chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a week later became very sick; Sore arm; Tested positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm), ILLNESS (a week later became very sick) and SARS-COV-2 TEST POSITIVE (Tested positive for covid-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. notprovided) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid-19). On an unknown date, the patient experienced MYALGIA (Sore arm) and ILLNESS (a week later became very sick). At the time of the report, MYALGIA (Sore arm), ILLNESS (a week later became very sick) and SARS-COV-2 TEST POSITIVE (Tested positive for covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment information was not provided.  Patient was born on the year 1984. Patient would like to know how long should they wait before getting their second dose. Patient stated they do not take any medication regularly.
Patient states has pain lifting arm and wakes up at night due to soreness from sleeping on it. Pain is tolerated and not moderate or severe. Patient doesn't really recall actual date when he began having continual pain and difficulty lifting arm. I called him on Tuesday 03/13/18 for his second dose of SHIINGRIX is when I was informed. Pt never called us about his complaints. I advised him not to strain his arm more or try to under physical therapy without proper knowledge. Note: Pt state's If he is be contacted by agency, if he's is unable to answer his phone, please leave him a message and he will call back.
activity change, fatigue, rhinorrhea, sore throat, cough, chest tightness, SOB, myalgias, light-headedness
1. Lymph node (?) under arm on same side as injection site very swollen (visibly), very sore 2. Significant exacerbation of auto-immune arthritis symptoms, pain, back pain For item 2, used prescribed Tramadol to control increased pain.  Unable to work due to pain and unable to use left arm (injection side) due to armpit pain.
"Covid arm" developed the evening of Thursday, April 1, localized redness, warmth, and minor swelling. By Friday evening, I had flu-like symptoms in addition to an intensly itchy rash approximately 3 inches in diameter at the injection site, and increased redness, swelling, and warmth. It is now about 1:15 am on Monday, April 5, and the rash is wrapping around my upper arm and covers an area greater than 8 inches in diameter, with bright red blotches and swelling, in addition to significant warmth, itchiness, muscle pain and discomfort in both my shoulder and elbow joints. Ice packs, topical triamcinolone cream, and 800mg of ibuprofen every 8 hours around the clock have so far done nothing to decrease the symptoms.
Immediately after injection arm became red and itchy - I gave BENADRYL liquid PO and ice pack. Pt waited 15 min. Symptoms started to lesson. I called Pt. 4 hrs later. Still red and itching but not too bad.
Within 5 min of injection weird taste in mouth, headache and fatigue for 5 days,  redness and hardness around injection site in form of circle. ( approx 2 inches in diameter.)  TWELVE DAYS after injection: 3/23/2021  Itching at injection site. extreme fatigue for 2 days thereafter. Redness and hardness around injection site returned also. Those side effects subsided by 3/26/2021 with the exception of the covid arm.   SEVENTEEN DAYS after injection:    3/28/2021 I woke up about 2:30 am by itchy hands.  Discovered a rash on my whole body. The rash was not like any reaction that I have had to my  allergic reactions I've had the past 40+ years. . it was blotchy and red. NO HIVES.  Since my breathing was fine, I did not take epi-pen and went to the hospital
This spontaneous report as received from a nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL for immunization. On an unknown date the patient's menstrual cycle was all messed up after immunization. The outcome of menstrual cycle is all messed up was reported as not recovered/not resolved. Additional information has been requested.
Fully vaccinated patient who admitted through ED with abdominal pain and increasing shortness of breath.  Provider discharge note below:    "Patient is a 96 year old male with a past medical history of heart failure with reduced ejection fraction, coronary disease status post remote PCI, atrial fibrillation on Eliquis , chronic obstructive pulmonary disease, seizure disorder who presented for vague abdominal pain and shortness of breath. Diagnosed with covid and fluid overload. Is chronically on 2L at home.  Improved with diuresis.  He was discharged on his home regimen, which had a p.r.n. dose of Lasix at night if he developed any fluids 1. Possibly some component of pulmonary hypertension with his last echo showing an RVSP of 63.  Follows with Dr. when last seen in the Heart failure Clinic in 2019. Thought to be asymptomatic from covid as presented more like fluid overload and on his home oxygen in received no COVID specific therapy.  He did complete a course of Rocephin and doxycycline for 5 days for possible pneumonia.  CT abd with nonspecific findings and abdominal pain resolved without intervention."
Experiencing side effect; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Experiencing side effect) in a male patient of an unknown age 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 26-Jan-2021, the patient experienced ADVERSE EVENT (Experiencing side effect). At the time of the report, ADVERSE EVENT (Experiencing side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Patient experienced fever of 100.4, chills, diarrhea, vomiting, nausea, dizziness, and joint/body pain. Patient also passed out and suspects hit head on toilet. There is a scratch on her forehead but no bump.
Pt felt dizzy and laid down on the floor. He stated he typically get's dizzy with needles. Pt was moved to a cot and assessed by MD. Mother reported that pt gets dizzy with blood draws and always lies down. Pt has autism, seizure disorder, and doesn't do well in new settings. While lying down pt complained of dizziness. Release to home with mother.
Sore injection site after vaccine; no other symptoms same-day. The morning after (04/12), woke up with chills, body aches, skin very sensitive to pressure, minor brain fog, minor body weakness. Possibly a fever overnight.
This spontaneous report as received from a pharmacist refers to a 71 year old female patient. The patient's medical history included history of shingles. The patient had no drug reactions/allergies. On 18-AUG-2014, reported as "2 days ago", the patient was vaccinated with ZOSTAVAX (lot # J014812, expiry date 20-FEB-2015, dose, route not provided) 19400 PFU for prevention of shingles recurrence. Concomitant therapies included omeprazole (manufacturer unknown), LAMISIL and pharmacist reports that the patient received a dose of acyclovir, 1 week prior to the ZOSTAVAX administration. The patient came back to the pharmacy today, 20-AUG-2014, with a "red, itchy welt with rash present around the injection site". Pharmacist reports that the patient reports that the symptoms began "later on in the evening, the same day that the vaccine was administered on 18-AUG-2014. There was no product quality complaint. No lab diagnostics studies were performed. No treatment was given for the event. The patient sought medical attention by contacting the pharmacy. There was no intervention done to prevent serious criteria. The outcome was reported as not recovered/not resolved. The causality of the event was not specified by the reporter. Additional information has been requested.
This case was reported by a nurse via call center representative and described the occurrence of local reaction in a child male patient who received FLUARIX Quadrivalent (batch number TS5F3, expiry date 9th June 2017). On 18th October 2016, the patient received FLUARIX Quadrivalent .5 ml. On an unknown date, several days after receiving FLUARIX Quadrivalent, the patient experienced local reaction, injection site erythema, injection site swelling and injection site tenderness. The patient was treated with diphenhydramine, cephalexin and hydrocortisone. On an unknown date, the outcome of the local reaction was recovered/resolved and the outcome of the injection site erythema, injection site swelling and injection site tenderness were unknown. The reporter considered the local reaction, injection site erythema, injection site swelling and injection site tenderness to be possibly related to FLUARIX Quadrivalent. Additional details were reported as follows: No concomitant medications or vaccines were reported. The patient received FLUARIX QIV vaccine in the left deltoid. The patient was not seen in the office for the FLUARIX reaction. This was reported by the parent after the fact and the reaction was no longer visible. The patient was given Diphenhydramine, Cephalexin, and hydrocortisone ointment as treatment. This case was linked with cases and, reported by the same reporter. The reported batch number (TD5F3) of FLUARIX QIV did not exist and was updated to TS5F3, as per the sales database. This case is one of the 5 cases (US2017169224, US2017169193, US2017169230 and US2017169229) reported by the same reporter.
Patient received first dose of Pfizer COVID-19 vaccine. Patient's husband alerted staff that patient was feeling lightheaded. When provider approached pt she was unresponsive, spastic with obstructed breathing and diaphoretic. Patient lowered to floor supine with knees elevated and regained consciousness after a total of roughly 45 seconds. Patient was not oriented to place. Patient became unconscious again for roughly 15 seconds and became alert with the use of smelling salts. Patient and husband endorsed history of syncopal episodes with prior vaccines. Patient endorsed anxiety surrounding vaccine administration. Patient denied any medical history aside from anxiety and specifically denied neuro history of seizures or pseudo-seizures. EMS was called immediately upon finding patient spastic with obstructed breathing. Patients pulse and O2 saturation were within normal limits for the entire episode. Her blood pressure was low with a systolic in the 90s initially, but increased to roughly 115 prior to EMS arrival. Patient remained alert and oriented x3. She was evaluated by EMS and taken to the hospital for further workup for possible seizure activity.
High fever day 2 through day 6/Day2, 101.9/Day 6 101; Vomiting; muscle aches; fatigue; lethargic; This is a spontaneous report from a contactable consumer (Patient). A 66-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 28Feb2021 13:45 (at the age of 66-years-old) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 07Feb2021 01:15 PM (Batch/Lot number: Unknown) as SINGLE DOSE for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Mar2021 07:00 the patient experienced high fever day 2 through day 6/day2, 101.9/day 6 101, vomiting within 24 hrs, muscle aches, fatigue, lethargic. The outcome of the events were not recovered. The patient did not receive any treatment for the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient accompanied by his mother came into clinic and requested a booster shot. After I, as team lead verified the minor was 12 years old and had received Pfizer for his primary series, I proceeded to begin preparing the Pfizer dose for administration. I was interrupted and told the Mother would prefer Moderna. I replied, "ok," then proceeded to prepare the Moderna booster dose of 0.25ml for administration. The moderna dose was verified by another nurse and then given by a different nurse. The patient was observed for 15 minutes by our staff while I conversed with the Mother. Finally, after the observation period was complete, the patient and Mother left the clinic.
Muscular pain; This is a spontaneous report from a Sponsored Program from a contactable consumer reported for her relative. A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient got the first dose and after 4 hours took Percocet due to muscular pain. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
fever; headache; body aches; This is a spontaneous report from a contactable Nurse via sales representative. This Nurse reported similar events for 6 patients. This is 5th of 6 reports.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced fever, headache, body aches on an unspecified date. The outcome of events was unknown.    information on the LOT/Batch number has been requested; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021034195 Same reporter/drug/event/different patient
0.25 ml Fluviron given. Vaccine meant > 4 yrs. Marked on box but not marked on actual vial. Pt had no reaction.
On 12/2 at 10:00am, patient attended an appt w/ Dr. as a follow-up for previous stroke monitoring. The doctor administered a mini-check up and with a series of cognitive exercises.  They ended their appt and planned for another follow-up appt. in January or February of 2004. The next day, patient was taken to an 1:30 afternoon appt at her regular physician.  She saw him for a brief 10 minutes as he administered a flu innoculation in her upper left arm.  On Saturday, 12/6/03, patient started experiencing chest congestion, but was alert and keeping to her normal holiday schedule. On Tuesday, 12/9/03, pateint started  experiencing stomache upset, throwing-up, lethargy and aches and pains. She took to her bed.  On wednesday eve, 12/10,after not being able to retain any food, soup of liquids, her children got her ready to take to the hospital. On Thursday morn, patientwas alert, coherent, but  very weak and her  family made attempts to drive her quickly to Emegency Room for treatment.  She went downhill and expired the following morning. 12/26/07-records received for DOS 12/11-12/12/03-Final diagnosis:massive hematemesis and or hemoptysis secondary to coumadin.  Presented to ED with increased shortness of breath, nausea and hemoptysis. Since then had progressive loss of energy. Increasing confusion and agitation. Nonproductive cough. Intubated and sent to ICU. Unsuccessful bronchoscopy. Upper GI bleeding secondary to coumadin and shocked liver. Massive pulmonary hemorrhage with multiple organ damage and coma. Pupils fixed and dilated, unreactive to light. No babinski. Acute oliguric renal failure most likely secondary to hypoxia. Severe metabolic acidosis with increased anion gap most likely seconary to lactic acidosis, hypokalemia. DOD 12/12/03 at 4:10 p.m. 2/19/08-record received-final cause of death pneumonia. Diabetes Mellitus
Last capsule of Vivotif came out in his stools; A spontaneous report was received from a pharmacist on 08NOV2023 regarding a male patient of unknown age whose "last capsule of Vivotif came out in his stools" (PT: Product residue present). The patient took Vivotif (typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or allergies were not reported.  It was reported that patient noticed that his last capsule of Vivotif came out in his stools. Reportedly, the pharmacist did not know if the capsule was open, but he believed that the capsule was "in one part".  The outcome of the reported event was unknown, at the time of this report.  The action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a patient was on Vivotif and last capsule of Vivotif came out in his stools (product residue present). It was reported that the patient believed that the capsule was in one part. Considering the case information, the causality of the above event is assessed as possible. The case is considered non serious as per medical assessment.; Sender's Comments: Company comment: It was reported that a patient was on Vivotif and last capsule of Vivotif came out in his stools (product residue present). It was reported that the patient believed that the capsule was in one part. Considering the case information, the causality of the above event is assessed as possible. The case is considered non serious as per medical assessment.
Patient received vaccine and in the waiting area after waiting for 6 minutes began to complain of lightheadedness. She stated that she has had a migraine for a few days. Patient's BP readings were 196/110, 195/107, 191/114. EMS was contacted and came to assess the patient. Her BP was 190/120 . She did not go to the hospital but was strongly advised to follow up with her doctor.
Temp 101.5-102, lymph nodes in axilla's swelling 10/20-1/21 with rash and very swollen and tender.  Malaise feeling  States he took Ibuprofen alternate with Aspirin to relieve pain.  10/22 He felt better and 10/23 no tenderness in axillary nodes but they are still swollen.  Off work Tuesday-Friday due to symptoms.
Hives/itchy rash at injection site 7 days post injection - lasted 48 hours
REDNESS, SWELLING, PRURITUS, HOT IN AREA WHERE VACCINE WAS GIVEN.
p/vax mom reported child having hives from waist down;pt is pale & weak;denies wheezing or SOB;discussed giving DPH & notify MD if gets worse;mom took child to ER;hives all over body;
really hit me bad, really feel sick; dehydrated; diarrhea for 2 days; Headache for 3 days; Nausea for 2 days; puking my guts out\could not keep anything down; Nausea; Headache for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (really hit me bad, really feel sick), DEHYDRATION (dehydrated), DIARRHOEA (diarrhea for 2 days), the first episode of HEADACHE (Headache for 3 days) and NAUSEA (Nausea for 2 days) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048821A and 037821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Breast cancer and Surgery (surgery on left side due to beast cancer 4 yrs ago.).   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (really hit me bad, really feel sick), DEHYDRATION (dehydrated), DIARRHOEA (diarrhea for 2 days), the first episode of HEADACHE (Headache for 3 days), NAUSEA (Nausea for 2 days), VOMITING (puking my guts out\could not keep anything down), NAUSEA (Nausea) and the second episode of HEADACHE (Headache for 3 days). At the time of the report, VACCINATION COMPLICATION (really hit me bad, really feel sick), DEHYDRATION (dehydrated), DIARRHOEA (diarrhea for 2 days), NAUSEA (Nausea for 2 days), VOMITING (puking my guts out\could not keep anything down), NAUSEA (Nausea) and the last episode of HEADACHE (Headache for 3 days) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs used were Oral medication for breast cancer. No treatment drugs were used.   This case was linked to MOD-2021-138850 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: TCR : AE outcome.event outcomes were updated.dose information was updated
Patient reported redness and pain under the injection site beginning the day following vaccination (10/14/22). Symptoms improved with warm compresses over the next few days.
Dizziness/ Very dizzy; Pain on her arms; very lethargic; Fatigue/ Extremely tired; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient receive first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Batch/lot number: EK9231), via an unspecified route of administration injection once to left upper arm in inner muscle on 10Jan2021 at single dose for covid-19 immunization. The patient had no relevant medical history and concomitant medications. The patient experienced fatigue/ extremely tired in Jan2021, dizziness/ very dizzy on 14Jan2021 18:30, pain on her arms in Jan2021. Consumer said she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine last Sunday and has been experiencing some side effects. These side effects include Dizziness, Extreme fatigue and Pain on her arms. She wants to know if this was normal. She got her shot, later clarified as COVID shot, at hospital last Sunday, so about a week ago, and had no side effects up until yesterday, she was extremely tired, and last night about 6:30PM, she was very dizzy until 5 this morning. She works at a hospital; they gave the shot. Outcome of extremely tired: stated she was in bed, was just very lethargic, being very dizzy went away at 5 this morning, states she has recovered completely but she is just a little off. When asked for vaccination card, states she shouldn't have gotten up that fast, this was really weird that it would wait 5 days. This was her first shot, thinks the dose was on the paper, it was 0.3mg, she was not sure. The outcome of events for dizziness/ very dizzy was resolved on 15Jan2021, for fatigue/ extremely tired was resolving, for other events was unknown.
Information has been received from a health professional concerning a 10 month old patient who in 2007 was vaccinated with a third dose of RotaTeq vaccine. The patient is late for the third dose of RotaTeq vaccine, but received the first two doses on time. No further information was available. It was unknown if medical attention was sought. There was no product quality complaint. Additional information has been requested.