chrisvoncsefalvay/vaers-outcomes huggingface dataset:
very thirsty, mouth is very dry; arm pain is a 10, pain under armpit and behind shoulder.; chills; very exhausted; fever; vomiting; These symptoms include tingling down arm; head was starting to throb; This spontaneous case was reported by a non-health professional and describes the occurrence of PARAESTHESIA (These symptoms include tingling down arm), DEHYDRATION (very thirsty, mouth is very dry), PAIN IN EXTREMITY (arm pain is a 10, pain under armpit and behind shoulder.), CHILLS (chills) and FATIGUE (very exhausted) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 12-Jan-2021.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PARAESTHESIA (These symptoms include tingling down arm) and HEADACHE (head was starting to throb). On 23-Apr-2021, the patient experienced DEHYDRATION (very thirsty, mouth is very dry), PAIN IN EXTREMITY (arm pain is a 10, pain under armpit and behind shoulder.), CHILLS (chills), FATIGUE (very exhausted), PYREXIA (fever) and VOMITING (vomiting). At the time of the report, PARAESTHESIA (These symptoms include tingling down arm), DEHYDRATION (very thirsty, mouth is very dry), PAIN IN EXTREMITY (arm pain is a 10, pain under armpit and behind shoulder.), CHILLS (chills), FATIGUE (very exhausted), HEADACHE (head was starting to throb), PYREXIA (fever) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
STIFFNESS; FELT A LITTLE MORE TIRED AND WENT TO BED A LITTLE EARLY; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no fever or sweating and was able to keep foot down and the patient had no other side effects. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUL-2021, Laboratory data included: SARS-CoV-2 antibody test (NR: not provided) 98.7. On an unspecified date, the patient experienced stiffness, and felt a little more tired and went to bed a little early. Laboratory data (dates unspecified) included: SARS-CoV-2 antibody test (NR: not provided) Inconclusive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt a little more tired and went to bed a little early and stiffness was not reported. This report was non-serious.
Woke up in the middle of the night with headache, chills, bodyaches.  Spiked a temperature later in the day of 100 degrees Fahrenheit. Symptoms lasted 36 hours.  I had Covid at the end of December 2020 and these were the same symptoms I had.
My arm was bruised badly (size of half dollar), hot and the area was sore just at the site of injection. It also became very itchy. This side effect lasted 7-8 days.
tiredness; weak; This is a spontaneous report from a contactable consumer (patient). A 90-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: EN6198, expiration date unknown), via an unspecified route of administration on 01Mar2021, as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not received Covid vaccination prior and had not tested Covid post vaccination. It was reported that, after receiving the dose of vaccine the patient experienced tiredness and was weak on 06Mar2021. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Left arm pain and swelling that started after "flu shot". The pain is worse at night and when she raises her arm forward and above her head. She states she does not have a history of shoulder issues.
The morning after (11/8/2016) my son got his second round of DTaP and Prevnar undeniably started to have full body shivers / neurological activity. He's developmental progress also seem to slow for about 6 months starting that day.   I did notice the same "shivers" after his first set of these shots that took place on 9/13/2016 but they didn't start happening so frequently and close together until he received his second doses. After the second does I knew he without a doubt was having an adverse reaction.   Over the period of November through December of 2016 the activity got really bad. Up to 15 to 20 full body shakes in a hour. I stopped shots completely at this point.  Then in January 2017 they slowly starting being less and less and by July 2017 they had stopped. Today, at the age of 2 he still doesn't have them anymore.
feeling cold; chills were so bad that was shivering; Still feeling not 100%; Every inch of the body was aching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Every inch of the body was aching), FEELING COLD (feeling cold), CHILLS (chills were so bad that was shivering) and FEELING ABNORMAL (Still feeling not 100%) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. A27A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN (Every inch of the body was aching). On 12-Mar-2021, the patient experienced FEELING COLD (feeling cold), CHILLS (chills were so bad that was shivering) and FEELING ABNORMAL (Still feeling not 100%). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, PAIN (Every inch of the body was aching), FEELING COLD (feeling cold), CHILLS (chills were so bad that was shivering) and FEELING ABNORMAL (Still feeling not 100%) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Patient reported that didn't had any fever and that needed an extra blanket and stated that is still feeling not 100%.
Admitted to hospital with increasing lethargy and shortness of breath after being diagnosed with COVID-19 on  8/28/21,
Tachycardia/ Rapid heart rate; This spontaneous case was reported by a nurse and describes the occurrence of TACHYCARDIA (Tachycardia/ Rapid heart rate) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 TACHYCARDIA (Tachycardia/ Rapid heart rate). At the time of the report, TACHYCARDIA (Tachycardia/ Rapid heart rate) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) Rapid heart rate.     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 medication provided by the reporter. No treatment information provided.
Patient received the Covid-19 vaccine.  Patient notified the observation RN that she felt that her hands were beginning to swell. I was called over and brought patient to the observations area. Patient had no c/o of shortness of breath, tightness in the throat or chest, or swelling of the lips, tongue, or face. She was able to remove her rings without issue. Treatment/intervention - Initial VS were as follows: 1700  HR 94, BP 183/87, O2 Sat 98% Patient was given 50mg of benadryl orally.  Subsequent VS: 1710 HR 88, BP 177/80, O2 Sat 99% 1719 HR 90, BP 152/92, O2 sat 98% Patient reported that her BP was elevated, but it was coming down.  She reported no further increase in swelling and that she was feeling better.  She was observed for a total of 45min.  She was instructed to consult with her MD and then schedule her second dose once given the ok.
Vomiting (5 episodes), body aches and pains, severe headache, extreme weakness and fatigue. Vomiting lasted about five hours, body aches and headache for 36 hours.  Weakness  and fatigue for almost five weeks.
This spontaneous report as received from a physician refers to an unspecified number of patients of unkonwn demographics. On an unspecified date, since 05-MAY-2014 an unspecified number of patients were vaccinated with PROQUAD (Merck). The reporter stated that on 05-MAY-2014 onwards her refrigerator and freezer units began to have temperature excursions and PROQUAD (Merck) was improperly exposed to temperatures above 5F as listed in the following sentences. PROQUAD (Merck), Lot # K007799 (expiration: 29-NOV-2015) was improperly stored to 22F for 1920 hours. All of the data listed here was reconfirmed with the reporter. No further information was available at the time of this report. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium, Additional Details: GAVE 50MG BENADRYL AND MONITORED PT FOR ANOTHER 25 MINUTES. SHE FELT WELL ENOUGH TO GO HOME WITH HER HUSBAND WITH INSTRUCTIONS TO CALL EMS IF NEEDED. PER PT AT FOLLOW-UP PHONE CALL AT 1950, SHE FELT BACK TO NORMAL WITHIN THE HOUR AFTER LEAVING PHARMACY.
1/31/22 patient arrives to ER with generalized weakness, hypoxia. SpO2 80%., placed on oxygen. Reports increased cough and fatigue. Shortness of breath with exertion and decreased appetite. Patient tested + for Covid 1/25/2022.
2nd day: small red mark/slightly swollen Days 3-4: Red expanded to almost cover arm. Slightly less red. Large swollen lump at vaccine site.
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Provider d/c note:  "52-year-old female with a past medical history of ESRD on HD, hydronephrosis with urostomy in place, and schizophrenia who presented to the emergency department with dyspnea and chest pain, symptom onset 1/19, tested positive for COVID 1/20.  CXR showed central interstitial prominence. EKG showed no ST or T-wave ischemic morphologies, troponin was elevated at 326, no clear established baseline in the setting of ESRD, delta was negative.  Cardiology was consulted and patient was started on a heparin drip given concern for NSTEMI.  Echo was obtained which showed EF 70-75%, small posterior pericardial effusion, otherwise unremarkable.  Given these findings and her symptoms, there was low suspicion for ACS, and heparin gtt was discontinued.  Suspect her presenting symptoms were attributable to COVID pneumonia.  During her hospitalization, the patient developed acute encephalopathy, with reported apneic episodes overnight her nursing. STAT ABG was obtained which showed acidosis with acute hypercapnic respiratory failure. The patient was subsequently put on BiPAP and she underwent urgent dialysis with Nephrology consultation. After these measures, the patient had resolution of her acute metabolic encephalopathy and hypercapnic respiratory failure with return to baseline mentation and maintained stable respiratory status and was weaned back to room air.  She was started on 5 day course of Decadron 6 mg daily to treat COVID, she will complete her course on discharge.  Given her apnea and hypercapnic respiratory failure, there was concern for underlying lung disease, for which referral for sleep study was placed and PFT was ordered.  Patient was evaluated for and recommended home therapies, for which RN/PT/OT home services were arranged. She was discharged in stable condition.  "
This spontaneous report as received from a medical assistant refers to a patient of unknown age. The patient was vaccinated with an expired dose of oral ROTATEQ on 29-AUG-2012. Lot number was unspecified but the expiration date was 23-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No symptoms reported. It was unspecified id the patient had sought medical attention. Additional information has been requested.
I did not receive the recommended 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1 injection of zoster shingles vaccine on 20th May 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 21-Nov-2022 Reporter's comment: The patient asked that he/she what do now or start fresh and get the first shot followed up by the second or do just get the second shot later on the day of reporting. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination.
At time of discharge, face noted to be very flushed, concerned with reaction to Hep B vs. normal reaction to crying. Patient waited 15 minutes; temperature elevated slightly to 99.2, HR 76, R 18. Sight of injection note erythematous or swollen, no hives noted on trunk or arms. Per mother via phone call states she did have hives and acted weird for a while. Refused any more vaccines.
Information has been received from a physician concerning a 5 year old male with an allergy to azithromytin (Zithromax) who on 06/05/1997 was vaccinated with varicella, virus vaccine live. On 10/16/01, the pt presented with chicken pox. The physician reported that the first lesion appeared on 10/13/01. On 10/16/01, the pt had approximately 12 itchy lesions and no fever. The pt had received medical attention for his experience. Additional information has been requested.
requesting information on a 14 year old administered PROQUAD; No additional AE details or PQC; This spontaneous report was received from a nurse, referring to a 14-year-old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies, and concurrent conditions were not reported.  On an unknown date, the patient was vaccinated with Measles, Mumps, Rubella, and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported). No additional adverse events details.
He received influenza vaccine 10/14 that night woke with severe pain in (L) with lumpy. Then hives and swelling of (L) thigh by injection site. Pain, swelling and hives x2 dose. Gave BENADRYL and oral steroid.
Immediate metal taste in my mouth. Severe joint and muscle pain. Cramping  especially abdominal. Diarrhea, nausea, vomiting. Fever. Throbbing headache. Chronic fatigue. I also seemed to have a racing heart rate , followed by shortness of breath.  The joint and muscle aches lasted for months. The diarrhea lasted for weeks. I still have the throbbing headaches, and chronic fatigue.    There are still times I feel I have a racing heart beat and have a hard time catching my breath.   I missed approximately one week from work.  I did not have enough strength to care for myself or take care of my daily activities.
Patient's wife reported sore arm the day after vaccine administered and 7 days worse pain extending to neck and shoulder. I advised most common event was sore arm. I was concerned still pain at 7 days post vaccine. She wanted recommendation and I stated if pain severe enough should see physician. Please note patient suffers also from dementia, and complained even before needle was inserted in bicep. I advised I would report event as protocol dictates.
Sinusitis actue, day 7, then pharyngitis, Malaise,  Myalgias
tested positive after getting the first dose (Jul2021), but patient did not have any symptoms; This is a spontaneous report from a Pfizer sponsored Program. The contactable consumer (patient's mother) reported for her daughter (the patient).   A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date were unknown), via an unspecified route of administration, on 01Jul2021, as single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient received the first dose of COVID-19 vaccine on the first of this month (01Jul2021) and then tested positive after getting the first dose (Jul2021), but patient did not have any symptoms and just wanted to report that now what reporter should if patient should get the second dose. Reporter wanted to know if patient should go on 22Jul2021 for her second dose. Outcome of the event was unknown.
Bells Palsy drooping of the left eye and mouth, started approximately 23 hour after the shot
Patient was shopping in the store right after the vaccination and daughter said patient started shaking and that she helped patient to the floor, and shouted for help. Pharmacist responded , patient was unconscious. She regained consciousness within a minute and was disoriented. patient's blood pressure was taken and it was 192/93.  Emergency paramedics were called and they took over care and transported  patient to the ambulance.
1 week upon completion of vaccination series, pt started having balance issues and new onset tinnitus, which is persistent
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4321893-00 (RA). A 47 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 09Sep2021 (Batch/Lot number: unknown) at the age of 47 years as dose 2, single and intramuscular, administration date 19Aug2021 (Batch/Lot number: unknown) as dose 1, single for Covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant) with onset 2021, outcome "recovering", described as "Clot blood"; NASOPHARYNGITIS (non-serious), outcome "recovering", described as "Cold". The action taken for adalimumab was unknown. Clinical course: Other Relevant History was Not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's assessment of the causal relationship of the events with the suspect product was provided at the time of this report. Since possible determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
adverse rxn to MMR shot pain redness swelling, hard fibrous tissue golf ball size;
The patient is 17 years old and received the Moderna vaccine, which is only authorized for patients 18 years and above.
6cm local erythema & minimal swelling; Given warm compresses, & Hydrocortisone cream;
Initial report received from a health care provider on 18 May 2010.  A 43-year-old male patient, with a history of injection site soreness after previous tetanus vaccines and no known allergies, had received a right deltoid injection of ADACEL, invalid lot number UF5008A provided, and an injection of TUBERSOL, lot number, route and site not provided, both on 24 March 2010 and now 2 months later continues to have soreness of right deltoid which was the site of the vaccine injection.  The patient reported that the area was very sore and "can't lay on that side".  The patient has experienced only soreness of the arm that was vaccinated and reported no other symptoms or reactions.  The patient's concomitant medications were LISINOPRIL, JANUVIA, and AMARYL.  The outcome was reported as not recovered.  Documents held by sender:  None.
Patient presented to Hospital on 06/03/2022 with worsening chest and back pain.  CT scan showed a significant enlargement of her descending aorta and several ulcers with concerning hematomas around the aorta.  Patient recently tested positive for Covid-19 on 05/27/2022.  Patient was admitted to hospital services and refused any intervention, knowing that the aneurysm may rupture and lead to death.  Patient requested palliative care and passed on 06/06/2022.
Fever; I flare-up usually when I have asthma flare-up; I feel like swollen; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received first dose bnt162b2 (BNT162B2, Batch/Lot number was not reported) via an unspecified route of administration on 05Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. On 08Aug2021 the patient medical history and concomitant medications were not reported. The patient experienced fever, I flare-up usually when I have asthma flare-up, I feel like swollen. The outcome of the events pyrexia, asthma was not recovered, the outcome of the event swelling was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
On Monday 2-8-2021 I attempted to work out and was very short of breath and had a high heart rate. My heart rate went into afib after I stopped working out out. My doctor sent me to a cardiologist who diagnosed afib with a stress test, echocardiogram and an EKG. I had a stress test the next day and was put on flecainide and a metoprolol beta blocker. I still felt bad after a few weeks. The doctor took me off of the metoprolol and doubled the dose of the flecainide. I then went into atrial flutter and the doctor placed me back on the metoprolol and eloquist in September.  In November I went back into afib and had to have cardioversion to shock the heart back into rhythm and I was scheduled for Ablasion.  I saw two doctors. I visited the ER on October 21st with chest pain.
Pfizer-BioNTech COVID- 19 Vaccine EUA: As the vaccine recipient was being administered the vaccine, some of the vaccine injection dripped out. The patient consented to for a new dose to be administered.