chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 71 years, in left arm for covid-19 immunisation; COVID-19 Vaccine - Manufacturer Unknown, as dose 4 (booster), single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), 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 and 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". Therapeutic measures were taken as a result of drug ineffective, covid-19. Covid 19 Treatment: Paxlovid with treatment start date 25Oct2023 and treatment stop date 30Oct2023.   The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
PATIENT DEVELOPED REDNESS AND SWELLING OF THE RIGHT UPPER EXTREMITY TREATED WITH BENADRYL AND STEROIDS
This spontaneous report as received from a certified medical assistant (CMA) concerning an unspecified  number of patients (gender and age unspecified) which reported that the patients received improperly doses of GARDASIL (dose, route and lot # unspecified) between 16-JUN-2014 and 13-JUL-2014. No adverse symptoms reported. Follow up was received on 19-AUG-2014 from a certified medical assistant. The reporter stated that the 11 years old patient of unknown gender was vaccinated with a dose of improperly stored GARDASIL (dose, route not reported, lot # J009243, exp. date 23-APR-2016) on 24-JUL-2014. This is one of several reports from the same source. Additional information has been requested.
experienced a rash on torso/Rash on Torso Chest and Neck/red/splotchy and a little itchy; This is a spontaneous report from a contactable consumer. A 30-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on 10Jan2021 11:30 at a single dose for COVID-19 immunization. Medical history included that patient was tested positive for Covid prior to the vaccine, in early to mid Oct2020. Concomitant medications included bupropion; and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). He took his normal prescription medications in the morning the day of vaccination. Patient stated he received his first dose on Sunday, 10Jan2021 and 36hours, reported as last night 11Jan2021, he experienced a rash on torso, "red/splotchy and a little itchy, but bearable". He noticed that he was breaking out in a blotchy red rash on his torso and chest and it was not going away. It's not too itchy. He was calling to see if this was a normal side effect.  He is not a HCP but works at a HCP office. He got his First Dose on 10Jan2021 at 11:30 and the rash started 11Jan2021 about 36 hours later. The Itching and spots showed up at the same time. The rash was only on the torso, chest, and neck. He was noticing that the rash was about the same as when it first started, and it gets worse when heat is applied like if he is in the shower. Patient has not taken any antibody tests and had no issues with vaccines in the past. He did not have to be hospitalized or seek further treatment for this rash. Patient wanted to report his side effects and "make sure it's nothing serious that needs to be addressed" and patient was asking for any information about report of rash and what needs to be done At the time of the report the patient felt fine and looked worse than he this it was. Patient asked if after experiencing side effects from the 1st dose, should he get the 2nd dose of vaccine. The outcome of the event rash on torso/rash on torso, chest and neck/red/splotchy and a little itchy was not recovered.  Information on the batch/lot number has been requested.
pt.recvd. 1st dose of vax in July 1990 & 2nd dose in November 1990 for unknown reason.@ time of rept. there were no ADR.
About 3 days after shot: severe inflammatory skin reaction began. Eventually covered about 1/3rd of my body. Still active, to now a lesser degree
I received my second dose of the Pfizer vaccine on a Tuesday evening and had no adverse symptoms that night.  When I woke up the next morning, I had a very, very bad headache and ringing in my ears.  The headache began to subside by that night, but the tinnitus continued.  By the following day (Thursday), the headache was gone but I was still tired and the tinnitus continued.  By Friday, I felt basically back to normal, except for the tinnitus.  It is now Tuesday, one week from the shot, and the tinnitus continues.
Rash appeared approx 7 hours after IPV/Hep B. Urticarial rash diffuse over entire body. Parents deny any new foods, soaps, exposure etc.
swollen arm for days; had a high fever 14 hours after shot; very bad headache; tired; sore arm couldn't lift it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm couldn't lift it), PERIPHERAL SWELLING (swollen arm for days), FATIGUE (tired), PYREXIA (had a high fever 14 hours after shot) and HEADACHE (very bad headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concomitant products included VALSARTAN, ATORVASTATIN, HYDROCHLOROTHIAZIDE (HCT) and ALPRAZOLAM (XANAX) for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm couldn't lift it) and FATIGUE (tired). On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen arm for days), PYREXIA (had a high fever 14 hours after shot) and HEADACHE (very bad headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 16-Jan-2021, PAIN IN EXTREMITY (sore arm couldn't lift it) had resolved. At the time of the report, PERIPHERAL SWELLING (swollen arm for days), FATIGUE (tired), PYREXIA (had a high fever 14 hours after shot) and HEADACHE (very bad headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient felt normal after 48 hours of shot and as of present day had no residual effects.   This case was linked to MOD-2021-016075.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up received included E-mail, event outcome and added events.
Metallic taste in mouth & tastebuds on her tongue were sore & swollen.  Patient called us today & informed us.  The RN referred her to see a Dr.  It is unknown when the onset was.  Client never returned my call.
Fatigue swelling of Right Ear internally, painful to the touch Sores in front of mouth, starting on right side (like a canker sore)
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient. A 66-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04May2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertrophic cardiomyopathy" (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 "recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 16Sep2023 to 21Sep2023. Additional information: Covid "rebound" symptoms 5 days after last dose Paxlovid.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3-5 mins after receiving, developed tachycardia, shortness of breath, dizziness, and nausea. Improved within 2-3 mins, cleared within 5-10 mins. No further reaction.
Woke up this morning  with a rash that ran  from side to side under breast half way to waist and from side of arm pits to top of breasts.  Just red but not itchy.
11/17/03 started with dry right eye and twitching of eye. Shortly after intermittent numbness of right side of face and external ear. On 12/3/03 facial and eye drooping and difficulty closing eye. Right sided neck pain. Headaches. 12/8/03 saw nurse, diagnosed with Bell's Palsy and started on Medrol dose pack 401G. Still in treatment
A large area of light red rash (about 3 inch length and 2 inches in width) appeared on the side of the upper right arm, about 2 inches away down from the injection site. It started to appear about 45 hours after the vaccination, and is still there as of now (about 72 hours after vaccination). The rash area is swelling and feels warm upon touch. I feel itchy in the rash area, and I feel difficulty raising the right arm
Injection 11/29, arm sore, fever up to 102 on day 2 & 3. Day 3 went to Emergency Rm for arm swelling, decreased ROM & fever. Reassured by ED physician since swelling had resolved & resolving ROM issues. No treatment noted at the emergency room visit.
This is a spontaneous report from a contactable physician via Pfizer sales representative. A 17-year-old female patient received the first dose of TRUMENBA via an unspecified route of administration in the left deltoid as single dose, and influenza vaccine (unspecified trade name) in the right arm, both on the same unknown date. Relevant medical history and concomitant medications were not reported. That evening and the next day, the patient reported to her mother that her left arm was very sore and she could not lift above her head when she went to sleep and her whole left side of body was sore and in pain. The next day (2nd day after vaccination), the mother called her doctor to report pain in the whole arm down to forearm, pain in left side of face, pain in left side of neck, and pain in left side of trunk from chest, back down to hip for the patient. The pain on the left side of body lasted approximately 24 hours. The patient declined to come to the doctor's office to be examined. There was no numbness or tingling. The left arm was a little blotchy, but not warm and red. The outcome of all events was unknown. Follow-up (14Oct2015): New information received from a contactable physician via Pfizer sales representative includes: patient's age: vaccine dose number, administration date and anatomical location; concomitant vaccine; clinical course; 'pain in left side of face', 'pain in left side of neck', 'pain in left side of trunk from chest, back down to hip' and 'left arm was a little blotchy' added as events.
Information has been received from a registered nurse regarding a 15 year old patient of unknown gender. The patient´s medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 02-OCT-2017, the patient was vaccinated with one improperly stored dose of VARIVAX subcutaneously (strength, anatomical location, dose number, lot number and expiration date were not provided) for prophylaxis. The VARIVAX was stored at a temperature range of 15 degrees Fahrenheit (°F) to 46 °F for the time frame of 5 hours. There was no previous temperature excursion and the call was not because of a data logger. No adverse effects reported. This is one of nine reports received from the same reporter. Sender's Comments: US-009507513-1710USA013246: US-009507513-1710USA013247: US-009507513-1710USA013249: US-009507513-1710USA013250: US-009507513-1710USA013251: US-009507513-1710USA013252: US-009507513-1710USA013253: US-009507513-1710USA001718.
Difficulty in breathing, Left upper quadrant pain.ED visit 3/16/2021. Pulmonary emboli diagnosis. Unprovoked.
Had experienced fatigue and site soreness with previous AVA vaccinations, usually given SC over triceps area. This vaccination given in anterior deltoid of L arm, within 24 hours experienced numbness, tingling, and muscle soreness to extent that she could not lift her arm. She bacame fatigued, listless, and experienced short-term depression for several days such that she "was bawling all the time". She also experienced nausea without vomiting, pain throughout her GI tract, without diarrhea, and moderate headache.
11/13/03 Mom brought daughter in for third hepatitis B for school certification. Mom said after last hepatitis B vaccine 10/26/01, her daughter was lethargic, had headache and broke out in welts on arms and chest. Mom said she stayed out of school the next day and she continued to give her Benadryl and the rash went away.
Mother states baby stopped breathing and turned blue after she fed him. Mother did CPR until the medics arrived and took the child to the hospital. Mother said child was breathing on his own when medics arrived. Mother states that the physician said the baby's reaction was due to the shots he had been given two days prior. Mother was asked if she had received statements for the shots the baby received and if she read the side effects. Mother said she did get the information about the shots but has not read them. Mother also stated that the baby developed a rash over his body the day he was admitted to the hospital. Baby was sent home on an apnea monitor.
Bruising and rash at and near the injection site.  Bruising occurred day after, rash developed around 10 days after.
I massaged the injection sight several times the date of injection as directed by the RN. My shoulder started getting very sore within minutes of the injection. I started taking ibuprofen about 2 hours after injection. The medication relieves a little of the pain but doesn't take it away. The pain has been getting worse the more time passes. It's extremely painful to put on and take off my bra, shirts, jackets. I can lift my arm straight out from my shoulder with great pain but lifting it higher than that is not only painful, but it feels like the muscles in my shoulder stop helping with the process. I don't really know how to explain that better.
Not able to get 2nd dose on the due date; Not feeling well; Low grade intermittent fever; This spontaneous case was reported by a consumer concerning himself of a 70-year-old male patient who received Moderna COVID-19 Vaccine (mRNA-1273) and experienced Inappropriate schedule of product administration (Not able to get 2nd dose on the due date), Malaise (Not feeling well) and Pyrexia (Low grade intermittent fever).     The patient's medical history and concomitant medications were not reported.  On 26-Feb-2021, the patient received first dose of mRNA-1273 of batch no. 025A21A via Intramuscular 1 dosage form. On 26-Mar-2021, the patient experienced malaise (Not feeling well) and pyrexia (Low grade intermittent fever). On 27-Mar-2021, the patient experienced inappropriate schedule of product administration (Not able to get 2nd dose on the due date).    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, SARS-CoV-2 test: Results pending.  Treatment medication included ibuprofen.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   At the time of the report, inappropriate schedule of product administration (Not able to get 2nd dose on the due date), malaise (Not feeling well) and pyrexia (Low grade intermittent fever) outcome was unknown.
On 03/06/2023, I woke up with a cold. It got progressively worse and then my ear started to hurt and the gland on my right side was sore. I went to a local urgent care where they diagnosed an ear infection. They prescribed AUGMENTIN 125 milligrams twice a day for ten days. Since beginning the medication, my symptoms have improved.
Developmental speech apraxia with sensory integration/fine motor control issues. Occupational therapy until 2/26/02. Speech therapy ongoing. Mild autism.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: numbness in limbs-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Severe
My symptoms started on a Sunday night with tightness in my throat when I swallowed. I thought the scratchiness in my throat came from cleaning. The next night I noticed the tightness in my throat was worse and I had dry mouth. I had some congestion, nothing major though. I didn't think anything of it. I was on vacation that week. I also had nausea. I took my dad to urgent care and I decided to test just to be safe, which was positive. This lasted about a week.
Passed out 6 hours after shot, not normal(3rd shift worker), fever set in 10 hours after shot, headache set in 18 hours after shot, fever subsided 18 hours after shot, currently experiencing constant sweating(rarely sweat even in heat), woke up with two hives on left arm that have gone away since I noticed them itching, right arm soreness, actual pain in right armpit.
01/30/21 Left arm red, sore; 02/01/21 general malaise, headache, rash on left shoulder and upper back; 02/05/21 joint soreness, knees, hips, shoulders; 02/08/21 muscle weakness, shaky; dizziness, loss of balance, diminished proprioception; 02/12/21 Orthopedic consult - 02/13/21 full body message - some relief; 02/15/21 Chiropractic adjustment - some relief; 02/24/21 PCP - steroids PO 5 days; 03/09/21 pain management - right hip steroid injection - some relief; 03/10/21 no relief from oral steroids, 03/16/21 pain management SI injection, some relief;still dizzy, loss of balance
Graves disease induced by SARS-CoV-2 infection or vaccine; This is a literature report for the following literature source(s): "A case report of new onset graves disease induced by SARS-CoV-2 infection or vaccine?" The full publication has been requested.   A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BASEDOW'S DISEASE (medically significant), outcome "unknown", described as "Graves disease induced by SARS-CoV-2 infection or vaccine".; Sender's Comments: As there is limited information in the case provided, the causal association between the event Basedow disease and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This spontaneous report as received from a 60 year old female patient with multiple sclerosis, arthritis, brain damage, methicillin-resistant staphylococcus aureus and pancreatitis refers to herself. Patient had no drug allergies. On 11-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot# unspecified), subcutaneous. Concomitant therapies included XANAX, mirtazepine (manufacturer unknown) and VICODIN. On 12-JUN-2013, the patient experienced feet broke out in a rash, swelled and had tingling sensation. The outcome of the events was reported as not recovered. No treatment was given. No lab tests were performed. The patient had not sought medical attention. Additional information has been requested.
all of the sudden her ankles are swollen which is not normal; Medicine taste in her mouth; Arm hurts; Having hot flashes; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Medicine taste in her mouth), PAIN IN EXTREMITY (Arm hurts), HOT FLUSH (Having hot flashes) and JOINT SWELLING (all of the sudden her ankles are swollen which is not normal) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included LORATADINE for an unknown indication.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced TASTE DISORDER (Medicine taste in her mouth), PAIN IN EXTREMITY (Arm hurts) and HOT FLUSH (Having hot flashes). On 12-Aug-2021, the patient experienced JOINT SWELLING (all of the sudden her ankles are swollen which is not normal). At the time of the report, TASTE DISORDER (Medicine taste in her mouth), PAIN IN EXTREMITY (Arm hurts), HOT FLUSH (Having hot flashes) and JOINT SWELLING (all of the sudden her ankles are swollen which is not normal) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was also not reported.
Pt. had a reaction at the injection site as reported by the patient. She had redness on the arm, her arm was hard to touch. The Dr gave her prednisone and she also took some tylenol. She is all fine now
SLUGGISH; SLEEPY; 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced sluggish, and sleepy. The action taken with covid-19 vaccine was not applicable. The outcome of the sluggish and sleepy was not reported. This report was non-serious. This case, from the same reporter is linked to 20210933142.
Systemic: Diarrhea-Medium, Systemic: sore throat-Medium
PARTIAL ERECTION LASTING MORE THAN 4 HOURS; This spontaneous report received from a patient concerned a 20 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced partial erection lasting more than 4 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from partial erection lasting more than 4 hours. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.