chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lot of sneezing; 99 fever; Small chill; Lack of drug effect; Had a breakthrough case of covid, mild case; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Aug-2021 and was forwarded to Moderna on 25-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Lack of drug effect), COVID-19 (Had a breakthrough case of covid, mild case), SNEEZING (Lot of sneezing), PYREXIA (99 fever) and CHILLS (Small chill) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jul-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect) and COVID-19 (Had a breakthrough case of covid, mild case). On 22-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SNEEZING (Lot of sneezing), PYREXIA (99 fever) and CHILLS (Small chill). The patient was treated with MONOCLONAL ANTIBODIES for COVID-19, at a dose of 1 dosage form. At the time of the report, DRUG INEFFECTIVE (Lack of drug effect), COVID-19 (Had a breakthrough case of covid, mild case), SNEEZING (Lot of sneezing), PYREXIA (99 fever) and CHILLS (Small chill) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jul-2021, Body temperature: 99 (High) 99 Fever. On 20-Jul-2021, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test positive. On 24-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive. On 26-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.         Patient also had a 24 hour test with positive COVID result.  Concomitant medications were not provided. Patient took monoclonal antibodies infusion as treatment for COVID-19.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Additional information received on 31 Aug 2021 contains new significant information. First dose date updated, new events added, lab data updated.; Sender's Comments: This report refers to a case of Drug ineffective for mRNA-1273, lot numbers unspecified. Based on the current available information and temporal association between the use of the product and the Drug ineffective event, a causal relationship cannot be excluded. For the event COVID-19, based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. Based on the compatibility of the events Sneezing, Pyrexia and Chills with a Covid-19 infection, these events are assessed as unlikely related to mRNA-1273.
The patient received the third/booster dose of BNT162b2; The patient reported that they felt like they had been hit by a train; This is a spontaneous report from a non-contactable consumer. An unknown gender patient of unknown age received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On an unknown date, the patient reported that they felt like they had been hit by a train. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event the patient reported that they felt like they had been hit by a train was unknown at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
10/27/2021 tested positive for COVID19 despite being fully vaccinated - presented to ED and treated with O2, remdesivir and dexamethasone then discharged to home 11/1/21.
Small amount of leakage down her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCHARGE (Small amount of leakage down her arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION SITE DISCHARGE (Small amount of leakage down her arm). On 27-Feb-2021, VACCINATION SITE DISCHARGE (Small amount of leakage down her arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Patient states that he feels light headed. He was instructed to lie down on the exam table to elevate his legs. Patient offered water and a snack, he only drink water. Patient states he feels better and no longer light headed. BP 100/60 O2 sat 98% HR 56 Patient released to go home.
10/24/05 Redness and pain in left shoulder where Pneumovax was given. Cold packs, ibuprofen, Benadryl; recommended if worsening of symptoms to see physician. 11/03, early AM, admitted to hospital for shortness of breath and rales per patient's daughter. Released from hospital following day.
Symptoms were noted January 8th 2022, increased bruising, pale,  palpitations.  First Hospitalization and diagnosis of Aplastic Anemia January 24th, second hospitalization Feb 2nd, third hospitalization Feb 7th. Disorder was suspected to have started 1-2 months prior. Treatments consisted of Blood and platelet transfusions performed multiple times up to current date.
severe poison ivy like rash dx as topical eczema p/ typical fever on day 10 p/vax;rash first looked like measles, then welts then pustules all over arms & legs lasting 6wk-8wk;skin splotchy;change in attitude, cries easily, grumpy, t1
19 days after the first shot I fainted and injured left ankle and bump on left forehead,  13 days after the second shot I fainted and injured my left ribs and bump on right forehead . I have not fainted before in 77 years.
rash/It's on my entire body's but mostly my arms and wrists; Severe itching; swelled on hands and feet; My finger tips on right hand are still numb; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (COMIRNATY),  via an unspecified route of administration, administered in Arm Left on 05Oct2021 12:00 (Lot Number: 30130BA), at the age of 47-year-old, as dose 2, single for COVID-19 immunisation. The patient's medical history included allergy to an unspecified drug. The patient received no concomitant medications. The patient was not pregnant at time of vaccination. The vaccine was administered at Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Historical vaccine included BNT162B2 (COMIRNATY), via an unspecified route of administration, administered in Arm Left on 14Sep2021 at 12:00 PM (Lot Number: EE3592), at the age of 47-year-old, as dose 1, single for COVID-19 immunisation. The patient reported she experienced rash that comes and goes. Seemed to be bad in the evening for some reason. It was on her entire body but mostly her arms and wrists. She had severe itching (she could't take it). First two days after second dose she swelled on hands and feet; that seemed to have stopped. Her fingertips on right hand were still numb. The events started on 05Oct2021 at 16:00. She never had a problem with breathing (Benadryl helped). As of 10Oct2021 she had been taking Benadryl for 5 days and she was going to go to doctor the next day because she couldn't take it anymore. The events were reported as non serious. The event 'swelled on hands and feet' was resolved on 08Oct2021, while other events had not resolved.  Follow-up attempts are completed. No further information is expected.
Sedation, Myalgia, Fever, UrticariaPruritus, Diarrhea, NauseaVomiting, fatigue. pain, redness and swelling at the injection  site. Narrative:  Other Relevant History:
Sanofi stating if shipment is more than 2 days not to use ,3 doses of Fluzone High Dose had been administered to patients; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA308846, 2019SA308921, and 2019SA309165 (same reporter).  This case involves a 89 years old male patient who received a 0.5 mL dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ290AB, Exp. Date 09-Jun-2020 via intramuscular route in the left deltoid on 04-Nov-2019 that had a shipment delay.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to incorrect product storage.  It was reported that the vaccines were shipped 30-Oct-2019 and were delivered this morning 04-Nov-2019. She has taken care of the replacements. Before they received the email, 1 dose of Fluzone Quadrivalent and 3 doses of Fluzone High Dose had been administered to patients.  At the time of reporting, 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 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.
102.8 fever, chills, Deira,  Light Headed. This went on for over a week. I still feel tired and light headed all the time. 99 fever still.
I had normal reactions for the first two days. Tired, chills, fever, severe muscle aches, headache, nausea. Today is day 3 and now I keep getting super dizzy.
Still feel the injection; Red; Lumpy; Warm to touch; Itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (Still feel the injection), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (Lumpy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included MONTELUKAST SODIUM, LEVOTHYROXINE, OMEPRAZOLE, ATORVASTATIN, DOCUSATE SODIUM (COL RITE STOOL SOFTENER), NIFEDIPINE, CELECOXIB (CELEBREX), GINKGO BILOBA (GINGKO BILOBA), PREDNISONE and FLUTICASONE FUROATE (ARNUITY ELLIPTA) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (Lumpy). On 13-Mar-2021, the patient experienced VACCINATION SITE PAIN (Still feel the injection). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE PAIN (Still feel the injection), VACCINATION SITE ERYTHEMA (Red) and VACCINATION SITE SWELLING (Lumpy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Left Deltoid: 4cmx5cm red raised area warm & painful to the touch (TDAP) Left arm: 3cmxcm pink reddish area warm & tender to the touch (Varicella) Right deltoid: 6cmx10cm red raised area warm & painful to the touch.  C/o of chills & headache; bilateral arms mildly erythemous - no swelling; no raised borders.
1 hour after shot, felt: Chest tightness Increased heart beat Felt warm in face Difficulty breathing Loss of taste  Lasted about 1 hour.   Chest tightness and difficulty breathing were mild and intermittent. Occasional chest pain. Nothing severe just felt uncomfortable.  After symptoms subsided, contacted doctor who recommended I go to urgent care to be checked out.
Spiked a fever of 102, Gave her Tylenol but fever did not drop. Fever went as high as 104.7 (Gave her a cool bath and alternated between Tylenol and Advil. Fever did drop at that point to 102 but the fever has stayed for the past 2 days with Tylenol not having much effect.
Patient reported swelling of arm beginning approx. six hours after vaccination.  Patient stated that it was hard and warm over night. Patient did take benadryl. Reported that swelling was going down this morning and resolving at 9am (approx. 20 hours after vaccination). Patient is related to healthcare professional and was told vaccine was administered to low on the arm.
Systemic: Hypotension-Medium, Systemic: Nausea-Medium
Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.) Event: Pediatric Pfizer Vaccine Lot Number FK5127, was improperly stored in an Immunizations Freezer that maintained a temperature between -15 Celsius and -24 Celsius. Per the Manufacture?s guidelines the vaccine must be stored in a Refrigerator maintaining temperature of 2-8 Degrees Celsius or an Ultra-Low Cold Freezer maintaining temperature of -90C or lower. The patient received the vaccine that was improperly stored.  Treatment: Not required, patient did not report any adverse reactions to the Vaccine.  Outcome: Patient's guardian notified and offered to restart the Pediatric Pfizer Covid Vaccine series again stored at the proper temperature.  Signs, Symptoms course, etc. None reported by the patient's guardian
Moderate burning on right leg from mid thigh to ankle. Difficult to have clothing or sheets touching.  Lasted about 8 to 10 days. Resolved. Mild Numbness in lips for a week. Resolved. Previous lip fillers used fyi within the last 18 months.  Extreme brain fog and fatigue that lasted about 8 to 10 days. Worst of it was over after five days.  Visual distortion in left eye that lasted 2 minutes on Jan 3rd. Small circular area rolled around in Visual field. Not painful and Resolved.  UTI around 1/10 assuming unrelated.
Fainted when urinating.  Loud buzzing/backward hearing in ears for 30 minutes afterward.   Malaise and weakness for the following 15 hours.  Anytime I attempted to walk or do things, I felt as if I would fall.
Blacked out; fractured nose; fainting; very tired and cold; very tired and cold; light headed; thirsty; nausea; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9266), via an unspecified administered in the left arm on 13Feb2021 at 08:15 AM at SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient was not pregnant at the time of vaccination. Medical history included arthritis (No chronic health conditions besides arthritis). Concomitant medications included venlafaxine hydrochloride (EFFEXOR), simvastatin, and colecalciferol (D3). The patient previously took cipro [ciprofloxacin hydrochloride] and experienced allergies. Historical vaccine includes first dose of (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL9262), via an unspecified route of administration in the left arm on 22Jan2021 at 5:00 PM for COVID-19 immunisation. It was reported that for 2 days, patient was very tired and cold. At day 4 while at her trainer, the patient experienced light headed, thirsty, nausea, and had blacked out. All tests were normal at emergency room (ER), but have fractured nose. The patient wanted to understand if this fainting can be related to the second shot. Cardiologist said no problems in the heart. All events started on 17Feb2021. There was no treatment received for all events. The patient had COVID test post vaccination via nasal swab on 17Feb2021 which showed negative result. On an unspecified date in 2021, the patient recovered from all events.
This spontaneous report as received from a medical assistant refers to a 16 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 08-JUL-2014 the patient was vaccinated with first dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # K005083, expiry date: 04-NOV-2016) and first dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J014584, expiry date: 16-JAN-2016) which were stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL and VAQTA. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
Arm still hurts, has lump around injection site, muscle pains, headaches, neck aches. Stated that it feels like she has arthritis.
6/18/2021 Bells Palsy began:  drooping of left facial muscles began.  Went quickly to ER:  very elevated blood pressure during triage and visit.     Ended up with problems on left side of face:   -drooping in the ear canal - ambient noises hurt (I'm a musician who had to wear ear plugs in that ear during rehearsals and performances for months!!) - Left eye stayed blurred and unfocused, and lost the peripheral vision on that side for many months.  It hurt to read any length of time or try to read my piano music with just one good eye - Drooping left cheek and lips not working for months - it was difficult to eat, had to adjust to smaller bites or items that were easier to eat.  Also could not sing since no lip control meant no pucker factor - so saying "f", "b" & "p"s were difficult!  I am approaching the 1 year mark - and I STILL do not have full recovery all of my left facial muscles.  My eye lid still does not raise all the way, I still to no have a full smile on that side, and that still effects my speaking/singing.
About 3 to 5  minutes after receiving the HPV #1 and Trumenba # 1 immunizations patient fainted while still in a sitting position on the exam table. She landed face down on the carpet. She rolled to her side then back. She responded after a few minutes, but was weak for a few minutes. Patient eventually was able to stand then walk. She left the office, accompanied by her mother. She was rechecked by the doctor on 6-23-16 and 6-27-16.
I did not have an adverse event after receiving the vaccine. I began not feeling well on 12/18/2022, I had a runny nose, sore throat and a cough. I tested positive for COVID-19 on 12/19/2022. I contacted my nurse practitioner and I got a prescription for PAXLOVID. I tolerated the medication with no problem.
This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not being well), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not being able to live her normal life), BALANCE DISORDER (balance is not good), GAIT DISTURBANCE (can't run) and DYSPEPSIA (heartburn) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939676, 001a21a and 042120a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) and PREDNISONE for an unknown indication. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 25-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 ml. On 25-Aug-2021, the patient experienced MALAISE (not being well), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not being able to live her normal life), BALANCE DISORDER (balance is not good), GAIT DISTURBANCE (can't run), DYSPEPSIA (heartburn) and NAUSEA (nausea). The patient was treated with FRUCTOSE, GLUCOSE, PHOSPHORIC ACID (EMETROL [FRUCTOSE;GLUCOSE;PHOSPHORIC ACID]) for Nausea, at an unspecified dose and frequency and PARACETAMOL (TYLENOL [PARACETAMOL]) for Heartburn, at an unspecified dose and frequency. At the time of the report, MALAISE (not being well), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not being able to live her normal life), BALANCE DISORDER (balance is not good), GAIT DISTURBANCE (can't run), DYSPEPSIA (heartburn) and NAUSEA (nausea) outcome was unknown. The prednisone was used for PRM.