chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10/4- at 1930 "thick" feeling of tongue and itching, fatigue, excessive thirst 10/5-hives noticed at 0600, thick tongue, itching - took BENADRYL at 0600, 1115, 1630. Approximately 10-15 hives on arms 10/6-hives spread to lower body and scalp.
At time of the shot, bright red face, rash, skin warm to touch. In the early evening chills, dizzy, waves of nausea. In the morning: vomit, nausea, chills, headache, dizzy
p/vax pt reported rt arm swelling, very red & feverish;swelling extended from shoulder to elbow;elbow joint very stiff & painful when moved;pt instructed to take ibuprofen & apply cold compress & return in 2 days for review;
Resident c/o nausea evening of 1/29 (nausea common for her post dialysis), had a large emesis at approx 2220, 0030 (unusual for resident to vomit)- received Zofran per order.   Skin cool and damp, Blood sugar 147 (checked due to h/o diabetes and poor intake).  At approx 230am Blood pressured checked and noted to be 52/29.   Resident transferred to ER, intubated and transferred to higher level of care where she passed away on 1/30 at 736pm.     Resident's medical notes indicated likely shock, cardiogenic in nature, sepsis (source unknown) along with a multitude of other co-morbidities that resident has.
Patient called the pharmacy where she got the shot this morning and said her arm was in severe pain and that the area around the injection site was red, inflammed, swollen and filled with fluid.
tinnitus - ringing in her head and swooshing; This is a spontaneous report from contactable consumer, the patient from a Pfizer sponsored program  A female patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on unspecified date as a single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. Patient thinks she had tinnitus, had ringing in her head and swooshing. The case was non-serious. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Heart and slight obesity issues" (unspecified if ongoing); "Heart and slight obesity issues" (unspecified if ongoing); "breathing long haul effects from having COVID-19 a year ago", start date: 2021 (unspecified if ongoing); "breathing long haul effects from having COVID-19 a year ago", start date: 2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid". Therapeutic measures were taken as a result of suspected covid-19. It was reported that patient had heart and slight obesity issues. Patient had been very impressed with Pfizer's Covid Vaccines, booster shots. Patient was having breathing long haul effects from having Covid-19 a year ago and felt protected. Unfortunately, patient developed Covid again. Patient was not hospitalized this time and was given drug Paxlovid. 5 days at home, patient feel better than patient had been in years. The lot number for bnt162b2 was not provided and will be requested during follow up.
Client received first dose of COVID vaccine @ 10:10am and complained of dizziness and nausea @ 10:25am.  Client assisted to zero-gravity chair and given a cold ice pack.  Vital signs assessed, initial blood pressure 77/50.  Client reports only eating grapes prior to vaccine, snack and water offered. Client denies shortness of breath, no medical conditions, not taking medications, no know allergies.  Client complained of abdominal pain that comes and goes @1029, reports no longer dizzy or nauseous.  Blood pressure at the time is 98/65.  Continued to monitor client, vital signs and blood pressure 105/65 @ 1039.   Client reports no more symptoms @ 1050, able to walk out of observation area with steady gait.
patient received the second dose from a vial that has expired based on the 12 hour expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received the second dose from a vial that has expired based on the 12 hour expiration) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 036C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received the second dose from a vial that has expired based on the 12 hour expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received the second dose from a vial that has expired based on the 12 hour expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter. No concomitant medication  information was provided by the reporter.
Several hours after receiving a TDAP patient felt ill and developed a fever. The area where she had received her vaccine was itchy and patient had some pain with arm movement. She also developed large hives on the same arm which radiated to her shoulder. Treatment was cool compresses to the area, take an ALAVERT daily and use 1%  Hydrocortisone cream to the area 3-4 times a day.
Redness, swelling & tenderness 4 cm X 4cm right upper arm lower half at IM PREVNAR injection site.
Rash all over her chest; Rash is very itchy; This spontaneous case from the was received on 18-Sep-2020 from other non-health professional (consumer) to agency (reference number: SEQW20-01965) and concerned a 59-year-old, female patient.  The patient's concurrent conditions and concomitant medications were not reported. The patient's past medication included influenza vaccination without any issues.  On 16-Sep-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location and route of administration: not reported) for prevention of seasonal influenza. The batch number was not reported.  On 17-Sep-2020 in the morning, one day after receiving Flucelvax Quadrivalent, the patient developed a rash all over her chest. The reporter stated that the rash was very itchy. Treatment measure included calamine lotion on the rash.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.  Company comment: The events of 'localized rash' and 'itchy rash' are considered as related to Flucelvax Quadrivalent vaccine.; Sender's Comments: The events of 'localized rash' and 'itchy rash' are considered as related to Flucelvax Quadrivalent vaccine.
Nausea, headache, chills, fever, fatigue, body aches. Symptoms were severe lasting 48 hours. Treated with Tylenol and rest.
No issue. No adverse event on patient.; Temeprature excurseion total time 25 min, 3 excursion. Escursion were not noted until after the fact due to employee error of cleanning data logger more than once a day; This spontaneous report has been received from a office manager, regarding a 13-years-old female patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 20-SEP-2022, the patient was vaccinated with one improperly storage dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, as prophylaxis (lot number and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (Strength, dose, scheme, route and anatomical location of administration were not reported).  Temperature excursion total time was of 25 minutes, divided in 3 temperature excursions, one on 09-SEP-2022 for 8 minutes, one on 16-SEP-2022 for 5 minutes and another one on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines were purchased with public, and privet founds and were given in private doctor's office/ hospital. The medication error occurred in the point of storage in clinical practice. No additional adverse event was reported.  This is one of several reports received from the same reporter.
6 hours post vaccine: Developed nausea, chills and fatigue that lasted 2-3 days Took 1000 mg tylenol every 6-8 hours, which lessened symptoms but did not ever completely relieve them Back to normal 4 days post vaccine
I got the shot at 5:05 PM on 4/17/21. My arm was sore and still currently is but is getting less sore. Around 950ish PM my face started to feel a little warm, then about 15 mins later I looked in the mirror and my face was red all over and it continued to get worse. Currently it is 11:20 PM and my face still feels very warm and is a deep red. I would compare it to a bad sunburn. I took my temperature and it was at 99.4.
R/thigh swollen, red & warm to touch, 48 hrs after vaccine. No areas of localized tenderness. Mom states R/thigh was bigger on 1/26/00. Child walks with noticable limp w/o guarding.
Dermatitis type rash on left arm within 48 hours of vaccine. Spread from left arm to right arm and bilateral upper inner thighs. Itched. Self resolved over 1 week. Treated PRN antihistamines seemed to help.
injection site pain; tiredness; headache; muscle pain; chills; joint pain; Eye pain; fever =(on Tylenol); feel febrile and woke up with the sweats at 2:am; injection site swelling; injection site redness; nausea; feeling unwell; This is a spontaneous report from a contactable nurse (patient). This 44-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL3249) intramuscularly in the right arm on 26Jan2021 (at the age of 44-years-old)  at 11:00 as a single dose for COVID-19 immunization. Medical history included allergy to bee stings. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously took thimerosal on an unknown date for an unknown indication and experienced drug allergy. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL0140) on 05Jan2021 at 10:30 intramuscularly in her right arm. On 27Jan2021 at 02:00 the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, eye pain, "fever = (on TYLENOL) feel febrile and woke up with the sweats at 2:am," injection site swelling, injection site redness, nausea, and feeling unwell. No treatment was provided for the events. Therapeutic measures were taken as a result of fever and included paracetamol. The clinical outcomes of injection site pain, tiredness, headache, muscle pain, chills, joint pain, eye pain, "fever = (on TYLENOL) feel febrile and woke up with the sweats at 2:am," injection site swelling, injection site redness, nausea, and feeling unwell were unknown. It was also reported the patient was not COVID tested post-vaccination.
both tested positive with Covid-19; both tested positive with Covid-19; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's wife) reported that a male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 24Mar2021 (Batch/Lot number: Unknown) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The consumer mentioned that she and her husband had the first dose on 24Mar2021, and both tested positive with Covid-19. The patient tested positive on 06Apr2021. The consumer would like to know if it is okay for them to take the second dose on 14Apr2021. The outcome of the events was unknown.  Information about Batch/Lot number has been requested.
Reported administering expired Moderna COVID-19 vaccine to two different individuals; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Reported administering expired Moderna COVID-19 vaccine to two different individuals) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Reported administering expired Moderna COVID-19 vaccine to two different individuals). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Reported administering expired Moderna COVID-19 vaccine to two different individuals) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants were reported. No treatment was reported.   This case was linked to MOD-2021-345957 (Patient Link).
This report was received from a health professional on 09 May 2008. The patient is one of three patients reported as part of a cluster. A child (exact age reported) experienced itching and redness at the injection site after receiving an intramuscular injection of DAPTACEL (lot number C2935AA). No other information was provided. The other two patients in this cluster are captured in case numbers 2008-01490  and 2008-01491. Additionally, this health professional reported fever and inconsolable crying following DAPTACEL and ActHIB administration, that event is captured in 2008-01488.
patient became dizzy after vaccine. she stayed dizzy for about an hour and then her daughter came to pick her up
The patient presents with rash. He is not having fever. Other comments include: was to get SYNAGIS today; however just today at sight of varicella imm: a 1.5 cm sts with many teeny vesicals on it appeared  imm was done 12.26.18 (within the 10 day window for a varicella imm reaction the more usual one with a few scattered vesicals with temp < 102/ lack of ++ discomfort) site in question is nontender. Outcome >>> for the local allergic reaction: observation and reporting only; defer SYNAGIS x 72 h
Woke up day after 1st shot.   Got extreme vertigo getting out of bed. Extreme nausea. Felt like I was going to vomit. Lasted 2-3 minutes. Within 10-15 min felt normal. Worked in office. Ate normal. Did some exercise in afternoon. Around 3:00 pm, 2nd wave of vertigo and nausea.   Spinning subsided in a few minutes. Nausea lasted about 30 min.
elevated platelets (thrombocytosis); passed out; felt hot; flu like symptoms; pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of passed out in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th January 2020, the patient received the 1st dose of Shingrix. On 9th January 2020, less than a day after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant), feeling hot, influenza-like symptoms and injection site pain. On 20th January 2020, the patient experienced thrombocytosis. On 11th January 2020, the outcome of the influenza-like symptoms and injection site pain were recovered/resolved. On an unknown date, the outcome of the passed out, feeling hot and thrombocytosis were recovered/resolved.   It was unknown if the reporter considered the passed out, feeling hot, influenza-like symptoms, injection site pain and thrombocytosis to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient's wife. The patient received Shingrix vaccine in unknown arm. The patient experienced passed out, feeling hot, influenza-like symptoms and injection site pain. The patient's platelets were elevated. The patient's wife reported that her husband planned to continue follow up with his physician. The ermergency room  visit was required. The reporter consented to follow up.
pt recv vax 11AUG97 & 1OCT97 pt had 24 varicella lesions that lasted for approx 1 wk;
Information has been received from a physician concerning a 4 year old male patient, who in approximately 2004 when he as a year old, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Now the patient who is 4 years old had shingles. He did not require going to the hospital, but was on methotrexate for an amorphous skin condition. Acyclovir was added. Unknown medical attention was sought. The child recovered. Further information has been requested.
Patient received both SHINGRIX and AFLURIA on the same day, different arms. Patient called later that evening stating he has flu like symptoms - body ache and fever, swollen lips, throat which disappeared right away. Pharmacist advised patient to take BENADRYL, TYLENOL or ADVIL and to go to the ER if any SOB or swollen throat appears again.
This spontaneous case was reported by an emergency medical technician and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-JAN-2022) and EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-JAN-2022) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Jan-2022 at 11:02 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Jan-2022 at 11:02 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-JAN-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-JAN-2022). At the time of the report, PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-JAN-2022) and EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 31-JAN-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.
having a quite few side effects/not feeling well; This is a spontaneous report from a Pfizer-sponsored program via a contactable female consumer(patient).  The female patient of an unspecified age received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. She previously received first dose BNT162B2 for COVID-19 immunization. The patient got the 2nd dose of vaccine last week 06Jan2021 but she's still having a quite few side effects/not feeling well in Jan2021. Outcome of event was not recovered.    Information on the lot/batch number has been requested.
Pt given H1N1 shot 0.5ml on 11/17/09. Has hx/o liver CA and transplant. 2 days later had fever/cough, Rhinitis and on 11/20 positive for Influenza A.
Mild fever 12 hours after vaccine, fever lasted about 24 hours, headache started about 24 h post vaccine, lasted forever a few hours.
Client called program requesting COVID vaccine dose.  Review of Client record indicated one dose of Moderna previously given,  client unable to identify which dose he was needing.  Upon arrival and review of client vaccine card he had completed a primary series already so appeared eligible for a bivalent booster dose. Dose given after completion of screening. At that time a second vaccine card was produced showing that client had received bivalent booster on 9-22-2022.  Situation was explained to client, 15 minute wait was completed, client has no change in condition noted, no untoward effects noted and had been provided an EUA prior to the dose with a verbal explanation of possible expected side effects from receiving the vaccine.
Shortness of breath, burning sensation in chest, tingling throughout body and primarily head, high fever, migraine, stomach pain, blurred vision, Spontaneous short duration sharp chest pain, irregular bowels, painful body aches.
COVID 19 Treatment; COVID 19 Treatment; 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 43-year-old male patient received BNT162b2 (BNT162B2), on 26Oct2021 as dose 3 (booster), single (Lot number: EW0187) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Allergy: Sulfa" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 03Oct2022, outcome "unknown", COVID-19 (medically significant) with onset 03Oct2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (02Oct2022) negative, notes: Tested negative 48 hours after my last dose of Paxlovid(Sunday); (03Oct2022) positive, notes: but positive the following morning (monday). Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical information: Tested negative 48 hours after my last dose of Paxlovid (sunday) but positive the following morning (monday). Possible rebound effect. No other medication in in 2 weeks.
Red lump and itchy at injection site same day , lasting 2 days and still going.
Body rash; Swollen tongue reaction; This case was reported by a consumer via and described the occurrence of generalized rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized rash and swollen tongue. On an unknown date, the outcome of the generalized rash and swollen tongue were unknown.   It was unknown if the reporter considered the generalized rash and swollen tongue to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The patient received 1st dose of shingrix and experienced body rash and swollen tongue reaction. No other information was not available. The information regarding consent to follow up was not reported.