chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Some of worst pain he had in his life in his arm; he was not able to raise his arm up, it was agonizing; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received first dose of bnt162b2 (BNT162B2, lot number: EW0158), via an unspecified route of administration on 07Apr2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Some of worst pain he had in his life in his arm, the patient guess it just the fourth day it was better today (unspecified), the patient could nearly lift arm all the way up, it had been very sore but for two days he was not able to raise his arm up, it was agonizing, the third day he could, yesterday he could kind of raise a little bit but today he raised it but it's still hurt. The last 11 years he was on top of the world, he never had a vaccine for anything that hurt like this did and he was not really feeling safe about going and getting another one if it is going to be worse. The patient would like some guidance from somebody. He had not talked to anybody that hurts like this (Clarification unknown). Treatment just took Tylenol. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Patient was given J&J vaccine at approximately 2:00pm on 11/16/21. During  his 15 minute observation period, the client reported "not feeling well" and that his heart was racing. Client c/o nausea, and subsequently began vomiting.  Vital signs were as follows: BP 133/87 Pulse 98 Oxygen Saturations 99%.  The client was taken to an exam room to lay down at approximately 2:15. Client was asked if he was having difficulty breathing. He responded that his chest was tightening. Supplemental oxygen provided via nonrebreather.  0.3mg of epinephrine was administered via Epi Pen to right thigh and emergency was called. Vitals signs at 2:23 were as follows BP 133/88 pulse 92 Oxygen Sats 99%. Vitals at 2:28 pm were as follows: 147/85 Pulse 93 oxygen saturation 100%. Medics arrived on seen. Patient left facility on a stretcher to the hospital.
Patient received the Moderna COVID-19 vaccine at her place of employment as a phase 1A essential frontline healthcare worker in a skilled nursing LTC facility on January 6 2021. The day after receiving the vaccine (1-7-21), she started to feel increased shortness of breath (she has shortness of breath at baseline due to chronic health conditions- CHF, asthma), a heavy feeling in her chest/lungs, sweating and fatigue. She contacted the pharmacy on January 8th, as we were the entity that vaccinated her to ask about vaccine reaction. Due to her medical history of MI and CHF, pharmacist did not want to dismiss this as a reaction to the vaccine, and recommended that she contact her doctor for further guidance. She did reach out to her care team, and ended up going to the emergency room for testing due to cardiac history and presentation of symptoms. She had diagnostic testing done (see item 19) and the ER doctor attributed her symptoms to an exacerbation of CHF and asthma, noting that vaccine involvement in the worsening of her symptoms can not be ruled out. Treatment/discharge instructions include: follow up with cardiology/pulmonology, furosemide dose was increased, potassium supplement restarted, and instructed to use inhalers already on hand when needed. As of time of report on January 9 2021, the patient was resting at home, doing well except still having symptoms upon exertion.
Sweating; Rash all over the upper torso and his back; Whole body is sore and achy; Chills; Fever of 102.6F; Pain in his arm to his hand on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), RASH (Rash all over the upper torso and his back), VACCINATION SITE PAIN (Pain in his arm to his hand on the injection site), MYALGIA (Whole body is sore and achy) and CHILLS (Chills) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (The patient is allergic to Haldol) and Drug allergy (The patient is allergic to Stemzine).    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced VACCINATION SITE PAIN (Pain in his arm to his hand on the injection site). On 29-Jul-2021, the patient experienced HYPERHIDROSIS (Sweating), RASH (Rash all over the upper torso and his back), MYALGIA (Whole body is sore and achy), CHILLS (Chills) and PYREXIA (Fever of 102.6F). At the time of the report, HYPERHIDROSIS (Sweating), RASH (Rash all over the upper torso and his back), VACCINATION SITE PAIN (Pain in his arm to his hand on the injection site), MYALGIA (Whole body is sore and achy), CHILLS (Chills) and PYREXIA (Fever of 102.6F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2021, Body temperature: 102.6 (High) 102.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  It was reported that the patient drank a lot of water as part of treatment.
This spontaneous report as received from a licensed vocational nurse (LVN) refers to a 13 year old female patient with no pertinent medical history and no known drug reactions/allergies. On 08-AUG-2011 the patient was vaccinated with GARDASIL lot # 0626AA dose 1 (route and site not reported). On 21-OCT-2011 the patient was vaccinated with GARDASIL lot # 1140AA dose 2 (route and site not reported). There was no concomitant medication. After each dose, on approximately August and October 2011 respectively, the patient experienced lightheadedness. No treatment was given for the adverse event. The patient spoke to physician for medical attention. No lab diagnostic tests were performed. On an unspecified date the patient recovered from lightheadedness. The causal relationship was not reported. Additional information has ben requested.
Consumer has two types of skin lesions; type 1 is in patches and tiny bumpy itching and burning; she developed skin rash in the face, scalp, back, neck, on the chest, arms, and fingers/ tiny bumpy itching; burning like crazy; red cone shape which looks like chicken pox; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning like crazy), ERYTHEMA (red cone shape which looks like chicken pox), SKIN LESION (Consumer has two types of skin lesions; type 1 is in patches and tiny bumpy itching and burning) and RASH (she developed skin rash in the face, scalp, back, neck, on the chest, arms, and fingers/ tiny bumpy itching) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced BURNING SENSATION (burning like crazy), ERYTHEMA (red cone shape which looks like chicken pox) and RASH (she developed skin rash in the face, scalp, back, neck, on the chest, arms, and fingers/ tiny bumpy itching). On an unknown date, the patient experienced SKIN LESION (Consumer has two types of skin lesions; type 1 is in patches and tiny bumpy itching and burning). The patient was treated with CORTISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (burning like crazy), ERYTHEMA (red cone shape which looks like chicken pox) and RASH (she developed skin rash in the face, scalp, back, neck, on the chest, arms, and fingers/ tiny bumpy itching) had not resolved and SKIN LESION (Consumer has two types of skin lesions; type 1 is in patches and tiny bumpy itching and burning) outcome was unknown.            No concomitant medication was reported.  biopsy was done on one of the patch lesions   This case was linked to MOD-2021-294343 (Patient Link).
Shingles rash; blisters appeared on the left side of the back and left under arm; red spots to darker spots; Irritation by her bra; Red spots; blisters are present but they are starting to crust over; pain all over the place where the rash was present; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st December 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 9th January 2020, 9 days after receiving Shingrix, the patient experienced pain. On an unknown date, the patient experienced shingles, blister, skin discoloration, skin irritation, red spotty rash and crust. On an unknown date, the outcome of the shingles, blister, skin discoloration, skin irritation, pain, red spotty rash and crust were unknown.   It was unknown if the reporter considered the shingles, blister, skin discoloration, skin irritation, pain, red spotty rash and crust to be related to Shingrix.  Additional details were provided as follows: Patient received Shingrix about a week later she started experiencing irritation by her bra rubbing underneath the arm. Next day blisters appeared on the left side of the back and left under arm. It got worse and worse and it wrapped around the left breast. It went from red spots to darker spots. It wrapped from middle of the spine, to the back, under the arm and over the breast.  All of this occurred on left side of the body. Patient stated that her back looked like was someone had whipped her and then it started to go away.  The blisters are present but they are starting to crust over on some of them.  On 8th January 2020 she visited her doctor, and she was confirmed to have Shingles. On 9th January 2020 she experienced pain all over the place where the rash was present, especially her breast area. Reporter consented to follow up.
I had covid in oct. 2021.  I loss sense of smell. I had covid pneumonia. I had a constant cough. I had abnormal oxygen levels. I was tired and super fatigue. I had headaches.  I did have a running nose.  Then I was diagnosed with hep B  in Nov 2021. I've never had that before.  After that, I had RSV a month later on Dec 2021. I had shortness of breath. it kept getting worse and worse. I was also hospitalized for 5 days.  I've recently been dealing with bronchitis. My 1st diagnosis was May 20th. I developed it twice in a month.
ALLERGIC DERMATITIS. TREATED WITH HYDROXAZINE 25 MG PO #90; PREDNISONE 20 MG #12
Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Mar2021 at 08:30 as dose 1, single (Lot number: EN6206), in right arm, on 28Mar2021 as dose 2, single (Lot number: ER8730), in right arm and on 10Nov2021 at 11:00 as dose 3 (booster), single (Lot number: F148028) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: 2006 (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hyperthyroid" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: Jun2005, stop date: Apr2022; SERTRALINE, start date: May2006, stop date: 27Apr2022; LEVOTHYROXINE, start date: Feb2006, stop date: Apr2022; ATORVASTATIN, start date: May2018, stop date: Apr2022; GLUCOSAMINE & CHONDORITIN, start date: May2005, stop date: Apr2022; VITAMIN D [VITAMIN D NOS], start date: Feb2002, stop date: Apr2022; CALCIUM + MAGNESIUM, start date: Feb2021, stop date: Apr2022; ALIGN, start date: May2020, stop date: Apr2022. Past drug history included: Erythromycin, reaction(s): "Known Allergies: Erythromycin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 16Apr2022, outcome "not recovered" and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: Oestrogen receptor assay: (unspecified date) Positive; Progesterone receptor assay: (unspecified date) Positive; SARS-CoV-2 test: (25Apr2022) Negative; (27Apr2022) Positive. Therapeutic measures were taken as a result of covid-19. Clinical course: I finished the course of Paxlovid on 20Apr2022. Tested negative for COVID on 25Apr2022. Upper respiratory symptoms recurred on 26Apr2022. Tested positive for COVID on 27Apr2022.  No follow-up attempts are possible. No further information is expected.
Flushing, hives, chest pain, shortness of breath few minutes after administration of immunizations.
On 06/23/2007 around 10:30pm patient was sleeping when she began convulsing.  Convulsions lasted for about 15 seconds and then she paused, opened her eyes, looked in my direction (took 1-2 seconds to do this) and then her eyes rolled up and she began convulsing again, this time lasting around 10 seconds.  Patient was then quiet for a second before she woke up screaming.  Patient was back asleep about 2 minutes later.  Total elapsed time was about 2.5 minutes.
Patient received undilated dose of Pfizer vaccine. Administering technician, thinking that the pharmacist previously diluted the vial, failed to add the diluent while drawing up and administered the dose. Patient has not yet experienced any adverse reaction on Day 1. However, the patient  has had a recent bout of COVID infection and is likely to experience some systemic side effects.
FEVER OF 105 ON 8/8/09 WENT TO ER, CXR, BLOOD TEST NEGATIVE. THEN FEVER ON 8/10/09 102.2-TYLENOL & MOTRIN FOR FEVER, INCREASE FLUIDS, FEVER RESOLVED BUT ON 8/13/09 RETURNED WITH RASH ALL OVER BODY.
the dose of PEDVAXHIB was mixed with sterile diluent so the patient received atotal of 1.2 mL; the dose of PEDVAXHIB was mixed with sterile diluent so the patient received atotal of 1.2 mL; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 19-JUN-202, the patient was vaccinated with a dose of  haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T024020 exp date 31-MAR-2023). The nurse stated that the medical assistant that prepared the dose mixed haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) with sterile diluent so the patient received a total of 1.2 mL. The nurse also stated that the patient received the complete 0.5 mL haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) dose, but it was mixed with 0.7 mL of sterile diluent.
Easily bruising after 2nd primary shot; Blisters in the mouth after 2nd primary shot; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Easily bruising after 2nd primary shot) and ORAL MUCOSAL BLISTERING (Blisters in the mouth after 2nd primary shot) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced CONTUSION (Easily bruising after 2nd primary shot) and ORAL MUCOSAL BLISTERING (Blisters in the mouth after 2nd primary shot). At the time of the report, CONTUSION (Easily bruising after 2nd primary shot) and ORAL MUCOSAL BLISTERING (Blisters in the mouth after 2nd primary shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment was reported.   This case was linked to MOD-2022-541772 (Patient Link).
12 hours after booster dose, severe chills, headache and dizziness.  No adverse affects were noted from first two doses.
Pt. developed rash to abdomen within 3 hours of receiving vaccine. Was seen by dr. at clinic. Given DECADRON IM, hydrocortisone cream and TYLENOL. Pt was seen again the next day 9/28. Rash was gone. RN tried to contact 7/22 but no answer.
Don't think the boosters are safe and neither was the initial 2 vaccinations I received. Still got Covid and a bad case; Don't think the boosters are safe and neither was the initial 2 vaccinations I received. Still got Covid and a bad case; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Don't think the boosters are safe and neither was the initial 2 vaccinations I received. Still got Covid and a bad case".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
-Friday-Monday 8/5-8 random intermittent muscles spasms all over body -Shot Wednesday 8-3 -Big red, hot, itchy welt with redness spreading & bruise 8/5-9 -Same welt reappeared 8/10-13 with large red ring around it -Massive leg cramp for at least 1 min on 8/9 -Random intermittent chest pains behind breasts from 8/9-11 & 16-17 -Dark bruise about 2 inches below welt from 8/9-15 -Whole body itchiness 8/11-present -Shingles nerve pain 8/9-present -Left arm numbness 8/11 - Nosebleed 8/11-12 & 8/14 - Anti itch & lidocaine cream made welt worse - Benadryl had no effect - No relief with Pepcid & Claritin  - Right earache 8/16 - Increased sneezing 8/13
70x85mm erythema & induration lt deltoid;area is hot;last booster 1975;pt given ATB;
Hives over joints of fingers, wrist, elbows, knees and ankles.  Developed on 2/12/2021, 8th day after vaccine was administered.  He went to MD on 2/15/2021 and was given steroid shot and started on prednisone. Reports that hives have improved greatly when I spoke with him on 2/17/2021.
This is a breakthrough covid case. This patient received both pfizer doses, completed series 1/11/21. Tested positive for covid 7/1/21. She had a community exposure.
Child presented to our office on 10-23-08. Left arm swollen, red, warm to touch. No fever. c/o arm pain. Area around injection site looked.
developed 'bumps' that are big like mosquito bites; left hand started tingling, pain, itching and gradually migrated up her left arm (opposite of injection); left hand started tingling, pain, itching and gradually migrated up her left arm (opposite of injection); left hand started tingling, pain, itching and gradually migrated up her left arm (opposite of injection); left arm really swollen; left arm really swollen and irritated; This is a spontaneous report received from a contactable consumer or other non hcp. A 44-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0182), via an unspecified route of administration in Arm Right on 03Jun2021 (age at vaccination 44years old) as single dose for covid-19 immunisation. Medical history included ongoing diabetes mellitus diagnosed from 20 years ago. The patient's concomitant medications were not reported. She received her first dose of the Pfizer Biontech Covid 19 vaccine on 03Jun2021 in right arm/shoulder. On 05Jun2021, she started have problems with opposite side; left hand started tingling, pain, itching and gradually migrated up her left arm (opposite of injection) and then she noticed the 'bumps'. Not only bumps but also itching and left arm really swollen and irritated. So to clarify, on the left side, she has 8 bumps on arm and elbow and one on her index finger. On her right side, she has one bump on right index finger and one on right arm (that was just noticed today). The area is Irritated, and she has tried cortisone, alcohol, hair dryer, but nothing is working. She took Benadryl last night and it helped her to get some sleep. The bumps are getting worse; they are not as swollen today, compared to yesterday. This was about mid-night on 05Jun2021. she has these little bumps, some are really big bumps, kind of like mosquito bites. there is no bite puncture, the bumps are hard and itchy. It is the same reaction she gets to a mosquito bite. she knows everybody is different. The bumps are hard and risen and hot to the touch and just itchy. her whole arm where the bumps are just itches. the bumps are on both hands, especially worse is on the left hand. The outcome of the events was unknown. Therapeutic measures were taken as a result of developed 'bumps' that are big like mosquito bites, left hand started tingling, pain, itching and gradually migrated up her left arm, left hand started tingling, pain, itching and gradually migrated up her left arm, left hand started tingling, pain, itching and gradually migrated up her left arm, left arm really swollen, left arm really swollen and irritated.  Follow-up (07Jun2021): This is a follow-up spontaneous report from a contactable consumer. This 44-year-old female consumer (patient) reported that: Report Type, HCP postal address, Dates for Reading through side effects and is getting, has like these bumps, Suspect product information, Other Products, Patient History.  No follow-up attempts are needed. No further information is expected.
Cough, aches followed by fever 102, we do not know how to treat it.
False and Inconsistent RPR Reactivity following Moderna 2nd dose. Presented with no syphilis symptoms. Has no history of syphilis and no history of receiving syphilis treatment.
morphea on shin  currently under care of dermatologist  waiting on  rheumatology appointment
SkinRash, Rash, 8cm Oval red rash surrounding injection site. Itching started on 12/30/20. Area is non-raised with no warmth noted.
Per conversation with patient on 10/18/2021, no adverse reactions noted other than a sore arm that lasated only a few hours.
Could barely walk, very achy, felt like balk was gonna split in two, could not get enough fluids, felt like a ton of bricks on my shoulders
On 4/5/2019 Pneumococcal 23 in OUR office left ARM Lot # R031961 Slight tender. Received Shingrix Vaccine ON 4/23/19.  Woke up middle of night pneumococcal site "on fire" Body aches fever foR 1 month abnormal liver, renal function and elevated CRP and Sed rate with muscle weakness
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 08-JUL-2016 the patient was vaccinated with an improperly stored dose of GARDASIL single-dose vial (SDV) lot # L035105 expiration date 14-MAY-2017, dose and route were unspecified. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of 8.7 Fahrenheit degree (also reported as Celsius degree). The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 9 Fahrenheit degree (also reported as Celsius degree). The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.