chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PT REPORT RED, BURNING ABDOMINAL/CHEST RASH. TODAY PT OBSERVED TO HAVE SMALL RED RASHES TO LEFT UPPER ABDOMEN.C/O BURNING IN THE AFFECTED AREA.
Swelled up arm; Red arm; 13 years old administered with the bivalent booster dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PERIPHERAL SWELLING (Swelled up arm), ERYTHEMA (Red arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 years old administered with the bivalent booster dose) in a 13-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (1st dose, lot number EW0179) on 06-Aug-2021, Pfizer (2nd dose and lot number FL3197) on 27-Aug-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 30-Sep-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Sep-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 years old administered with the bivalent booster dose). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelled up arm) and ERYTHEMA (Red arm). At the time of the report, PERIPHERAL SWELLING (Swelled up arm), ERYTHEMA (Red arm) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 years old administered with the bivalent booster dose) outcome was unknown.            Concomitant product use was not provided by the reporter.  On 30-Sep-2022, the patient received first booster dose.  Patient currently has no adverse effects except for a swelled up and red arm. The patient handled it better than the previous two doses.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-654904 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654904:Same reporter
Left arm/deltoid where flu shot was administered was quite sore for weeks after shot. Is still numb ever since he got immunized.
Information has been received from a office manager in a physicians office concerning an adult male with asthma who on Dec 19 2005 was vaccinated intramuscularly in the left arm with a 0.5 ml dose of Pneumococcal 23v polysaccharide vaccine (lot 650329/0747P). Concomitant therapy included unspecified inhalers for the treatment of asthma. On Dec 21 2005, the patient presented to the physicians office with left arm tenderness to touch, slight swelling, and a rash that encircled the arm like a bracelet. It was reported that the patient was treated with oral prednisone 5mg tablets, cetirizine hydrochloride (Zyrtec) 10 mg tablets. The physician requested a lot check. No product quality complaint was involved. The reporter considered the patients adverse experience to be other important medical events (OMIC). Additional information has been requested.
p/vax pt had red swollen legs, crying, would not eat; fever; limp; went to sleep or became unconscious;could not wake pt p/24hr; pt taken to ER; hosp
I am currently pregnant and due July 2022. Following the vaccine I developed swelling in my arm about 4 inches below the injection site with a red, itchy rash. I also developed increased nausea, nasal swelling, cough, sore throat, dizziness, increased and occasional rapid heart rate, excessive fatigue, and laryngitis all which lasted approximately 10 days.
MORE TIRED THAN USUAL; MUSCLE ACHES; This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, and not able to drink milk, and other pre-existing medical conditions included: Patient had no known drug allergies. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 204A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-AUG-2021, the patient experienced more tired than usual. On 13-AUG-2021, the patient experienced muscle aches. The action taken with covid-19 vaccine was not applicable. The outcome of the more tired than usual and muscle aches was not reported. This report was non-serious.
pt recvd 2nd dose of vax & devel five unusual lesions which could not be determined as chickenpox;@ 4 & 8 weeks p/2nd vax lab eval revealed pt did not seroconvert;No further details were provided;
After getting Shingrix on July 21, 2019, the patient started breaking out on his back July 23, 2019. Realized it was shingles on Sat. following July 23. Went to emergency room at Hospital & was given the proper meds
For the first time in my life, since childhood, I am having intermittent stabbing ear ache. Painful.
Swollen arm at site @ 4 PM grew to shoulder by morning pain through whole arm. Headache, fatigue at 5 PM slept the rest of the day through 11 AM . Arm still swollen and red hot to the touch have put ice on it still getting bigger, tightness in chest and short of breath 2 days later , seen my dr she stated it is an allergic reaction and she recommended I do not get the second dose since this one has made me sick.
Pain, / in the arm (site of injection); swollen / in the arm (site of injection); redness in the arm (site of injection); general discomfort.; This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, unknown after receiving Bexsero, the patient experienced injection site pain, injection site swelling, injection site erythema and general discomfort. On an unknown date, the outcome of the injection site pain, injection site swelling, injection site erythema and general discomfort were unknown.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and general discomfort to be related to Bexsero.  Additional details were reported as follows: The age at vaccination was not reported. Nurse informed that after the vaccination of patient with Bexsero, the patient experienced pain, swollen, redness in the arm (site of injection) and general discomfort. The reporter consented to follow up. This case is 1 of the 13 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR209822:same reporter US-GLAXOSMITHKLINE-US2020208660:same reporter US-GLAXOSMITHKLINE-US2020AMR210161:same reporter US-GLAXOSMITHKLINE-US2020AMR210158:same reporter US-GLAXOSMITHKLINE-US2020AMR210163:same reporter US-GLAXOSMITHKLINE-US2020AMR210157:same reporter US-GLAXOSMITHKLINE-US2020AMR210164:same reporter US-GLAXOSMITHKLINE-US2020AMR210162:same reporter US-GLAXOSMITHKLINE-US2020AMR210165:same reporter US-GLAXOSMITHKLINE-US2020AMR210160:same reporter US-GLAXOSMITHKLINE-US2020AMR210159:same reporter US-GLAXOSMITHKLINE-US2020AMR210156:same reporter
I have" COVID arm" on the outer aspect of my left arm after 2nd dose of the Moderna vaccine.  Site of ADR is itching, red, hot and painful to touch and the circumference is the size of a medium orange.  I have had persistent headaches since the 2nd dose as well.
Information has been received from a legal firm regarding a case in litigation concerning a female who on 4/29/99 was vaccinated, at the age of 9 months, with a dose of hep B vaccine that reportedly contained 12.5 micrograms of toxic mercury in the prreservative thimerosal. Other immunizations reported included the first and second doses of hep B vaccine, recomb (Engerix B) received on 7/29/98, and 10/1/98 that each contained 12.5 micrograms of toxic mercury; the first, second, third and fourth doses of Tripedia received on 10/1/98, 12/3/98, 1/22/99, and 2/10/00 that each contained 25 micrograms of toxic mercury; and the first, second, third and fourth doses of haemophilus B conjugate vaccine (Act-HIB) received on 10/1/98, 12/3/98, 1/22/99 and 7/29/99 that each contained 25 micrograms of toxic mercury. Subsequently, the pt experienced mercury poisoning allegedly as eleven doses or  total of 237.5 micrograms of toxic mercury that were administered to the pt between 7/29/98 and 2/10/00. To date, the pt had received the neurological, social and developmental milestones anticipated for a child of her age. The pt's mercury poisoning persisted. Upon internal review, mercury poisoning was considered an other important medical event (OMIC). No further info is available. The case is closed. Upon review of info, it is necessary to indicate that manufacturer product, Act-Hib, does  not contain thimerosay (mercury). Case is closed.
Fever for over 4 weeks beginning 3 days post second shot. Fever ranges from 99.3-100.1.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 08Mar2021 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies. Concomitant medications included estrogen nos, progesterone, testosterone (BIOIDENTICAL HORMONES) and thyroid (MANUFACTURER UNKNOWN) for an unknown indication from unknown start date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 11Feb2021 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. 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 COVID vaccine. On 11Mar2021 at 18:00 the patient experienced fever for over 4 weeks beginning 3 days post second shot of vaccine. fever ranges from 99.3-100.1 (unspecified units).  Patient's normal temperature was low around 96-97 (unspecified units). The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event fever was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Recipient had tenderness and warm to the touch behind right ear and right side of neck.  Hard time swallowing.  Could not turn his head.
COVID-19/ loss smell and taste/ have lingering stuff from COVID; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID-19/ loss smell and taste/ have lingering stuff from COVID) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048621A, 088D21A and 012M20A MTTDT) for COVID-19 vaccination.     No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Iodine allergy, Shellfish allergy and Bronchiectasis.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19/ loss smell and taste/ have lingering stuff from COVID). At the time of the report, COVID-19 (COVID-19/ loss smell and taste/ have lingering stuff from COVID) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Oct-2022, SARS-CoV-2 test: Positive.         Patient was taking other medication. Patient received first and second booster doses of Moderna COVID-19 Vaccine on 02-Nov-2021 and 30-Mar-2022 respectively. Patient's symptoms began on 05 or 06-Oct-2022. Patient isolated for 5 days as recommended by the CDC. No Hospitalization due to COVID-19. No treatment received.   This case was linked to US-MODERNATX, INC.-MOD-2022-662368 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662368:Husband case
Patient came to covid clinic requesting the pediatric pfizer vaccination, and the patient's mom insisted on patient getting pediatric pfizer as it was instructed by the family's physician. The patient was 12 years old at the time of the clinic.
The day after the immunization, late afternoon, I developed violent chills and could not stop shaking for about 20 minutes.  At that time I developed a fever of 101.5 F.  Fever went away during the night and did not return.  However, the next day I developed a headache which worsened during the evening hours.  This headache lasted through the night (I could not sleep as a result of it); it then faded away during the next day.  FYI:mfr is Sanofi
pt recvd vax 21APR93 & exp a local react manifested by redness, swelling, heat & soreness; pt recovered; No further details were provided;
BY ERROR, MODERNA  COVID 19  VACCINE BOOSTER DOSE #4 WAS ADMINISTERD IN FULL DOSE (0.5ml)  NO ADVERSE EVENT REPORTED BY PATIENT
pt recv vax 2NOV95&3NOV95 devel a red,warm patch below the inj site&a red,itchy rash;also exp body aches,lethargy&fatigue;6NOV95 devel 10x6cm erythematous,warm to touch lesion;achy joints;ecchmotic area @ inj site;lupus like rash
stated that her gland is swollen on her right side; stated that she has a noise in her ear and can hear her jaw moving on her right side; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the first dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Batch/lot number: EL3249), via an unspecified route of administration into right arm on 22Jan2021 9:10 at a single dose for covid-19 immunization. The patient medical history and concomitant medications were none. The patient stated that she had the Pfizer Covid 19 vaccine this morning at 9:10 to her right arm. Her gland was swollen on the right side and she had a noise in her ear and can hear her jaw moving on her right side on 22Jan2021 and when she talked and ate that it sounds like someone was crunching rubber. No investigation assessment and no treatment received. She wanted to know if it is something that she should be worried about. The outcome of the events was not recovered.
Initial information received on 15-Mar-2019 regarding an unsolicited valid non-serious case received from Other health care professional. This case involves a 17 years old female patient received an expired dose of vaccine MENACTRA. The patient's past medical history and family history were not provided. The patient did not receive any concomitant medication. On 14-Mar-2019, the patient received injection of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5835AB, expiry date 27-Feb-2019 via unknown route in the left deltoid. It was an actual medication error due to expired vaccine used. It was reported that patient received MENACTRA vaccine on 14-Mar-2019, which was expired on 27-Feb-2019. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender- none.
Pt recvd MMR vax as a child; Pt currently exhibited a lack of response to mumps; no further details were provided;
The patient experienced flu-like symptoms following the vaccine. Additionally, she developed a lipoma at the vaccination site which still appears very swollen and causes discomfort (nearly 3 months after vaccine was administered).
high fever; heart racing; This case was reported by a nurse via sales rep and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and heart racing. On an unknown date, the outcome of the fever and heart racing were unknown.   The reporter considered the fever and heart racing to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingrix and complained of a high fever of 103 degree Fahrenheit, heart racing went to emergency room concerned.  The reported believed they were related. Adverse event lasted 2 days.  The patient did indicate that she would be getting 2nd dose.      Lab Comments: lab test performed on unknown date
Patient had dizziness, blurred vision, sweats, high blood pressure starting two hours after Shingrix vaccine (10:08 AM administered). He is doing some better after going to the hospital.
Two days following the vaccine I had severe pain in my upper arm and shoulder. It was extremely painful to dress or perform activities of daily living. I took ALEVE which did help slightly. On January 21, I finally went to my physician for treatment. It (the vaccine) was administered above the deltoid muscle.
About 15 to 20 minutes after the shot the patient felt warm and hot on the inside, flush to the face, and itchy on her face, all over her body on the inside and out. Her face was red and appeared to have a rash. She took one 25mg pill of Benadryl dye-free liqui gels. The one pill helped mostly. The next morning when she woke up she still felt somewhat itchy all over, throughout the day that feeling slowly went away, and there were no more adverse reactions, and she did not take any more medications besides her daily scheduled ones, which does include singular and claritin.
ADULT DOES OF HEP A AND HEP B WERE GIVEN INSTEAD OF PED DOSES.
Left thigh 9 x 8.5 cm circular, raised erythematous lesion. Large localized reaction.
I just started feeling very week and tired, with sharp pains that migrated. My rt shoulder hurt really bad and then my rt upper thigh area. The pain was severe enough to keep me from sleeping. The pains then started going every where in my body, but for shorter durations. Then I started getting a dull discomfort in my chest area in the left side near heart area, which was like a very uncomfortable fullness. This kept me from sleeping and scared me since it was near my heart area. Went to ER 6/25/2021.
Tinnitus in the second ear (right); This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Bicuspid aortic valve" (unspecified if ongoing). Concomitant medications included: LOSARTAN; AMLODIPINE. Vaccination history included: Bnt162b2 (Dose 1, single (Lot Number: Not provided) in the right arm), administration date: 25Jan2021, when the patient was 31 years old, for COVID-19 immunisation, reaction: "Tinnitus in the first ear (left)". The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "Tinnitus in the second ear (right)". The event "tinnitus in the second ear (right)" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of tinnitus.  Additional Information: The patient did not receive other vaccine in four weeks and his other medications in two weeks were losartan and amlodipine. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not have COVID prior vaccination, was not tested for COVID post vaccination and 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-2021330066 Same reporter, patient, and drug; Different dose and event
Fatigue, lightheadedness, Fever (99.9-100.1), nausea and weakness.
MMR, Varicella and Hep A given all given for second time at 15 month appointment, when child should have received HIB, Dtap and Prevnar 13.
Pt developed swelling and redness at injection site in the left arm where Zostavax administered along with report of a low grade fever in.
Swelling, redness of the deltoid area. Left upper arm (1 inch diameter).
This spontaneous report as received from a nurse refers to four patients of unknown age and gender. On an unknown date, the patients were vaccinated with expired doses of ROTATEQ (lot # H012252, expiry date 29-JAN-2014), 2 ml, oral. All dose of ROTATEQ were stored properly and supported by in house data. No adverse events were reported. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
This patient received the Adol/Adult formulation (Purple top) Pfizer instead of the Pediatric Pfizer. Patient received 0.2 ml (partial dose). No adverse events yet, but patient/guardian were educated regarding medication error, s/s myocarditis, worsening side effects.
Antibiotics, Z pack, Steriod Injection, Nerve Block, Another Nerve Block scheduled for 01/12/2016.
Large reddened area 6 inches x 4 inches, hot to touch, swollen.
Large red spot at injection site. Started swelling, and shaking so family took her to the emergency room.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single, 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Connective tissue disorder" (unspecified if ongoing), notes: took immunosuppressants. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took Paxlovid on 25May2023 to 25May2023  No follow-up attempts are possible. No further information is expected.
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Visual Changes/Disturbances-Severe, Additional Details: left pharmacy in ambulance, gave iv in ambulane
pt had a sequestration crisis p/vax; pt devel a t101, HBF 65 & had to be hospitalized for treatement;