chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bilateral swelling and stiffness in hands, trigger finger in right hand; Bilateral swelling and stiffness in hands, trigger finger in right hand; TMJ pain; right arm pain from shoulder to wrist; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 29Mar2022 at 08:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Acid reflux" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 17Aug2021, when the patient was 50-year-old, for COVID-19 Immunization, reaction(s): "Severe pain in Left knee"; BNT162b2 (Dose Number: 2, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 07Sep2021, when the patient was 50-year-old, for COVID-19 Immunization, reaction(s): "Sudden severe pain in Left foot". The following information was reported: PERIPHERAL SWELLING (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious), outcome "not recovered" and all described as "Bilateral swelling and stiffness in hands, trigger finger in right hand"; TEMPOROMANDIBULAR JOINT SYNDROME (non-serious), outcome "not recovered", described as "TMJ pain"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "right arm pain from shoulder to wrist". The events "bilateral swelling and stiffness in hands, trigger finger in right hand", "tmj pain" and "right arm pain from shoulder to wrist" required physician office visit and emergency room visit. Therapeutic measures were not taken as a result of peripheral swelling, musculoskeletal stiffness, temporomandibular joint syndrome, pain in extremity. Additional information: No COVID prior vaccination. No COVID tested post vaccination. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300287304 same patient, different vaccine dose and different event.;US-PFIZER INC-202300287305 same patient, different vaccine dose and different event.;
Continued arm pain near injection site and down arm; Continued arm pain near injection site and down arm; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 18Apr2021 at 11:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, obesity, macular degeneration, knee surgery, C-section and known allergies  to latex, cows [diary and meat, not eggs], sulfas(sulfonamide allergy) and two others that she could not remember. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levonorgestrel (MIRENA), paracetamol (TYLENOL), melatonin (MANUFACTURER UNKNOWN) and multivitamins (MANUFACTURER UNKNOWN); all for unknown indication from unknown date and unknown if ongoing. On 18Apr2021, the patient experienced continued arm pain near injection site and down arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events continued arm pain near injection site and down arm was recovered with sequelae (also reported as recovered with lasting effects) on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
1. 6/15/09 called arm red & swollen (? which) home care  2. 6/24/09 Erythema Multi form no explanation not sure if due to vaccines
Patient requested vaccine be given in GM. Patient refused to have vaccine given in deltoid. Vaccine given in right GM. Alerted nursing supervisor, discussed with medical director, contacted patient and advised she would have to get 2nd dose in deltoid. Patient denies pain or adverse issues at this time.
approximately 1- 1 1/2 hours after receiving vaccine patient reported face feeling hot and noticed hives and rash on body
01/05/22 presents to ED for "Intentional Ingestion". PMHx of "1x suicide attempt"
Pt received FLUVIRIN on 8/8/14 and called 8/19/14 stating her left arm at site of injection is very painful and hurts to lift it (her (L) arm). Informed patient to ice the site of inject, take APAP for pain and follow up w/MD in day or 2.
Very High Fever followed by aches and pains with congestion then a severe headache like a migraine and ending with 3-4 days of diarrhea
Pain at the injection site; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female 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 injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-OCT-2022 Reporter's Comment: Nurse shared her own personal experience regarding adverse events after having received the 1st dose of Shingrix. She stated that she experienced pain at the injection site for about a week. The reporter did not consent to follow up.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. The patient received COVID 19 Treatment Paxlovid from 11Sep2022 to 15Sep2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
chills with hot flashes; chills with hot flashes; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (chills with hot flashes) and CHILLS (chills with hot flashes) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced HOT FLUSH (chills with hot flashes) and CHILLS (chills with hot flashes). At the time of the report, HOT FLUSH (chills with hot flashes) and CHILLS (chills with hot flashes) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment information were not provided by the reporter. Concomitant medications were not reported by reporter.
3 separate nose bleeds 2 less severe after first shot. One the day after the 1st shot in the am and 6 days later in the am.  1 more severe after 2nd shot. 2 hours after the shot   The shot was given to me around 4 pm. Went to the emergency room because I couldn?t get the blood to stop.
Pt vaccinated with DTP/MMR developed fever up to 102 and cranky on 19OCT90; fever up to 103.7 on 21OCT90.
Chills, Nausea, fatigue for the first 8 hours, followed by sweating for another 2 hours Pain at injection site
Pt had a syncopal event.  Pt states "I did not eat today at all" pt given apple juice and crackers Vitals: 117/54,62, 16, 99% on RA -- > 113/60, 65,18, 99%.  Pt stable and released from the vaccination site after 30 mins observation.
mom states fever started 4PM but never not higher than 101;11OCT96 10AM face broke out in welps-hives;mom called MD-who did not examine pt-MD did not know what the cause was;pt does eat eggs;
On the day of the Injection, I felt the usual pain as the first injection. That evening I began to feel itching on my palms and in between my fingers on both hands. The next day the itching continued and that morning I broke out with a rash (hives) on my arms, forearms, underarms and on my torso front and back. I called the dr's office and spoke to a triage nurse that advised me to take over the counter meds to treat the symptoms ,(itching and hives). The symptoms continued and I made an appointment to see a dr on Sunday. I had a sore that appeared on my left buttock. I realized that it was in the same area that I had acquired shingles a few years before. (Con't)
Expired Pediarix dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 4977T, expiry date 5th September 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th September 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 8th September 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-SEP-2022 Reporter's comments: The nurse practitioner reported that the patient was administered an expired dose of Pediarix. The vaccine administration facility was the same as primary reporter The consent to follow-up was given by email if needed. Additional Supportive Information: The patient received expired Pediarix, which led to expired vaccine used.
CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXIA 10/29/2021 &  4/8/2022  --  RECURRENCE OF SAME SYMPTOMS
C/O heavy chest, unable to take deep breath. Feels like cold air with deep breathing.  Throat feels tight.
periods don't flow anymore, it literally stopped/doesn't come and flow like it should; spots black blood; menstrual irregularities; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 24 year-old female patient received bnt162b2 (BNT162B2), administration date 18Jul2021 (Batch/Lot number: unknown) at the age of 24 years 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), when the patient was 24 years old, for Covid-19 Immunization. The following information was reported: AMENORRHOEA (non-serious) with onset Aug2021, outcome "not recovered", described as "periods don't flow anymore, it literally stopped/doesn't come and flow like it should"; INTERMENSTRUAL BLEEDING (non-serious) with onset Aug2021, outcome "unknown", described as "spots black blood"; MENSTRUATION IRREGULAR (non-serious) with onset Aug2021, outcome "unknown", described as "menstrual irregularities".  Follow-up (09Sep2021): This is a follow-up spontaneous report from a contactable Nurse. This Nurse reported for a patient (Reporter's Daughter).It included: Patients details, Reaction(s)/Event(s) details,Drug(s) Information.  Additional Information:History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was only had her childhood vaccine.The patient did not visited Physician Office but she has an appointment next week with a gynaecologist. The patient did not received prior Vaccinations (within 4 weeks).The patient does not had AE(s) following prior vaccinations.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.  Follow-up (13Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
HAD THE VIRUS (COVID-19); This spontaneous report received from a patient concerned a female of an unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient had previously first dose of received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 in total administered for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series: 1). The patient received second dose of covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 in total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date following vaccination with covid-19 vaccine ad26.cov2.s, the patient had the virus (covid-19) (Dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had the virus (covid-19) was not reported. This report was non-serious.
No additional AE reported.; a 4 month old child was inadvertently administered a dose of PNEUMOVAX23; a 4 month old child was inadvertently administered a dose of PNEUMOVAX23; This spontaneous report was received from a medical assistant concerning a 4-month-old patient. No concurrent condition, medical history, or concomitant therapy was reported.  On 16-SEP-2021, the patient was inadvertently vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 mL (strength and route were unknown; lot # T040202 has been verified to be a valid lot number, expiration date reported as 20-SEP-2022 but upon internal validation was established as 11-SEP-2022) for prophylaxis (Inadvertent exposure to vaccine and Inappropriate age at vaccine administration). No additional adverse event was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T040202; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Pt recv vax on 1/13/99; 10 min post vax pt exp urticaria of face & chest; tx=Epinephrine
At 11:46 am the client stated she had a flush feeling and dry mouth. BP149/111m HR130 RR22. Client stated her throat felt like it was closing. 911 called and administration of 0.5ml of Epinephrine given subcutaneously. EMS arrived at 12:04pm and Benadryl 50mg given by EMS, EMS assessed patient, EMS left after 15minutes, patient refused to go to emergency room. Vital Signs continued by Nursing staff at clinic, 132/80BP, HR106, RR22. Patient left clinic and returned to work. Patient was called 6 hours after incident for follow up and was feeling fine. No residual symptoms.
No adverse reactions have been reported; doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and NO ADVERSE EVENT (No adverse reactions have been reported) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reactions have been reported). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired) and NO ADVERSE EVENT (No adverse reactions have been reported) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reactions have been reported) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (doses to patients on 5JUN2023 from vials of the Moderna COVID-19 bivalent vaccine that had expired).    No concomitant medication was reported.   It was reported that no adverse reactions have been reported by any patients.  On 04-Jun-2023, the vial was initially stored in the refrigerator and did not underwent any temperature excursions.  No treatment medication was reported.  This case is reported for patient 45 out of 50 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-735331 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735331:Master case
pt recv vax#2 & immed p/vax had induration & edema measuring 20 x 16cm around inj site; tolerated 3rd & 4th shots w/ premedications of tylenol & benadryl
Rt arm pain and swelling one day after injection admitted on second day after administration. Temp 99F, WBC 15.7 upon admission.  Case analysis indicates pt experienced cellulitis.  Nurse follow up on 09/03/04 states: "Complete."
Pfizer covid monovalent vaccine was given instead of Pfizer bivalent covid vaccine.
This report was received from a registered nurse refers to a male patient of unknown age who was in a non-merck investigator-initiated study. On an unspecified date, in August 2012, the patient was vaccinated with a doses of GARDASIL (lot number 660393/0067X) (dose and route not reported) that was expired 20-OCT-2010. No adverse effects had been observed or replied. Due to the nature of the study, the reporter declined to provided any patient identifiers. She would like to know if the patient should be revaccinated. Reporter called back on 16-OCT-2012 to stated that there was no additional information to provide, and she was not comfortable faxing these forms back. She requested that no additional follow-up forms or letters were sent to the office on this matter. This is one of several reports that recovered from the same source. Additional information is not expected.
Fever up to 102, myalgia, malaise, sore throat.  Treated symptoms.
High fever, 100.9 at last check, a headache, and sore upper arm near injection point
CHILLS; FEVER; BODY ACHES; NAUSEA; This spontaneous report received from a patient concerned a 42 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol user, non smoker, high blood pressure, anemia, pre- diabetes, and vitamin d deficiency, and other pre-existing medical conditions included no known drug allergies were reported.no drug abuse or illicit usage reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: CV7528 BCHD) dose was not reported, administered on 26-MAR-2021 for COVID-19 vaccination. No concomitant medications were reported. On 26-MAR-2021; the subject experienced chills. On 26-MAR-2021 the subject experienced fever. On 26-MAR-2021, the subject experienced nausea after one hour post vaccination. On 26-MAR-2021;the subject experienced body aches. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, nausea, chills, and body aches. This report was non-serious. Parent Case no: 02065321
pt recvd vax;had an emesis;T 105;unable to keep T down;to er, MD stated rxn to immun & ordered pedia progen;apap also given;
About 7 hours following the vaccine, my throat started getting very sore.  It hurt a lot when I swallowed.  It felt like there was a big lump in my throat that i could not swollow.  I also noticed ulcers/bumps on the back of my throat.  Also, my mouth felt itchy/tingly.  My eyes got red, and i had a slight mucousy discharge from them.  I took Advil to try and relieve the throat pain and also took 2 Benadryl.  This isn't the first time this has happened to me.  This is the third time - it wasn't as severe as my first two episodes which I have several years ago.  Those two times involved vomiting, wheezing, the same throat problems, along with severe aching of my body.  I was sick for 3-4 days.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 at 14:30 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: rosemary" (unspecified if ongoing), notes: known allergies: rosemary; "known allergies: soy" (unspecified if ongoing), notes: known allergies: soy; "osteoporosis" (unspecified if ongoing); "migraine" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "known allergies: Keflex", notes: known allergies: Keflex,; Percocet, reaction(s): "known allergies: Percocet", notes: known allergies: Percocet; Erythromycin, reaction(s): "known allergies: erythromycin", notes: known allergies: erythromycin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid antiviral treatment was given for COVID 19, (lot GF1137) from 25Oct2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Modern a COVID-19 Vaccine EUA Redness, rash and itching at injection site 8-9 days after injection received
severe diarrhea is reported in pt who recvd flu vax last year; pt ate eggs 24 hrs following fluogen & exp above sx; pt has no h/o allergies to eggs;