chrisvoncsefalvay/vaers-outcomes huggingface dataset:
collapsed left lung; Does not feel good; tired all the time; Left arm pain; feel terrible; Pain spread to middle of chest; Painful to breathe; Hard to get a breath; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PNEUMOTHORAX (collapsed left lung) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0470 2orZ 1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced PNEUMOTHORAX (collapsed left lung) (seriousness criteria hospitalization, medically significant and intervention required). On 20-May-2021 at 7:30 PM, the patient experienced FEELING ABNORMAL (feel terrible), CHEST PAIN (Pain spread to middle of chest), PAINFUL RESPIRATION (Painful to breathe), DYSPNOEA (Hard to get a breath) and VACCINATION SITE PAIN (Left arm pain). On an unknown date, the patient experienced FEELING ABNORMAL (Does not feel good) and FATIGUE (tired all the time). The patient was hospitalized for 3 days due to PNEUMOTHORAX. The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and Surgery (Tube placement in her chest) for Pneumothorax. At the time of the report, PNEUMOTHORAX (collapsed left lung), FEELING ABNORMAL (feel terrible), CHEST PAIN (Pain spread to middle of chest), PAINFUL RESPIRATION (Painful to breathe), DYSPNOEA (Hard to get a breath), FEELING ABNORMAL (Does not feel good), VACCINATION SITE PAIN (Left arm pain) and FATIGUE (tired all the time) outcome was unknown. Not Provided          No concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.  Patient stated that she had hole in the chest due to the tube placement to treat her collapsed lung.  It was reported that the patient experienced symptoms on 20 May 2021.  Company comment: 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.   This case was linked to MOD-2021-169206 (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 events, a causal relationship cannot be excluded.
Sharp and tight pain in shoulder area between neck and upper shoulder on left side.  Followed by an extreme spike in blood pressure and pulse rate.  Also included a clammy sweating from forehead.  Volunteer nurse took blood pressure.  Top number rose over 185.  Bottom number over 100.  At one point 175/153.  I?ve never had a high blood pressure health problem.  Pulse was accelerated and heart began to palpitate irregularly.  I laid down on reclining medical chair.  Chest, neck, ears began to turn red.  A few hives started to pop up.  Nurse had me take 50mg of Benadryl.  I was under observation by the staff for 2 hours.  During that time my adrenaline accelerated and I began to shake sporadically.  I continued to rest, drink water and eat crackers.  I was sent home once blood pressure got to approximately 153/80.
Caller reported patient only got 1 dose of GARDASIL 9 in OCT 2022. Patient missed 2nd dose. No additional; AE reported. No PQC reported. AE follow up letter was not sent as caller denied consent. No further information was provided.; No additional AE reported.; This spontaneous report was received from a pharmacist, referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unspecified day in October 2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, vaccination scheme, anatomical site of vaccination, route of administration, lot number and expiration date were not reported) as prophylaxis.  On an unknown date, the patient missed the second dose (product dose omission issue). No additional adverse event reported.
Itchy watery eyes, sneezing, coughing and wheezing and later on, fever. Took 2 benadryl and inhaler (albuterol)
Moderna COVID-19 Vaccine EUA  Left sided nerve pain, mid thoracic region posterior and mid-axilary, back of left leg and left lateral foot. Sensitive to light touch. Generalized Body chills and lethargy. Left sided body aches.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 08-SEP-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 0.5 ml orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported).  The improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
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 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 10:25 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 10:25 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, 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 26.17 for dose administered on 13-Feb-2021.  No concomitant medications were reported. Batch number 031L20A underwent temperature excursion on 13-Feb-2021 with temperature 32 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-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 Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
Light-heartedness, headache, slight fever, pain/soreness at injection site, on day 2.
This is a spontaneous report received from a non-contactable reporter (Consumer or other non-HCP). The reporter is the patient. A 35-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) on 05Apr2022 as dose 1, single (Lot number: unknown), at the age of 35 years, in the left arm for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19: Yes. The patient did not receive any concomitant medications. The following information was reported: HEART RATE INCREASED (non-serious) with onset 03May2022, outcome "not recovered", described as "Fast heartbeat occurred 4 weeks after". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of the heart rate increased. Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a registered nurse concerning a patient of unknown age and gender, who on 28-MAR-2012, was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported), on 30-MAY-2012 the patient received the second dose of GARDASIL (dose, route and lot # not reported) and the third dose of GARDASIL (dose, route and lot # not reported) on 20-JUN-2012. The patient was not experiencing any known symptoms. Additional information has been requested.
H1N1 mist was given and my son had a nose bleed and has had them once daily spontaneously since.
losing taste; 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 AGEUSIA (losing taste) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (losing taste). At the time of the report, AGEUSIA (losing taste) outcome was unknown.            Concomitant medications were not provided by the reporter.  Treatment information was not reported.
Strong metal taste in my mouth.  Started after the 1 dose.  But now, after the second dose, it is much more pronounced.; My tongue is covered with a white pus-like substance/oral thrush; My entire mouth cavity feels like I drank a very hot liquid that burned my month; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 11:00 (Lot number: EW0150) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Sjogrens syndrome" (unspecified if ongoing). Concomitant medication(s) included: PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]. Vaccination history included: Bnt162b2 (lot number: ENW99,, administration time: 10:30 AM, vaccine location: Left arm, dose number: 1), administration date: 19Mar2021, for COVID-19 immunisation, reaction(s): "Strong metal taste in my mouth". The following information was reported: DYSGEUSIA (non-serious), outcome "not recovered", described as "Strong metal taste in my mouth.  Started after the 1 dose.  But now, after the second dose, it is much more pronounced."; ORAL CANDIDIASIS (non-serious), outcome "not recovered", described as "My tongue is covered with a white pus-like substance/oral thrush"; ORAL DISCOMFORT (non-serious), outcome "not recovered", described as "My entire mouth cavity feels like I drank a very hot liquid that burned my month". The events "strong metal taste in my mouth.  started after the 1 dose.  but now, after the second dose, it is much more pronounced.", "my tongue is covered with a white pus-like substance/oral thrush" and "my entire mouth cavity feels like i drank a very hot liquid that burned my month" were evaluated at the physician office visit. Therapeutic measures were taken as a result of dysgeusia, oral candidiasis, oral discomfort.  Additional information: the patient had no other vaccine in four weeks. Strong metal taste in her mouth. Started after the 1 dose. But now, after the second dose, it was much more pronounced. Her tongue was covered with a white pus-like substance. Her entire mouth cavity felt like she drank a very hot liquid that burned her month. Treatment for oral thrush with oregano. The patient had no covid prior vaccination. She was not covid tested post vaccination.   No follow-up attempts are possible. No further information is expected.
CHRONIC HYPOXEMIC RESPIRATORY FAILURE 12/1/2022, ACUTE ON CHRONIC HYPERCAPNIC RESPIRATORY FAILURE
menstrual stopped completely; hot flashes; pre menopausal symptom; Other vaccine same date vaccine date 15Oct2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15Oct2021 (Lot number: Fe3592) at the age of 51 years as dose 3(booster), single for covid-19 immunisation. Relevant medical history included: "Muscle spasms" (unspecified if ongoing); "anemia" (unspecified if ongoing); "mitral valve" (unspecified if ongoing); "prolapse" (unspecified if ongoing), notes: mitral valve prolapse. Concomitant medication(s) included: FLU, administration date 15Oct2021; VITAMIN D3; TYLENOL; ZINC; BACLOFEN. Past drug history included: Flagyl, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Er8732, Location of injection: Arm Right), administration date: 26Mar2021, when the patient was 51 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: En6204, Location of injection: Arm Right), administration date: 05Mar2021, when the patient was 51 years old, for Covid-19 Immunization. The following information was reported: AMENORRHOEA (non-serious) with onset 15Oct2021, outcome "not recovered", described as "menstrual stopped completely"; HOT FLUSH (non-serious) with onset 15Oct2021, outcome "not recovered", described as "hot flashes"; MENOPAUSAL SYMPTOMS (non-serious) with onset 15Oct2021, outcome "not recovered", described as "pre menopausal symptom"; PRODUCT USE ISSUE (non-serious) with onset 15Oct2021, outcome "not recovered", described as "Other vaccine same date vaccine date 15Oct2021". The events "menstrual stopped completely", "hot flashes", "pre menopausal symptom" and "other vaccine same date vaccine date 15oct2021" were evaluated at the physician office visit. Therapeutic measures were taken as a result of amenorrhoea, hot flush, menopausal symptoms, product use issue.  Additional information: Patient was advised to take magnesium for hot flashes. The patient was not diagnosed with covid prior to vaccination. The patient was not tested for covid post vaccination. patient did not receive other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected.
headach, runny nose, orange/reddish coloring in 3" circle at injection site, 14 days after injection, lasted 6 hours.
Itching, swelling, rash, around the site of the needle, by morning it was bright red and very sore, latest until 10-4-2012.
Pt got Pfizer pediatric dose instead of adult booster dose of J&J-PCP to notify patient and patient is to return for correct dose.
On 29 October 2001, the vaccinee received an injection of Engerix-B. It was not known if she had received previous injections of Engerix-B. On a unspecified date, the vaccinee developed a local reaction at the injection site that was 4 inches in diameter. As of 31 October 2001, the outcome of the event was unknown.
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in an 82-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.    For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant product use was reported. Date the vial was initially stored in the refrigerator was unknown. Expiration date was reported as 07-APR-2022.  The vial did not undergo any temperature excursions.  No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains Non significant information.
swelling of upper arm-more than usual; warm, but not localized; swelling hot & tender arm;
fainting vs mild seizure, recovered in less than 1 minute, but had 2 brief episodes of stiffening/posturing during that time (occurred about a minute after vaccines were given)
I had an ongoing localized skin rash on left leg and right hand at time of  covid vaccination.  Approximately 2 day after shot I had single bumps/ rash on back of neck, arms and face.  I have been treating with Zyrtec and Hydrocortisone Cream.
rash; This spontaneous report was received from a pharmacist and refers to a 66-year-old male patient. The patient pertinent medical history included encephalitis (reported as developed encephalitis on an unknown date in the past), chronic obstructive pulmonary disease (COPD) and diabetes. The patient had no allergies or drug reactions.  On 11-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S018140, expiration date 02-MAR-2021, intramuscular (dose, site of administration were not provided) for prophylaxis. On 11-OCT-2019 (reported as later that day), the patient experienced a rash on his arm away from the injection site. The patient contacted the pharmacist, who recommended diphenhydramine (BENADRYL) for the rash. The outcome of the event was reported as not recovered. The causality assessment was not provided.
There is interaction with Plavix; I felt like I had a gumball on my jaw with my cheek and that felt real heavy; My tongue filled up the whole roof my mouth; I had cloudiness like when you get out of the swimming pool, you have a powder around your eyes and I had that; I could not walk; I have fallen numerous times; My legs they feel really heavy; fallen numerous times since the injection; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. Patient was also taking clopidogrel bisulfate (PLAVIX), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. On an unspecified date the patient felt like they had a gumball on their jaw with their cheek that felt really heavy. The patient thought their tongue swelled up but that's the throat so maybe that's just the throat, patient doesn't know. All patient knows was that their tongue filled up the whole roof their mouth. Patient had cloudiness described as when you get out of the swimming pool, you have a powder around your eyes. The patient called their family doctor the other day and the doctor asked the patient not to stand out, so the patient didn't get out of the car and stand out. When the patient got home, they could not walk to their front door on their own and their legs are still like that. The patient has fallen numerous times since the injection and it just their legs they feel really heavy and they are just giving down. The other thing is the patients nurse told the patient that there is interaction with Plavix. The patient couldn't put Plavix down because everybody over 50 or 60 at the most are all on blood thinners. Patient did not receive any treatment for the events. Outcome of tongue swelled and cloudiness was not recovered (patient mentioned they are still having this). For the rest of the events, it was unknown.   No follow-up attempts are possible; information about lot/batch cannot be obtained.
This spontaneous report was received from a health professional refers to 5 unspecified patients of unknown demographics. Pertinent medical history and drug allergies were not reported. On unspecified dates, these patients received doses of improperly stored PROQUAD (Merck) (lot # L002419, expiry date: 23-JUL-2016). Concomitant medications were not provided. No adverse effect was reported. Outcome of the event, incorrect product storage was unknown. Causality assessment was not provided. This is one of two reports received from the same source. Additional information has been requested.
sister had shingles vaccine, a year passed, she got shingles/ suspected vaccination failure; shingles; no pain just a little itch; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pruritus. On an unknown date, the outcome of the vaccination failure, shingles and pruritus were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pruritus to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's sister. The age at vaccination was not reported. The patient got shingles vaccine and a year passed and she got shingles. The patient had no pain just a little itch. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming herpes zoster were unknown at the time of reporting.