chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shivering; stomach pains; diarrhea; This case was reported by a consumer and described the occurrence of shivering in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th December 2020, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced shivering, stomach pain and diarrhea. On an unknown date, the outcome of the shivering was recovered/resolved and the outcome of the stomach pain and diarrhea were not recovered/not resolved.   It was unknown if the reporter considered the shivering, stomach pain and diarrhea to be related to Shingrix.  Additional details were provided as follows:  The patient self reported the case. The age group was not reported but was selected as adult as per vaccine indication. The patient asked how long a reaction could last from taking the Shingrix shot.
Patient went to observation area and was sitting with his mother after receiving vaccine at 03:41 PM on RA. Patient told nurses at 03:45 PM he felt lightheaded, was seeing blurry vision, and his stomach hurt. Patient was pale, diaphoretic, and had unstable vitals. First set of vitals was taken on the RA at 03:46 PM with BP 80/40 mmHg, HR 90 bpm, RR 18 bpm, and oxygen at 98%. Patient was told to take slow deep breaths, was given an ice pack for the neck, water to drink, and some pretzels. At 03:48 a second set of vitals was taken on the LA with BP 120/60 mmHg, HR 56 bpm, RR 18 bpm, and oxygen at 100%. Patient claimed vision was no longer blurry, he was no longer lightheaded, and stomach no longer hurt. Patient was no longer diaphoretic and was no longer pale. Last set of vitals was taken on the LA at 03:50 with BP 122/78 mmHg, HR 56 bpm, RR 17 bpm, and oxygen 100%. Patient stayed for an additional 15 minutes and left at 04:16pm with his mother. He claimed to feel back to normal. Both patient and his mother, father, and sister were educated on what to do if he starts to feel these symptoms again.
4 hours, post vax, baby suddenly lay still, rolled eyes and fell asleep for 1/2 hour and then woke up screaming, lasting for 2 hours. 12 hours later, temperature was 101.4F to 102.9F for 12 hours and then loose stools but was alert and happy.
Pt reported severe fatigue and off and on nausea.  Fatigue continues.  Also reported numbness of left pinky and part of palm two weeks following vaccine. Visit with provider, determines that numbness is not related to vaccine.   Pt received second dose of Moderna vaccine 2/16/21. Lot # 006M20A.  exp 7/12/21.  at 9:00 am. Left deltoid IM, fatigue continues
Complete paralysis of left arm, 103 fever for 48 hrs , still tiredness after 30 days
Information has been received from a healthcare professional regarding an unspecified number of patients of unknown age. On an unknown date, the unspecified patient received improperly stored oral ROTATEQ (dose was not provided, Lot number reported as J000987, expiration date 11-SEP-2014). Two doses of the improperly stored ROTATEQ were received on 28-MAR-2014. The improperly stored ROTATEQ was exposed to 13C for an undetermined timeframe. Healthcare worker will provide timeframe when products are back in recommended storage range. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
PROJECTILE VOMITING, BLOOD AND LOOSE STOOLS, LACK OF APPETITE, CRYING. DR. SENT TO HOSPITAL AND CHILD DX WITH INTUSSUSCEPTION.  12/15/09 Received PCP medical records of 12/8/09.  Patient experienced cough, stiffness, fussiness, decreased appetite x 1 day & diet refusal x 1 day, loose stools x 1 day.  Exam revealed lethargy.  Sent to ER.  12/21/09 Received partial ER medical records of 12/8/09 from PCP.  IS suspected.  Transferred to higher level of care. FINAL DX: Intussusception.  1/11/10 Received additional ER medical records from higher level of care facility.  Exam revealed RUQ mass.  Ileocolic IS confirmed & resolved with enema.  Admitted for observation, progressed well & d/c to home.
Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a 40-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-076597 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076597:Second Dose Case
This spontaneous report as received from healthcare professional refers to a 12 month old female patient. The patient did not have any medical history, concomitant medication or drug history. On 05-SEP-2017, the patient was vaccinated with VARIVAX lot # N008829 and expiry date: 16-MAR-2019, 0.5 ml for prophylaxis which has undergone temperature excursion. No adverse effects were reported. It was reported that the patient will receive a booster dose at the age of 4. There were no lab tests performed. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1709USA002643: US-009507513-1709USA002626.
pt had staring spells 24hr p/vax;T99.1 ax;pt had listless spells w/sz 2 to 3 wk post vax;hosp x 4 days;3wk p/vax;
Red hard circle on arm/ redness; Sore arm; Hard sore spot; Heart palpitation/ heart went out of rhythm/it kept doing same tilland it's been back to normal; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Jul-2021. The most recent information was received on 29-Jul-2021 and was forwarded to Moderna on 30-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitation/ heart went out of rhythm/it kept doing same tilland it's been back to normal), ERYTHEMA (Red hard circle on arm/ redness), PAIN IN EXTREMITY (Sore arm) and INJECTION SITE INDURATION (Hard sore spot) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included ENALAPRIL MALEATE (VASOTEC [ENALAPRIL MALEATE]), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, the patient experienced PALPITATIONS (Heart palpitation/ heart went out of rhythm/it kept doing same tilland it's been back to normal). On an unknown date, the patient experienced ERYTHEMA (Red hard circle on arm/ redness), PAIN IN EXTREMITY (Sore arm) and INJECTION SITE INDURATION (Hard sore spot). The patient was treated with ALPRAZOLAM (XANAX) for Adverse event, at an unspecified dose and frequency. On 24-Jun-2021, PALPITATIONS (Heart palpitation/ heart went out of rhythm/it kept doing same tilland it's been back to normal) had resolved. At the time of the report, ERYTHEMA (Red hard circle on arm/ redness) had resolved and PAIN IN EXTREMITY (Sore arm) and INJECTION SITE INDURATION (Hard sore spot) had not resolved.        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.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow up received on 16 Jul 2021 contains no significant information On 29-Jul-2021: Additional events erythema, pain in extremity and injection site induration were added. Outcome of palpitations was updated from unknown to recovered resolved.
03/22/2021 within three hours of the vaccination Dose 1, flu like symptoms. Dose 2, experienced at 03:00 AM severe headaches and body aches, progressively experienced exhaustion and fatigue. It was a struggle to complete daily activities. Was unable to continue with normal exercise routine. Prescribed an Inflammatory drug Meloxicam helped with pain and reduced inflammation. Bladder frequently emptying, was put on a medication.
L arm became red, swollen and painful. Symptoms began around 0200am. Patient had TMAX 101 x 48 hrs post onset. Symptoms started approx 10 hrs after administration of vaccine.
Headaches for about 8 weeks post shot 2.  And on March 18, admitted to hospital with eye palsy in 3 rd optic nerve.
Severe headache, neck hurt, vomiting 8-8-17, to ER 8-8-17-tests and labs performed. Given IV BENADRYL, COMPAZINE, sent home, no relief, to pediatrician next day, given IM TORADOL, sent home, no relief, to ER again next day. MRI, CT scan, labs, transferred to Hosp. by ambulance. Diagnosed abnormal vessels on brain. 8-8-17-patient came home from her job complaining of severe headache, she took OTC meds that were not effective, toward evening her condition got worse with severe headache, neck pain, and her eyes were very sensitive to light. She was taken to Emergency room and on the way there, she began vomiting in car. Hospital ER, ran tests, CT scan of head, lab work, found nothing wrong, gave her IV COMPAZINE/BENADRYL, she slept some time there and was sent home, still having head/neck pain. Next day head/neck pain continued, she was taken to her pediatrician, he gave her IM injection of TORADOL for "migraine" and sent her home. Injection of TORADOL not effective. Next morning, (Day 3) I returned patient to ER, this time she was too weak to walk, had to be wheeled in by wheelchair, severe headache, neck ache, unable to open eyes, unable to eat. Hospital ran more tests, more blood work, recommended ambulance transfer to Hospital for seizures. And having abnormal blood vessels on brain. Spent from 8-10-17 until 8-15-17 in Hosp. neurology department. She is now on anti-seizure medication 2 times/day, and 81 mg aspirin daily. Patient has no history of headache, migraine, or seizures until this all started 8-8-17, just 6 days after injection of BEXSERO, and MENVEO/MENACTRA injections.
sciatic nerve just blow up. This time it quickly turned into tremendous pain; no energy; I slept most of the time; tired; chills; fever; headache; flu-like ache; muscle pain; queasiness; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263), via an unspecified route of administration, administered in left arm on 19Feb2021 at 13:15 (at the age of 77-years-old) as single dose for COVID-19 immunisation. The patient took the first dose of BNT162b2 (lot number E13246) on 27Jan2021 at right arm for COVID-19 immunisation. Medical history included High blood pressure (BP) and cholesterol, all managed. The patient had also history of sciatica nerve pain in in early Jan2021, resolved with 5 days of meloxicam. Concomitant medication included atenolol, hydralazine, pravastatin and budesonide/formoterol fumarate (SYMBICORT). The patient reported that 2 hours after vaccination, at home, she felt tired, quickly turned to chills and fever. Body temperature was 99.9 F. She never run temps. This was followed by headache, flu-like ache, muscle pain, queasiness, and just terrible in general. She spoke with nurse who gave her shot to see if I should take any fever reducers. She said try to hold off, but if bad, take Tylenol or Ibuprofen. On 20Feb2021 sciatic nerve just blew up. She had an episode in early January, but Meloxicam worked in 5 days and she was fine. This time it quickly turned into tremendous pain-could not walk without help, trouble getting in or out of bed and to the bathroom. She was screaming out in pain. She started taking Tylenol and then Ibuprofen. Nothing helped. She had a few Meloxicam pills left and took one 22feb2021. Temps were rising daily (101.5) chilled, no energy. She slept most of the time straight chair. Sciatica was better, but not gone. Day 9, she walked outside, temp was normal. She was sent for flu & Covid tests (nasal swab), both negative.  The outcome of events was recovering.    No follow up attempts are possible. No further information is expected.
Patient had fever, chills, and then her heart started racing. In my office it was 125. I sent her to an urgent care to rule out any arrhythmias, as we do not have an ECG.
Rash beginning on neck near jaw line, proceeding to spread all over face, including eyelids, ears and down chest
This case was reported by a consumer via call center representative and described the occurrence of cold sores in a 77-year-old male patient who received SHINGRIX for prophylaxis. In February 2019, the patient received SHINGRIX. In February 2019, 14 days after receiving SHINGRIX, the patient experienced cold sores, tremor and fatigue. On an unknown date, the outcome of the cold sores was not recovered/not resolved and the outcome of the tremor and fatigue were unknown. It was unknown if the reporter considered the cold sores, tremor and fatigue to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient chose to remain anonymous and declined to answer any detailed questions. The patient received the vaccine 4 weeks ago and a week or so after that he had shaking and fatigue. A week later a sore appeared on his penis. The patient described it as a cold sore. The patient said he used to get cold sores on his cheek but has not had one in years. The reporter did not give consent to follow up.
Loss of memory for 2 - 2 1/2 hours.  Could not remember awareness of conversations, actions, or routine.  Never before experienced this type of event in life.
Asymptomatic, tested positive 8/11/21, case is in a facility .
TINGLING SENSATION/ PINS AND NEEDLES IN THE FINGERS OF LEFT ARM; JOINT ACHES; EYES HURTED; BODY ACHES; ARM SORE; CHILLS; A BASE BALL SIZE LYMPHATIC MASS IN THE LEFT AXILLA; SLIGHT HEADACHE; PAINFUL INJECTION; This spontaneous report received from a patient concerned a 48 year old male. The patient's height, and weight were not reported. The patient's past medical history included: lymph node swelling of both armpits, and concurrent conditions included: non alcohol user, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse or illicit drug use. The patient was previously treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 0421A21, expiry: UNKNOWN) dose was not reported, administered on 21-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-AUG-2021, the patient experienced painful injection. On 22-AUG-2021, the patient experienced eyes hurted. On 22-AUG-2021, the patient experienced body aches. On 22-AUG-2021, the patient experienced arm sore. On 22-AUG-2021, the patient experienced chills. On 22-AUG-2021, the patient experienced a base ball size lymphatic mass in the left axilla. On 22-AUG-2021, the patient experienced slight headache. Laboratory data included: Blood pressure (NR: not provided) 220/110 mmHg, 168/98 mmHg, CBC (NR: not provided) Normal, CT scan (NR: not provided) Negative for blood clot, and Ultrasound scan (NR: not provided) Lymphatic mass in the left axilla. On 23-AUG-2021, the patient experienced tingling sensation/ pins and needles in the fingers of left arm. On 23-AUG-2021, the patient experienced joint aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 22-AUG-2021, was recovering from painful injection, and arm sore, had not recovered from body aches, slight headache, eyes hurted, a base ball size lymphatic mass in the left axilla, and joint aches, and the outcome of tingling sensation/ pins and needles in the fingers of left arm was not reported. This report was non-serious.
Patient received flu and shingles vaccines on 9/14/2023. Post vaccination, she experienced pain, swelling, redness on area of shingles vaccination (Left arm) that lasted 4-5 days.  She has been experiencing dizziness that has not gone away and states she does not have any blood pressure or blood sugar problems when she checked.
devel large erythematous, macular/papular patch on rt thigh surrounding inj site;similar rash on face w/scattered red papules over rest of body;otherwise well, no sx;
Pale and behavior changes w/n 4 hours of flu shot - lasted about 1 hour.
Chills; Fatigue; Both sides of her arm are swollen; Arms felt tingling; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Both sides of her arm are swollen), PARAESTHESIA (Arms felt tingling), CHILLS (Chills) and FATIGUE (Fatigue) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PERIPHERAL SWELLING (Both sides of her arm are swollen) and PARAESTHESIA (Arms felt tingling). On 23-Jan-2021, the patient experienced CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, PERIPHERAL SWELLING (Both sides of her arm are swollen), PARAESTHESIA (Arms felt tingling), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
a 9 year old female patient received a dose of Quadracel/No AE; a 9 year old female patient received a dose of Quadracel instead of Adacelwhich was prescribed/No AE; a 9 year old female patient was prescribed a dose of Adacel/No AE; Initial information received on 27-Sep-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case is linked to case 2019SA272368.  This case involves a nine years old female patient received a 0.5 ml booster dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] lot C5635AA, expiry date: 18-Jun-2021 via intramuscular route in the left deltoid on 23-Sep-2019 instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] which was prescribed to her.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2019, the patient received a dose Booster dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5635AA via intramuscular route in the left deltoid.  It was an actual medication error due to inappropriate age at vaccine administration, wrong vaccine administered and product prescribing error.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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.  List of documents held by sender: none.
Pt came in for the second dose. After 5 minutes of vaccination patient fainted down. I checked the pulse and breathing and one of techs called 911. Pt was breathing and pulse was fine too. Paramedics arrive in 5 minutes and check the oxygen level and did other tests. Pt was shaking little bit and looking pale. Pt was transferred to hospital for further monitor.  Pt haven't had any reaction with 1st dose.
Had an itchy rash 1 week later, all over chest, doctor thinks it was an allergic reaction, also on arms, legs and back. Doctor said it was drug allergy, still having rash and hives, been taking Allegra twice a day. Took over a month to resolve, still having minor lingering effects.
no additional AE'S; improperly Stored; Administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medication were not provided.  The previous temperature excursion of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) was reported as 30.28 Fahrenheit degrees (F) for 19 minutes and 34.81 F for 35 minutes. On 19-MAR-2021, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T020616,expiration date 16-MAR-2023, dose was reported as 1 (unit unknown); strength and route were not provided) for prophylaxis (product storage error). Administered dose of vaccine was stored in the temperature of 28.34 F for 1 hour and 2 minutes. No additional adverse event was reported. Data logger was involved.  This is one of several reports received from same reporter.; Sender's Comments:  US-009507513-2104USA002463:Original Case : 2104USA002463
Within 24 hours symptoms occured: Muscle spasms in legs , moving up to Trunk, dumping syndrome with intestinal pain, spasms, gelled excretement, and excessive urination every 10 minutes for 6 hours, dizziness, extreme vertigo, visual hallucinations, photo sensitivity, balance issues, extreme sound sensitivity, extreme fatigue,
Tested blood sugar on 01-22 in the AM.  Normal sugar test is in the 150's. The blood sugar was in the high 180's.  Tested the blood sugar on 01-23 in the AM and it is still in the high 180's.
Nasal congestion, post nasal drip, then sore throat, fever, sneezing, coughing, headache
It was 18 hrs later I had sore muscles on the arm, fatigue, low energy and mainly exhaustion and then the back pain. I had mild nausea the next morning, I felt sick and tired. No fever and no chest pain.
lot of pain at the shot location; body aches; headache; Chills; muscle aches; tiredness; nausea; diarrhea; This is a spontaneous report from a contactable consumer. A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0172), dose 2 via an unspecified route of administration, administered in left arm on 22May2021 at 15:45 (at the age of 42-years-old) as 2nd dose, single dose for COVID-19 immunization. Patient's medical history and concomitant medication were not reported. The patient had penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0172), dose 1, administered in left arm on 01May2021 at 15:30 as 1st dose, single dose for COVID-19 immunization. on 23May2021 at 00:00, the patient experienced lot of pain at the shot location, body aches, headache, chills, muscle aches, tiredness, nausea and diarrhea. The patient did not receive treatment for the events. The reporter assessed the events as non-serious. The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.