chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019 (dose and route were not reported) for prophylaxis. The vaccine was exposed from 47°F to 77°F for 12 hours. There was no temperature excursion. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643: Original Case: 1707USA006643.
Person  was given a Covid vaccine today and within 5 minutes started breaking out in large blotches, started on neck and went down body and back. Nurse was called into the observation room to assess the patient. Patient was on her portable oxygen on 2L. No severe SOB noted RR 32, not labored. BP 128/88. Stated she has a lot of allergies and uses an EPI pen some. Did not have one on her. Stated she did not want one used on her at this time due to she was not having a severe reaction to the vaccine only the red blotches that itched. She was calm and not struggling for air nor felt her airway closing up. She did ask for the Diphenhydramine to be administered. This was done by nurse, taken from the ER kit (50MG/1ML) given in patients left arm. She began to stop itching immediately and by 30 minutes of observation by RN all the blotches were gone and no itching noted. Patient was alert and oriented x3 when she left the clinic. Instructed her to go to ER if any other episodes reoccurred. States she would. The Covid vaccine was given at 1:25PM. The itching and blothes noted at 1:32PM. Assessment and Benadryl given at 1:38PM. Patient was observed until 2:10 PM.
T-98.6. Pt. states has a knot under her arm - upon examination by school nurse found knot to be in her armpit. Immunization was given on left deltoid & knot was in left armpit. Called immunization board & they suggested she seek med. attention/no warmth or redness at injection site.
ADMINISTRATION ERROR A Medical Assistant had given the wrong vaccine to the patient. Vaccine that was suppose to be given was MCV Menquadfi but was given instead Men B Bexsero. Provider was informed and parents were contacted to informed them by the provider. CDC and manufacture were contacted for advise on 08/29/23 in the morning, was informed by both parties that there is no harm to the patient as Men B Bexsero can be received to ages 10-20 years old. Patient has not had a reaction.
Intense Anxiety and Depression along with rapid weight loss, hot flashes, rapid heart beat and hair thinning
Patient reported to clinic she had taken a positive pregnancy test 10/21/2019 at a local Emergency Room. Came to clinic for confirmation and referral to OBGYN. Requested to have this seasons flu vaccine. Provider agreed, verified with our pharmacy if OK to give to patient or if their was a preservative free dose available to give to adult pregnant female. Pharmacist advised we did not have preservative free dose available and to give from multi-dose vial. Multi-dose vial dose given to pregnant patient. Expected due date is 6/2020.
During Nurse visit, Adult patient was administered Hep B for pediatric/adolescents instead of Hep B for adults.
Vaccine was administered in the side of her arm and not in her deltoid muscle; Pain; Nausea; Headache; Injection site swelling; redness 2 inches below the injection site; A spontaneous report was received from a 64 year old  female nurse, regarding herself who received second  dose of Moderna Covid-19 vaccine and experienced nausea, headache, injection site swelling, redness 2 inches below the site , pain and injection given on the side of arm instead of deltoid.  The patient's medical history included Covid-19 infection from 13-JAN-2021 to 22-Jan-2021. Her concomitant medications were not provided. No information on allergies.   On 27-JAN-2021, prior to the onset of events, the patient received 2nd of two planned doses of Covid-19 vaccine for the prophylaxis of Covid-19 infection. (Lot#011M20A).   On 27 Jan 2021,  the patient states that vaccine was given on side of her left arm instead of deltoid muscle. On the same day, she experienced nausea, headache, injection site swelling, redness 2 inches below the injection site and pain.  Action taken with the vaccine is not applicable as the individual completed 2 doses.  The outcome of the event, injection given on the side of arm instead of deltoid, was considered recovered/resolved on 27 Jan 2021.   The outcome of the event, nausea, was considered resolved on 28-JAN-2021  The outcome of the event, headache, injection site swelling, redness, pain, were considered not recovered/no resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   The causality for the event incorrect route of vaccine administration is assessed as Not Applicable
Moderna COVID-19 Vaccine EUA  Starting about 7 days after injection: Itchy, swollen, red, warm area surrounding injection site, on left arm. Also, swollen & slightly painful lymph nodes in left arm pit.
localized inflammatory rxn or rt tricep area extending down to elbow;erythematous lesion elevated, hard & red;
Headache, Myalgia, Arthralgia, SkinRash, 1/21/2022 last night began to experience hives and fatigue, this morning 1/22/2021 headache, body aches, neck and shoulder stiffness Narrative:
4 inches x 4 inches erythemalic rash on left thigh, no swelling, not warm to touch and is not itchy. Pt. does not complain of any pain.
Pt presented to clinic with 5.5 x 5 in area of redness and swelling at injection site. Area was hot to touch. 1 1/2 tsp of BENADRYL administered in clinic, cool pack applied to area and marked with marker to monitor for worsening. Area did not respond to treatment in clinic.
Seven strictures resulting in a loss of 12 to 18 inches of small intestine; Sore leg muscle; This is a non-interventional study report from the marketing program received from a non-contactable 59-year-old female consumer (patient) based on information received by Pfizer that: A 59-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6205 and Expiration date was not reported), via intramuscular on 09Mar2021 as SINGLE DOSE for covid-19 immunization; adalimumab (HUMIRA), subcutaneous from 2019 (Batch/Lot Number: 1136916) to 17Feb2021, at 40 mg, citrate free (40 mg,1 in 1 wk) for moderate to severe adult Crohn's disease. Medical history included depression, hypertension, appendicectomy from 2010 to an unknown date, Nonsmoker and abstains from alcohol. Concomitant medications included celecoxib (CELEXA) taken for depression; pindolol (PINDOLOL) taken for hypertension. In Nov2020, the patient experienced seven strictures resulting in a loss of 12 to 18 inches of small intestine. On 09Mar2021, the patient experienced sore leg muscle. Seriousness of the event seven strictures resulting in a loss of 12 to 18 inches of small intestine was reported as hospitalized and medically significant. The patient underwent lab tests and procedures which included biopsy: no significant findings on 05Feb2021, colonoscopy: stricture on Nov2020, laparoscopy: seven strictures on 05Feb2021. Adalimumab was permanently withdrawn on 17Feb2021.On 05Feb2021, the Seven strictures resulting in a loss of 12 to 18 inches of small intestine resolved. On 10Mar2021, the Sore leg muscle resolved. Causality for HUMIRA 40MG/0.4ML (ADALIMUMAB): The reporter causality for the event(s) of Seven strictures resulting in a loss of 12 to 18 inches of small intestine and Sore leg muscle with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility. Company opinion is that there is no reasonable possibility that the events of Seven strictures resulting in a loss of 12 to 18 inches of small intestine and Sore leg muscle are related to HUMIRA 40MG/0.4ML(ADALIMUMAB).  No follow-up attempts are possible. No further information is expected.
pt recv vax & 3 days later devel a diffuse raised rash over all extremities & 2 papules around waist;rash began @ the site of vax;tx w/DPH & recovered;
small patch of hives on hip opposite side from vaccinated arm.  intermittent rapid heartbeat for 24 hours.
PATIENT DEVELOP BELL'S PALSYNEXT DAY OF VACCINATION PRESCRIBE ANTIINFLAMATORY
This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 04-DEC-2017, the patient was vaccinated with an improperly stored dose of PROQUAD lot # N016994, expiration date 29-NOV-2018, for prophylaxis (strength, dose, route and frequency were not reported). The PROQUAD was reconstituted with a properly stored sterile diluent (MERCK) lot # M034763, expiration date 22-APR-2019. The temperature excursion was of 6°F to 14°F, during 120 hours 30 minutes. However, a previous temperature excursion of 47 °F to 50°F for 35 minutes was also reported. A digital data logger was involved. No adverse effects were reported. Additional information is not expected. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1712USA013991: US-009507513-1801USA003524: US-009507513-1801USA003525: US-009507513-1801USA003526: US-009507513-1801USA003527: US-009507513-1801USA003520: US-009507513-1801USA003521: US-009507513-1801USA003522: US-009507513-1801USA003612.
A report has been received from a Health Professional concerning a patient, Female subject, Height: 47.3 Inches; Weight: 58.0 Pounds, who had been receiving Nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced nosebleed. Reporter stated a couple of seconds after she received the second dose of FLUMIST she had a nosebleed. The patient recovered from the event of nosebleed on an unspecified date. The report was considered to be non-serious. Summary of follow up information received by AstraZeneca/MedImmune from Health Professional on 23-Oct-2012: Patient height, weight, ethnic origin, medical history and siblings added; Reporter occupation, event outcome and Vaccinated at and purchased with updated.
Subject reported muscle aches within 24 hours of receiving the vaccine; Subject reported muscle aches and chills within 24 hours of receiving the vaccine; This is a spontaneous report from a contactable consumer. A 37-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on an unknown date in Apr2021 as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within two weeks of vaccination. On an unknown date in Apr2021, the patient experienced, muscle aches and chills within 24 hours of receiving the vaccine. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle aches and chills were recovered on an unknown date in Apr 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
expired dose of Boostrix was administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number BR352, expiry date 27-AUG-2022) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: expired dose of Boostrix was administered to a patient).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 15-SEP-2023 The pharmacist called and reported an expired dose of Boostrix was administered to a patient which led to expired vaccine used. At the moment of the call reporter did not had any information about the patient or vaccination date. The reporter did not consent to follow up.
Chills; Arm is sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2, Solution for injection) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Single), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm is sore".  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt reports she has persistent, mild arm pain at the injection site more than 6 weeks after receiving vaccine. No other symptoms reported.
She said her arm is still sore up till today. It comes and goes but has not gone away yet. She said she has not lost range of motion just a sore arm still.
Patient reports that two days after getting 2nd dose of Pfizer COVID19 vaccine she started having frequent watery stools (up to 10 per day), lack of appetite, and she developed a fatty tumor at the injection site. Electrolytes including potassium, magnesium, and calcium were also lowered. She has had multiple doctor's visits and a hospitalization as well.
Discomfort left shoulder, some swelling at site, achy, headache, hives over left shoulder, some overweight left side of neck (vaccine given IM left deltoid).
This spontaneous report as received from a pharmacist refers to a 66 years old male patient with none Drug Reactions/Allergies. The patient was vaccinated IM with a dose of PNEUMOVAX 23 (Lot number HO 09826; expiration date 11-FEB-2014) into the right arm on 01-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 01-OCT-2012, following the PNEUMOVAX 23, the patient developed decreased mobility in his right arm. No treatment was given for the event. At the time of the report, the patient had not recovered from decreased mobility in his right arm. The relatedness for decreased mobility in his right arm was not reported for PNEUMOVAX 23. Additional information has been requested.
Pt received Janssen J&J COVID-19 vaccine on 4/6/2021.  Pt presented to triage on 6/20/2021 (area to be initially assessed and then admitted to L&D) in active labor and almost immediately delivered.  She was admitted for recovery and tested for COVID via NP PCR as part of routine admission.  Test resulted positive for COVID-19, pt asymptomatic.   Baby was delivered early, no weight listed for baby.  Pt was at 38w5d as dated by LMP.
hepatitis B nonresponder; Literature Report:   This literature report has been received from authors of a published article, titled as above, regarding an adult patient. The medical history, current conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with initial series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 59 (unit not provided). And the patient was vaccinated with the second series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 60 (unit not provided) on an unknown date. Total number of standard hepatitis B vaccine (recombinant) doses were 6. The patient did not respond to two complete standard hepatitis B vaccine (recombinant) vaccine series and was termed as nonresponder (Vaccination failure). The outcome of vaccination failure was unknown.  The causality between vaccination failure and hepatitis B vaccine (recombinant) was related.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2207USA004701:
12/02/21 presents to ER ED with "shortness of breath". PMHx of "HTN, HLD, PACs (now a-fib), AAA s/p repair, CKD IV, OSA, sinus bradycardia, and dementia"
Profusely sweating a couple hours after shot.  Whole body aches/weakness and migraine started 24 hours after shot and lasted about another 24 hours. up and back to work today, but very weak, tired, hot, and sometimes dizzy.
Information has been received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On an unspecified date, the patient was vaccinated with an improperly stored dose of ROTATEQ orally, lot number N022015 with expiration date on 10-MAR-2019 (strength and dose number were not provided), for prophylaxis. The ROTATEQ was stored at a temperature range of 47 degrees Fahrenheit (°F) to 77 °F (55°F), for a time frame of 30 hours and 43 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1808USA002488: US-009507513-1808USA002489: US-009507513-1808USA002490: US-009507513-1808USA002491: US-009507513-1808USA002453:
After second shot I have developed severe Tinnitas. Have just seen/confirm Tinnitas with ENT SPECIALIST.
pt recv vax 8JUL96 & 22OCT96 pt was seen by MD w/fever of 102.4, v & BOM;23OCT96 more v x 5, temp still 101 & irritable;no improvement was seen @ MD on 24OCT96 pt sent to ER;IN ER 24OCT96 pt placed on IV fluids & rehydrated;dx meningi
Sore arm within 8 hours of receiving vaccine shot. Currently 20 weeks, 4 days pregnant. No other side effects from dose 1.
Patient complained of slight headache post vaccination. She stated "did not take my blood pressure pill and did not drink water". V/S BP 168/76 P 68 T 97.6, O2Sat 98% RA. Offered and accepted electrolytes drink, and rested for 25 mins. V/S rechecked BP 142/64 P 62, O2Sat 99% room air PTD. Patient stated she feel better relaxation and fluid intake. No further complain reported. Patient left the clinic in stable condition accompanied by family member.
temp 100 1 day p/vax & 27MAR-no sequelae;
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown dates, approximately in January 2016 (reported as between 14-JAN-2016 and 20-JAN-2016), the patients were vaccinated with an improperly stored doses of VARIVAX lot # L021215, expiration date 10-JUN-2017; lot # L001330, expiration date 13-JAN-2017; lot # L011084, expiration date 01-APR-2017 (dose and route of administration were not specified). Administered doses of the vaccine underwent temperature excursion at 43.7 Fahrenheit degrees for 94 hours and 42 minutes. No adverse effects and no previous temperature excursion were reported. Additional information has been requested.
Positive COVID test; Positive COVID test; Headache; stuffy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 22 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Apr2021 (Lot number: EP6955) at the age of 22 years as dose 2, single and intramuscular, administered in arm left, administration date 25Mar2021 (Lot number: EP6955) 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 (medically significant), COVID-19 (medically significant) all with onset 17Nov2021, outcome "recovering" and all described as "Positive COVID test"; HEADACHE (non-serious) with onset 17Nov2021, outcome "recovering", described as "Headache"; NASAL CONGESTION (non-serious) with onset 17Nov2021, outcome "recovering", described as "stuffy". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Nov2021) positive, notes: Nasal Swab. The action taken for bnt162b2 was unknown. Therapeutic measures were not taken as a result of vaccination failure, covid-19, headache, nasal congestion.  Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19.
Extreme dry mouth morning after vaccine; Red sores on inner, upper lip; Red sores on inner, upper lip; Continuing fatigue; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170), via an unspecified route of administration in the right arm on 15May2021 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. Medical history included sjogren's syndrome, depression, anxiety, asthma and fruit allergy from pineapple. Concomitant medications included levothyroxine sodium (SYNTHROID), mometasone furoate (ASMANEX), duloxetine hydrochloride (CYMBALTA) and birth control (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM), cefixime (BIOXIN), benzocaine (MANUFACTURER UNKNOWN) and resorcinol,chlorothymol, benzocaine (LANACANE); all on unknown dates for unspecified indications and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16May2021, the patient experienced extreme dry mouth morning after vaccine followed by red sores on inner, upper lip. Last for a few days then go away but return in another part of the mouth/lip and continuing fatigue. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events extreme dry mouth, red sores on inner, upper lip and continuing fatigue were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
23 year old developed migraine headaches with photophobia and nausea which were ongoing. No history of headaches. Prevented deployment to Iraq. Seen in neurology. Placed on triptans. Last contact 03/13/03. Still symptomatic. Pt has not responded to calls, therefore do not have follow-up or all data for address/unit, etc.