chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever, cough, not feeling well, vomiting  ED to Hosp-Admission Discharged  8/16/2021 - 8/21/2021 (5 days)  Hospital   MD  Last attending Treatment team Shortness of breath  Principal problem  Care Coordination Progress Note LPN (Licensed Nurse)    referral received for Covid today. Called ato screen patient. Reached patient in hospital room, but patient states he is HOH over phone and requests I call wife.  She was educated on the program and its benefits. He is appropriate and agreeable to the program.  Kit to be delivered  to their home by delivery service. She was advised to go ahead and open up the kit when when it arrives to their home  unpack the tablet and charger, charge the tablet, and then turn on the tablet which will walk her through an instructional video to explain how to obtain his first set of vitals.  Patient was also given our contact information. One of the RNs, with the program will call her after receiving the first set of vitals to further explain the program. patient verbalized understanding. Patient reports having the following equipment Scale, Blood pressure cuff and monitor and thermometer. Kit direct shipped to patient's home. Program referral re entered in EMR. Original did not populate into computer program. After several attempts referral still did not populate into computer. Profile entered manually.kit assigned
Tingling around nose and mouth. Cold water given, reactions are starting to be relieved after drinking water.
BODY ACHES; SWOLLEN THROAT; CHILLS; FEVER OF 103.8; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to penicillin, and allergic to sulfa, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient has no previous history of headaches. she has no food allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced body aches. On 10-MAR-2021, the subject experienced swollen throat. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced fever of 103.8. On 10-MAR-2021, the subject experienced headache. On 10-MAR-2021, the subject experienced nausea. Laboratory data included: Body temperature (NR: not provided) 103.8. On 11-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 11-MAR-2021, was recovering from chills, fever of 103.8, body aches, and nausea, and had not recovered from swollen throat. This report was non-serious.
pt presented to clinic 16FEB96-2 days p/vax;mom states t104 w/a strange high pitched whining cry;
SEVERE RASH: large, unabated, red to dark red, raised welts. The initial rash started under arms covering from underarm to hip as circular patterns. Then spread into the back. Covered sides, back, neck, into scalp, upper arms, buttocks, knees (front and back), thighs. Rash appeared mostly as one large/connected reddish glob. Spread occurred within 2 hrs from initial onset at 8pm. SEVERE RASH Lasted 8 hrs and would lessen but then new lesser rash would appear and is still present to lesser degree.  Rash itched and burned.   Treated self with a Claritin pill and cortisone cream all over rash. Took a Benadryl tablet the following day.  Rash decreased each day. Rash still present to a lesser degree on 3rd day after it started with the rash appearing more as reddish dots. **Pictures are available upon request**
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) 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 was not reported. Concomitant medication(s) included: LEXAPRO. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 14Feb2023 to 18Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Baby Paralyzed; now unable to move his body, from the neck, down, after taking the shots; Inappropriate age at vaccine administration; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: PARALYSIS (medically significant), outcome "unknown", described as "Baby Paralyzed"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "now unable to move his body, from the neck, down, after taking the shots"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), outcome "unknown", described as "Inappropriate age at vaccine administration".Clinical course :The video documents how a healthy, robust child deteriorates in just 13 days.  The lot number for bnt162b2 was not provided and will be requested during follow up.
First soreness in my throat. After one week problems to breathing, headaches, palpitations.
4/13/11 Felt "skin crawling", itching over left upper arm at vaccination site extending from near shoulder to elbow. Discovered rash forming. Seen 4/14/11, maculopapular lesions 28cm by 25 cm, florid red, non-pustular. Lesion itself 1cm by 1 cm (vaccinia site). 4/15/11 seen at clinic with (Rt) cheek tingling & drooping (slight) (Rt) side of mouth. Taking Ibuprofen 400 q 6 hours, ZYRTEC q AM & BENADRYL 50 mgm at HS. To return to clinic 4/18/11 8 am.
Patient had a brief and resolved vasovagal syncopal episode.  Stated feelings of dizziness, tingling/cramps to R upper leg, and sweating/diaphoresis.  This occurred about 5min post vaccination and resolved completely about 15min post vaccine.
it is really bad; Ankles are swollen; Bumps on feet; red spot on face and hands; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Ankles are swollen), BLISTER (Bumps on feet), RASH MACULAR (red spot on face and hands) and FEELING ABNORMAL (it is really bad) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced JOINT SWELLING (Ankles are swollen), BLISTER (Bumps on feet) and RASH MACULAR (red spot on face and hands). On an unknown date, the patient experienced FEELING ABNORMAL (it is really bad). At the time of the report, JOINT SWELLING (Ankles are swollen), BLISTER (Bumps on feet), RASH MACULAR (red spot on face and hands) and FEELING ABNORMAL (it is really bad) outcome was unknown. Not Provided          No concomitant medication information reported. No treatment information was provided.
medical assistant gave TUBERSOL as an Intramuscular injection instead of a TDAP vaccine with no reported adverse event; Initial information received on 24-May-2021 regarding an unsolicited valid  non-serious case from a other health professional (office manager).  This case involves a 53 years old male patient who was tested with 0.1 ml total TUBERCULIN TEST [TUBERSOL] (once, solution for injection, lot - C5751AA, expiration date: 19-Sep-2022) as an intramuscular injection in the left arm instead of a DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE for tuberculin test on 24-May-2021 by medical assistant (wrong product administered).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccines were given to the patient.  It was an actual medication error due to wrong vaccine administered (same day latency).It was reported that consumer was coming in for a physical and was supposed to receive TDAP.   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 the 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.
This spontaneous report as received from a physician refers to a 77 years old male patient. The patient was vaccinated subcutaneously with 0.65 ml ZOSTAVAX (lot number not reported) on 27-JUL-2012. On 31-JUL-2012 the patient experienced headache, nausea, fatigue and body aches in the neck area. The patient had sought unspecified medical attention. The outcome was unknown. Additional information has been requested.
Violent trembling from chills (3 hours), high fever (16 hours), diarrhea, vertigo, migraine
Narrative: Patient presented to the ED after testing positive for COVID 9/28 with GI symptoms of nausea, vomiting, diarrhea, as well as mild shortness of breath and muscle aches. He was admitted 10/1. He was admitted primarily for rhabdomyolysis in the presence of COVID.
gave a 63 year old patient Fluzone High Dose during a visit for the flu vaccine only/NO AE; gave a 63 year old patient Fluzone High Dose/NO AE; gave a 63 year old patient Fluzone High Dose/NO AE; Initial information received on 18-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 63 years old male patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE], during a visit for the flu vaccine only.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 14-Nov-2019, the patient received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ300AB, expiry date- 26-06-2020 via intramuscular route in the left arm.  It was a case of actual medication error due to inappropriate age at vaccine administration, Wrong vaccine administered and overdose.  At the time of report 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.
Left arm was red and swollen; Left arm was red and swollen; Pain radiating from shoulder to neck and head; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 31-year-old female patient received pneumococcal 20-valent conjugated vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 14Sep2022 at 11:04 as dose number unknown, 0.5 ml single (Lot number: FJ2598, Expiration Date: 30Jun2023) at the age of 31 years, in left arm for immunisation. The patient's relevant medical history included: "compromised immune status" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "genetic/chromosomal abnormalities" (unspecified if ongoing); "endocrine abnormalities" (unspecified if ongoing); "prediabetes" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Allergies" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN as 500 mg, daily.  The following information was reported: ERYTHEMA (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 16Sep2022, outcome "recovering" and all described as "Left arm was red and swollen"; PAIN (non-serious) with onset 16Sep2022, outcome "recovering", described as "Pain radiating from shoulder to neck and head". The events "left arm was red and swollen" and "pain radiating from shoulder to neck and head" required physician office visit.  Additional information: The patient took PREVNAR 20 and had a reaction to it. The patient had the reaction two days after the vaccine was given. Vaccine was given on 14Sep2022 and she had a reaction on 16Sep2022. Her left arm was red and swollen. Then, she had a pain radiating from her shoulder to her neck and head. This occurred two days after the vaccine. Then, the patient was seen again on 26Sep2022, and she had improved. She had decreased pain in her shoulder.   Follow-up attempts are completed. No further information is expected.
No adverse event; patient received improperly stored dose of VARIVAX; This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies were not reported. Concomitant therapy included sterile diluent (MERCK STERILE DILUENT). On 05-MAR-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (therapy type: digital data logger) (VARIVAX), first dose, lot # S025609, expiry date reported as 18-AUG-2021 for prophylaxis (strength, frequency, route were not reported) (product storage error). The administered dose of the vaccine experienced a temperature excursion, total time in the range 15 degree Fahrenheit to 46 degree Fahrenheit (-9 degree Celsius to 8 degree Celsius) -5.48 Celsius for a time frame of 7 hours as recorded by a data logger. The vaccines had no previous temperature excursion. No adverse effects were reported. The outcome of product storage error and no adverse event was unknown.
Day 1 ? 3:00pm vaccine Day 2 ? fatigue and slight chills, no fever Day 3 ? fatigue, fever of 100, headache Day 4 ? position and light sensitive headache, chills but no fever, fatigue  At exactly 74 hours, it all disappeared.
Fever and gastrointestinal symptoms started on Wednesday. Gastrointestinal symptoms include strong cramps nausea and diarrhea. These are worsening to the present date.
an improperly stored vaccine was administered; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information regarding the patient's concurrent condition, pertinent medical history, drug reaction or allergy and concomitant therapy was provided.   On 25-JAN-2021, the patient was administered improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (1 injection, lot # T026954, expiration date 13-APR-2022, strength and route were unknown) for prophylaxis and Hepatitis A Vaccine, Inactivated (VAQTA) (1 injection, lot # T013546, has been verified to be a valid lot number, expiration date was reported as 27-OCT-2021, but upon internal validation established as 28-OCT-2021, strength and route were unknown) for prophylaxis.   Administered vaccines were stored above 9 degree Celsius (13.4 degree Celsius) for 2 hours and 9 minutes. There was no previous temperature excursion reported. The digital data logger was involved.
Fever, swelling, and warmth started the day following injection. Pain x 3 weeks and swelling still present at this time.
i had redness and swelling 2 days after the shot, then it went away and came back on day 8.   itchiness, swelling & redness on day 8 are back
pt premedicated with benadryl, reported thoat itching and redness at injection site. pt took another benadryl after administration. pt tolerated medication well upon taking second dose
my arm at the injection site broke out in a red spotted rash; my arm at the injection site broke out in a red spotted rash; This case was reported by a consumer and described the occurrence of injection site erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced injection site erythema and injection site rash. On an unknown date, the outcome of the injection site erythema and injection site rash were unknown.   It was unknown if the reporter considered the injection site erythema and injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. The 1st dose of Shingrix was received on unknown arm. After Shingrix shot the patient's arm at the injection site broke out in a red spotted rash on the 3rd day. The patient asked about getting 2nd dose as it had been almost 6 months since 1st dose.
She fainted during the booster shot this morning after receiving the booster shot yesterday at 1pm. She also fainted during the second covid-19 vaccine dose last summer. I know this was because of the vaccine.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2011, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The ZOSTAVAX did not prevent shingles or zoster-related injuries as intended. On or about 25-OCT-2016, the patient was treated by a physician for herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles and zoster-related injuries, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Severe eczema; Atopic dermatitis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 30Nov2021 as dose number unknown (booster), single (Lot number: FH8027) at the age of 72 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Primary Immunization series complete; dose number unknown.), administration date: 16Feb2021, for covid-19 immunization. The following information was reported: DERMATITIS ATOPIC (non-serious) with onset Jan2022, outcome "not recovered", described as "Atopic dermatitis"; ECZEMA (non-serious) with onset Jan2022, outcome "not recovered", described as "Severe eczema". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of eczema, dermatitis atopic.  Additional information: NDC number, UPC number, expiry date of covid vaccine, Clobetasol: Unknown. The patient reported that after he had first booster covid shot Pfizer he developed severe eczema, atopic dermatitis, severe case and the only way he was able to control it is to put him on Pfizer Cibinqo and his insurance company wanted him to pay  a lot of money every month for Cibinqo to cure the severe eczema that he had and he was sure it was the result of the covid booster from Pfizer. This one has the original vaccination and the first booster he got. EN6200, that was for the second shot. Site of vaccine administration: arm. Start date of event: Consumer stated, Jan2022, he doesn't know the exact date 15Jan. Outcome of the event: Consumer stated, probably worsened. Treatment: Consumer stated, yes, topical cortisone (clarified as Clobetasol) and because that did not work, they put him on Cibinqo. Clobetasol: Dose: 0.5 percent. Frequency: Consumer stated, On the affected area twice a day.
Breakthrough COVID-19 case with  Fever >100.4,  Subjective fever (felt feverish), Chills,  Muscle or body aches,  New loss of taste or smell, Shortness of breath or difficulty breathing,  Chest pain,  Fatigue or tiredness,  Abdominal pain. Hospitalized 8/29/2021-9/1/2021. Diagnosed with kidney failure and COVID-19 pneumonia.
Right after the injection within a couple of days I got my period which I have not had in over six months and then I spotted three more times throughout the month of April and a couple of times and month of May. I?ve had severe cramping as well as pain in my ovaries.
My left upper arm-at the site of the vaccination is red, swollen, bumpy and VERY itchy- like a rash.
Acute onset vertigo evening of vaccine hospitalized, treated with valium, released next day. Presently, still not completely well. 1/04/09 Patient feels problem with Dyscaria/buring with urination are temporarily linked to treatment of Flurix.
Pt had headache and sore throat for the next 3 days after vax. On 01/02/2005 had 1 spot took Tylenol vomited through night. On 01/03/05 had fever, covered in pox, itchy. Contacted doctor on 01/04/05 who recommended Benadryl which kind of helped. Has been applying Caladryl for itchiness, oatmeal baths. Temp normal.
This spontaneous report was received from a physician, via company representative, concerning an approximately 15 year old female patient. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 06-MAY-2017, the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly, for HPV prevention, lot #N035486 (strength, dose, frequency and expiration date were not reported). On an unknown date in November 2017 (reported as around 6 months following the first dose of GARDASIL 9), the patient experienced joint pain, severe anxiety, muscle issues, and abdominal issues. At the time of reporting, the outcome of joint pain, severe anxiety, muscle issues and abdominal issues was unknown. The causal relationship between the vaccination with GARDASIL 9 and the events was not provided by the reporting physician. This is one of two reports received from the same reporter; who had a concern that this would suggest something hereditary. Lot Number N035486 not valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). Sender's Comments: US-009507513-1804USA008466.
Headache, Myalgia, Fever, NauseaVomiting, dehydration Narrative:
Moderna vaccine (NDC 80777-0273-98) lot # 039D21A + GTIN 00380777273983 was administered after the beyond date of 10/23/2021. Contacted Manufacturer Moderna = no need to repeat the dose.
Started off by massive headache sick to my stomach every bone in my body hurt every joint fingers bris elbows and then I thought I was freezing.  Now today 11/24 I have a Bullseye at the shot site and my arm is still very hot