chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever of 99.7; Myalgias; arm was sore; felt like I was hit by a Mac Truck; general malaise; Aching in the body; headache; Chills; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (arm was sore), FEELING ABNORMAL (felt like I was hit by a Mac Truck), MALAISE (general malaise), PAIN (Aching in the body) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse reaction. Concomitant products included METFORMIN, GLYBURIDE, SIMVASTATIN, DULAGLUTIDE (TRULICITY), AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication, LISINOPRIL.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was sore), FEELING ABNORMAL (felt like I was hit by a Mac Truck), MALAISE (general malaise), PAIN (Aching in the body), HEADACHE (headache), CHILLS (Chills) and MYALGIA (Myalgias). On 16-Feb-2021, the patient experienced PYREXIA (Fever of 99.7). On an unknown date, the patient experienced NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (arm was sore), FEELING ABNORMAL (felt like I was hit by a Mac Truck), MALAISE (general malaise), PAIN (Aching in the body), HEADACHE (headache), CHILLS (Chills), NAUSEA (Nausea), MYALGIA (Myalgias) and PYREXIA (Fever of 99.7) outcome was unknown. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 99.7f 99.7F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the events included Tylenol, Ibuprofen, Zofran.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Chills, headache, nausea, myalgia and fever are consistent with the product safety profile
Several minutes after vaccination, patient starting to feel light headed, and flushed. Patient drank some water and used an ice pack on forehead, hands to cool down.  After 10 minutes, she felt better and was able to walk out of pharmacy on her own.
I had a pneumonia shot (unspecified pneumonia shot)/I had no reaction with that other than the muscle on that arm, I got the shot and it (left arm) swelled for a couple of days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), on 17Apr2022 as dose 1, single (Batch/Lot number: unknown) at the age of 69 years, in left arm. The patient's relevant medical history included: "AFib" (unspecified if ongoing), notes: Comments: AFib. The patient's concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "I had a pneumonia shot (unspecified pneumonia shot)/I had no reaction with that other than the muscle on that arm, I got the shot and it (left arm) swelled for a couple of days". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previous Information: Updated suspect product coding.
On 07/20/2000 the patient experienced "attenuated breakthrough chickenpox" on her face, back and arms. Unspecified medical attention was sought. Additional information has been requested.
First reaction was uneasy pressure around or within stomach (upper abdomen area) and similar feeling around lungs but not sure if the feeling came from the stomach or around the lungs.  Later, stomach upset would come and go and somewhat diminish but bronchial tubes and lungs would seem to begin to secrete liquids causing coughing beginning about 04/05/2014.  Respiratory symptoms seemed to grow and more fluids in bronchial tubes needing clearing by strong out-breaths to clear passages or coughing which began to begin to happen in short spasms.
After approximately 12 hours,  the injection site became red, swollen and itchy with second inoculation.
Mild soreness, heavy bruising/swellg (hard swollen bump) at injec site same night as vacc give- approx 2 hrs later. Two dys later, light reddish/pink rash appears just under bruise (swelling down on bruise by then). No itching from rash at the time; just two separate reactions, one directly underneath the other. It's definitely taken 2-3 full weeks for bruising to break up and rash to fade. However, just when I thought rash was gone, as it really faded by 2nd week, a darker, bumpier red rash appeared in same spot underneath the bruising at injec site. Very mild itching and not regular. This rash didn't last as long and faded away in approx 1 week or so (3rd week after initial injec on Tues 1/5/21). Pics if needed.
pt left after being monitored for 15 mins without any issues. pt came back around 1505 with complaints of swollen lips, itchy throat and chest tightness. airway not compromised and  pts vitals were as follows 143/79, 98.7, 80 pulse, 16 RR, 98% Spo2. pt admitted at  Immediate care centre adjoining the clinic. pt was given Benadryl 25 mg PO, 40 mg Prednisone PO, Pepcid 20 mg PO. pt was discharged with Medrol pack.
Pt c/o 12-24 hours after receiving Pneumovax. Pt c/o swelling, redness, warmth from deltoid to elbow. Aches also, resolved 72 hours after shots.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. In July 2014, the patient received the first dose in the series of GARDASIL (injection; dose, lot# and expiration date were not reported). In July 2015, the patient received the second dose in the series of GARDASIL (injection; dose, lot# and expiration date were not reported). On 17-MAR-2016 (reported as now), the patient was in the office to receive the third dose in the series of GARDASIL (it was unknown if the patient received the dose). No adverse effects were reported. Additional information has been requested.
Migraine; watery eyes; tremors in her whole body; started feeling little headachy again; stomach is queasy; chills; headache; tiredness; nausea/queasiness; This spontaneous case was reported by a consumer and describes the occurrence of LACRIMATION INCREASED (watery eyes), TREMOR (tremors in her whole body), MIGRAINE (Migraine), CHILLS (chills) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine and Hypothyroidism. Concomitant products included DIHYDROERGOTAMINE MESILATE (MIGRANAL) for Migraine, THYROID (ARMOUR THYROID), ACETYLSALICYLIC ACID (ASPIRIN 81), VITAMIN D [VITAMIN D NOS], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), VITAMIN C [ASCORBIC ACID], CALCIUM and DIAZEPAM for an unknown indication.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced CHILLS (chills), HEADACHE (headache), FATIGUE (tiredness) and NAUSEA (nausea/queasiness). On 11-Mar-2021, the patient experienced HEADACHE (started feeling little headachy again) and NAUSEA (stomach is queasy). In May 2021, the patient experienced TREMOR (tremors in her whole body). On an unknown date, the patient experienced LACRIMATION INCREASED (watery eyes) and MIGRAINE (Migraine). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 09-Mar-2021, CHILLS (chills), HEADACHE (headache), FATIGUE (tiredness) and NAUSEA (nausea/queasiness) had resolved. In May 2021, TREMOR (tremors in her whole body) had resolved. At the time of the report, LACRIMATION INCREASED (watery eyes), MIGRAINE (Migraine), HEADACHE (started feeling little headachy again) and NAUSEA (stomach is queasy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Thyroid function test: low (Low) After second dose, patient's thyroid hormone test showed low.. On 30-Apr-2021, Thyroid function test: low (Low) Patient's thyroid hormone level showed low normal.. On 01-Jun-2021, Blood thyroid stimulating hormone: normal (normal) Patient's TSH level showed normal..         This case was linked to MOD21-108068 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up received on 07-Jun-2021: Updated concomitants, lab data, medical history.Added new events tremor and migraine.; Sender'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.
This spontaneous report was received from a pharmacist, concerning a 78 year old male patient. The patient's concurrent conditions included hospitalization from an unknown date, due to a pre-existing unspecified condition. The patient's pertinent medical history and concomitant therapies were not reported. On 01-MAR-2018, during hospitalization, the patient was inadvertently vaccinated with PNEUMOVAX 23, intradermally into the left arm, for prevention (dose, lot number and expiration date were not reported). On 02-MAR-2018, the patient complained of pain and swelling at the injection site and was given acetaminophen (TYLENOL). On that same date, the patient was discharged home.  The patient was recovered from pain and swelling at the injection site by the time of the report. The reporter did not assess the causal relationship between vaccination with PNEUMOVAX 23 and the events.
Morning of 4-2-07 child developed fine rash on anterior and posterior trunk along with a low grade fever.
Fever to 102 w/in 24 hrs; lt thigh induration, redness @ inject site-6x7 cm-needle aspirated 3FEB92; oral & IV ATB, surgery-incision & drainage;
I tested positive for COVID-19 on March 10, 2023 I experienced really bad cough, fever, fatigue, I was prescribed Paxlovid and cough suppressant for my symptoms.
Had shot on left arm but a red rash with blisters developed on right arm. Doctor prescribed steroid and VALTREX.
Patient felt faint few minutes after receiving vaccine.  Patient examined by provider, given snacks and water and assisted to lie down.  Felt better few minutes after and discharged home approx 15 min afterwards.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 64-year-old male patient who received SHINGRIX (batch number G933B, expiry date 22nd November 2020) for prophylaxis. On 16th August 2018, the patient received SHINGRIX (intramuscular) .5 ml. In August 2018, less than a month after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The pharmacist did not know when the patient started noticing the symptoms. This case has been linked with cases US2018158121 and US2018GSK160732 reported by the same reporter.
INITIAL SUBCLINICAL/UNRECOGNIZED MYOCARDITIS LED TO COVID-19 VACCINE INDUCED CARDIOMYOPATHY RESULTING IN HEART FAILURE WITH REDUCED EJECTION FRACTION 20% AND PULMONARY EDEMA
Deep left shoulder pain, decreased range of motion. Mild symptoms the day of the vaccination that went away fairly quickly. The recurrence of the discomfort and the severity constitute the  possible adverse reaction
Patient developed difficulty breathing with short shallow breaths and hoarseness.  Parents proceded to take patient to ER for treatment.  Patient was treated for tracheobronchiolitis and croup.  Given Decadron orally and script for Orapred.
103 degree fever for 48 hours Severe fatigue and pain Shortness of breathe and difficult breathe occurred over the follow days and ending in a trip to the Emergency Room
Pregnancy Fetal Anomaly Diagnosis: Severe Hydrocephalus at 22 weeks Parents have two healthy prior children,
Vaccine was given by MA on 1/12/18, the next day patient reported, while at our office on 1/16/18, that she experienced redness, swelling, warm to touch, fever, pain that radiated into her neck, blurred vision, chest pain and pressure. On 1/16/18 patient reported that day that all symptoms were subsided except the redness, swelling and slight blurred vision. Patient was evaluated by myself, another nurse, and Dr.
Decreased appetite, both arms swollen at injection site of Prevnar, DTaP, IPV - Benadryl, Tylenol and warm compresses
Blood in stool starting 2 days after vaccines were given. No improvement after milk was eliminated by breastfeeding mother. Blood in stool persists as of 09/28/2015.
Patient had flu vaccine on Monday 01/23/12. Came home from school Tuesday 01/24/12 at 3:00 pm. Complaining of arm hurting, redness noted by mom. Took to APRN at clinic. She treated patient with prednisone x5 days. Arm red, swollen, warm around site.
Over time I have had increasing Dyspnea to the point that my pulse ox goes down to 81 when I am walking
Pt. received Moderna vaccine at another site on 2/15/21 and did not receive the second vaccine 4 weeks later. She spoke to her physician and was told that she would need to restart the series. She came to our pharmacy and was told the same thing, in error, by our pharmacist. She received her first Pfizer vaccine on 6/17/21 and the second on 7/8/21.
Had mild menstrual bleeding and cramps. Had not had a period since Jan 1 2020. Was supposed to be menopausal
About 10 minutes after the second dose, I started to feel very dizzy and not like myself. Something felt really off. About 15 minutes later my lips started to feel a little numb. I was taken to the ER next to the facility I was in. I was observed there, and they did an EKG which was normal. My heart rate was very high and I was observed for a while because my symptoms had started to resolve. That night I felt nauseous and very tired. I was dizzy and nauseous for the next few days but then I felt normal. I had only had arm soreness and a little fatigue after the first dose.
30min p/vax pt devel 2 hives one on lt cheek, one on rt upper lip;no diff breathing;no hives on torso or extremities;given DPH;
SWELLING AND DISCOLOR OF TONGUE.  SOME DISCOMFORT, MOUTH ,VERY DRY. LIPS VERY CHAPPED AND DRY.
CONSTANT BAD SMELL IN NOSE. SMELL IS A TYPE OF BURNT SMELL AND SOMETIMES I CAN TASTE IT AS WELL WHEN I SWALLOW. MAINLY A CONSTANT SMELL THAT DOESN'T GO AWAY.
had side effects; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (had side effects) in a 23-year-old male patient 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 an unknown date, the patient experienced IMMUNISATION REACTION (had side effects). At the time of the report, IMMUNISATION REACTION (had side effects) 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.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Live Follow-Up appended
Patient presented to Hospital on 08/26/2021 with increased SOB, confusion and hypoxia, with O2 saturation in the 70's.  In the ED patient was tested positive for Covid-19, the patient was placed on nasal cannula and admitted to hospital services.  Patient required both optiflow and NRB over with sill borderline oxygen saturations.  CT imaging revealed extensive pneumonia r/t Covid-19.  Patient continued to decline despite maximum therapy and CAP.  Palliative care was consulted and decision and was made for comfort care.  Patient expired on 09/03/2021.
Swollen left deltoid area along with pain in left arm: patient unable to lift left arm due to increased amount of pain. Hurts from left deltoid area down to left elbow and left midaxillary area. Pain is unbearable at times and has not stopped since the date of injection.
Patient received dose 1 of Moderna vaccine. She used the restroom right after shot, and upon exiting the bathroom, passed out. She was feeling dizzy, so immediately sat on the ground before fainting. Another patient yelled for help, and I immediately ran out to her aid. I also had one of my staff members call 911. The patient regained consciousness as I arrived, and was able to talk to me. I determined that this was a syncope reaction, and not an allergic or anaphylactic reaction. I elevated her legs, and waited for the ambulance to arrive. The EMTs analyzed her, and released her to go home with her parent.
DTaP/IPV injection site reddened, swollen to golf ball size. Facial swelling with spots. ER prescribed KEFLEX, prednisone, nupracin to site.
Narrative: c/o SOB + 8/10 CP that radiates up left side of neck. pt unable to give specific time frames of onset of SOB + CP, but thinks they have started on friday after his second covid shot. endorsing nausea with dry heaves at home, in triage he vomtted coffee ground emesis, ~325ml. Breakthrough COVID infection requiring hospitalization
Patient contacted the pharmacy the day after she received her shot that she had fever/chills/extreme nausea. She reported that it had started around 11 am that day. Advised patient to take anti-pyrogenic medication and rest and to follow up with either the pharmacy or her physician if her symptoms did not resolve within approximately 24-48 hours. Patient has not yet contacted the pharmacy to follow up at this point but asked that her symptoms be reported.
The patient is a 78-year-old female who was admitted with COVID-19 pneumonia and acute renal failure, hyponatremia, hypokalemia, and hyperglycemia with history of type 2 diabetes.  The patient did not qualify for remdesivir and was placed on Decadron.  The patient was on room air by day of discharge. The patient was seen in consultation with Nephrology and Pulmonary Medicine during the course of admission here along with Infectious Disease.  By day of discharge, she was cleared by both Pulmonary Medicine, Infectious Disease, and as such the patient is being discharged home with doxycycline for a week.  Clearance was also requested from Nephrology regarding the serum sodium, which was obtained.
I woke up with a 101.8 fever on Tuesday morning at 3 am. Had covid symptoms for 2 days, fever, chills, severe body aches and skin sensitivity, I had covid in Aug (8/19-8/28) This was just like how I felt when I had covid.
Got the Moderna vaccine two weeks later he received a second shot; A spontaneous report was received from a caregiver concerning a male patient, who received the second dose of the Moderna's COVID-19 vaccine (mRNA-1273) 2 weeks apart.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date, the patient received the first of two planned doses of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection. Two weeks later (on an unspecified date) the patient received the second dose of Moderna vaccine (Inappropriate schedule of vaccine administered).   No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 therefore, action taken with the drug in response to the event was not applicable.  The outcome of the event was considered recovered.; Reporter's Comments: This report refers to a case of Inappropriate schedule of vaccine administered for mRNA-1273, lot number was not provided and with no associated AEs.
10 mins after BOOSTRIX, MENACTRA, Hep A, Varicella vaccines - felt dizzy & fainted (vasovagal syncope). Recovered 1-2 mins. 2 hours later came back in office w/ chills & shooting pain legs = gave MOTRIN, slowly recovered 30 mins - 1 hour.
Thyroiditis subacute; Lymphadenopathy; Tachycardia; This is a spontaneous report from a non-contactable consumer. A 41-years-old female patient received first dose of bnt162b2 (FIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 (at age of 41-years old) as dose1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced thyroiditis subacute, lymphadenopathy, tachycardia. It was reported that calculated time to onset (TTO) was 14 days. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100974883
I am verycold; Muscles hurt; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (I am verycold) and MYALGIA (Muscles hurt) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING COLD (I am verycold) and MYALGIA (Muscles hurt). At the time of the report, FEELING COLD (I am verycold) and MYALGIA (Muscles hurt) outcome was unknown.            Patient reported that he was very cold and Got second shot yesterday.  Patient was very cold and muscles hurt.  Asked whether normal.  Concomitant medications were not provided.  Treatment medications was not given.
Swelling, hives, hot to touch, itchiness, soreness on upper left arm (approx 4" x 6")
Severe chills, shaking, felt close to passing out. This occurred after I had slept several hours. The next day, I felt wiped out; no appetite.
Miscarriage at 5 weeks pregnant. Had first appointment, ultrasound and blood work on 5/11/2021. Covid vaccine on 05/12/2021, first signs of miscarriage on 05/13/2021. Bleeding was followed by cramps. I saw Dr. on 05/14/2021 for miscarriage. Due date was January 10, 2022. Fourth pregnancy. Once previous miscarriage.