chrisvoncsefalvay/vaers-outcomes huggingface dataset:
rash became more and in a few more places on my right leg; Shingles; blistered after 2 days.; Nerve pain; muscle soreness; pain in my Hip Flexor tendon and in my quardiceps tendon; few spots on my thigh; This is a spontaneous report from a contactable consumer or other non hcp.     A 41-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 26Apr2021 15:45 as 1st dose, single for covid-19 immunisation. Medical history included hypothyroidism ongoing. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE); thyroid (ARMOUR THYROID). The patient had not known allergies. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that, Received first dose of Pfizer on 26Apr2021. On 13May, she started developing nerve pain, muscle soreness, pain in my Hip Flexor tendon and in my quadriceps tendon. I also had a few spots on my thigh. As the next 4 days progressed, the rash became more and in a few more places on my right leg. Became blistered after 2 days. Went to the doctor on 17May and was diagnosed with Shingles. The nerve pain on, muscle soreness, pain in my hip flexor tendon and in my quadriceps tendon, few spots on my thigh on 13May2021 08:00 with outcome of recovering, rash became more and in a few more places on my right leg on 17May2021 with outcome of recovering, blistered after 2 days, on 15May2021 with outcome of recovering , shingles on 17May2021 with outcome of recovering. Therapeutic measures were taken Antiviral meds as a result of nerve pain (neuralgia), muscle soreness (myalgia), pain in my hip flexor tendon and in my quadriceps tendon (tendon pain), few spots on my thigh (rash macular), rash became more and in a few more places on my right leg (rash) , blistered after 2 days. (rash vesicular), shingles (herpes zoster).
Red, swelling, hardening, warmth, itchy at site of injection. Fatigue and joint pain.
arm is sore; Dizzy; Couldn't see real good; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is sore), DIZZINESS (Dizzy) and VISION BLURRED (Couldn't see real good) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm is sore), DIZZINESS (Dizzy) and VISION BLURRED (Couldn't see real good). At the time of the report, PAIN IN EXTREMITY (arm is sore), DIZZINESS (Dizzy) and VISION BLURRED (Couldn't see real good) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant medication was not provided.
10 x 10 cm erythema (R) deltoid area (around Tdap injection) with swelling and tenderness.
swelling of the feet; lower back pain; tingling sensation in fingers; chills; fever; headache; joint pain; knee pain/ elbow pain/ wrist pain; fatigue/ Feels very tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (swelling of the feet), BACK PAIN (lower back pain), PARAESTHESIA (tingling sensation in fingers), CHILLS (chills) and PYREXIA (fever) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling of the feet), BACK PAIN (lower back pain), PARAESTHESIA (tingling sensation in fingers), CHILLS (chills), PYREXIA (fever), HEADACHE (headache), ARTHRALGIA (joint pain), ARTHRALGIA (knee pain/ elbow pain/ wrist pain) and FATIGUE (fatigue/ Feels very tired). On 15-Mar-2021, PYREXIA (fever), HEADACHE (headache) and ARTHRALGIA (joint pain) had resolved. At the time of the report, PERIPHERAL SWELLING (swelling of the feet), BACK PAIN (lower back pain), PARAESTHESIA (tingling sensation in fingers), CHILLS (chills), ARTHRALGIA (knee pain/ elbow pain/ wrist pain) and FATIGUE (fatigue/ Feels very tired) had not resolved.            No concomitant medication was provided by the reporter. Patient called in to give some updates about the side effects that she was still experiencing until now. It was her second time to call Moderna and she said she still have symptoms.  She said she already went to her two primary doctors but had not figured out yet as to what was going on with her. She was planning to visit her rheumatologist anytime this week for her third consultation. No treatment medication was provided by the reporter.     Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow up received contains significant information: Events added: Swelling of the feet, knee pain/elbow pain/wrist pain,  fatigue/ Feels very tired, lower back pain, tingling sensation in fingers. Outcome of Chills was updated to not recovered.
Bubble under the skin like when a TB test is given the next day. The following day, a hard spot started to form at the injection site. The day after, the surrounding area started to swell (about 2-inch diameter), became red, and started to itch. That part lasted for about 2 weeks with the injection spot got a little bigger and harder. About week three, the surrounding area went away and the injection spot got a little smaller but still feels like there is small pebble under the skin,
Lump on my arm; Pea sized blister filled with fluid near the injection site; This is a spontaneous report received from a contactable consumer (patient). A 66-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in arm left on 25Feb2021 at 14:00 as DOSE 1, SINGLE for covid-19 immunization. Vaccine facility was reported as pharmacy or drug store. Medical history included hypertension, diabetes and two stents in arteries from an unknown date and unknown if ongoing. Concomitant medications included losartan 100 mg, amlodipine 5 mg and hydrochlorothiazide: all taken for an unspecified indication, start and stop date were not reported. Patient was not aware of any allergies. Other vaccine in four weeks was reported as no. Prior vaccination and post vaccination patient was not tested for covid. Patient reported as soon as vaccine was administered (25Feb2021 at 14:00) the technician said that he saw a lump on my arm. He said my body reacted to the vaccine very quickly. Noticed when he got home that there was a pea sized blister filled with fluid near the injection site. It had been 5 days and the blister was still on arm. The patient was concerned that he had not received the full dose of this vaccine. The patient could not find any other documentation of this being a side affect. The patient was not treated for the events. The events did not result in emergency room/ physician office visit. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
fever; lymphadenopathy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Mar2021 13:41 (Lot number: EL3247) at the age of 51  as dose 2, single for covid-19 immunisation. Relevant medical history included: "HBP" (unspecified if ongoing). Concomitant medication(s) included: SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE taken for hypertension (ongoing); IRBESARTAN taken for hypertension (ongoing). Vaccination history included: Bnt162b2 (Time: 13:01, Anatomical site of injection: Rt. Arm, Route of administration: Intramuscular, Batch/Lot number: EL3247, Dose: 1), administration date: 22Feb2021, for COVID-19 Immunization; Flu, administration date: Oct2021, for Immunization; Tetanus vaccine (For tetanus vaccine - 20 years ago had 6 month reaction on my arm (lump that would flare up at night with pain)), for Immunization, reaction(s): "Lymphadenopathy". The following information was reported: LYMPHADENOPATHY (non-serious) with onset 24Nov2021 09:00, outcome "recovered", described as "lymphadenopathy"; PYREXIA (non-serious), outcome "unknown", described as "fever". Therapeutic measures were taken as a result of lymphadenopathy.   Additional information: the event requires the initiation of new medication of Tylenol. Complete only if a 3rd dose was administered. Check one option: Booster dose due to high of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications). Need an N/A response in mass it was opened to 18+ earlier than other states.  Comments/Narrative: 2nd Covid Vaccine: I had Lymphadenopathy with a golfball (half-sized) lump on my neck + lumps under my armpit. I had fever etc.+ This was reported previously.  No follow-up attempts are possible. No further information is expected.
PATIENT RECEIVED J&J DOSE AT 17 YO. J&J VACCINE IS APPROVED FOR AGES 18 YO AND UP.
Pt recv vax on 3/26/99; on 4/5/99 pt exp fussiness, fever (99F), lesions/ and a lump on rt leg
Patient reported pain, swelling and heat from the immunization in the left arm. Patient reported chills/fever as well (symptoms).
Rash on abdomen, groin area and legs. Developed 3 days after vaccine
Pfizer COVID 19 Vaccine EUA  Pfizer Dose 1 2/26/21 (EN6198) Pfizer Dose 2 3/18/21 (EP7534) COVID Positive 7/6/21  7/6/21: The patient presents to ED with diarrhea and Pt is 78 y/o female who presents to the ED complaining of chronic diarrhea onset since March that worsened over the last two weeks. Pt has had a cough as well. Pt has had a previous colonoscopy, but was told by GI that it was "too soon to have another." Pt denies any recent antibiotics, recent sick contacts, or recent travel. Pt states she is diabetic and her sugars have been 112 in the morning and 150 in the evening. Pt denies any abdominal surgery. Pt admits to cough, nausea and back pain, but denies vomiting, bloody stools, fevers, chest pain, shortness of breath, and abdominal pain aside from a pain that occasionally radiates down to her pelvic which she does not have currently. Pt denies a bowel movement today. Pt admits to both Covid-19 vaccine doses in March. Pt received the Pfizer vaccine.. The onset was chronic.  The course/duration of symptoms is worsening.  The character is not bloody.  Risk factors consist of not recent antibiotic use, not infectious exposure and no recent travel.  Associated symptoms: abdominal pain, nausea, cough, denies vomiting, denies fever, denies chest pain and denies shortness of breath. Patient seen examined emergency department for chief complaint of diarrhea that has been present for several weeks.  Patient has seen her GI doctor.  She states that stool cultures were obtained.  Stool cultures reviewed, which demonstrated all negative stool cultures.  Due to patient's persistent diarrhea, workup was obtained to rule out acute dehydration verses AKI verses electrolyte abnormality.  Workup obtained demonstrates no acute findings.  Patient was updated results.  On reexamination, patient states he has had no episodes of diarrhea in the ED.  This juncture, I believe patient is stable for discharge home with close follow-up with GI.  Patient is agreeable.  Return precautions are discussed, including change in mental status, decreased urinary output, or any other concerns..
I swell up now till my throat closes. Im constantly keeping at migraine. I cant even fit into my jeans.
DEATH; BLOOD CLOT; This spontaneous report received from a consumer via social media through company representative concerned a female of unspecified age, race and ethnicity. 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, and batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered on an unspecified date for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, following the vaccination developed blood clots and died six months later. On an unspecified date, the patient died from unknown cause of death. It was unspecified whether an autopsy was performed. The reporter reported that, "I heard today they completely pulled J and J off the market. I don't know for sure though. I was also told that a nurse was forced so she would not lose her job. She developed blood clots and died about 6 months later." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of blood clot was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: 20220236855-COVID-19 VACCINE AD26.COV2.S-Death,Blood clots. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Erythematous rash on LUE (painful to touch) nonvesicular.
Pt. had reaction at inj. site 18 hours later. Itchy red swollen and warm. Pt. was prescribed Prednisone 5mg 1 2x day for 2 days and 1 po daily x 2 days. Pt also rec. DECADRON 4mg and DepoMedrol 40mg. Advised CLARITIN, ZYRTEC, ALLEGRA in AM. BENADRYL PM. Pt. contacted next morning and has improved.
high fever up to 103 nausea stiff neck joint pain sever headache - shooting pain and pressure chills  fatigue muscle soreness loss of appetite difficulty sleeping diarrhea over a five day period
Muscular tightness (R) deltoid - couldn't lift arm. Onset within 2 hrs. lasted 72 hours Tx with MOTRIN.
Swollen on right arm and the armpit hurts to put arm down, tingling and numbness in right hand
Information has been received from a licensed practical nurse concerning a 20 year old female patient with sulfa allergy and a history of dysmenorrhoea who was vaccinated intramuscularly with three 0.5 ml doses of GARDASIL (lot#s for dose one and dose two not reported. Lot# for dose three 663559/1178Y) into the left deltoid respectively on 01-MAY-2009, 21-JUL-2009 and 18-MAY-2010. Concomitant therapy included YAZ. On 11-JUN-2010 the patient developed a gold ball size lump on her left arm which was painful to the touch with no bruising after receiving the third dose of GARDASIL. On 15-JUN-2010, the office received a phone call from the patient and the physician's recommendations were to use ice and ADVIL. On 21-JUN-2010 the patient called back and was still complaining about the arm pain. On 22-JUN-2010 the patient came in to see the physician. She was examined. There was a 2cm induration on the left upper arm which was very tender. There was no discoloration. Patient was able to move her arm. She was very upset. At the time of this report, the patient had not recovered. Follow up information has been received from the licensed practical nurse concerning the 20 year old female patient who on 18-MAY-2010, at 9:30, was vaccinated intramuscularly with the third dose of GARDASIL (lot # 663559/1178Y) into the left upper arm. On 11-JUN-2010 the patient called to report a golf ball size lump on her left arm with no bruising. The patient was instructed to use ice and ADVIL. On 21-JUN-2010 the patient called back and still reported some problem. On 22-JUN-2010 the patient came in to see the physician. She was examined. There was a 2cm induration with no erythema on the left upper arm which was very tender. Patient was able to move her arm. She was recommended pain medications, ice or hot. She was very upset with her condition. She declined pain medications. At the time of this report, the patient's outcome was not reported. Follow up information has been received from a nurse practitioner who reported that on 01-SEP-2010 the patient was called. She still had grape size tender lump at injection site which was tender to touch and pain with exercise. The pain was relieved with ibuprofen. The patient stated that there was no change in status for a while. Additional information has been requested.
24 hours later I developed a "black eye" on the right eye.  No swelling. No tenderness. Just a very dark purple black bruise appeared on right eye in the inner corner.
on 5/28/11 developed fever of 101 degrees Fahrenheit that lasted 1 day, on the evening of 06/06/11 first noticed mild rash on face that spread to trunk and back
After I got my 1st COVID shot (Moderna April 6th), I started noticing my thumbs get numb and tingly (Hypoesthesia). At first I disregarded it because, a year ago, I had a mild spinal cord injury (requiring a neck brace). And after wearing the brace, I had a similar symptom that would flare up. So, when my thumbs did this, I figured, ?perhaps it?s my old injury just flaring up?? But, this time, the hypoesthesia began engulfing my pinky fingers too. I was obviously disturbed; but, I also figured it could simply be stress and carpal tunnel. This continued throughout the month in a mild way. After my 2nd COVID shot (May 4th), the tingly numbness spread to both heels and toes. And in the week following the vaccination, the numbness started to quickly shoot up both of my legs? all the way to the top of my butt cheeks. And finally, even my testicles started feeling tingly and numb.  It got to the point where I could barely handle sitting down for more than 10 minutes. My calf muscles also started to constantly twitch. So, with Guillain Barre Syndrome on my mind, I went into the E.R. They did a spinal tap and the labs came back normal. A month later, the symptoms slowly began to subside.
COVID rebound with symptoms starting July 10; COVID rebound with symptoms starting July 10; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 31-year-old male patient received BNT162b2 (BNT162B2), on 18Oct2021 at 16:00 as dose 3, (booster), single (Lot number: FH8027) at the age of 30 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown). The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Jul2022, outcome "not recovered" and all described as "COVID rebound with symptoms starting July 10". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (10Jul2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2 weeks. COVID rebound with symptoms starting July 10, antigen was positive and turned positive faster than the same brand of test prior to beginning paxlovid, suggesting a higher viral load. Symptoms thus far are less severe though, no fever unlike prior to paxlovid.
shingles in corner of eye; This spontaneous case was reported by a consumer and describes the occurrence of OPHTHALMIC HERPES ZOSTER (shingles in corner of eye) in a 77-year-old female patient 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OPHTHALMIC HERPES ZOSTER (shingles in corner of eye) (seriousness criterion medically significant). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Herpes zoster, at an unspecified dose and frequency and VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) for Herpes zoster, at an unspecified dose and frequency. At the time of the report, OPHTHALMIC HERPES ZOSTER (shingles in corner of eye) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 3:58 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 3:58 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 56.09 for dose administered on 20-Mar-2021.  No concomitant medications were reported.  Vial was moved to fridge on 09-Mar-2021. Product moved to clinic on 20-Mar-2021. Batch number 031A21A underwent temperature excursion on 20-Mar-2021 with temperature 44 degrees Fahrenheit from 03:00 PM to 04:00 PM. Beyond use date for the vial was reported as 08-Apr-2021.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).