chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Oral herpes sore on lip (small) after 10 years of not getting one. Started the very night I got the second dose.; Oral herpes sore on lip (small) after 10 years of not getting one. Started the very night I got the second dose.; This is a spontaneous report from a non-contactable consumer (reporting on herself). A 43-years-old Non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Lot Number and Expiration Date was not reported), via an unspecified route of administration in Arm Left on 29May2021 14:00, as 2nd dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported.  Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Lot Number and Expiration Date was not reported), via an unspecified route of administration in Arm Left on 08May2021 14:30, as 1st dose, single for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Patient did not have any known allergies. On29May2021 17:00, patient experienced oral herpes sore on lip (small) after 10 years of not getting one. started the very night i got the second dose. Patient did not receive any treatment for adverse events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovering. Event occurred in a country different from that of the reporter.  This may be a duplicate if the reporter also submitted directly to his/her local agency.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This case was reported by a healthcare professional and described the occurrence of a bad reaction in a subject of unspecified age and gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX (unknown). At an unspecified time after vaccination with TWINRIX, the subject experienced an unspecified bad reaction. At the time of reporting the outcome of the event was unspecified. Follow-up information received on 08 July 2008 indicated that the subject was an adult male. On an unspecified date, he received TWINRIX at 1.0 ml in an unknown arm and then received a dose of Pneumovax in the other arm. Six hours following vaccination with TWINRIX, the subject developed pain and swelling in the arm (a systemic reaction) that he received TWINRIX. The subject took Tylenol without benefit. He returned to the physician's office and was seen as having whole limb swelling, pain and was unable to move his arm. The subject was sent to the emergency room and it was unknown if the symptoms were improving at the time of reporting. In the reporter's opinion, the events were probably related to treatment with TWINRIX. Follow-up information received on 29 July 2008 indicated that the subject was a 25 year old HIV positive male. He received 1st dose of TWINRIX in the left deltoid on 24 June 2008. He also received a dose of PNEUMOVAX on 24 June 2008 in the right deltoid. That evening, about 6 hours following vaccination with TWINRIX on 24 June 2008, the subject developed a fever and swelling and tenderness of the left arm. The subject returned to the clinic on 25 June 2008 at 12:00 and his left arm was swollen, red and tender to the touch. The subject left arm was tender from the shoulder to the elbow. He had a fever of 101 degrees. The subject was escorted to the hospital emergency room. The events were considered to be clinically significant and or required intervention. Cellulitis at the injection site was diagnosed (onset reported as 24 June 2008). The subject was treated with Benadryl, Decadron and Augmentin. Complete resolution of cellulitis, fever, tenderness of the arm and tenderness to the touch were reported. These events were also reported to be related to treatment with TWINRIX. All other events were reported as improved. Further immunizations with TWINRIX were discontinued.
I experienced congestion and runny nose, headaches, muscle aches, tiredness and I also tested positive for COVID-19, I also had a severe nose bleed.
No adverse event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medication information provided. Pharmacist reported that they have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30 day beyond use date. Before use date reported was 12-May-2022. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live Significant follow up received: Patient information and vaccination details updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
indication: History of HPV; she is experiencing pain in her left shoulder; she can feel a knot underneath the skin at the injection site; This spontaneous report was received from a 45-year-old female patient, who was reporting on herself. The patient's concurrent conditions, drug reactions or allergies were not reported. Her concomitant medications included fexofenadine hydrochloride (ALLEGRA). The patient's medical history consisted of hysterectomy, two right hip surgeries, three ear surgeries and Human papilloma virus infection (HPV).  On 07-JUL-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 dose, route of administration reported as injection, in her upper left arm (exact dose, lot number and expiry date were not reported) for prophylaxis (indication reported as history of HPV; product use in unapproved indication).  On the same date, she experienced pain in her left shoulder and could feel a knot underneath the skin at the injection site. It was also stated that she could not sleep on her arm because of the pain. The patient received a hot compress as a treatment for the events. It was reported that the patient sought medical attention and she notified her doctors. Following lab diagnostics or studies were performed: genetic test (reported as geno test) and colonoscopy however no results were provided. The outcome of the events was reported as not recovered.  The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Fever, chills, nauseous, diarrhea, headache  Took Tylenol  Lasted 2 1/2 days
fever; headache; nausea; chills; swollen, red, warm left arm; red, warm left arm; warm left arm; first dose of Shingrix in November 2019/because of the COVID lockdown, she has not gotten her second dose; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fever, headache, nausea, chills, swelling arm, erythema of extremities, skin warm and social problem. On an unknown date, the outcome of the fever, headache, nausea, chills and swelling arm were recovered/resolved and the outcome of the erythema of extremities, skin warm and social problem were unknown.   It was unknown if the reporter considered the fever, headache, nausea, chills, swelling arm, erythema of extremities and skin warm to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in November 2019 but she cannot remember the exact date, but it was in her left arm, and because of the COVID lockdown, she has not gotten her second dose.  The patient states that the first dose caused her had fever, headache, nausea, chills, and a swollen, red, warm left arm which all events subsided.   The patient did not consent to follow-up.
Developed shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Developed shortness of breath) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Developed shortness of breath). At the time of the report, DYSPNOEA (Developed shortness of breath) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient developed shortness of breath after first dose of vaccination, which lasted approximately 5 days.  The patient used rescue inhaler for relieving the symptom.  No concomitant medications were reported.
Sore arm beginning 1.5 hours after vaccination, and lasting 2 days  Injection site swelling beginning 1.5 hours after vaccination, lasting one day Dizziness beginning next day and lasting ~12 hours  Headache beginning next day and lasting ~12 hours  Muscle aches, beginning next day and lasting 12 hours  Hot flashes, beginning next day and lasting 12 hours  Redness at injection site, beginning two days after
pruritic skin reactions at the site of Yellow Fever vaccine injection; at the site, were somewhat tender; Initial information received on 21-Apr-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 17 years old and unknown gender patient who experienced "pruritic skin reactions at the site of yellow fever vaccine injection and at the site, were somewhat tender," after receiving vaccine Yellow Fever Vaccine [Yf-Vax].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Yellow Fever Vaccine (lot number, expiry date: not reported) via subcutaneous route in unknown administration site (form strength: unknown) for prophylactic vaccination.  On an unknown date the patient developed a non-serious events of "pruritic skin reactions at the site of yellow fever vaccine injection" (vaccination site pruritus) and "at the site, were somewhat tender" (vaccination site pain) (unknown latency) following the administration of YELLOW FEVER VACCINE.  It was reported, "We have a moderate size travel clinic, and over the past 3-4 days have received 3 reports of localized, pruritic skin reactions at the site of SQ Yellow Fever vaccine injection. The 3 individuals were 17,18, and 49 years old. They began 2-3 days post vaccination, at the site, were somewhat tender and indurated initially, but quickly became intensely pruritic while expanding."  Action taken with YELLOW FEVER VACCINE was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Recovering / Resolving for both the events.
Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 21-MAR-2016, the patient was vaccinated with an expired dose of PNEUMOVAX 23 (0.5 ml, lot # K008409, expiry date: 04-MAR-2016, intramuscular) (expired vaccine used). No adverse effects were reported. Additional information has been requested.
an outbreak of HIVES; lhe hives were "super uncomfortable"; This spontaneous report was received from a 65-year-old female patient referring to herself. The patient's drug reactions/ allergies included sulfa. The patient had no concomitant medications or pertinent medical history.  On 29-JUL-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, lot # and expiration date were not reported) via intramuscular route for prophylaxis.    On 30-JUL-2020, the patient experienced an outbreak of HIVES, which were "super uncomfortable" but not life threatening. Treatment diphenhydramine hydrochloride (BENADRYL) was given. The outcome of the events was recovering. The patient confirmed it was not anaphylactic shock, but a possible reaction from the syringe/vaccine's administration itself. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Presented to ER at 20:20 with c/o difficulty breathing. Treated in ER with IV SOLUMEDROL and BENADRYL. Admitted to hosp. with allergic reaction and stridor. D/C home 10/15/08 at 3:00 pm on MEDROL DOSE PK.   11/11/08 Reviewed hospital medical records of 10/14-10/15/2008. FINAL DX: allergic reaction to flu vaccine w/acute respiratory distress Records reveal patient experienced hoarseness, SOB & stridor.  Tx w/IV steroids & antihistamine.  Improved & d/c to home on continued oral meds & tapering steroids.
100.6 fever, diarrhea, very sore and hard  injection site. called in sick to work.
Sore from elbow to shoulder. Takes 400mg Motrin after morning- both arms, right hurts more than left.
currently showing a negative immune response to MMR/had similar issue with Varicella Vaccine; This spontaneous report was received from a physician and refers to a 18-year-old patient of an unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with 1st measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (formulation defaulted as subcutaneous Injection, dose, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient was vaccinated with 2nd measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (formulation defaulted as subcutaneous Injection, dose, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (formulation defaulted as subcutaneous Injection, dose, anatomical location, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, the patient experienced a negative immune response to measles, mumps, and rubella (MMR) and had similar issue with varicella vaccine (vaccination failure). Outcome of the event was unknown.  Causal relationship between vaccination failure and suspected therapies was related.
Fever; This is a spontaneous report from a contactable consumer (Patient). A male patient of an unspecified age received BNT162B2 (COMIRNATY; Formulation: Solution for injection, Batch/Lot Number: was not reported) via an unspecified route of administration, administered in Deltoid Left on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. on an unspecified date of 2021 the patient experienced fever. Reporter stated that he had a problem and it seemed as if it was not only me but I had the vaccine but, I thought this effect will go away and it never went away and first shot I had because I took the Pfizer, the first one on left shoulder and initially I did get any experience any side effect other than just slight fever. The outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (24Aug2021) This Follow-up activities closed: Batch/lot number not available for vaccine/BNT162B2.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100994048 same reporter/ AE/ drug, different patient;US-PFIZER INC-202100994049 same reporter/ drug, different AE/ patient
Pt. grandmother called at 9:30 am stated that left arm swelled to size of lemon, red streaks down arm.  Took to ER last night, gave Benadryl at ER.  States has fever 101 given Tylenol.  Instructed pt. to come in to the office for exam ASAP.  At 4:10 pt never showed. left message at pt home to contact office.
Pt developed an egg shaped reddened, hot area on the upper back part of her right arm where she got her varicella shot yesterday.  It was noted by the school nurse at school today.
Vomiting & extreme fatigue - 9:30p on 9/3/2021 Severe chills/profuse sweating/severe joint pain - 5am on 9/4/2021 until 10pm on 9/4
A-Fib Narrative: Employee sort medical attention for heart related issue one day after receiving the 4th dose of Moderna. Was seen in ED and Cardiology. Scheduled for procedure soon
Recently my memory has failed a lot. I am blank; This is a spontaneous report from a contactable consumer (patient herself). A 79-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19, solution for injection, Batch/Lot number not reported ) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE (age at vaccination 79 years old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced recently my memory has failed a lot on an unspecified date with outcome of unknown.  No follow-up attempts are possible; Information about lot/batch number cannot been obtained.
coughing; arm was hurting; had no energy; in bed for a week; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing), PAIN IN EXTREMITY (arm was hurting), ASTHENIA (had no energy) and MALAISE (in bed for a week) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery (MELANOMA SURGERY).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (coughing), PAIN IN EXTREMITY (arm was hurting), ASTHENIA (had no energy) and MALAISE (in bed for a week). At the time of the report, COUGH (coughing), PAIN IN EXTREMITY (arm was hurting), ASTHENIA (had no energy) and MALAISE (in bed for a week) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
sore throat; not feeling 100%; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 24Mar2021, outcome "unknown", described as "sore throat"; MALAISE (non-serious) with onset 24Mar2021, outcome "unknown", described as "not feeling 100%".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Lymph nodes on left side of body swollen and painful.  Skin was red and hot. This continued for weeks.  Went to Dr. on 2-15-2022 for treatment.  Was put on antibiotics on 2-15-2022.
Swelling, large fluid filled vesicle formation, followed by fever, chills, malaise, weight loss, cough. Now (11/8) arm normal, sub fever/malaise persists.
Patient developed neck pain with radiation into both arms and back two days after Shingrix administration. Pt went to ER on 1/29/2020 which resulted in benign work up. Prescribed meloxicam for neck pain. Patient came in to see Dr for follow up on 2/3/2020. Pt was still experiencing neck stiffness at office visit.
There were no adverse effects reported; The patient was vaccinated with a expired dose of properly stored of ROTATEQ; This spontaneous report was received from a licensed practical nurse, referring to a 4-months-old female patient. There was not concurrent conditions, medical history, concomitant medications, drug reactions or allergies reported.   On 06-AUG-2019, the patient was vaccinated with an expired dose of properly stored Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) for prophylaxis, orally, lot# N030174 and expiration date on 13-JUN-2019 (dose and strength were not reported). There were no adverse effects reported.
REDNESS/SPLOTCHINESS; LIGHTHEADED/DIZZINESS; NAUSEA; MILD DISORIENTATION.
Client received first dose of Moderna Vaccine. Consent signed by the client's mother.  Per manufacturer's guidelines, client was not eligible for the  vaccine due to being under the age of 18. The doctor notified Moderna and the Center for Disease Control and Prevention (CDC) of the incident.  Parents were notified that the first dose that was given to the child was not in accordance with the  CDC and manufacturer's guidelines. They were also informed  that the CDC and Moderna were notified of the incident and that the CDC has allowed the second dose series to be administered to children 16 years and older in similar situations.  The parent/guardian was given the option to return  to the clinic at the scheduled interval and for their child to receive the second dose series to provide better protection against the COVID-19 infection.
Adult got pediatric dose, later got replacement dose; Adult patient got pediatric dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B 10 mcg) for prophylaxis.   On an unknown date, the patient received Engerix B 10 mcg. On an unknown date, an unknown time after receiving Engerix B 10 mcg, the patient experienced underdose (Verbatim: Adult got pediatric dose, later got replacement dose) and adult use of a child product (Verbatim: Adult patient got pediatric dose). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 14-Apr-2023 An adult patient was given a pediatric dose of Engerix B and then went back on the same day and received an adult dose of Engerix.  Remove patient identifier was asking, what would a GlaxoSmithKline advise for next steps. Unable to speak to healthcare provider for consent. An adult patient received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
Immediate edema and erythema approximately 2 inches in diameter. Pain and erythema at injection site 12/07/2001. No treatment.