chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a mild rash under the injected arm; Tenderness at the injection site; slight fever; mild nausea; mild head/body aches; mild head/body aches; mild pain in the injection shoulder; This is a spontaneous report from a non-contactable consumer or other non HCP (patient). A 48-year-old male patient received bnt162b2 (BNT162B2, formulation; Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 12Feb2021 at 11:45 (Batch/Lot number was not reported) as DOSE 2, SINGLE (at the age of 48-year-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if patient had Known allergies. It was unknown if patient received other medication in two weeks prior to the COVID vaccine or not. 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. Historical vaccine included first dose of bnt162b2 on unspecified date for covid-19 immunisation and experienced mild pain in the injection shoulder which was more painful and more widespread than dose 1. The patient experienced tenderness at the injection site and a mild rash under the injected arm, 3 to 4 hours post vaccination, he had mild pain in the injection shoulder which was more painful and more widespread than dose 1. After 6 to 8 hours post vaccination, patient had slight fever and mild nausea. Fever resolved within the hour and nausea persisted until bedtime. After 8 to 10 hours post vaccination, he had mild head/body aches. After 18 hours post vaccination, he had still rash under the injection arm. It was reported that through the next 24 hours, most side effects had faded. The patient underwent lab tests and procedures which included Nasal Swab which was negative on Feb2021. No treatment was received for the events. The outcome of events slight fever recovered on 12Feb2021 and all other events recovered on unknown date of Feb2021.  Information on the lot/batch number has been requested
12/12/06 mother stated patient went to emergency room and had infection in his left arm where he received vaccine. 12/13/06 mother called to say that MD said reaction was not from immunization but was an infection. Mother was asked to bring child to health department. Agreed to bring him 12/14/06. 12/14/06 Mother said MD said swelling going away and MD said was a reaction to immunization. Asked mother to sign release of information to obtain MMR recovery. Mother did not come to health department nor did she bring child. 12/15 mother said arm was fine.
Pfizer vaccine. Patient stated she was having some slight pain in her sternum area, then she stated it moved to her "belly" making her nauseas, then stated her throat felt like it was a little scratchy. Symptoms did not all happen at same time, the progressed. Patients blood pressure was115/75 pulse 81. Patient alert and oriented, appeared in no distress. Patients mom at side. Decided to drive her to the hospital. Did not want this RN to call 911.
One hour after vaccine had swollen tongue while at work (in a hospital). I went straight to ER and was short of breath unable to talk by the time I reached ER (anaphylaxis). Also rash to chest and arms.
Initial report received on 21 August 2009 from a health care professional.  A 63-year-old male patient who was receiving wound management, had received a second intramuscular left deltoid injection of ADACEL, lot number UF551AA (lot number C3159) on 14 August 2009.  Five days post-vaccination, the patient developed redness, swelling, and warmth at the injection site.  The patient was evaluated by a physician and diagnosed with "infection."  No cultures were performed to confirm the infection.  The patient received corrective treatment with BENADRYL, ROCEPHIN and Doxycycline, and recovered on 12 August 2009, two days after the onset of the adverse events.  The reporter for this case is the same as for cases 2009-03624 and 2009-03625.  Documents held by sender:  None.
Patient received 4 vaccines: Tdap, MCV, Flu shot and HPV. Immediately after (while still sitting in chair), patient complained of being "hot" and feeling "faint". I told pt to stay seated and called for another nurse the the next room to grab a Coke. I got cool compresses to put on pt's back of neck, and to wipe face. Pt vomited into the trash can. Told pt to slowly sip the Coke. After about 15 minutes of sitting, the patient felt much better. Pt left our office with her mother. The mother came back into the office after about 3 minutes and said that her daughter was feeling faint again. Daughter was sitting in the hot car, wearing a flannel long sleeve shirt. It was about 98 degrees outside. Pt told me that she felt hot again and like she was going to faint. Another nurse went to get a cold compress for the pt. Once applied, pt felt better. I told the mom that we should bring the pt in the office for about 10 minutes to make sure she's alright. Pt said again that she felt better and mom said she thinks she will be ok. HR was 60 beats/ minute. I instructed the pt to stay cool for the rest of the day, don't do anything strenuous, and if felt faint again to lie down. I told the mom to monitor pt for rest of today, and contact dr if there are any more issues. My office number was on the shot record. I told mom she could call me if she had any more questions.
33yr old female who presents for breast concerns. Thursday morning she woke up and her breasts felt engorged and the left was worse than the right and milk was coming out of the left.  It was about a teaspoon in amount.  She has had a tubal ligation for contraception. She now has pain on the left side of her breast and into her armpit and into her shoulder.  She does have a FH of breast cancer.  She has a maternal aunt with breast cancer. She does have lupus. She is having troubles emptying her bladder.  She does think she empties okay but the stream can be slow to start. She takes provera 30 mg daily to prevent menses.  ASSESSMENT: urinary issues Breast tenderness Nipple discharge PLAN: Her breast exam was benign and reassurance given that most likely her tenderness was due to hormonal changes of her breast.  I do want to check a tsh and prolactin given the nipple discharge. I do want to order a diagnostic mammogram and u/s to be safe as she is concerned about her tenderness.  If this is normal, reassurance given. Will start with a urine culture.  If her urinary symptoms aren't improving, will refer to urogyn.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 49-year-old female patient (not pregnant) received the 1st dose, BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EL3247), at the age of 49, in left arm, on Mar 3, 2021, at 10:00, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had pain in extremity (after the first dose, left arm was sore for three days starting the day of the jab and the next two days), onset Mar 3, 2021, with outcome of recovered (Mar 2021). Therapeutic measures were not taken as a result of pain in extremity. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within 2 weeks of vaccination. No allergies to medications, food or other products. No known allergies. No COVID-19 prior vaccination, and not tested post vaccination. No follow-up attempts possible. No further information expected.
On way home from Dr I saw flashing red lights. At first I though I was being stopped by a policemen, then realized the whole interior of my car was flashing red. No shoulder on road to pull off so I had to keep driving looking thru red windshield fro 3 to 4 mins.
Case number PHEH2015US019858, is an initial spontaneous report from a pharmacist received on 02 OCT 2015. This report refers to a 34-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN 2015/2016 (batch number: 1514801) intramuscularly at a dose of 0.5 ml on 02 OCT 2015. The pharmacist reported that the vaccine FLUVIRIN that had reached 52 degree for 30 minutes was administered to the patient. No adverse event was reported following the medication error (incorrect storage of drug).
Whole arm went completely numb,  went to her face and left side of her body, legs are also numb; Nerve damage; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Whole arm went completely numb,  went to her face and left side of her body, legs are also numb) and NERVE INJURY (Nerve damage) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (Amoxicillin) and Sulfonamide allergy. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), VITAMIN C [ASCORBIC ACID], VITAMIN D NOS and ZINC for an unknown indication.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced HYPOAESTHESIA (Whole arm went completely numb,  went to her face and left side of her body, legs are also numb) and NERVE INJURY (Nerve damage). At the time of the report, HYPOAESTHESIA (Whole arm went completely numb,  went to her face and left side of her body, legs are also numb) and NERVE INJURY (Nerve damage) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Computerised tomogram: normal (normal) Normal. In September 2021, Magnetic resonance imaging: normal (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications also included Probiotics.  The treatment information was  not provided.  It was reported that patient's ER doctor  was considering nerve damage and  patient will be referred to Neurologist if numbness persist.
6:30 PM chest tightness, shortness of breath, swollen throat which improved but around 8 PM extreme eye redness, eye discharge and swelling, headache, head pressure, fever, myalgias.
flu like symptoms; bedriden; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced influenza-like symptoms and bedridden. On an unknown date, the outcome of the influenza-like symptoms and bedridden were recovered/resolved.   The reporter considered the influenza-like symptoms to be related to Shingrix. It was unknown if the reporter considered the bedridden to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself. The age at vaccination was not reported. The patient's age at vaccination might be around 57 or 58 years. The patient received his 1st dose of Shingrix 3 months ago of reporting and less than a year after receiving Shingrix, the patient experienced flu like symptoms for a couple of days and spent one entire day in bed. The patient was trying to make a decision on whether to get the 2nd dose but first wanted to know if there was any efficacy after 1st dose and could the side effects be the same with the 2nd dose. The patient did not want to provide any demographics except his first name and did not provide any additional details.
pt recvd vax MMR vax IM instead of SC on 7JUL93; 2 days later pt devel diffuse hive & a low grade fever; sx persisted for more than 2 wks; No further details were provided;
pt came in with red, hot rash on upper (L) arm measuring approximately 11 cm in circumference. 2 day after receiving DTaP in that area.
Pharmacist administered vaccine that had expired on 8/11/23. No adverse events reported by patient. He will repeat dose.
Ectropion of left eye. Daughter concerned about eye and possible swelling. No apparent angioedema.
Passed out twice; Pain in the injection site; Slight headache; A spontaneous report was received from a consumer concerning a 24-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, passed out twice, pain in the injection site, and slight headache.   The patient's medical history was not reported. No concomitant medications were reported.   On 26 Dec 2020 at 1:58 pm, approximately three hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L2DA) intramuscularly for prophylaxis of COVID-19 infection.   On 26 Dec 2020, at 5:00 pm, the patient passed out. She also had pain in the injection site and a slight headache.   On 27 Dec 2020, at 8:30 am, the patient passed out again. No treatment information was provided.  The Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the events, passed out twice, pain in the injection site, and slight headache was unknown.; Reporter's Comments: This case concerns a 24 year old female patient, who experienced a serious unexpected event of loss of consciousness and non-serious expected event of injection site pain and headache. The event occurred apparently few hours after first dose of mRNA-1273 (Lot # 026L2DA) administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Syncopal episode immediately following vaccine administration. Patient was seated, no fall sustained. Blood pressure dropped to 76/48, recovered to 96/56 in 5 minutes.
Patient felt dizzy, light headed, and her limbs felt heavy and spongy (how she described it)
pt recv vax 28AUG96 & on 13JAN97 pt devel chicken pox w/15 lesions;no fever was noted;no further details were provided;
No additional AE; HCP called to report temperature excursion for ROTATEQ that was administered to a patient. No additional AE/PQC.  ?    Names of vaccines involved (including lot/exp): ROTATEQ, lot/expiration unknown by reporter ?    Temperature: (9.1C) ?    Tim; This spontaneous report was received from a medical assistant and refers to a 6-months-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 03-JUL-2023, the patient was vaccinated with an improperly storage rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, administered for prophylaxis (dose, frequency, strength, lot #, expiry date, and route of administration were not provided). Temperature excursion occurred at 9.1 C for 5 hours. No previous temperature excursion was reported. No additional information or adverse event was reported.
Case number PHEH2015US021630, is an initial spontaneous report from a health care professional received on 22 Oct 2015. This report refers to a 2 years old male patient. Medical history and concomitant medications were not reported. The patient was inadvertently vaccinated with FLUVIRIN (batch number: 1516201) intramuscularly on 21 Oct 2015. No adverse event was reported following this medication error.
Kinrix was administered to a patient 3 years of age catch up the series of Dtap IPV; Inappropriate schedule of vaccine administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number HB7L7, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included DTap IPV (received  two previous doses on an unknown date).   On 23rd April 2021, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 23rd April 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The Kinrix dose was given to the patient at 3 years of age to catch up the series of Dtap IPV, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. The reporter could not read the lot number and expiration date very well. The patient was received two previous doses of DTap IPV vaccine. The reported batch number HB717 not found in sales data sheet and was corrected to HB7L7. The reporter requested follow up by post.
Information has been received from physician concerning a 16 year old female patient who on approximately 05-JAN-2007 ("7 weeks ago") was vaccinated with the first dose, 0.5ml, IM, of Gardasil. There was no concomitant medication. The physician reported that the patient stated she "did not feel well when checking out and turned white and fainted when being taken back into the examining room." The physician clarified that the patient "did not lose consciousness or hit her head because he caught the patient." He confirmed the patient fainted "within 5 minutes" of the vaccination, and remained "groggy for up to 30 minutes" after the vaccination. The patient was then "considered recovered," and left the office. The physician considered the events to be disabling. Additional information has been requested.
redness; knot underneath; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness, knot underneath there.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.   Redness, Knot underneath there.  Treatment details included Ice.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), redness and knot underneath  was Not recovered/Not resolved .
I experienced severe chest pain on 05/06/2021 and was having a great deal of difficulty breathing. My wife ended up taking me to the ER at 06:00AM at the ER. The doctors ordered an EKG upon arrival along with drawing some blood. I was then given some Ibuprofen and something for my stomach. They ordered an Echo Cardiogram the next morning and prescribed some Ibuprofen 600mg (1 tablet 3x per day) for two weeks per the Cardiologists. On 07/15/2021, I had an appointment with my Cardiologist who performed another EKG and then on 09/16/2021 I went to the ER again with breathing difficulty and my lungs were full of fluid. The doctors discovered that my artificial heart valve had broken (one of the leaflets) which required surgery on 09/22/2021 which required a hospital stay of 12 days.
pt recv vax 2MAY97 & 5MAY97 pt devel double pneumonia & was hosp;pt was very congested, very fatigued & exp vomiting;tx w/albuterol, nebulizer & APAP;
he does have 3 spots on his heart muscle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 17-year-old male patient received BNT162b2 (BNT162B2), on 18Jun2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. An unspecified medication was also considered as suspect by the reporter. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN ), for COVID-19 IMMUNIZATION. The following information was reported: CARDIOMYOPATHY (medically significant), outcome "unknown", described as "he does have 3 spots on his heart muscle". The patient had a reaction after the second dose of the Pfizer COVID-19 vaccine that was administered on 18Jun2021. He wound up taking steroids (corticosteroids) and recovered but he does have 3 spots on his heart muscle.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
It was reported that a 39 year old  female received a TD Adult vaccination on 01/26/2001 at 10am. Reportedly between 6 and 7pm that evening the pt developed a 1cm x .8cm, red and raised - no blisters, no extended margin -left forearm volar. T99.8 Degrees F. Treatment of Benadryl per oral was prescribed. The pt reportedly recovered from this experience. From follow up # 1 correspondence received on 03 APr 2001, no further information was provided. See reports U2001-00435, U2001-00436, U2001-00438, U2001-00448 through U2001-00454 and U2001-00456 through U2001-00461, same reporter.
Vaccine administrator (certified by Immunizations course) inadvertently provided a PPD utilizing the Anthrax vaccine .1cc intradermally.  Pt was not indicated to receive Anthrax (presented for PPD and Flumist) but had previous Anthrax vaccinations due to deployment.  PT advised immediately of the error.  No initial redness at site of inadvertent injection. Pt also received Flumist, PPD, and Anthrax additional by SC route per PT request. Pt will return within 48-72 hours for PPD reading (PPD was placed after incident in opposite arm) and will follow up at that time with Ambulatory care Clinic staff related to inadvertent Anthrax injection (Intradermal) to ensure there are no complications.  Head Nurse notified by immunization staff after encounter completed.  Head Nurse discussed incident with patient and advised to contact clinic if pain, redness, or swelling at site of injection occurs or Go to ER immediately if any acute issues occur. Contacted Dr, Immunizations Physician and advised of the incident.  He concurred with plan of care and advised there is a minimal likelihood of complications, other than local irritation to affected area, that may occur. Administrator provided patient with personal contact information for any questions, concerns, or issues.  2.  Patient was followed up by clinic providers on 16 DEC 2008, 17 DEC 2008, and 19 DEC 2008.  Provider visit on 19 DEC 2008 advised patient to return to clinic only as needed due to resolving redness and irritation.  Lab tests completed on 19 DEC 2008 were within normal range.  Specific medical documentation available in electronic record.  Administrator contacted on 30 DEC for verbal follow up.  Pt reported ½ dime size reddened area with a small nodule like a "BB" under skin.  Provider advised and no further medical action is needed at this time.  Continue to monitor and RTC if conditions worsen or return.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was inadvertently vaccinated with the improperly stored dose of GARDASIL 9 (lot # L043213, expiration date 28-AUG-2017; dose and route of administration were not reported). The vaccine was stored in 22.6 degrees of Celsius for 2 hours and 40 minutes. No adverse effects and no previous temperature excursion were reported. The call was made because of the data logger. Additional information has been requested.
None Stated Arm sore after shot but later came back and said not due to shot but tendonitis concidence. Patienct came in for third time to say saw another MD and said arm was due to the shot she got 11/19/090