chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION (RUNNING NOSE, CONGESTION, SORE THROAT, SINUS PRESSURE, AND MILD BODY ACHES); This spontaneous report received from a consumer concerned a 34 year old male. The patient's height, and weight were not reported.  The patient's past medical history included: stomach ulcers, and concurrent conditions included: ulcerative colitis. The patient was previously received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, 1 in total, administered on 30-APR-2021 for prophylactic vaccination (Dose number series 1). On 12-NOV-2021, the patient received additional covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A expiry: UNKNOWN) dose was not reported, 1 in total, for prophylactic vaccination (Booster dose, dose number series 2). Concomitant medications included omeprazole DR (delayed release) (20 mg, capsule) for prevention of stomach ulcers, mesalazine DR (1.2 g, Tablet) for ulcerative colitis, and prednisone (10 mg, tablet) for ulcerative colitis flare. On 20-NOV-2021, the patient tested positive for COVID-19 infection (BinaxNOW) (suspected covid-19 infection and suspected clinical vaccination failure) with symptoms - running nose, congestion, sore throat, sinus pressure, and mild body aches. (Dose number series 2). Laboratory data included: COVID-19 antigen test (NR: not provided) which came positive on 20-NOV-2021 via home antigen testing kit. (Dose number series 2) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211149678-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Headache, chills, fever, muscle and joint pain, weakness, fatigue, shortness of breath and SEVERE pain in right arm in area of injection
generalized hives starting in the legs, spreading up the trunk and arms, and then the scalp and face
Patient signed up for a booster dose and received a booster dose early. First dose was administered 3/17, so it was received 22 days instead of 26 days per manufacturer.
patient had first dose and was waiting for 15 minutes. After leaving and driving to work, patient states she felt numbness and tingling in her tongue on the left side of face. Patient denies shortness of breath or dizziness. No rashes noted. Patient was evaluated and patient agreed to be monitored for another 30 minutes. Symptoms resolved after 30 minutes.
Stridorous breathing "seemed to stop breathing" eyes rolled back in head for several seconds; (probable sz);
PATIENT HAS A RASH IN THE AREA OF SHOT. ABOUT 3 INCHES LONG GOING DOWN ARM, LIKE A BAND.
Nausea, dizziness, light headed, head spinning, blurred vision.  Lasted 3 days.
Took the vaccine...had shingles again/Suspected vaccination failure; Had shingles again; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-AUG-2022 Reporter's Comments: This case was received from the patient via interactive digital media. The patient had shingles and then later took the Shingles vaccine. The patient had shingles again. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Rash, hive at injection site on day of vaccine treated with 20 mg pepcid and oral Benadryl. Red circular rash on arm and fever of 99.7 next day  with increasing rash size to 3 inches in diameter at injection site, treated with advil , Pepcid, and Benadryl (oral and topical).  Friday 1/22/21 rash is hot, itchy,  and swollen and treated by doctor for cellulitis with Cephalexin.
The Kinrix was given before the age of 4.  Child was 3 years 6 months.
On the evening of 1/31/21 which is 6 days after the second COVID vaccine at about 9 pm he got an extremely painful headache for several hours. On the morning of the next day while sitting down for breakfast he said he was not feeling well and within 2 or 3 second he lost consciousness for about 45 seconds.
The HCP administered an expired Moderna Vaccine to the patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The HCP administered an expired Moderna Vaccine to the patient) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 939901) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The HCP administered an expired Moderna Vaccine to the patient). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (The HCP administered an expired Moderna Vaccine to the patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported. No treatment reported.
p/vax AM pt woke up w/blotches on face, then all over body by saturday noc;rash x 3 days & cleared;2x3x1cm hematoma rt thigh inj site;mom stated introduced child to rice cereal & used J&J baby oil first time;mild fever;
No adverse event; Bivalent doses administered after the BUD to patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) in a 55-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 20-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients).    Concomitant medications were not reported.  Total 51 doses from Lot AS7140C Bivalent doses were administered after the BUD to patients. Treatment medications were not reported.
VERY SORE LYMPH NODE IN GROIN WHICH GOT MUCH BIGGER RED AND SORE; SORE CHEST; PINS AND NEEDLES; MIGRAINE; VOICE IS GOING AWAY; HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 20-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On DEC-2021, the patient experienced voice is going away, and headache. On 20-DEC-2021, the patient experienced migraine. On 21-DEC-2021, the patient experienced very sore lymph node in groin which got much bigger red and sore, sore chest, and pins and needles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from very sore lymph node in groin which got much bigger red and sore, voice is going away, and headache, and the outcome of migraine, sore chest and pins and needles was not reported. This report was non-serious.
Tested positive for COVID-19 via rapid antigen test on 20Jun2022; Tested positive for COVID-19 via rapid antigen test on 20Jun2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old male patient received BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Lot number: EL9262), in left arm, on 14Mar2021 as dose 2, single (Lot number: EP7534), in left arm and on 23Dec2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jun2022, outcome "recovering" and all described as "Tested positive for COVID-19 via rapid antigen test on 20Jun2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2021) Positive, notes: Nasal Swab; (19Jun2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Additional information: There was no other vaccine in four weeks. Tested positive for COVID-19 via rapid antigen test on 20Jun2022. There was no covid prior vaccination. There was covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
There hasn't been an adverse reaction to immunization. Pt was given the immunization at the incorrect time.
At 15:45 pt reported heat sensation in her chest radiating across her chest and into her L arm. Vitals at 15:45 are: T:98.1 P: 107 RR: 17 BP:145/100 O2: 98%. Pt encourgaed to take deep breaths and offered cold pack. Cold pack placed on back of pt's neck. Vitals at 15:55 are: T:98.1 P:102 RR: 18 BP:130/100 O2: 97%. Pt states ice pack helped releive the heat sensation. Pt monitored for an additional 10 minutes. Pt reports symptoms have subsided. Last set of vitals at 16:10 are: T:98 P: 100 RR:16 BP:125/90 O2:99%
Patient with prior hx of anaphylaxis - required 30 min wait, ~ 25 mins into wait time - reporting slight swelling of lips, sensation of itchy throat/tightening, appearance of hives on arms.  Patient alert and oriented, breathing comfortably.  Advised will take to ED dept for further evaluation - patient refusing wheelchair - ambulatory.  Walked to ED dept with NP, report given to ED, registration completed.
ear ache; terrible sore throat; arm pain; fatigue; muscle pain; joint pain; chills; Nausea; vomiting; Headache; severe swelling at the injection site; low grade fever (99 to 101.9F) daily; This spontaneous case was reported by a consumer and describes the occurrence of EAR PAIN (ear ache), OROPHARYNGEAL PAIN (terrible sore throat), PAIN IN EXTREMITY (arm pain), FATIGUE (fatigue) and MYALGIA (muscle pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not reported.  Concomitant products included LEVOTHYROXINE for Product used for unknown indication, HYDROCORTISONE and AMLODIPINE BESILATE (NORVASC) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EAR PAIN (ear ache), OROPHARYNGEAL PAIN (terrible sore throat), PAIN IN EXTREMITY (arm pain), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (Nausea), VOMITING (vomiting), HEADACHE (Headache), VACCINATION SITE SWELLING (severe swelling at the injection site) and PYREXIA (low grade fever (99 to 101.9F) daily). At the time of the report, EAR PAIN (ear ache), OROPHARYNGEAL PAIN (terrible sore throat), PAIN IN EXTREMITY (arm pain), FATIGUE (fatigue), MYALGIA (muscle pain), ARTHRALGIA (joint pain), CHILLS (chills), NAUSEA (Nausea), VOMITING (vomiting), HEADACHE (Headache), VACCINATION SITE SWELLING (severe swelling at the injection site) and PYREXIA (low grade fever (99 to 101.9F) daily) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.
Initially a low-grade headache within 4 hours. Later that evening muscle aches and pains in thighs and knees similar to flu-like symptoms. Taking TYLENOL the following morning around 7:00 am in an attempt to arrest the headache. These symptoms lasted approximately 72 hours and TYLENOL was taken during the course of the symptoms. On this day, flu-like symptoms have subsided but continue with a low-grade headache. Injection site remains tender but no redness or swelling.
Approximately 1.5 hrs following infection, the majority of left side of the the patient's body went numb/tingly, including upper and lower extremeties and the left side of the torso. Symptoms remained for 3-4 days, gradually improving. Patient also experienced severe headache pain, body aches, fever, chills and general malaise which lasted for approximately 2 days.
Deep aching pain in upper arm, and shoulder left side. Onset 1 week after Tdap. Pain duration approx. 3 mo. Weakness of arm occurred approx. 2 weeks after onset of symptoms. Numbness of thumb also occurred in left hand at same time. Numbness and weakness of arm continues. Mostly some weakness continues.
Woke up at midnight with chills, fatigue and nausea. I took 3 Advil (generic version) and after one hour symptoms subsided.
Patient reported a reaction after receiving 2 vaccines(Arvexy and Flublok) where her arm was red and swelled up slightly for 2 days. No treatment was taken by patient for symptoms. Reported that the symptoms resolved themselves after 2 days.
PT WOKE THIS MORNING, 4/1/18 AT AROUND 8AM & EXPERIENCED: ACHES, CHILLS, TEMP OF 100.7 TO 101. PT CALLED INTO PHARMACY AROUND 12 NOON. ADVISED PT TO TAKE IBUPROFEN BASED NSAID W/ FOOD OR MILK TO HELP W/ ACHES, PAINS, & CHILLS. REMINDED PT IT IS COMMON SIDE EFFECT OF THE VACCINATION.
Patient approached consultation counter about reaction. Pharmacist took patient into consultation room where patient demonstrated reaction. (L) arm approximately 2-3" below injection site. 2" x 4" red, raised area, warm and painful to touch. Also had reaction to pneumonia vaccine last year urgent care visit, resolved 2-3 days later.
Headache, Myalgia, Arthralgia, NauseaVomiting, fatigue, chills, sore arm (at inj site),  Narrative:  Other Relevant History:
This spontaneous report as received from a medical assistant refers to patient of unknown age and gender. On 01-AUG-2016, the patient was vaccinated with improperly stored dose of M-M-R II lot # L029266 (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
Gut ache and diaherra Unsure if related to vaccine, but reporting as suggested.
Within 24 hours of receiving a Shingrix and Boostrix vaccine in the left arm the patient was complaining of pain, warmth, and erythema in the arm.  By 48 hours the redness had spread to a few inches of the injection sites. but the swelling was limited. The patient had no systemic effects.
tested positive for Covid-19 with symptoms; tested positive for Covid-19 with symptoms; booster; This is a spontaneous report received from a contactable reporter (Consumer) from product quality group. A 62-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Nov2021 (Lot number: EW0186) at the age of 62 years as dose 3 (booster), single; administered in arm right, administration date 19Mar2021 (Lot number: EN6204) at the age of 61 years as dose 2, single; and administered in arm right, administration date 26Feb2021 (Lot number: EN6205) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Stroke patient" (unspecified if ongoing), notes: Stroke patient; "Heart condition" (unspecified if ongoing), notes: Heart condition. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 05Nov2021, outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Jan2022, outcome "recovering" and all described as "tested positive for Covid-19 with symptoms"; INFECTION (medically significant), outcome "recovering", described as "breakthrough infection". The events "tested positive for Covid-19 with symptoms" and "breakthrough infection" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: lung (01Jan2022) they were clear; PCR [Nasal Swab] (02Jan2022) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19, infection. Additional information: The reporter reported a breakthrough infection. The reporter's husband tested positive for Covid-19. (02Jan2022) and he had some fever and cough. Since the patient was high risk, his doctor asked him to go by the ER to check his lungs and they were clear on 01Jan2022. The patient has no known allergies. The patient was not diagnosed with Covid-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The reporter considered the events was non-serious.
Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine that had been more than 30 days in the refrigerator was given to 16 patients/vaccinate past its expiration date of 10/1/21) to be not applicable.    Concomitant medication information not provided.  Treatment information not provided.
pt recvd vax & 3 wks p/vax 2 exp flu-like sx, rash on arms, low-grade fever, swollen glands & metallic taste;
Tinnitus - constant ringing in both ears; This is a spontaneous report from a non-contactable consumer (patient). A 41-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration in the left arm on 03Apr2021 13:00 (Lot Number: EW0151) as 1st dose, single dose for covid-19 immunization. The patient has no medical history. The patient was not diagnosed with COVID-19 prior to vaccination The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the most recent COVID-19 vaccine in a hospital. The patient experienced tinnitus - constant ringing in both ears which started within about a week of injection (09Apr2021) and has been going on for 7 weeks. The adverse event result in doctor or other healthcare professional office/clinic visit and the event was considered serious with seriousness criteria of disability. The patient has not been tested for COVID-19 since the vaccination. The patient did not received treatment. The outcome of the events was not recovered.   No follow-up attempts are possible, information on the lot/batch number cannot be request. No further information is expected.
No adverse effects were reported; patient received improperly stored dose of VARN AX; This spontaneous report was received from an office manager referring to an unspecified patient of unknown age and unknown gender. Information of concurrent condition, medical history, and drug reactions/allergies were not provided. Concomitant therapy included sterile diluent.  On 03-JAN-2019, the patient received improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # N014368 with expiration date 09-MAY-2019, dose detail and route were not reported), for prophylaxis. No adverse effects were reported. The vaccine was stored at 15 to 46 Fahrenheit degrees (-9 Celsius degree to 8 Celsius degree) (1.93 Celsius degree) for 34.5 hours. There was no previous temperature excursion and data logger was involved.
Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 82 years old female patient who had expired fluzone HD, while she received vaccine FLUZONE HD. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVENAR 13 for Immunisation. On 28-Sep-2018, the patient received a 0.5 ml once dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI848AA via intramuscular route in the left deltoid. It was also a case of actual medication error due to expired vaccine used. The patient outcome is reported as Not Applicable for FLUZONE had expired given to a patient. 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
Muscle/ body aches (back, leg and arm pains) and joint pain (wrists), even feet difficulty bending and pain back and hips sitting  low-grade fever  Brain fog; trouble focusing/ concentrating.