chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got chills; fever 3 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In APR-2023, the patient received Shingles vaccine. In APR-2023, less than a day after receiving Shingles vaccine, the patient experienced chills (Verbatim: Got chills) and fever (Verbatim: fever 3 days). The outcome of the chills and fever were unknown.   It was unknown if the reporter considered the chills and fever to be related to Shingles vaccine.     It was unknown if the company considered the chills and fever to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 26-Apr-2023 The patient got the shingles vaccine two days ago and it gave him/her chills and fever for three days.
Both inside of wrists broke out with rash then left wrist became blisters Since 3/8/2021 and still have it  Cream with steroid  Shot of steroid
slightly warm to touch; itchy; bumpy; having a little bit of rash in that area; Little red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (slightly warm to touch), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE INDURATION (bumpy), VACCINATION SITE RASH (having a little bit of rash in that area) and VACCINATION SITE ERYTHEMA (Little red) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE WARMTH (slightly warm to touch), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE INDURATION (bumpy), VACCINATION SITE RASH (having a little bit of rash in that area) and VACCINATION SITE ERYTHEMA (Little red). At the time of the report, VACCINATION SITE WARMTH (slightly warm to touch), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE INDURATION (bumpy), VACCINATION SITE RASH (having a little bit of rash in that area) and VACCINATION SITE ERYTHEMA (Little red) 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.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up document received contain no new information.
ISM(Indolent systemic mastocytosis); accentuation (swelling) of lesions of MPCM; accentuation (swelling) of lesions of MPCM; facial swelling; flushing; Initial information received on 25-May-2020 regarding an unsolicited valid serious case from other healthcare professional, issued from a literature article.   This case is linked to case 2020SA136384(same literature).  This case involves a 15 years old patient who experienced facial swelling (swelling face), flushing(flushing), accentuation(swelling) of lesions of Maculopapular cutaneous mastocytosis(urticarial pigmentosa), (condition aggravated) and ISM-indolent systemic mastocytosis (systemic mastocytosis), while he/she received vaccines MMR, HPV VACCINE and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer; HPV VACCINE(not produced by Sanofi Pasteur) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (not produced by Sanofi Pasteur) (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed facial swelling (swelling face), flushing(flushing), accentuation (swelling) of lesions of Maculopapular cutaneous mastocytosis (urticarial pigmentosa), (condition aggravated) and ISM-indolent systemic mastocytosis (systemic mastocytosis), (Unknown latency) following the administration of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE, (Unknown latency) following the administration of HPV VACCINE and (Unknown latency) following the administration of MMR. All the events were assessed as medically significant.  Laboratory test results included: Tryptase - On an unknown date: 62.9 Ng/mL  Final diagnosis were swelling face, flushing, urticarial pigmentosa, condition aggravated and systemic mastocytosis.   It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events were not reported.  There will be no information available on batch number for this case.; Sender's Comments: This case involves a 15 years old patient(unknown gender) who experienced systemic mastocytosis and condition aggravated after vaccination with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE, MMR and HPV VACCINE(other manufacturer). The time to onset was not known. Further information regarding medical history, concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be  assessed.
Sister stated her sister had a sore throat and difficulty breathing. When she walked upstairs she became short of breath. She also had a fever of 104. She went to the ER where they admitted her. The doctors stated they do not what it is, and she is now on a ventilator.
vertigo; similar symptoms to "when I had COVID" after dose 1; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo) and VACCINATION COMPLICATION (similar symptoms to "when I had COVID" after dose 1) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (On 14Nov2020 she was hospitalized in ICU step down had double pneumonia. Now has diagnosis of a-fib since being ill with COVID-19.) on 06-Nov-2020. Concomitant products included LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN D 12 HOUR) and DIPHENHYDRAMINE, PARACETAMOL (EXTRA STRENGTH TYLENOL PM) for Allergy.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION COMPLICATION (similar symptoms to "when I had COVID" after dose 1). On 28-Mar-2021, the patient experienced VERTIGO (vertigo). The patient was treated with MECLIZINE [MECLOZINE] on 30-Mar-2021 for Vertigo, at an unspecified dose and frequency. On 30-Mar-2021, VERTIGO (vertigo) had resolved. At the time of the report, VACCINATION COMPLICATION (similar symptoms to "when I had COVID" after dose 1) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-080194 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow-up received, updated patient demographics, batch number, de-re-challenge fields, event outcome and added concomitant medications, treatment.
1JUN92 recvd 1 dose of Engerix-B & 3JUL92 exp nausea, vomiting, muscle paralysis & headache;
Moderna COVID-19 Vaccine EUA.  Administered shot at 12:37 pm.  Left arm felt tingly a little.  By 12:55 my entire face, both arms and chest were numb to touch.  Alerted staff and they took my blood pressure which was 190/110 with pulse 104.  Staff took vitals several times over the course of an hour  (188/110 pulse 104, 160/108 pulse 94, 162/98 pulse 85)  During that time the numbness decreased.  I did not have any trouble breathing. They let me leave around 2pm and said that if my symptoms worsen to go the ER.  By 3:00pm when at home, my pressure was 127/82 pulse 78.   Slight headache at time of this report (8:30 pm).
Woke up in the middle of the night with a deep ache starting at the base of neck, all the bones ache, in the skeletal, shooting my spine which hurt to move. Soft tissue muscles still ache. Took Ibuprofen but stop. Took two aspirins today. Still having cold sweats. Not getting better. Going on four weeks. Refuse to take steroids because of what it did to my mother. Pain is not too bad right now. No fever. Has a cold sweat.
Pt had 2nd of Vaccination today and presented with dizziness, anxious and palpitations 10 minutes after the injection. She relates at history of HTN on HCTZ, no cardiac history or diabetes. She works as a Medical Staff and her nurse manager happened to be present and is staying with her. Her initial VS were very tachycardic and hypertensive. 1437  EKG was applied VS  163/114  HR 145  RR 24 sats 100% she does not know her baseline BP. She continues to be lightheaded and dizzy despite sitting in chair and resting with the RN manager. Called Doctor and he recommended to call the RN stat however a code campus was already in process.  Second VS at 1449 191/97  HR 145   RR 20 and sats 100% very lightheaded. An IV was placed 22 G to right hand by RN. THe RN stat  Team now also at bedside.1500 ER RN with wheelchair to take pt to the ER with RN manager accompaning pt. In ER BED 18 report given to RN same RN who transported pt last VS 174/93  HR 142 RR 18  sats 100%. Having a STAT 12 lead at 1507 in the ED.  Doctor informed of pts admit to the ER and sent report and pts MRN to him.
Myalgia, Fever, shivering, dizzy, sweaty; Narrative:
A non-serious spontaneous report of we administered expired H1N1 was received from a health professional concerning a nine-year-old female.  Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 01-March-2010. On 15-March-2010, the patient received expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable and the event was considered resolved.
Pt received TD booster next morning pt's arm was red/swollen. She went to MD and was diagnosed with cellulitis was given Augmentin 1000mg for 10 days.
1/7 - noted bilateral lower extremity, nodule like rash 12/3 - Received Shringrix Rash still present Pictures are available
I mistakenly took a BOOSTRIX vaccine from our immunization fridge rather than an INFANRIX and inadvertently administered it to my 7 month old patient. Once I realized what I had done I immediately notified the doctor and the mother of the patient. Dr. then notified the Health Dept to speak with one of the immunization nurses there. They together reviewed the prescribing information. Dr. then went and spoke with and reassured the mother of the error and what to watch for in the case of an adverse reaction.
On 4 or 5 occasions between Summer 21 and March 22 I experienced a large itchy lump under the skin which becomes a weeping lesion. They occur in various spots, L thigh, L wrist, back. They go away by themselves, takes about 3-4 days. Doctor believes it is bacteria around a hair follicle. I am to shower once a week with Hibiclens but lumps returned.
Headache, Myalgia, Fever, NauseaVomiting, fatigue Employee reported fatigue 100.1 degrees, headache, myalgia, fatigue, nausea. Resulted in unable to work 1/26/2021 and 1/28/2021. He sought medical attention from Hospital via phone call. Took Tylenol.
Chief complaint of right arm numbness, pain, difficulty speaking, asymmetry of lips at 2:30 in the afternoon following a vaccination of Influenza and Typhoid at 11:30am.  Patient was taken to hospital by EMS.
Patient presented to Pharmacy 8 days post COVID injection (1st dose)   On Day 8 patients arm became red at injection site approximately 3 inches in diameter. Red and warm.    Patient is medical student who had the NP onsite look at it and stated potential cellulitis. Patient referred to Urgent care for Medical Care.
pt recvd vax; lab eval showed varicella zoster, IgG, 0.03 which is considered neg;
This might or might not be connected to the COVID19 vaccination, however that is a new condition that I did not have ever before. I went to a doctor on May 31st as I had shoulder pain and was diagnosed with bursitis. The doctor recommended a steroid injection (Kenalog) to cure this. I had a steroid injection before without any adverse reaction, so I was fine with it. Shortly after this I had a very strong allergic reaction, rash all over the body, swollen face and starting trouble breathing,  so I had to go to the ER. They treated the condition and it has not occured after again. However I just learned from a friend that he had a similar issue with a new allergic reaction that he never had before so he had so see the ER (and he was vaccinated with Pfizer as well while I don't have his details to share), so maybe this is indeed connected to the vaccination.  I will definitely have myself re-tested for allergies to be prepared. Also I was prescribed  an EpiPen for emergencies
"COVID arm" - red rash ring about 2.5" in diameter around the injection site. Not raised. Not painful or itchy. Resolved after 7 days.
Head/body aches  Low grade fever  Chills Tiredness  Took acetaminophen for pain & fever
Pt did not respond to series of Recombivax; titer neg; recv Engerix-B booster dose & 06Feb91 titer neg.
MMR given 06/04/02. Joint pain and swelling in knees and large joints began 06/20/02. Now has numbness, pain and swelling in hands.
Chills; Grade 2 sore arm, shot occurred too close to shoulder; Insomnia; muscle aches /grade 2 muscle aches; This is a spontaneous report from a contactable healthcare professional, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 07Apr2021 at 12:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and endometriosis. The patient was allergic with codeine and percocet (non-anaphylactic allergies). Concomitant medications included salbutamol (ALBUTEROL), linum usitatissimum seed oil (FLAXSEED OIL), B complex (MANUFACTURER UNKNOWN), C (MANUFACTURER UNKNOWN) and multivitamin (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 15Mar2021 at 10:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 07Apr2021 at 23:30, the patient experienced grade 2 sore arm (reported as shot occurred too close to shoulder), insomnia, muscle aches and chills about 12 hours after second dose of vaccination. The patient had grade 2 muscle aches the next day. The events did not result in doctor/other health care professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events insomnia, grade 2 sore arm, muscle aches/grade 2 muscle aches and chills was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Limb swelling involving entire right arm, within 24 hours of vaccination. Erythema from elbow to shoulder and down right flank. Rheumatologist prescribed Keflex treatment for 7 days on 09/25/2008. Improving by 09/29/2008
Patient with 2 doses of Pfizer COVID vaccination, last dose 09/09/2021, who admitted with complications of COVID.  Provider d/c note below:  "patient presented with dyspnea found to have covid pneumonia and respiratory failure. Treated with decadron/remdesivir and o2 support, weaned off to room air. Completed 10 days steroids and discharged to HCF for rehabilitation."
received expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th June 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 30th June 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 6-Jul-2022 Reporter's comment: The office manager stated that one of their employees received an expired dose of Engerix-B. The health care professional did not had patient's initials or date of birth at time of call.  The reporter also did not had the lot or expiry date, but stated that he believed it expired at the end of May.  The reporter consented to follow-up via postal. Additional supportive information: The patient received an expired dose of Engerix-B, which led to expired vaccine used.
The evening after the injection, patient is experiencing pain in upper arm and shoulder near collar bone/neck. She doesn't report any redness or swelling. She states that she is able to lift and move her arm.
11 DAYS AFTER 2ND PFIZER SHOT PATIENT DEVELOPED SHINGLES CONFIRMED BY DR.
Headache; incoherent; shaking from head to toe; lightheaded; She was totally out of it; nausea; Fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of INCOHERENT (incoherent), TREMOR (shaking from head to toe), DIZZINESS (lightheaded), FEELING ABNORMAL (She was totally out of it) and NAUSEA (nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (No symptoms.) on 07-Apr-2020. Concurrent medical conditions included Chronic back pain since 1985 and High cholesterol since 2016. Concomitant products included OXYCODONE and GABAPENTIN for Back pain, SERTRALINE for Depression, SIMVASTATIN for High cholesterol, VITAMIN D3, FISH OIL and IRON for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced INCOHERENT (incoherent), TREMOR (shaking from head to toe), DIZZINESS (lightheaded), FEELING ABNORMAL (She was totally out of it), NAUSEA (nausea), PYREXIA (Fever) and CHILLS (chills). On an unknown date, the patient experienced HEADACHE (Headache). On 03-Mar-2021, INCOHERENT (incoherent), TREMOR (shaking from head to toe), DIZZINESS (lightheaded) and HEADACHE (Headache) had resolved. At the time of the report, FEELING ABNORMAL (She was totally out of it), NAUSEA (nausea), PYREXIA (Fever) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment medications were provided. COVID-19 Test- Q-TIP up nose (No symptoms);Tested Positive.   This case was linked to MOD-2021-262720 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-up information contains new event  information- Headache. New event outcome-Recovered for-Dizzy, Headache, Shaking, Incoherent.New medical history- COVID-19, Chronic back pain,  High cholesterol.Contains new product information-2nd dose information, Concomitant drugs, Contains updated patient demographics.
Pt complained of severe arm pain. Stated that the vaccine was given very high by shoulder. Pain unrelieved by pain med. MD wants to see her.
Chills starting Saturday 4.10 at 16:30, shivering increasing in intensity throughout the evening and night. Feeling like I could never be warm enough. Accompanied by pounding heartbeat that could be reduced through breathing exercises and meditation until I dozed off and reawakened with the same pounding heartbeat. Woke feeling weak and exhausted Sunday 4.11 with full-body rash, barely able to move left arm, and hard, dark red skin on my face. No appetite. Slept most of the day and night under extra blankets to feel warm. Monday 4.12: body rash and facial redness still there. Unable to stay awake most of the day. Queasy feeling in stomach. Slept most of the day. Tuesday 4.13: body rash and facial redness finally gone. Feeling weak, but able to eat two light meals. Able to stay awake most of the day and take a brief walk in the evening. Wednesday 4.14: feeling weak from the events of the previous days, but trying to resume normal activities. Eating lightly, no strenuous exercise.
Feeling bad; Stomach is hurting; Alot of air in the stomach; Fatigue; Headache; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling bad), ABDOMINAL PAIN UPPER (Stomach is hurting), FLATULENCE (Alot of air in the stomach), FATIGUE (Fatigue) and HEADACHE (Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 131L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced FEELING ABNORMAL (Feeling bad), ABDOMINAL PAIN UPPER (Stomach is hurting), FLATULENCE (Alot of air in the stomach), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Muscle pain). At the time of the report, FEELING ABNORMAL (Feeling bad), ABDOMINAL PAIN UPPER (Stomach is hurting), FLATULENCE (Alot of air in the stomach), FATIGUE (Fatigue), HEADACHE (Headache) and MYALGIA (Muscle pain) outcome was unknown.            Concomitant medications were not reported. Treatment details not provided Action taken with mRNA-1273 in response to the events was  not applicable Patient agreed to follow-up with Safety. Preferred contact method is phone.
sore arm; dry nose; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), NASAL DRYNESS (dry nose), CHILLS (chills) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), NASAL DRYNESS (dry nose), CHILLS (chills) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (sore arm), NASAL DRYNESS (dry nose), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        concomitant medications for high blood pressure medication, vitamins and something for her eyes. Treatment details included Tylenol. Cetirizine.