chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pink discoloration and bullseye; redness; injection site pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN DISCOLOURATION (pink discoloration and bullseye), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PAIN (injection site pain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Thyroid cancer (Right lobe removed 1996) in 1996. Concurrent medical conditions included Penicillin allergy, Drug allergy (to Urecholine), Drug allergy (to sulfa), Drug allergy (to cephalosporin), Iodine allergy, Shellfish allergy, Food allergy (to strawberry) and Food allergy (to Banana). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced SKIN DISCOLOURATION (pink discoloration and bullseye), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PAIN (injection site pain). At the time of the report, SKIN DISCOLOURATION (pink discoloration and bullseye), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE PAIN (injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       for treatment doxycycline was prescribed but not administered. prednisone 40mg dose pack was prescribed, diphenhydramine was used and famotidine was recommended but not administered.
COVID-19 treatment; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete; unknown manufacturer), for covid-19 immunisation. The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "not recovered"; DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Negative; (Jul2022) Positive; (Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical Course: Patient received treatment drug as Paxlovid from 01Jul2022 to 06Jul2022 for COVID-19. Tested negative finally on day ten of initial COVID infection. Major bitter taste in mouth for the five days of plaxovid. Started Plaxovid on day 2. 7 days after Plaxovid stop. retested positive. Extreme fatigue and congestion so far. Still positive.am on day 8 post Paxlovid. Patient did not received any other medications/products within 2 weeks of starting COVID-19 treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information was received on 06-JUL-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX (lot, expiration, dose and route not reported) vaccine on or about 23-APR-2014, administered by a physician as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 18-APR-2016, the patient was treated by her physician for a vesicular outbreak that was diagnosed as severe shingles. The patient was prescribed gabapentin (manufacturer unknown), LYRICA and CYMBALTA for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expense, pain and suffering and other damages. Additional information has been requested.
mom called MD & reported that pt recvd DTP/OPV/HIB/MMR 13APR93 & devel sz w/t105; pt taken to ER & treated for ear infect;
SIXTH DOSE FROM VACCINE VIAL ADMINISTERED WHEN ONLY 5 DOSES INTENDED PER VIAL
Information has been received from a health professional concerning a 59 year old female who on 18-FEB-2008 was vaccinated with a 0.65 ml. subcutaneous dose of Zostavax (Oka/Merck) (lot# 659324/1835U). After receiving the vaccine (approximately 18-FEB-2008), the patient experienced injection site reaction, and blisters the size of a palm of a hand on the arm. The patient was seen in the office by the physician and was given a diagnosis of cellulitis. No laboratory or diagnostic studies were performed. Treatment was not reported. At the time of this report, it was indicated that the patient was recovering. A product quality complaint was not reported. A lot check was requested. This is one of two reports from the same source. Additional information has been requested.
CHILD DEVELOPED A NOSE BLEED AFTER RECEIVING H1N1 NASAL SPRAY. CHILD'S TEMP WAS 100.0. PARENT STATED NOSE BLEEDS ARE COMMON. CHILD SENT HOME W/ PARENT DUE TO ELEVATED TEMP. F/U W/ PARENT [FOC] WHO STATED CHILD IS FINE.
Pt had already finished the Hep B series, and the Hep B vaccine should not have been given. No immediate adverse reaction.
On 2nd day that morning woke up with very sharp pains on my left neck and ear was painful; This is a spontaneous report from a contactable consumer (Patient). A 69-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EN9581), via an unspecified route of administration, administered in Arm Left on 29Jan2021 15:30 as single dose for covid-19 immunisation. Medical history included diabetic hypertension, covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took codeine, morphine and iodine and experienced drug hypersensitivity. On 02Feb2021 02:00, the patient reported on 2nd day that morning woke up with very sharp pains on my left neck and ear was painful. On 2nd day that morning woke up with very sharp pains on my left neck and ear was painful I did advil 800mg each 6hour. It did remove pain Tylenol 1000 also didn't remove pain use heating pad didn't remove did get to see my doctor on 02Feb2021 still having sharp in neck and back of head. The action taken in response to the event for BNT162B2 was not applicable. Therapeutic measures were taken as a result of on 2nd day that morning woke up with very sharp pains on my left neck and ear was painful. The outcome of event was not recovered.
67-year-old male presents emergency department with rhinorrhea, nasal congestion, nonproductive cough he chest tightness in past few days. He states his son was surrounded by several people have tested positive for Covid. He states that his son's testing is currently pending. He denies any chest pain, nausea, vomiting, diaphoresis, numbness, tingling, weakness, abdominal pain, flank pain, rash, ear pain, headache, photophobia, phonophobia, change in vision, or other concerns or complaints at this time. He has not attempted any medications or treatments for symptoms and denies any exacerbating or relieving factors. Office Visit 2/8/2021 Urgent Care  PA-C Family Medicine Suspected COVID-19 virus infection Dx Cough  ? Nasal Congestion  ? Chest Pain  ? Covid-19 Screening  ? Generalized Body Aches ? Headache Reason for Visit
Pt recvd 3 doses of Engerix-B in 1989; Titer tested 16APR91 & found to be a non-responder; given a booster dose; titer tested again OCT91 remained a non-responder; 2nd booster is being considered;
Woke up the next morning super weak and nauseous. Had little energy and no appetite. Slept most of the day. Friday (3 days after) felt tired and weak.
Fever, muscle pain all over the body, joint pains all over, especially kidney area,  strong headache, sleeping all day.
because hog a shingles recurrence/It sucks and the vaccine seemed to have reactivated it in me/Suspected vaccination failure; because hog a shingles recurrence/It sucks and the vaccine seemed to have reactivated it in me; deep deep sciatic pain; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: because hog a shingles recurrence/It sucks and the vaccine seemed to have reactivated it in me/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: because hog a shingles recurrence/It sucks and the vaccine seemed to have reactivated it in me) and sciatica (Verbatim: deep deep sciatic pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and sciatica were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and sciatica to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and sciatica to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-Mar-2023 The case was received from the patient via interactive digital media. The patient stated that unfortunately the shot did not work for everyone, he or she in that 9 percent , dang it. The patient stated that his or her deep deep sciatic pain was off the charts this last month because the shingles recurrence.  Any relief ideas welcome, please. The patient stated that he or she still got them. The patient combined two other vaccines on the same day and his or her immune system might have been overwhelmed. 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.
days/couple weeks she found a red patch on left arm; Felt a little warm the second day of first dose (left arm); soreness after first dose (left arm); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness after first dose (left arm)), VACCINATION SITE WARMTH (Felt a little warm the second day of first dose (left arm)) and ERYTHEMA (days/couple weeks she found a red patch on left arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     Concomitant products included BUDESONIDE (PULMICORT) for Asthma, OLMESARTAN for Blood pressure abnormal, MIRTAZAPINE for Insomnia NOS, ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS) for Macular degeneration, BUPROPION HYDROCHLORIDE (WELLBUTRIN), BIFIDOBACTERIUM LACTIS (PROBIOTIC [BIFIDOBACTERIUM LACTIS]), MONTELUKAST, CALCIUM, OMEGA-3 [OMEGA-3 NOS] and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness after first dose (left arm)). On 27-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Felt a little warm the second day of first dose (left arm)). On an unknown date, the patient experienced ERYTHEMA (days/couple weeks she found a red patch on left arm). At the time of the report, PAIN IN EXTREMITY (soreness after first dose (left arm)), VACCINATION SITE WARMTH (Felt a little warm the second day of first dose (left arm)) and ERYTHEMA (days/couple weeks she found a red patch on left arm) outcome was unknown. Early morning on 24Feb2021(2 extra strength Tylenol) night on 23Feb2021 took (2 extra strength Tylenol) on 23Feb2021 took (2 Extra Strength Tylenol)      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medications were reported.
tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Jan2022, outcome "unknown" and all described as "tested positive for Covid". It was reported that the patient tested positive for Covid on 12Jan2022 (reported as last Wednesday). The patient had no symptoms till 18Jan2022 when she/he tested negative in a home test in Jan2022. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) positive, notes: Wednesday; (Jan2022) negative.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Narrative:  COVID infection following COVID vaccine series 03/12, Pfizer, dose #1 04/09, Pfizer, dose #2 12/24 COVID swab, result: detected 12/24 pt cc: sore throat, myalgias, sore throat, rhinorrhea and a dry, non-productive cough. exposure: unknown 12/24 SARS-COV-2 Variant Sequencing: pending 12/24 pt admit ED cc: sore throat, myalgias, sore throat, rhinorrhea and a dry, non-productive cough dx: Covid-19 LOS: 1 day
The patient is suffering from nausea, vomiting, profuse sweating, a large lump under the left armpit and inability to eat.
Redness at the injection site; Swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) in a female patient of an unknown age 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 VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Pt says she felt dizzy and that things were spinning immediately after the shots were injected. She says this feeling lasted about 1 week after the shots.
PATIENT STATES HE HAS RED AREAS ON BOTH ARMS (OPPOSITE OF ELBOWS). VERY RED, ERYTHEMA. AREA IS ROUGHLY 6 INCHES, IN AN OBLONG SHAPE. THIS IS BILATERAL TO BOTH ARMS AND SYMMETRICAL.
Patient developed hives and red lesions related to a rash on his entire chest, stomach/abdomen area, back and back of his neck. Patient stated he noticed the symptoms started 3/27/18 in the morning before he went swimming. He stated the rash was not painful or itchy.
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS POSTURAL (dizzy when he stand up), FATIGUE (fatigue) and NAUSEA (nausea) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012120A and 010M20A) for COVID-19 vaccination. Concomitant products included AMLODIPINE, LOSARTAN and METFORMIN for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS POSTURAL (dizzy when he stand up), FATIGUE (fatigue) and NAUSEA (nausea). At the time of the report, DIZZINESS POSTURAL (dizzy when he stand up), FATIGUE (fatigue) and NAUSEA (nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided.
I have a ball (nodule) in my left arm and it is swollen. It hurts a lot.
?Covid Arm? experienced 8 days after first dose and today, a few hours later after second dose. Large, red, swollen oval patch at vaccination site, hot, painful, itchy.
A week after first dose, I had an extremely heavy period. Even when it ended, I?ve still been spotting daily all month and look like I?m starting another period a week early.  I am perimenopausal and irregular but I haven?t had that type of extreme heavy flow since I was in my 20?s. No bad cramps though which is good.
Vertigo type symptoms; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in the left arm on 01Apr2021 at 09:15 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 15:30, in the afternoon, the patient experienced vertigo type symptoms. The event resulted in doctor or other healthcare professional office/clinic visit. The patient was given information regarding vertigo and treatment included chiropractic adjustment. The clinical outcome of the event vertigo type symptoms was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Soreness started at injection site about 2 PM and migraded down my arm into fingers sending sharp pains.  By 6 PM my shoulder was very sore and couldn't lift my arm.  I woke and 12:14 and my left side was sore and stiff, including ribs and collar bone.  My left breast felt like it was in a vice.  I woke at 6:18 and my ribs were better but the pain in the shoulder and arm is still very painful.  I am very tired.
problem with shot site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had Shingle's Shot problem with shot site.
pt recvd vax & 6 days post vax presented w/erythema multiforme;tx DPH then atarax & steroids
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 11-JAN-2019, the patient was vaccinated with improperly stored dose of PROQUAD (lot # R017800, expiration date: 19-DEC-2019, dose and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent. No adverse effects were reported. Administered dose of PROQUAD experienced temperature excursion between -14 to -10 Celsius degrees for 30 minutes. There was no previous temperature excursion reported. Digital data logger was involved. This is one of seven reports received from the same reporter. Sender's Comments: US-009507513-1901USA009536.
injection arm red rash patch; injection arm itch; injection arm pain; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (injection arm red rash patch), PRURITUS (injection arm itch) and PAIN IN EXTREMITY (injection arm pain) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced RASH ERYTHEMATOUS (injection arm red rash patch), PRURITUS (injection arm itch) and PAIN IN EXTREMITY (injection arm pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RASH ERYTHEMATOUS (injection arm red rash patch), PRURITUS (injection arm itch) and PAIN IN EXTREMITY (injection arm pain) outcome was unknown.
A few min after the shot I felt a strange cool, airy feeling in my chest. A little light headed. Went away within 3 min.
I experienced menstrual like cramps and minor lower back aches. Later during the day the cramps started to calm down, At nighttime I experienced flu like symptoms, I started to feel a sore throat that was by my tonsils. I also had aches under my eyes The next day I still had a sore throat and I also experienced earaches. A couple days later the eye aching got worse. I also started to have sharp pains in my stomach. I  also wasn't able to eat anything , when I did eat one snack I felt very stuffed. I experienced a minor headache. At night a couple days later I still had experienced some more stomach aches that became very painful. When I start going to the bathroom I saw some blood. Couple weeks later I felt a little bit better , I by chance pushed on my lower stomach area close by my pelvis and it felt very sore. After all this I felt better and gained my energy back. Then that's when I felt the stomach pains  by my kidney again and the menstrual like cramps. Not until May did all of my cramps and pains come to a stop.
Itching which progressed to rash, then within next 2 days to wheezing and shortness of breath.
Breakthrough COVID-19 infection  Headache, congestion, cough, fever, chills, anosmia
Patient received vaccination and then while sitting to wait for his father to receive his vaccination he began to slump over having a syncope event and some mild shaking. Patient quickly came to and was confused and disoriented. 911 was called to assess patient and after assessment patient was able to leave on his own efforts.
Increase in frequency but not severity/quality of hot flashes.  Starting the day following the shot, and for about a week, I was having frequent (estimating 5 to 8) hot flashes each day.  In the last couple of days it has declined to 2 or 3 per day.  My typical frequency prior to the shot was about once every two days.
13 July shortness of breath shortly after receiving the vaccine--rest and fresh air improved symptom. 17July red itchy bumps around neck, chin and jaw--washed area and refrained from scratching. Symptom dissipated over a couple days. 18 July wet intermittent cough began and lasted for a couple weeks--zinc, vit C, neti pot and good hydration to treat.