chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen face. Mostly on the left-side. Tingling around chin and lips. Face hurt to touch. Throat was tight and hard to swallow. Very tired, couldn't wake up. Symptoms started about 2 hours after the shot. Researched online but couldn't find anything regarding an allergic reaction, only severe reactions needing EpiPen. Went to bed, couldn't wake up. I called my doctor and he said there was no information regarding allergic reactions. He thought I had a sinus infection. My family sent me to the ER where the doctor said I had an allergic reaction. He prescribed prednisone. He told me to contact the CDC to find out if prednisone would counteract the portion of the vaccine I received, since prednisone will fight the infection and the vaccine gave me an infection.
Pain and burning with urination, started 28 hours after the shot. Ongoing for 24 hours. Resolved with lots of hydration.
weak; Low kidney function; Low platelets/platelets numbers are low; kidney numbers are low; Fever up to 102.5F; This is a spontaneous report from a contactable consumer. A 32-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 08:00 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation.  Medical history included covid-19 from Nov2020 to an unknown date.   Patient previously received the first dose of BNT162B2 for  covid-19 immunization. There were no concomitant medications. Consumer is the sister of the patient that after getting the second dose of the Pfizer covid vaccine is experiencing after several days fever up to 102.5F on 04May2021, low platelets and low kidney function. her brother who is too weak right now to call.  He got his second vaccine and right now it will be 2 weeks ago, he got it on 03May2021, he had the COVID virus in Nov, it has been 2 weeks since the second dose as of tomorrow and he has had 102 degree fever the whole time throughout the day and night. She is trying to understand if this is something to be concerned about. He had blood work done and his platelets numbers are low and his kidney numbers are low and she is looking for peace of mind of if this is commonly reported adverse event or maybe the steps to be taken. She says she works for (Company) so she familiar with having to report adverse events. Her brother is also awaiting chest x-ray results, he was negative for mono, flu, and negative for COVID.The patient underwent lab tests and procedures which included body temperature: 102.5 fahrenheit on 04May2021, chest x-ray: unknown results, influenza virus test: negative, investigation: low   on 13May2021, mononucleosis heterophile test: negative, platelet count: low   on 13May2021, sars-cov-2 test: negative. Outcome of events was unknown.  Information on the lot/batch number has been requested.
fainted day after vaccination; dizziness; Initial information received on 07-Sep-2023 regarding an unsolicited valid serious courtesy case received from other health professional.  This case involves Adult and unknown gender patient who had fainted day after vaccination and dizziness after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient had No allergy. At the time of the event, the patient had ongoing Blood pressure high and High cholesterol.  Concomitant medications included Lisinopril; Alendronate Sodium (alendronate); and Atorvastatin for Product used for unknown indication.  On 3-Sep-2023, the patient received unknown dose of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation, batch number and expiry date) via unknown route in Right arm for prophylactic vaccination (immunization).  On 04-Sep-2023 at 10:30 hours, the patient had dizziness and fainted day after vaccination (syncope) (latency: 1 day 10 hrs 30 min) following the administration of influenza quadrival A-B high dose HV vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (dizziness, fainted day after vaccination).  At time of reporting, the outcome was Recovered / Resolved on 04-Sep-2023 for both the events.   Seriousness criteria: The event fainted day after vaccination (syncope) was assessed as medically significant.; Sender's Comments: Sanofi Company Comment dated 15-Sep-2023: This case involves Adult and unknown gender patient who had fainted day after vaccination and dizziness after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent]. Based on the information provided regarding this case, causal role of the company suspect product cannot be excluded. However, lack of information regarding past medical treatment(s), family history information precludes comprehensive case assessment.
This spontaneous report was received from a healthcare worker refers to a multiple patients of unknown age and gender. No pertinent medical history was reported. Since 28-JUL-2014, the patients were vaccinated with (Merck) VARIVAX (dose, route, lot# were not reported) after being improperly stored. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.
No adverse event; Giving a bivalent booster and it leaked out of the syringe; Accidental underdose; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (Giving a bivalent booster and it leaked out of the syringe), ACCIDENTAL UNDERDOSE (Accidental underdose) and NO ADVERSE EVENT (No adverse event) in a 56-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Spikevax (Dose 1), Moderna COVID-19 Vaccine (Dose 3) and Spikevax (Dose 2); for Flu vaccination: flu in the last 14 days (in the last 14 days.). Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Spikevax, Spikevax and flu in the last 14 days.    On 21-Dec-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 21-Dec-2022, the patient experienced DEVICE CONNECTION ISSUE (Giving a bivalent booster and it leaked out of the syringe) and ACCIDENTAL UNDERDOSE (Accidental underdose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE CONNECTION ISSUE (Giving a bivalent booster and it leaked out of the syringe), ACCIDENTAL UNDERDOSE (Accidental underdose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for DEVICE CONNECTION ISSUE (Giving a bivalent booster and it leaked out of the syringe) and ACCIDENTAL UNDERDOSE (Accidental underdose).    No concomitant medication was reported.  Reportedly, patient had received 2 primary shots and 2 booster shots from Moderna.  Reporter stated that, she was giving a patient the bivalent booster in patient's arm, but it leaked out of the syringe. The pharmacist stated that the patient did not report any side effects.  No treatment information was provided.
Massive vertigo attack; Severe migraine; can't go anywhere; pain medication wasn't working at all; Pain; couldn't eat anything down; eye was so swollen; Passed out right after the injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out right after the injection) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out right after the injection) (seriousness criterion medically significant). On an unknown date, the patient experienced VERTIGO (Massive vertigo attack), MIGRAINE (Severe migraine), MOBILITY DECREASED (can't go anywhere), DRUG INEFFECTIVE (pain medication wasn't working at all), PAIN (Pain), FEEDING DISORDER (couldn't eat anything down) and EYE SWELLING (eye was so swollen). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out right after the injection), VERTIGO (Massive vertigo attack), MIGRAINE (Severe migraine), MOBILITY DECREASED (can't go anywhere), DRUG INEFFECTIVE (pain medication wasn't working at all), PAIN (Pain), FEEDING DISORDER (couldn't eat anything down) and EYE SWELLING (eye was so swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant list is provided.  Treatment information was not provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Came in today and reported had rash after 1st dose on 2/24/21 and after 2nd dose on 3/17/21. Reported rash to bilat arms, hands, and ankles. Did not report any side effects from first dose when came in to receive 2nd dose.
Patient took last of 4 doses of VIVOTIF 3.20. awoke 3.21 with slight knew pain but as day progressed, pain increased dramatically and knee swelled. Could barely walk by end of day. Took ibuprofen on 3.22 and elevated and iced. Saw PT on 3.22 who could not identify source of sx. Some improvement noted on 3.23 and better on 3.24.
I had a slight sore throat, slight cough, and tiredness for two days. I went to see the doctor who prescribed the antiviral, but I felt better after two days.
No PQC or additional AEs reported.; Caller reports expired dose of MMR II administered; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 02-JUL-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA) (M-M-R II) 0.5 ml, intramuscularly, lot # S020161 was confirmed to be valid, expiration date 30-JUN-2021 (anatomical location was not reported) for prophylaxis. No additional adverse events were reported.
I was confirmed positive for Covid-19; I was confirmed positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 25 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18Feb2021 (Lot number: EL3247) at the age of 25 years as dose 2, single and intramuscular, administered in arm left, administration date 28Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: vaccination failure, COVID-19 all with onset 23Dec2021, outcome recovered (2021). Therapeutic measures were not taken as a result of vaccination failure, covid-19. No follow-up attempts are possible. No further information is expected.
mom had reported that pt was fine when got home, went to sleep woke up & had inc crying shrill, high pitched-crying last several hr & nothing mom did comforted child;mom spoke to RN on 2AUG96 around 10AM told RN pt had finally calmed down;
This spontaneous report was received from a medical assistant concerning a 15-year-old patient of an unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 26-MAY-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot number: M003659, expiration date: 02-SEP-2017, dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Right eye swelling, right eyeball will not move past midline on right side.  Intermittent pain/spasm on right side of head and above right eye near eyebrow.
Initial case received from a nurse, who is also the patient's parent, on 15 November 2009. A 19-year-old female patient received a right intramuscular injection of Influenza A (H1N1) 2009 Monovalent Vaccine - Preservative (lot number UP022AA) on 12 November 2009, and three days post-vaccination complained of her right eye not closing and her lip drooping on the left side of her mouth. The patient had no other neurological symptoms. According to the reporter, the patient's gait, hand strength, and muscle strength were all normal. The patient had no medical history, and was not ill at the time of vaccination; concomitant medications included iron tablets and ibuprofen. At the time of the report, the events remained ongoing. Documents held by sender: None. 12/1/09 Medical records received for date 8/20/09 to 11/12/09. DX: rt. facial paresis, Bell's palsy.  Pt received seasonal flu vax on 8/20 and H1N1 vax on 11/12. OV on 11/16 pt. c/o rt. eyelid paralysis, unable to taste on rt. side of tongue, smile uneven, rt side facial weakness. Assessment: (+)rt side facial drooping UE, and LE strength WNL.
Palpitations, HYPERtension,  flushed, increased BP, irregular HR  Narrative:  Stated that 5 min after vaccine started feeling flush, BP was 40-50  points above usual baseline for individual. Went home and rested. Still felt  awkward while at home. used apple watch and noted irregular HR on EKG  feature. Noted that BP and heartrate returned close to baseline 6 hours post  vaccine without use of medication.
Case number PHEH2014US001240 is an initial spontaneous report received from a pharmacist on 13 Jan 2014: This report refers to a 15-year-old male adolescent who was inadvertently vaccinated with FLUCELVAX (batch number: unknown) intramuscularly at a dose of 0.5ml on 11 Jan 2014. No adverse event was reported following this administration error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 27 Jan 2014: The labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Adverse Event: Patient itchiness at injection site, along with swelling, redness, hard lump below surface of skin accompanied with pain/discomfort. First started occur on 06/12 and progressed to more severe symptoms Sunday through current.  Treatment: Patient sought treatment through urgent care. Diagnosed as cellulitis. MD was going to prescribe Clindamycin to treat infection. Patient had Clindamycin already from an infection in her nose (surface scratch) coincidental to adverse event. MD stated to continue antibiotic to treat both infections. Patient due to follow up with urgent care on Thursday 6/17.
Uncomplicated pregnancy but mother has type 1 diabetes and hypothyroidism monitored by regular OB and high risk MFM.   On 1/31/21, I developed discharged of clear vaginal fluid later diagnosed at the hospital with preterm premature rupture of the membranes.
Patient developed arthritic-type pain in his right wrist 2 days after 2nd dose of Moderna.
Initial report from the pharmacist received on 15 Dec 2009: This neonate received 0.25ml dose of FLUVIRIN on 09 Dec 2009. No further information reported at the time of the report.
red patches on arms, legs, groin & hands w/extreme itching; 1 1/2-2 hrs in duration, lasted 3 days; sx occured mainly p/meals;
Wednesday, day of vaccine, soreness in arm, started out feeling bruised then progressed to stiffness and pain in my shoulder joint.  Thursday my whole body ached, especially my knees and hips, I felt feverish.   Thursday night a severe headache developed and persisted through Saturday morning.  ibuprophen and acetemetiphine did nothing to relieve any of the symptoms.
Symptoms - ? Patient reports she began with HA, body aches and chill around 11:00 am yesterday.  Patient reports at approximately 02:00 am on 2/5 woke up with fever (Tmax 101) and took 600 mg ibuprofen at 02:30.  At time of call no fever.   Last day of work and shift - ? scheduled for work today (2/5) at 11:00 am Home remedies? -   rest and ibuprofen 600 mg at 02:30 Any improvement? - mild Recommendation?   Patient educated to continue to monitor symptoms at home and to take ibuprofen and Tylenol as directed in the paperwork and to increase fluid intake. Patient educated to manage her symptoms and to adhere to the Illness in the Workplace Policy.  Patient verbalized back understanding and denied further questions at this time.
I had nausea within an hr, diarrhea within 2hrs. Have been sick since with moderate body aches & fatigue. My right arm gland swelled to a golf ball size, bruising the exterior . My left throat gland blew up, right did too. Sore throat, some congestion.  I have talked to 2 of my Drs, I am to have bedrest. I have blisters, boils..3-4 in my right nostril that hurts. None on the left.  My dr wanted me to consult you.
12 hours after vaccination. Severe body aches, fever and headache. 16 hours after vaccination, throat started closing and experienced difficulty breathing and vomiting. Blood pressure dropped 98/40. Went to the ER due to almost complete loss of airway.
This case was reported by a physician via call center representative and described the occurrence of encephalitis in a 69-year-old female patient who received SHINGRIX for prophylaxis. In March 2019, the patient received the 1st dose of SHINGRIX. On 18th March 2019, 7 days after receiving SHINGRIX, the patient experienced encephalitis (serious criteria hospitalization and GSK medically significant), viral meningitis (serious criteria hospitalization and GSK medically significant), fever (serious criteria hospitalization) and aphasia (serious criteria hospitalization). The action taken with SHINGRIX was unknown. On an unknown date, the outcome of the encephalitis, viral meningitis, fever and aphasia were unknown. It was unknown if the reporter considered the encephalitis, viral meningitis, fever and aphasia to be related to SHINGRIX. Additional details were provided as follows: The patient received the dose of SHINGRIX vaccine one week prior to being hospitalized. The patient presented with fever and aphasia and was hospitalized. After doing some test work, results suggested that the patient had encephalitis and or viral meningitis. No further details were provided. Lab Comments: In March 2019, after doing some test work, results suggested encephalitis and/or viral meningitis.
Patient was sweaty, feeling faint and reported feeling like heart is racing. Blood pressure dropped to 88/58. Spoke to patient and reported not having had breakfast and being a bit nervous about the vaccine. Patient was seated and observed. When offered to call 911, patient reported feeling better and not needing to call 911. After drinking 2 cups of water and eating a breakfast bar, patient rested for about 45 to 50 minutes and was feeling well. Blood pressure at 10:39am was 110/65 and patient was feeling well by then so he wanted to leave. Requested patient to get up slowly and walk around a bit before leaving and he felt well. Advised to call doctor if any issues and to not drive if not feeling well as patient reported not having anyone who could pick him up at this time. Note that patient is on an antidepressant.
Patient received Influenza and Pneumococcal 23 on 9/20/22, both to left deltoid. On 9/21/22 patient noticed arm to be red, warm, swollen. Patient came into clinic today on 9/23/22 with continued redness and warmth to left arm, below the deltoid and above the elbow, measuring 5 in width and 4 in height. No swelling noted. No fevers. Patient does admit to some improvement today since 9/21/22. Provider evaluated reaction and determined its a localized reaction to both vaccines given in the same deltoid. Patient was given ice pack and advised to apply ice to localized area, advised to take OTC pain relivers for discomfort. Advised to call or return to clinic if no improvement.
Had the same thing (arm was red, hot, hard and itchy at injection site); Had the same thing (arm was red, hot, hard and itchy at injection site); Had the same thing (arm was red, hot, hard and itchy at injection site); Had the same thing (arm was red, hot, hard and itchy at injection site); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Had the same thing (arm was red, hot, hard and itchy at injection site)), VACCINATION SITE INDURATION (Had the same thing (arm was red, hot, hard and itchy at injection site)), VACCINATION SITE PRURITUS (Had the same thing (arm was red, hot, hard and itchy at injection site)) and VACCINATION SITE ERYTHEMA (Had the same thing (arm was red, hot, hard and itchy at injection site)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 VACCINATION SITE WARMTH (Had the same thing (arm was red, hot, hard and itchy at injection site)), VACCINATION SITE INDURATION (Had the same thing (arm was red, hot, hard and itchy at injection site)), VACCINATION SITE PRURITUS (Had the same thing (arm was red, hot, hard and itchy at injection site)) and VACCINATION SITE ERYTHEMA (Had the same thing (arm was red, hot, hard and itchy at injection site)). At the time of the report, VACCINATION SITE WARMTH (Had the same thing (arm was red, hot, hard and itchy at injection site)), VACCINATION SITE INDURATION (Had the same thing (arm was red, hot, hard and itchy at injection site)), VACCINATION SITE PRURITUS (Had the same thing (arm was red, hot, hard and itchy at injection site)) and VACCINATION SITE ERYTHEMA (Had the same thing (arm was red, hot, hard and itchy at injection site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment medications reported.
pt exp t103+, had sz where body became stiff & heaved, eyes rolled to back of head;parents took pt to ER immed;sz occurred about 5PM & fever most of the day;no pertussis @ next shot interval;
Admitted with SOB; CXR: bronchitis, ? infiltrate; + covid PTA at SNF;  Labs: D-dimer 8.43, CRP 1.64 Ferritin 1283.6 Tx: Maxipime, Remdesivir, Vit D3, Vit B12, merrem, solu-medrol, singulair, Zinc:   Initially on 4 LPM NC O2; down to room air at D/C
R29.810 RIGHT FACIAL MUSCLE WEAKNESS 4/1/2023 RIGHT FACIAL MUSCLE WEAKNESS G40.001 EPILEPSY, PARTIAL IDIOPATHIC W STATUS EPILEPTICUS 4/3/2023 RIGHT FACIAL MUSCLE WEAKNESS
Redness, swelling, warm to touch, fever, fatigue, blistering to (L) deltoid area. TX: ROCEPHIN, OMNICEF.
Nurse practitioner wrongly gave Kinrix as a catch up dose of DTaP and polio. Daughter is now having asthma and allergy symptoms daily as well as nervous tics. All new onset