chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever 101.5 f , migraine, whole body ache, stiffness all over body, congestion
bronchitis; coughing; couldn't talk; sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRONCHITIS (bronchitis), PAIN IN EXTREMITY (sore arm), COUGH (coughing) and SPEECH DISORDER (couldn't talk) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 31-Mar-2021, the patient experienced BRONCHITIS (bronchitis). 31-Mar-2021, the patient experienced COUGH (coughing) and SPEECH DISORDER (couldn't talk). At the time of the report, BRONCHITIS (bronchitis), PAIN IN EXTREMITY (sore arm), COUGH (coughing) and SPEECH DISORDER (couldn't talk) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment details included antibiotics and steroids. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Glands in neck began to feel quite tender beginning about 2pm and slowly progressed to be quite swollen by the following day.
One day after flu shot c/o SOB. Saw PCP on third day after shots. Treated with Proventil. Condition improved within 4 days.
STEMI treatment: went into V fib arrest and did CPR and went to cardiac cath and received PCI discharged home
Hospitalized (1.29.22 - 2.1.22); COVID-19 positive (1.28.22); ED visit (1.28.22); fully vaccinated Admission Date: 1/29/2022  Discharge Date: 02/01/2022  DETAILS OF HOSPITAL STAY: Pneumonia [J18.9] HOSPITAL COURSE: Patient is a 5 y.o. female with no significant PMHx who was admitted for hypoxia secondary to pneumonia.  Patient presented to ED on 1/29 following a 4-day history of fever, cough and poor appetite. She was initially evaluated in the ED on 1/28 due to fever (T104F) but she was deemed stable for discharge. On 1/29, she was brought back to the ED for worsening symptoms. In the ED, patient noted to be hypoxic and started on 2L NC. CXR obtained in ED notable for bilateral perihilar and bibasilar patchy consolidations (R>L). COVID-19 PCR negative. 1x dose given for possible CAP. Patient admitted to the floors for further management.  While admitted to the floors, patient did continue to intermittently require supplemental O2 especially when asleep. She was switched from Ampicillin to Amoxicillin once PO intake had improved. A film array was obtained 1/31 from her previous nasal swab due to concerns for Mycoplasma. FA positive for COVID-19 and Metapneumovirus. Discussed with ID about positive result on similar swab that initially tested negative, and they recommended treating the result as a true positive. Patient received 1x dose of Decadron given need for supplemental O2 and COVID-19 illness. At time of discharge, patient was clinically stable and breathing comfortably on room air. Discussed with mom that she may continue to be intermittently tachypneic at home but we do not expect her to have increased work of breathing. She will need to take 3 more doses of Amoxicillin to complete a 5-day course of abx for her superimposed bacterial pneumonia. She will not need to continue on steroids. Return to care precautions provided to family. Patient discharged home in stable condition.
Patient's wife came in later and said that patient had fever and chills.  She reported it started sometime after he got home.
ax temp of 103; wheezing seen in ER @ 930PM; pt put on Proventil;
Despite completing COVID19 vaccine series in March, the oatient developed bodyaches, headache, congestion and was diagnosed with COVID(+) pneumonia. She is currently hospitalized with dyspnea and bilateral multilobal pneumonia.
Severe pain, swelling, redness, large localized reaction, developed into cellulitis lasting over 2 weeks.  He states he had the same reaction with first vaccine that lasted about 8 days.
This is a spontaneous report from a non-contactable consumer via Pfizer sales representative. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date about a year ago at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient reported major swelling, lot of pain, redness and cellulitis. The symptoms lasted for 2-3 weeks. The patient was put on antibiotic and recovered. No follow-up attempts are possible, information about batch number cannot be obtained.
Bit sick; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (Bit sick) in a 51-year-old female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Bit sick). At the time of the report, ILLNESS (Bit sick) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-311010 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow-Up received. Serious Disability is changed to No as per SD and case is downgraded to Non-Serious
Just the side effects that literature said I might have. I had COVID last June, and I was very fatigued and had muscle aches. For about 36 hours, I felt exactly like that after receiving the shot. I?m fine today. I plan to get shot #2. This was NOT an allergy and I?m not even sure it qualifies as a reaction. They were side effects that I was told I might have. I?m reporting I had them.
SEVERE INTESTINAL PROBLEMS CAUSING 2 TRIPS TO EMERGENCY ROOM & 3 ROUNDS OF ANTIBIOTICS WITHOUT RESULTS. DIARRHEA, CRAMPING, VOMITING
This spontaneous report as received from a physician via a field representative refers to a 19 year old female patient. Medical history and concurrent medications were not provided. On an unknown date the patient was vaccinated with GARDASIL 9. On an unknown date the patient experienced migraine and some redness and pain around the injection site. The outcome of the events was unknown. See case 1610USA005927 from the same reporter regarding the patient's 18 year old sister who experienced the same events. Addition information has been requested.
very much like a blood clot; R leg swelling; very hematoma; big red patch; warm sensation in the the leg; pain that he never had; normal pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (very much like a blood clot) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (normal pain in the injection site). On 04-Apr-2021, the patient experienced THROMBOSIS (very much like a blood clot) (seriousness criterion medically significant), PERIPHERAL SWELLING (R leg swelling), HAEMATOMA (very hematoma), ERYTHEMA (big red patch), FEELING HOT (warm sensation in the the leg) and PAIN IN EXTREMITY (pain that he never had). At the time of the report, THROMBOSIS (very much like a blood clot), PERIPHERAL SWELLING (R leg swelling), HAEMATOMA (very hematoma), ERYTHEMA (big red patch), FEELING HOT (warm sensation in the the leg), PAIN IN EXTREMITY (pain that he never had) and VACCINATION SITE PAIN (normal pain in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities
tc from mom on 14FEB95 to report rash lt hip advised to call MD for further instructions;phone call from mom on 26FEB96 to advise pt w/cellulitis;tx ATB, seen by dermatologist, question as to tx between phone call on 14FEB96 & 24FEB96;
Severe throbbing pain at site of injection approximately 4 hours after administration that would not diminish after ice or ibuprofen. Unable to move arm without having severe pain. Unable to sleep due to pain. On 4/4/22 finally called PCP  for further treatment which included pain medication.
Tiredness, muscle pain, chills, joint pain, fever, nausea, difficulty breathing/shortness of breath
14 cm x 5 cm erthy/swollen area L upper arm at site of vaccination. Fever 103-104
There was not an "adverse" event. NO symptoms. Patient was given and a dose of 12 year and older COVID 19 vaccine and is 11 years and 3 months.
ON 1/21/2020 RESIDENT WAS EXPERINCING CHILLS AND LOOSE STOOLS.  FOLLOWING THIS EPISODE BECAME UNRESPONSIVE, PALE, DIAPHORETIC AND BRADYCARDIC. PALLIATIVE CARE WAS PROVIDED.  RESIDENT PASSED AWAY APPROX. 10 HOURS LATER.
Hives began approximately 88 hours after vaccine #2 at 2am on 2/16, worsening by 10am same date. I went to my primary MD, who suggested Loratidine during the day and Cetirizine during the evening as needed. He also gave me a Rx for Prednisone to be used only if respiratory symptoms develop. I took my first Loratidine at 1:00pm, and have taken a second dose today at 11:00am, due to hives starting again. I did not take any Cetirizine, and I have not needed the Prednisone.
No Additional AE; HCP called to report that the patient was administered  PROQUAD and VARIVAX in the same day. No Additional AE/PQC.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.      On 18-JUL-2023 the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (albumin status: rHA) lot # w039840 and expiration date 12-JUN-2024, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided) and varicella virus vaccine live (oka/merck)(VARIVAX) lot # x006981 (valid for varicella virus vaccine live (oka/merck)(VARIVAX)) and expiration date established as 07-MAR-2025, 0.5 milliliter for prophylaxis (dose number, route and site of administration were not provided) (overdose and no adverse event).
Schedule for dose 2 of Rabavert today, but he missed Day 7. Today is Day 18; Case reference number US-BN-2021-002197  is a spontaneous case report initially received from a nurse via Agency (reference number: USBAV21-0419) on 18-Aug-2021, and concerns an adult male patient (in his 30s).  The patient's medical history and concomitant medication details were not provided.  On 30-Jul-2021, the patient received the first dose of RabaVert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at dose of 1 milliliter (mL), administered intramuscularly, for pre-exposure prophylaxis for international travel.  It was reported that the patient was on the schedule for the second dose, on day 7, but missed the second dose (explicitly coded as 'Product dose omission'), and had not received it yet as of day 18, which is the time of this report.  At the time of this report, it was unknown whether the patient developed any adverse event nor if the patient received the second dose yet.  No further information was provided.; Reporter's Comments: Product dose omission issue is listed for RabAvert per convention. Reportedly, the patient missed the scheduled second dose on day 7 after first vaccination for pre-exposure prophylaxis, which is consider as product dose omission issue. No information regarding concomitant medication and medical history were provided. No associated adverse event was reported. Reported event is not related to suspect vaccine, but to human action. The case is considered as non-serious.; Sender's Comments: Product dose omission issue is listed for RabAvert per convention. Reportedly, the patient missed the scheduled second dose on day 7 after first vaccination for pre-exposure prophylaxis, which is consider as product dose omission issue. No information regarding concomitant medication and medical history were provided. No associated adverse event was reported. Reported event is not related to suspect vaccine, but to human action. The case is considered as non-serious.
General malaise, facial flushing, hoarse voice, anterior cervical adenopathy 24 hours after vaccine x 24 hours then sinus headache, left deltoid tenderness, anterior cervical nodes less tender, rx with TYLENOL. Thursday after MMR, general arthralgia and recurrent facial flushing x 24 hours. General malaise and all symptoms resolved 6 days after onset.
Left eye was not closing; Left face drooping; Extreme pain behind his left ear; Can't blink; A spontaneous report was received from a consumer concerning a 65-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events left side of his face was drooping/facial paralysis, extreme pain behind his left ear/ear pain, can't blink/corneal reflex decreased, and his left eye was not closing/eye movement disorder.   The patient's medical history included COPD, congestive heart disease and chronic problems with his back. No relevant concomitant medications were reported.  On 4 Jan 2021, 17 days prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 026L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 21 Jan 2021 the patient had an unexpected reaction. He got up that morning and felt fine, but as the day went on, he noticed that when he spoke, the left side of his mouth was not moving, then he noticed his left eye was not closing and that side of his face was drooping. He was not in any pain at that point. He made an appointment to see his general doctor the next day, 22 Jan 2021, after the exam he was diagnosed him with Bell's Palsy (BP) and referred him to a neurologist and ophthalmologist. The earliest he could see the ophthalmologist back was next week and he could not get the neuro to call him back. His doctor prescribed him prednisone which he completed after 7 days but said the BP symptoms have not improved. Then on Saturday, 30 Jan 2021, he started feeling extreme pain behind his left ear. Everyday the pain got worse. His pain medications were not helping the pain behind his left ear. He could not see out of his left eye and he could not blink. The event left side of his face was drooping was considered as medically significant.  Action taken with mRNA-1273 in response to the events left side of his face was drooping, extreme pain behind his left ear, can't blink, and his left eye was not closing was not provided.   The events left side of his face was drooping, extreme pain behind his left ear, can't blink, and his left eye was not closing was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Information has been received from a health professional concerning a 17 year old female who on 26-SEP-2007 was vaccinated with the second dose of GARDASIL intramuscularly in the glute. On 27-SEP-2007 the patient experienced a macular papular rash on both cheecks of the face. Subsequently, the patient recovered on 27-SEP-2007 from macular papular rash on both cheeks of the face. The patient sought unspecified medical attention when her mother called the office. Additional information has been requested. This is in follow-up to report (s) previously submitted on 11/14/2007. Information has been received from a health professional concerning a 17 year old female who on 25-SEP-2007 was vaccinated with her second dose of GARDASIL vaccine intramuscularly in the left glute (lot# 658664/0928U). The patient had a vaginal yeast infection for 7 days at the time of the injection. She had not taken DIFLUCAN yet. On 26-SEP-2007 the patient broke out in a fine, pink, macular papular rash over both cheeks "where you would place hands if holding head." Subsequently, the patient recovered completely after 2 hours on 26-SEP-2007 from macular papular rash on both checks of face. The patient sought unspecified medical attention when her mother called the office. The patient returned to school and was not keen to be examined. The plan is to keep the patient for 1 hour in office after 3rd injection on 26-JAN-2008. Additional information has been requested.
My legs became Extremely weak for 1 1/2 Days.  I was very tired too
ten year old who was inadvertently given Quadracel/ no adverse event; Initial information received on 16-May-2019 regarding an unsolicited valid non-serious case received from other health care professional.  This case involves a 10 years old male patient who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past vaccination(s) included DTAP in 2009 and IPV in 2009 (last dose of each was in 2009).  The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications were none.  On 13-May-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5532AA and expiry date 09-Oct-2020 via intramuscular route in left arm.  It was a case of actual medication error due to inappropriate age at vaccine administration. It was also reported that the child needed his 4th dose of Dtap and IPV.  No adverse event reported (symptoms-none).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
48 hours diarrhea and weakness, unable to keep fluids down, admitted to hospital through ED for diarrhea, stool culture, IV fluids. Discharged after 4 days diagnosis gastroenteritis/norovirus, dehydration and hypokalemia
10:53 AM 10-14-14 reported a burning sensation with the injection. Later that day around 12:00 noon noticed a bruise at the injection site. Noticed around 1600 that area was red and warm to touch. woke up 10-15-14 with upper (L) arm swollen and hot to touch.
On 1/6 at approximately 9am hour, I noticed joint pain in my fingers while typing, muscle soreness in my upper back, a headache, and a slightly sore throat. It quickly went down hill with a fever, chills, worsening joint and muscle pain everywhere, nausea, severe fatigue, worsening sore throat, tingling and numbness in all extremities at random locations. It is now 3pm, about 21 hours since vaccination-fever has broken once (I took ibuprofen at 2pm) but returned but not as high, and severe headache with light sensitivity. The joint pain and numbness has faded but I am left with severe muscle soreness, like I was in a car accident. Oh and I lost taste sometime today. Also I had injection site pain for both doses, starting the morning after.
Patient presented for Moderna COVID vaccine  and was asked to wait 15 min post vaccine for monitoring. Patient presented with numbness, tingling sensation in the neck and left wrist pain with weakness including 4th and 5th digit. Injection was administered in opposite arm (right). Tingling sensation then escalated to whole body with nausea and dizziness. BP reading was 149/78 and 160/74 with 15 min intervals. EMS was contacted at 1355 to transport patient to the ED. Numbness and tingling in the knee, unable to use left hand to text and left side whole body. Patient is able to elevate both arms at same level. EMS arrived at 1408 and transported patient to the ED at 1411
Toxic synovitis.  Rapid development of acute left hip pain.  Started approximately 3pm on Friday.  By Sat AM was non weight-bearing.   Went to ER.  Normal CBC, ESR, CRP.  Large hip joint effusion.  Given ibuprofen at approximately  11 AM.  Symptoms started improving (rapidly) by about 4pm.   Was running by 7 pm.  No residual symptoms Sunday AM
Little red bumps that itch A LOT.  Started with2-3, has now increased to about 10.  Centered I?m area where shot was received. Have tried different sensitive skin lotions and Cortizone cream (only helps for about an hour). Took 1 Benedryl one night and that was the only night the itching didn?t wake me up. Started about a week after the shot. Still getting worse and today is 2 weeks since the shot. Will give it another week or so before I decide to make a doctor visit.
Changes to menstrual cycles after vaccination. Heaviest cycles ever experienced in my life.  Still experiencing 6 months later.
5 hours later patient experienced pain, soreness and redness of injection site and around the arm. Felt warm to the touch.
DIZZINESS, ATAXIA, WEAKNESS FOR 1 WEEK, THEN DEVELOPED HYPERGLYCEMIA AND DEHYDRATION AND ACUTE DELIRIUM AND HYPERTENSIVE EMERGENCY REQUIRING ICU HOSPITALIZATION
Soreness at jab site; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 16 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: INJECTION SITE PAIN (non-serious), outcome "unknown", described as "Soreness at jab site".  Additional information: The patient has no health issues. Takes multi vitamin.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Per parent report: Pt. became ill for about a week, feeling fatigue/drowsy, HA, no energy, loss of appetite and her HA turned into a migraine that lasted about 6 weeks
Patient returned to pharmacy 1 week after administration of ZOSTAVAX complaining of pain at injection site. Patient is blind, so I examined area which was red and a little warm. Patient also said it itched it has been a month and red, raised circle is still there but patient says it is feeling better. Continuing to monitor and recommend therapy for symptoms.