the shoulder to the elbow on the arm, where PNEUMOVAX 23 was administered". Both patients also experienced the area being "hot to touch". No treatment was given for the events. These symptoms lasted for an unspecified amount of time, and the current status of the unspecified patients was unknown. The pharmacy intern requested a lot check for this lot of PNEUMOVAX 23. The causal relationship between the events and PNEUMOVAX 23 was unknown. An investigation into the manufacture of lot M020521 was completed and confirmed that all in-process quality checks were satisfactory. The results indicated that the lot was manufactured in accordance with manufacturing site standard operating procedures. The lot was confirmed to have met the requirements for market release. Following medical review of the AE report and the Quality investigation, there were no identified concerns related to quality within the results of the investigation. Additional information has been requested. Sender's Comments: MERCK 1610USA008156:Mfr number.
Site: Pain at Injection Site-Mild, Systemic: Abdominal Pain-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Mild, Systemic: Weakness-Medium, Additional Details: pt was advised to lie down with legs elevated.  bp was monitored several times until symptoms of sweating, nausea subsided and pt was feeling better.
Swelling, heat and redness started at injection sight and a rash developed.  The rash then began spreading over my entire body.  Arms, torso, back, legs (top of thighs had the worst reaction). Small amount of itching at injection sight, but the overall rash was not itchy.  It looked like my body was covered with the measles. The swelling of my arm took place approximately 2-3 days after the vaccine was given.  The rash started spreading and worsening for the next few days.  I contacted my doctor and began taking Zyrtec, Benadryl, Pepcid and using Hydrocortizone cream.  I saw my doctor on February 10 (one week after vaccine and received a steroid shot). The next morning after the shot, the rash was greatly improved and continued to improve and disappear by taking a course of steroids.