chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 41 year old female. 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 administration was not reported, batch number: 201A21A and expiry: 21-SEP-2021) dose was not reported, frequency 1 total, administered on 22-JUL-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 19-SEP-2021, the patient started experiencing covid-19 infection symptoms (confirmed clinical vaccination failure). On 26-SEP-2021, polymerase chain reaction (PCR) test was performed and on 01-OCT-2021, the test result was positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint number 90000195846.; Sender's Comments: V0: 20211006398-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure . This event is considered not related. The event 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 than the drug. Specifically: SPECIAL SITUATIONS
Feeling very achy after dose 1/muscle aches after dose 1; Feeling very tired after dose 1; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Feeling very achy after dose 1/muscle aches after dose 1) and FATIGUE (Feeling very tired after dose 1) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Feeling very achy after dose 1/muscle aches after dose 1) and FATIGUE (Feeling very tired after dose 1). At the time of the report, MYALGIA (Feeling very achy after dose 1/muscle aches after dose 1) and FATIGUE (Feeling very tired after dose 1) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient after the first dose felt very achy and tired and had muscle aches.  No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-405640, MOD-2021-405666 (Patient Link).
Called mom on 7/2/18 to check on sister and mom reports that Patient has 1 "bug-bite" like spot on left thigh. She has also felt a little warm over the weekend. She did not have any signs of spot on Friday when I talked to mom and is acting normal and feels normal temperature today.
RASH ON BOTH LEGS, LIMITED TO THIGHS. IMPROVED AFTER 12 DAYS. TREATED WITH OTC BENADRYL AND OTC TOPICAL STEROID (HYDROCORTISONE)
Patient reports getting hives, throat swelling, and restlessness (couldn't sleep) all beginning at about 9pm on the same day as the shot was administered. She states the hives (with raised bumps) resolved within 1 day, however the rash associated with it lasted approximately 3 days. Throat swelling was better by the next morning, so only lasted about 12 hours. The restlessness lasted for 3 nights.
Patient says that all of left deltoid and left tricep is inflammed and quite painful. Two floating nodules have appeared over the left collarbone. Both nodules are very sore. Range of motion OK. Temperature is 97.2 F. No Dizziness. Recommending ibuprofen and ice to patient. Recommending consulting MD.
Inflammatory Nodule that is red and tender to touch. Resolved after 7 days no treatment.
(1) 4 + Local reaction (L) arm (2) C/o mild swelling of bottom lip, redness and swelling noted at site of injection and arm warm to touch - (3) Mom states TYLENOL given and cold towels used to arm as ordered - Advised to take child to PCP ASAP, use OTC BENADRYL, cold compresses to site.
This case was reported by a other health professional via call center representative and described the occurrence of erythematous rash in a 2-year-old female patient who received PEDIARIX (batch number 4233K, expiry date 5th September 2016). On 27th October 2014 09:30, the patient received the 2nd dose of PEDIARIX. On an unknown date, the dose was an unknown dose. On 29th October 2014, 2 days after receiving PEDIARIX, the patient experienced erythematous rash and pruritus. On an unknown date, the outcome of the erythematous rash and pruritus were recovered/resolved. It was unknown if the reporter considered the erythematous rash and pruritus to be related to PEDIARIX. Additional information: a 2 year old patient experienced a localized rash (itchy and red) following vaccination.
The patient is a 5 year old male with a recurrent desmoplastic infantile ganglioglioma who began treatment on study to evaluate the effects of vaccinations with HLA-A2-restricted glioma antigen-peptides in combinations with Poly-ICLCfl on 7/16/2012. The patient developed a macula-papular rash on his legs within 4 days of receiving his first set of injections on 7/16/12, which waxed and waned. The day after he received his 2nd vaccine on 8/9/2012, he developed widespread urticaria -grade 2-. He was seen at the emergency department of hospital on 8/10/2012 where he was treated with po BENADRYL and ZYRTEC. He was sent home on BENADRYL and ZYRTEC and the hives resolved over the next few days.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX. Concurrent medical conditions included neuromuscular disorder nos and Globulins deficiency. Concomitant products included amitriptyline, levothyroxine, Mesalamine and ranitidine. On 20th April 2018, the patient received the 1st dose of SHINGRIX. On 20th April 2018. several hours after receiving SHINGRIX, the patient experienced pain in arm, erythema, swelling and skin warm. On 21st April 2018. the outcome of the heartbeats increased. On 25th April 2018, the patient experienced itchy upper limbs. In April 2018, the outcome of the heartbeats increased was recovered/resolved. On an unknown date, the outcome of the pain in arm, erythema, itchy upper limbs, swelling and skin warm were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, erythema, heartbeats increased, itchy upper limbs, swelling and skin warm to be related to SHINGRIX. Additional details were provided as follows: The patient was vaccinated in the morning and reported that she started to feel pain in the left arm a few hours after the vaccination. A red, raised area which was hot to the touch also presented a few hours following the vaccination and had not resolved. The next day after vaccination she began to experience a fast heart beat. It measured 111 to 112 beats per min. This symptom resolved by that evening at 8:00 pm. The night before the day of reporting the area on her left arm started to feel itchy.
Sore muscles; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore muscles) and ARTHRALGIA (Joint pain) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L02A) for COVID-19 vaccination.     Concomitant products included APIXABAN (ELIQUIS) for Drug therapy, METOPROLOL SUCCINATE and DOXYCYCLINE for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced MYALGIA (Sore muscles) (seriousness criterion medically significant) and ARTHRALGIA (Joint pain) (seriousness criterion medically significant). At the time of the report, MYALGIA (Sore muscles) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-256561 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
REPORTING BECAUSE PATIENT 16 YRS OLD, WHICH IS LESS THAN THE RECOMMENDED AGE OF  18 YRS. PATIENT HAD MINOR SORE ARM FOR 2 DAYS FOLLOWING VACCINATION
PATIENT BEGAN WITH EXCESSIVE SWEATING, PALENESS, DIZZINESS AND NAUSEA.
Patient reported redness, swelling, hives, itching in right arm (opposite arm from vaccine administration).  Symptoms presented 3 days after vaccine & have persisted X 3 days.  Pt instructed to take oral BENADRYL & call MD.  MD called 9/8 by pharmacy Dr.
As the son of a medical doctor, I have received an annual flu shot every year since my teens - or earlier. In 2015, as a senior, I opted for the FLUZONE High Dose Flu shot, my first. Within 2 weeks I developed genital lichen planus (confirmed by dermatologist) when I never suffered from this condition previously. It has not gone away since and is both painful and embarrassing. I will NEVER get the high dose flu shot again based on my experience, as well as my Registered Nurse (a senior) sister who experienced a violent reaction to the same vaccine. In addition, when I received my annual, REGULAR, flu shot yesterday, my physician advised against the high dose in my case.
Bleeding under the skin at site of injection; A little bruising at site of injection (possibly due to itching); Hot at site of injection; Itching at site of injection; Lump at site of injection; Redness at the site of injection; Lump at site of injection (size of 1/2 Lemon); Red has progressed to entire arm of injection; Soreness at the site of injection; Not sleeping at night; Unable to walk; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (Not sleeping at night), GAIT INABILITY (Unable to walk), VACCINATION SITE HAEMORRHAGE (Bleeding under the skin at site of injection), VACCINATION SITE BRUISING (A little bruising at site of injection (possibly due to itching)) and VACCINATION SITE WARMTH (Hot at site of injection) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M420A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Congestive heart failure. Previously administered products included for an unreported indication: PNEUMOCOCCAL VACCINE. Concurrent medical conditions included Allergy to vaccine (Unspecified allergic reaction 2 years ago.). Concomitant products included WARFARIN for an unknown indication.    On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced SLEEP DISORDER (Not sleeping at night), GAIT INABILITY (Unable to walk) and VACCINATION SITE PAIN (Soreness at the site of injection). On 26-Feb-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Bleeding under the skin at site of injection), VACCINATION SITE BRUISING (A little bruising at site of injection (possibly due to itching)), VACCINATION SITE WARMTH (Hot at site of injection), VACCINATION SITE PRURITUS (Itching at site of injection), VACCINATION SITE SWELLING (Lump at site of injection), VACCINATION SITE ERYTHEMA (Redness at the site of injection), VACCINATION SITE SWELLING (Lump at site of injection (size of 1/2 Lemon)) and VACCINATION SITE RASH (Red has progressed to entire arm of injection). The patient was treated with CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, SLEEP DISORDER (Not sleeping at night), GAIT INABILITY (Unable to walk), VACCINATION SITE HAEMORRHAGE (Bleeding under the skin at site of injection), VACCINATION SITE BRUISING (A little bruising at site of injection (possibly due to itching)), VACCINATION SITE WARMTH (Hot at site of injection), VACCINATION SITE PRURITUS (Itching at site of injection), VACCINATION SITE PAIN (Soreness at the site of injection), VACCINATION SITE SWELLING (Lump at site of injection), VACCINATION SITE ERYTHEMA (Redness at the site of injection), VACCINATION SITE SWELLING (Lump at site of injection (size of 1/2 Lemon)) and VACCINATION SITE RASH (Red has progressed to entire arm of injection) outcome was unknown.
fever; This is a spontaneous report from a contactable nurse.  A 6-decade (reported as around late 50s or early 60s) female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient experienced fever on unspecified date with outcome of the event was unknown. Information on the Lot/Batch Number has been requested.
Dtap given IM in right thigh (8/21/06. Seen in office 8/22/06 with moderate swelling of right thigh and knee, blotchy erythema, not indurated, hot or tender. No treatment.
Narrative:  Pt. calls in to report symptoms that started following 1st COVID vaccine. He reports he received 1st vaccine on 2/8. Reports on Monday evening, 2/8 and all day yesterday he felt feverish, severe chills, had HA, fatigue, few episodes of vomiting, and felt dizzy/unbalanced. He reports he feels better today, and was able to tolerate a mile walk/run on his treadmill w/o difficulty. Of note, he reports he had COVID dx in Nov.
Fever, chills, nausea, and really bad injection site pain (swelling, bruising, redness, and hotness)
This spontaneous report as received from a Licensed practical Nurse refers to unspecified number of patients of unknown demographics. Patients concurrent conditions and relevant medical history was not reported. The reporter stated that, on an unknown date, unspecified number of patients were vaccinated with improperly stored doses of (Merck) VARIVAX (lot number, dose, frequency and route unspecified) (incorrect product storage). Concomitant medications were not reported. No adverse effects (no adverse event) were reported. The outcome of the events was unknown. The causality of the events with suspect therapy was not reported. Product quality issue was not involved. This is one of the several reports from the same reporter. Additional information has been requested.
Patient's left arm swelled up and was sore to touch.  Has not improved since date of immunization.  Ironically, right arm is fine.  Patient has taken Benadryl to treat reaction and is going to see her PCP for additional treatment.
patient received bivalent booster for dose 1 of primary series. was caught shortly after it occurred, patient was contacted and explained what happened and she was going to return to the clinic for revaccination but has not returned yet. We will continue to contact her. Marked dose as invalid in immunization registry
Three days after injection had rash and arthralgias of R arm. Pt was administered in R arm. 6 days after injection arthralgias in hands, shoulders, elbows, knees, wrists and unable to use a pen/pencil or climb stairs. Still monitoring.
This case was reported by a sales representative and described the occurrence of not responding to therapy in a subject of unspecified age and gender who was vaccinated with ENGERIX B (GlaxoSmithKline). On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of ENGERIX B (unknown). Forty-two days after vaccination with the 3rd dose of ENGERIX B, the subject experienced not responding to therapy. A product complaint was associated with this event. The sales representative received an email from a doctor's office. Vaccine was purchased through Henry Shrine and 42 days after all seven subjects were given the 3rd dose of ENGERIX B, a lab assay was completed. The lab reported that all seven subjects were non-reactive to hepatitis A and B. The healthcare professional believed that the event was caused by a quality issue. No other quality issues identified. The sales representative reported the event as "lack of effect".
This is a spontaneous report from a contactable nurse. A female patient (age unknown) received a dose of PREVNAR13 on an unspecified date. Relevant medical history, concomitant medications and past product history were not reported. Following administration of the vaccine, the patient experienced urticarial rash. The patient's vital statistics at the time of the event were weight 31 lbs, head circumference: 48cm and height 36.5 in. The patient's physical growth was normal and developmental milestones (language/speech; emotional/social; fine/gross motor skills; and cognitive thinking) were all within normal range. Subsequently, on an unspecified date, the patient recovered from the event. Follow-up (23MAR2011): Follow-up attempts completed. No further information expected. Follow-up (18APR2011): New information reported from a contactable nurse includes: clarification that the event was urticarial rash. Follow-up attempts completed. No further information expected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 21-SEP-2016 the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot # K021444, expiration dated 17-SEP-2016). No adverse effect reported. Additional information has been requested.
Telephone call reported client had reaction to pneumonia vaccine left deltoid region that affected left arm and side of body. Redness, rash and pain. Client seen Doctor 11/15/05
March 3, 2021 Syncope episode, heart stopped for 7 seconds, pacemaker implanted on March 4, 2121. Respiratory issues since second vaccine to include Shortness of breath, fatigue, palpitations, dizziness, and light headedness.
Around 10/19/10 patient came in with a sore arm. Nothing looked red or infected. On 10/29/10 patient called stating that his arm was still sore when he lays down.
had hypotonic-hyporesponsive episode 2 days after DTaP/IPV vaccine
Vaccine was administered at 10:25am. Patient walked over to the waiting area and as he was walking he passed out and fell to the ground. Vitals were taken at about 10:28am: B/P 132/74 HR 70 RR 18, glucose 120. Patient was able to state his name and where he was located, but kept his eyes closed and kept stated he felt "confused and dizzy" and was apologetic.  EMS was called at 10:30AM and when EMS was here pt was noted to have another syncopal episode.  Patient was transported to Hospital via ambulance.
Trouble with proprioception both arms felt "disconnected." like they wanted to fall off for 3 days. Experienced pain at injection site thru mid-Feb. Then tapered off in late February. Bruise at injection site that lasted a long time.
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) from product quality group. The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 57 years 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: "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa; "Graves'" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Negative, notes: I had 3 negative tests starting 18Jan; (Jan2023) Negative, notes: I had 3 negative tests starting 18Jan; (18Jan2023) Negative, notes: I had 3 negative tests starting 18Jan; (28Jan2023) Positive, notes: Tested positive 28Jan. Therapeutic measures were taken as a result of drug ineffective, covid-19; The patient received Paxlovid from 13Jan2023 to 17Jan2023. No follow-up attempts are possible. No further information is expected.
Headache, Nausea, major Acid Reflux and Heartburn, extreme knee joint pain, Chronic Angioedema, Chronic Hemorrhoid, Chronic "Urticarial Vasculitis!"
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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2022 as dose 3 (booster) , single, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergies: Red Iodine" (unspecified if ongoing). The patient's 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. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not have other medications in 2 weeks. The patient was treated with Paxlovid from 19Sep2022 to 24Sep2022. It was reported that the patient was healthy.
Patient with swollen axilla to same arm as vaccination, developing 3 days after vaccine.  Exam with no other signs to suggest an infection/abscess.  Did have chills/Headache night of vaccine.  Exact address of pharmacy performing vaccination or Lot # is unknown.
Individual did not inform medical staff until after vaccination that he had already received Moderna vaccine prior to receiving Janssen vaccine. Moderna was administered to patient on 4/10/21 first dose, 5/8/21 second dose. Janssen was administered on 7/22/21.
This report described injection site induration in a 15 month old female. On 05/07/01, the vaccinee received her fourth right thigh dose of DTaP. She subsequently experienced injection site induration, edema and redness (3" X 3" area). The parents contacted the physician within two days of vaccination. On 05/09/01, diphenhydramine hydrochloride was prescribed. As of 05/11/01, the adverse events were resolving.