chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe Rash, itchy and burn, blotch of redness  all over body.  Couldn?t sleep at night and it?s going on for over 3 weeks.  Took methyl Prednisolone  for last 10 days but allergies haven?t been improve.  Please help if you can!
2-3am: shaky, chills, injection site pain (throbbing), lethargy 3-5am: shaky, chills, dizziness, heart racing, tunnel vision, injection site pain, lethargy, weakness 5-7am: shaky, chills, excessive sweating, injection site pain  7am-10am: shaky, chills, lethargy, weakness  10am-noon: weakness
Crying nonstop from 1am-8am. Shots were given at 3:20pm the day before.
Information has been received from a healthcare worker concerning a male patient who on unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot # 667914/1067Z, expire date 28-FEB-2012, route not reported). The healthcare worker reported that on an unspecified date, the patient developed redness and swelling at the injection site after administration of PNEUMOVAX 23. It was unknown if the patient sought medical attention. At the time of the report patient's outcome was unknown. This is one of two reports received from the same source. Additional information has been requested.
pt recv vax 20AUG96 & 12SEP96 pt devel a mild rash consisting of 6 itchy lesions on neck, ear, & abd;pt did not exp resp problems or a fever;pt recovered;
booster; shingles; I broke out with a red rash; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "booster"; HERPES ZOSTER (non-serious) with onset 2021, outcome "unknown", described as "shingles"; RASH ERYTHEMATOUS (non-serious) with onset 2021, outcome "unknown", described as "I broke out with a red rash". The events "shingles" and "i broke out with a red rash" were evaluated at the physician office visit.  Additional information: Consumer stated I received the drug on a Tuesday, one week later, the following Tuesday, I broke out with a red rash. I went to my doctor's office, and they told me that it was shingles, and I am thinking that was a reaction to my getting the booster or third dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
When I received the shot, I was taking Zyrtec 10 mg.  I had moderate pain for about 48 hours afther the injection.  At the beginning of January, I reduced the Zyrtec dose to 5 mg, since my seasonal allergies are decreased in winter.  One night, I forgot to take the dose. The following day, January 8, I noticed a rash about a 2 inches below the injection site.  There was itching and mild pain as well. Despite resuming Zyrtec (5 mg) that same night, the itching has persisted. The initial rash is resolving and currently barely visible. I continue to have mild, dull pain in the arm, particularly at the site of the rash.
This spontaneous report was received from a technician via nurse regarding to a 38 year old male patient. The patient's medical history, concurrent conditions were not reported. Concomitant medications included sterile diluent. On 21-JUL-2017, the patient was inadvertently vaccinated with VARIVAX (lot # M033214, expiry date 13-JUL-2018) reconstituted with a diluent for prophylaxis (dosing details unspecified) instead of ZOSTAVAX. No dose of ZOSTAVAX was administered. It was unspecified why the error occurred. It was unspecified whether product was documented incorrectly as ZOSTAVAX as a result of any product confusion. No adverse effects were reported. No further information provided. Product quality complaint (PQC) was not reported.
About 2 minutes after injection, patient became severely dizzy/lightheaded with no other symptoms.  Unable to stand unassisted.  Placed in Trendelenberg position, offered water and cool compress.  Vital signs within normal limits except BP elevated at 155/77.  Symptoms resolved after about 15 minutes and she was discharged home in improved and stable condition.
Patient reported feeling the worst he has ever felt; his body ached all over and it lasted for a day .
Information has been received from a medical assistant concerning a 60 year old female patient with drug hypersensitivity to DEMEROL and no pertinent medical history, who on 09-DEC-2008 was vaccinated with a dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included calcium (unspecified) and vitamin D (unspecified). On 12-DEC-2008 the patient developed a rash on her chest. The patient was examined in the office on 16-DEC-2008 was diagnosed with possible shingles. The rash was distributed on the mid-anterior chest wall extending to the epigastric area and consisted in non-vesicular, non-pustular, pruritic, mildly painful lesions. The patient was prescribed CLARITIN and topic KENALOG cream. The patient's shingles persisted as of 16-DEC-2008. Follow up information has been received from a nurse practitioner and a physician concerning a 60 year old female patient with drug hypersensitivity to DEMEROL and a history of chickenpox in her childhood, who on 09-DEC-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (lot# 662856/1559X). Concomitant therapy included calcium (unspecified) and vitamin D (unspecified). On 16-DEC-2008 (previously reported as 12-DEC-2008) the patient developed rash-papules 35+ bilateral lesions mid upper anterior chest and was diagnosed with possible shingles. The affected dermatomes were C4 and T2-T4 with a qualified pain as 3 from 0-10 (Most). A photo of the lesion was taken (16-DEC-2008) showing skin eruptions on chest. On 22-DEC-2008 the patient was "almost completely" recovered. Additional information is not expected.
Patient was vaccinated with Pediatric Pfizer dose when he was 12 yo and should have been vaccinated with and Adult Pfizer dose
Fever 12 hour duration Chills 24 hour duration headache 12 hour duration sore arm 5 day duration Body aches 24 hour duration Brain fog 2 day duration exhaustion 5 day duration
angina within 15 minutes of injection resolved but occasional return to similar symptoms over 2 months
No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (have gotten really sick), HEAD DISCOMFORT (my head is not in the right place/  I can't think straight), MALAISE (I still do not feel well), ASTHENIA (weakness), NAUSEA (nausea) and THINKING ABNORMAL (can't think straight). At the time of the report, ILLNESS (have gotten really sick), HEAD DISCOMFORT (my head is not in the right place/  I can't think straight), MALAISE (I still do not feel well), ASTHENIA (weakness), NAUSEA (nausea) and THINKING ABNORMAL (can't think straight) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-012401 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-012401:
Patient had her 1st Moderna COVID 19 shot in left deltoid.  About 25 min later,  patient complained of left sided throat swelling.  Vital signs: BP 150/92, P90, respirations - WNL, patient denied shortness of breath, skin- warm, dry. Pt did not want to go to hospital  Pt was given Benadryl PO (suspension). Patient waited with adult children 15 more minutes.  Pt reports she felt a little better, still felt like swelling was there, but wanted to go with family home. Verbalized understanding to seek medical attention if she felt worse.
delayed hypersensitivity reaction, significant arm redness and swelling starting DAY 8 POST VACCINATION, treated with allegra,ice,tylenol, peak symptoms day 12 then solution approximately 1 week later took dose 2 in contralateral arm, developed viral symptoms high fevers then smaller area localized redness and swelling at site days 2-3 despite taking allegra, using ice, resolved within 3-4 days
8/25/03 1620 fever to 102.3. Treated with acetaminophen. Resolved within 1 day. No other symptoms or signs. Had blood drawn prior to vaccination.
(L) anterior thigh erythema, edema and warm to touch. 3x5 wide area with induration over entire area.
Symptoms within 24 hours after injection: headache, nausea, jaw pain, chills, tightness in chest Symptoms between 24-48 hours after injection: tingling in left hand, blurry vision, light-headed
aching; temperature is 101.4; shivering; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 25th June 2019).   On 30th September 2019, the patient received the 2nd dose of Shingrix. In October 2019, 11 hrs 10 min after receiving Shingrix, the patient experienced shivering, pain and fever. On 1st October 2019, the outcome of the shivering was recovered/resolved. On an unknown date, the outcome of the pain and fever were unknown.   It was unknown if the reporter considered the shivering, pain and fever to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left deltoid. At 6:50 pm, the day before the reporting date, the patient received Shingrix. At 6 am In the morning of the reporting date, the patient experienced shivering, which lasted for 1 hour and 45 minutes. The patient has aching and his temperature was 101.4 degree C. The patient was able to eat toast and drink tea. The reporter consented to follow up.
No known adverse effects; She reported that an administered dose of PNEUMOVAX underwent a temperature excursion on 02/13/2020 prior to being administered to 1 patient on 02/17/2020; Information has been received from a nurse regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions, and concomitant medications were not reported.  On 13-FEB-2020, a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection for prophylaxis (lot number: S006778 and expiration date: 28-NOV-2020) (route of administration, strength and anatomical location were not reported) underwent a temperature excursion and subsequently, on 17-FEB-2020. the improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was administered to 1 patient (incorrect product storage).   The pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was stored at a temperature range of 1.9 degrees Celsius (°C) for the time frame of 3 hours and 51 minutes. There was no previous temperature excursion and the call was because of a data logger.   No known adverse effects were reported.
L thigh 7X9 cm, warm, erythematous area @ previous injection site. Mom states area doubled since injection.
Extreme swelling in the armpit lymph node; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 8729) via an unspecified route of administration in the left arm on 10Apr2021 at 14:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021, the patient experienced extreme swelling in the armpit lymph node. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event which included treatment with unspecified pain medication and warm compress to try and reduce swelling but there had been little to no change. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme swelling in the armpit lymph node was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
The pt experienced edema with erythema, tenderness, hardness and warmth to the touch.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "obesity" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected Covid-19. Additional Information: Patient reported that she received Anti-viral Paxlovid From 09May2022 to 14May2022 for Treatment of COVID-19, Adverse event: Rebound COVID symptoms began about 24 hours after finishing last dose of Paxlovid. Increased congestion in nose & throat, headaches, fatigue, sore throat, ear ache, and leg/ankle edema. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On 11/15/00, states not able to get out of bed. Aching with fever 99F-101F. Right arm swollen, coughing. On 11/16/00, office visit to doctor, who stated it was an allergic reaction to pneumonia shot. Red almost to elbow. Back and chest hurting but the doctor didn't hear anything in chest. Rx'd antihistamine and Advil with bed rest.
large red area 2 inch round; area is hardened; her arm starting itching really bad; area is swollen; This spontaneous case was reported by a health care professional and describes the occurrence of ERYTHEMA (large red area 2 inch round), INDURATION (area is hardened), PRURITUS (her arm starting itching really bad) and SWELLING (area is swollen) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced ERYTHEMA (large red area 2 inch round), INDURATION (area is hardened), PRURITUS (her arm starting itching really bad) and SWELLING (area is swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (large red area 2 inch round), INDURATION (area is hardened), PRURITUS (her arm starting itching really bad) and SWELLING (area is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter. Treatment for the events included Benadryl and ice on area.
Late night on the 12th after feeling bad due to an elevated temperature, I noticed my forehead was sore like it was bruised. When I looked in a mirror, I noticed a red splotch on my forehead that felt slightly raised like it was swollen. Sunday morning I checked and it was mostly gone. It?s now a very pale red almost normal skin color and less sore but still is to touch.
First a small blister will appear. I f agitated or popped  the area around it will raise. It then becomes EXTREMELY itchy. The blisters appear one at a time, usually 3-5 a day, every day. They are on my lower and upper legs, my torso, back of my neck, arms, in my hair and on my face. Itching, OMG they itch.   I have tried Triamcinalone, Benadryl spray & tablet, CBD cream. Each gives a little relief but nothing long term. The itching is so bad it will wake me up in the middle of the night.
Throat swelling, SOB, rash on chest. Symptoms began to occur within 4 min after injection. Began to improve within 20 mins, without medical treatment. Throat swelling completely  resolved at about 30 mins without medical treatment. Given solumedrol benadryl, although symptoms had already begun to resolve.
I revieved the vaccine about 09:15 and felt fine all day other than a sore arm. At about 21:00 I started having teeth chattering rigors  and just could not get warm . At about 01:00 it stopped and a massive migraine across my forehead and the back of my head basically ear to ear. I took 650mg of tylenol and about 30 minutes later I started burning up and sweating, which continued for about 4 hours. I didn't have any upper respitatory symptoms and I didn't measure my temperature.  As of 0800 the following morning I still have the migraine.
Rapid heart rate and pain in upper chest for about 15-20 minutes.  Called 911, they gave two EKGs which appeared to be normal.
Dizziness; Nausea; This is a spontaneous report from a contactable other hcp, the patient. This 33-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), intramuscularly in the right arm on 28Dec2020 at 07:45 (at the age of 33-years-old) as a single dose for COVID-19 vaccination. The patient's medical history was reported as none. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication was reported as none and no other medications were received within 2 weeks of the vaccination. On 28Dec2020 at 08:00, the patient experienced dizziness and nausea. No therapeutic measures were taken as a result of the events. The events resulted in the patient requiring a doctor/clinic visit. The clinical outcome of dizziness and nausea was resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
people ask HCP what to do if they are beyond the window for administration of the second dose and they have not received it yet; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (people ask HCP what to do if they are beyond the window for administration of the second dose and they have not received it yet) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (people ask HCP what to do if they are beyond the window for administration of the second dose and they have not received it yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (people ask HCP what to do if they are beyond the window for administration of the second dose and they have not received it yet) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  Treatment information was not provided
On Friday 17JUL92 t101 & was listless; Sat 18JUL92 temp began @ 102 & elevated to 104; pt given APAP & sponge baths q 4 hrs; mom contacted MD;
Feeling unwell/ NOT FEELING WELL; Runny nose; Cough; Dizzy; Headache; Tiredness/ TIRED; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell/ NOT FEELING WELL), RHINORRHOEA (Runny nose), COUGH (Cough), DIZZINESS (Dizzy) and HEADACHE (Headache) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 21-Dec-2021, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (Feeling unwell/ NOT FEELING WELL), RHINORRHOEA (Runny nose), COUGH (Cough), DIZZINESS (Dizzy), HEADACHE (Headache), FATIGUE (Tiredness/ TIRED) and NAUSEA (Nausea). At the time of the report, MALAISE (Feeling unwell/ NOT FEELING WELL), RHINORRHOEA (Runny nose), COUGH (Cough), DIZZINESS (Dizzy), HEADACHE (Headache), FATIGUE (Tiredness/ TIRED) and NAUSEA (Nausea) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Concomitant medication was not provided.  No information regarding treatment medication was provided.
CHILLS; NAUSEATED; FEVER; HEADACHE; ACHE ALL OVER; This spontaneous report received from a patient concerned a male of unspecified age. 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: 1802068, and expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced ache all over, chills, nauseated, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the ache all over, chills, nauseated, fever and headache was not reported. This report was non-serious. This case, from the same reporter.
I had a headache, nausea, sore throat, mild diarrhea. I took a test and it came back negative. I still have a runny nose but it's nothing serious. It is just really unusual because I never get nauseous.
I was getting ready for the gym and I could not stand. I was very dizzy and had to crawl to bed. I had to lay in bed for 24 hours. I had fever, chill, and an upset stomach. I had diarrhea and did not feel like myself. The next day I felt better and was completely back to normal after 3 days. I still continued to have unusual bowel movements.