chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CDC reports: 8 mo infant developed a fever to 104.5 & convuls episode following DTP/OPV. Hospitalized 3 days.
Pt reports tender, marble-sized lump in left axilla which appeared within 24 hours after moderna dose #1 4/9/21 (re. 4/10/21) As of 4/13 mass still present with mild warmth and no erythema.
pt recvd vax in SEp93 & devel cellulitis in the inject arm;
Right arm got swelled up; Blisters on right arm; Red ring on right arm; Could not lift right arm to head area; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Right arm got swelled up), BLISTER (Blisters on right arm), ERYTHEMA (Red ring on right arm) and DYSKINESIA (Could not lift right arm to head area) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO), LISINOPRIL and BUSPIRONE HCL for an unknown indication.    On 13-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PERIPHERAL SWELLING (Right arm got swelled up), BLISTER (Blisters on right arm), ERYTHEMA (Red ring on right arm) and DYSKINESIA (Could not lift right arm to head area). On 26-Apr-2021, PERIPHERAL SWELLING (Right arm got swelled up), BLISTER (Blisters on right arm), ERYTHEMA (Red ring on right arm) and DYSKINESIA (Could not lift right arm to head area) had resolved. Not Provided   Treatment medication included Doxycycline.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    This case was linked to US-MODERNATX, INC.-MOD-2021-101407 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101407:First dose case
The day after the vaccine onset swelling right axilla to half the size of an orange with moderate to severe pain, followed by a temperature of 100.4 degrees that night and generalized pain and fatigue the next day requiring time off work. Last year I took the same vaccine with no side effects.  Earlier this year I ad these same side effects with 3 days of incapacitation after the second covid vaccine in March 2021. I then had swelling and discomfort in my left axilla intermittently for several months and my mammogram had to be repeated. I did not report it as no one said it was abnormal and I didn't know where to report it to. I believe that the vaccines are related or something has changed my system to react to the flu vaccine this way. I am using ibuprofen for pain and i'm not sure how long this will last this time.
Information has been received from a physician concerning a 64 year old female with asthma, hypertension, arthritis, "common variable hypogammaglobunemia" and mycotic allergy and a history of chickenpox and rotator cuff tear who on 16-JAN-2007 was vaccinated subcutaneously into the left deltoid with 0.65 ml of zoster vaccine live (Oka/Merck) (lot# 654604/1406F). Concomitant therapy included NORVASC, MOBIC, ZOLOFT, ADVAIR, NEXIUM, globulin, immune, aspirin and allergenic extract. The physician reported that the patient had received zoster vaccine live (Oka/Merck) and developed a recurrent HSV lesion that was more vigorous than usual. The patient was originally seen by a dermatologist who did not culture the lesion on the lips which was improving without treatment. However some of the lesions got worse and the dermatologist cultured group b strep and it was found to be cellulitis. The vesicular lesions of HSV were improving while the patient was on FAMVIR. When the physician spoke to the patient in MAY 2007 her symptoms had resolved and the physician had recommended that the patient continually take acyclovir. On 24 JUN 2007 the patient informed the physician, via telephone contact, that she was asymptomatic and wanted to stop the acyclovir. The physician advised the patient to continue therapy. It was unknown if the patient continued therapy. On 20 SEP 2007 the patient contacted the physician, via telephone, and reported that her lesions were "as bad as in March" and wanted to increase the acyclovir to therapeutic levels and treat strep with amoxicillin (+) clavulanate potassium (AUGMENTIN). On 16 OCT 2007 a dermatologist wanted to have the patient stop acyclovir and do a biopsy to have lesions cultured. The dermatologist mentioned a "diagnosis of keratosis". An infectious disease physician saw the patient on "the same day" and advised the patient to stop the amoxicillin (+) clavulanate potassium. The patient continued to take acyclovir. The patient had HSV-1 antibodies and high titer, but her culture was negative for HSV-a. Lab diagnostic studies performed included cultures of lesions, "t-subset was found normal at testing for AIDS done at Harvard", on "02 OCT 2007 CBC, CMP, HSV antibody screen type 1 was over 5.0". The physician wanted it to be known that he does not feel this is an AE because many people have HSV outbreaks. There was no product quality complaint. Additional information has been requested.
Body aches, headaches, fatigue, redness (bloat like) on inner right thigh.
Pt arrived with abdominal pain.  Pt was scheduled for an EGD and tested COVID positive.
About 10 min after receiving vaccine had itching in throat &eyes & tingling in Benadryl 50 mg. is given by First Aid Station.
hives; allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and HYPERSENSITIVITY (allergic reaction) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included Thyroid cancer.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 12-Mar-2021, the patient experienced URTICARIA (hives) and HYPERSENSITIVITY (allergic reaction). At the time of the report, URTICARIA (hives) and HYPERSENSITIVITY (allergic reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided.      Reporter did not allow further contact
I contracted in April of 2022, I had lack of energy, runny nose cough and shortness of breath. I had to take deep breaths to get over this contagious feeling I was having. This went on for 4 days. I took Paxlovid. I feel great now.
Two days after vaccination, I had swelling from the left side chest cavity and underarm. Also, some skin redness and soreness in armpit! It lasted 3-4 days.
Janssen COVID-19 Vaccine EUA: patient presents to clinic with shoulder pain that started when vaccine administered. Patient reports the immunization hurt a lot more than it usually does when patient receives a vaccine. The following day arm and shoulder continued to hurt. After a few days the muscle became less painful but the pain in the shoulder continued and was deeper as if it was in the shoulder joint itself. Over five weeks later the pain is still sharp within the shoulder with reaching up or across. Patient reports no pain without movement. No numbness, tingling, redness, swelling, bruising, fever, chills, recent injury, or weakness documented. Ibuprofen was not helpful. Patient administered steroid injection during visit and follow-up with physical therapy arranged. Patient reports mild pain relief after injection.
Breakthrough case admission after 4 vaccines  Moderna 2/4/21 Lot# 013M20A;  Moderna 3/4/21 Lot# 030A21A;  Moderna 10/29/21 Lot# 041C21A;  Moderna 8/23/22 LOt# 052B22A
sore throat-aching behind eyes- chills-fever-tiredness-missed 2 days of work; aching in legs & hips-sx lasted 1 wk; tiredness lasted several days longer;
shaking chills lasting 10 hours; severe frontal headache; nausea; intermittent dizziness; muscle pain; joint pain; fatigue; This is a spontaneous report from a contactable nurse (patient herself). A 64-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3302), intramuscular (left arm), on 20Jan2021 09:00, at single dose, for covid-19 immunization. Medical history included allergies: penicillin, sulfa, environmental. Concomitant medications included levothyroxine; cetirizine hydrochloride (ZYRTEC ALLERGY); calcium; and colecalciferol (VIT D3). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), on 30Dec2020 16:00, intramuscular (left arm), for covid-19 immunization at 64-years-old. The patient experienced, "10-11 hr" post injection, on 20Jan2021 20:00 started shaking chills lasting 10 hours. The patient also experienced on 20Jan2021 20:00 severe frontal headache with nausea and intermittent dizziness, muscle pain, joint pain, and fatigue - which all resolved after about 24 hr after onset. No treatment was received for these adverse events. The patient recovered from all the events on 21Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior to vaccination and have not been COVID tested post vaccination.
Information has been received from a registered nurse concerning a female patient who on an unspecified date was vaccinated with a first dose of VARIVAX (Merck) (Lot # and route not reported) and in October 2006, "four years ago", was vaccinated with a second dose of VARIVAX (Merck) (Lot # not reported). The nurse reported a low titer result with the patient who had administered two doses of VARIVAX (Merck) (Lot # not reported). Titer was performed in September 2010. The patient sought unspecified medical attention. At the time of the report the outcome of the patient was unknown. Follow up information has been received from the register nurse who stated that there were not adverse events. No further information is expected.
Pain and soreness at injection site; fatigue (fell asleep upon returning home despite good Night of sleep the night before); dizziness; nausea; headache
Got Covaxin as first dose and Moderna as second dose; 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 PRODUCT ADMINISTRATION ERROR (Got Covaxin as first dose and Moderna as second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE INACT W.VIRION NIV-2020-770 (COVAXIN [COVID-19 VACCINE INACT W.VIRION NIV-2020-770]) for COVID-19 vaccination.    No Medical History information was reported.   On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received first dose of COVID-19 VACCINE INACT W.VIRION NIV-2020-770 (COVAXIN [COVID-19 VACCINE INACT W.VIRION NIV-2020-770]) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (Got Covaxin as first dose and Moderna as second dose). At the time of the report, PRODUCT ADMINISTRATION ERROR (Got Covaxin as first dose and Moderna as second dose) had resolved.            No concomitant medication details was reported. No treatment medication details was reported.    Reporter did not allow further contact
1 month after dose #2, I started having irregular periods. My menstrual cycles have always lasted 26 days, but in Feb and earlyMarch have lasted only 21 days, and then only 14!! In addition, my periods are lasting twice as long, with spotting in between. I am not pregnant, nor do I have any history of bleeding disorders.  No increased bruising or other signs of thrombocytopenia.
c/o numbness and tingling of arms, legs and feet @1342 Given 25mg Benadryl I.M. @ 1343 No respiratory symptoms, swelling, redness, or racing heart. No further c/o requested to go home. Released at 1408
Initial information received on 06-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 16 years old female patient who received a 0.5ml fourth dose of vaccine IPOL batch number: N1J451M, expiration date: 05-Oct-2019 via subcutaneous route in the right arm on 06-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included was MENACTRA and BEXSERO. It was an actual medication error due to Inappropriate schedule of vaccine administered. The patient received 3 IPOL vaccinations when she was young, however missed her 4th IPOL vaccination at age 4 and she was administered the 4th IPOL injection when she was 16 years of age. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
approx 30 hrs p/receiving MMR pt had itching rash (fine, red) over entire body; 2-3 days p/vax states exp joint pain in every joint; also states exp some SOB 2 days p/vax on 8MAR93;
Patient broke out in hives all over his body and his joints swelled up. Urgent care Center diagnosed him with serum sickness, likely from the vaccine. He was treated with dexamethasone, Benadryl every 8 hours and Zyrtec.
experienced site pain, redness, itching swelling.  Chills Fever, HA, Pain,nausea,vomiting,diarrhea, rash, swollen glands
I tested positive for COVID on 03/02/2022 when a friend of mine said she tested positive. I had a runny nose sneezing postnasal drip, o2 at 95% and these mimicked my usual pollen allergies. On the following Friday I did video call with my doctor and take my usual OTC regimen and was advised a quarantine was not necessary at that point in time. I am fully recovered and had no issues since.
nausea; fever; extreme shivering; arm pain; woke up from his sleep around midnight; This case was reported by a consumer and described the occurrence of nausea in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 23rd October 2020, refer case US2020AMR256481).   On 23rd December 2020, the patient received the 2nd dose of Shingrix. On 23rd December 2020, less than a day after receiving Shingrix, the patient experienced nausea, fever, shivering, pain in arm and sleep disturbance. The patient was treated with ibuprofen (Advil). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the nausea was recovered/resolved and the outcome of the fever, shivering, pain in arm and sleep disturbance were not recovered/not resolved.   It was unknown if the reporter considered the nausea, fever, shivering, pain in arm and sleep disturbance to be related to Shingrix.  Additional details were provided as follows: The patient received 2nd dose in the left arm. The reporter stated that, after vacination had upper arm pain started in the night and woke up from his sleep around midnight with extreme shivering and fever varying between 99 to 100 degrees celcius. The patient usually sleeps on his stomach but because of the nausea he could not but today morning the nausea has resolved. Th patientr took Advil. The reporter consented to follow up. For the tolerence of 1st dose refer case US2020AMR256481.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR256481:
intense chest pain; increase in blood pressure; increase in heart rate especially with exertion; shortness of breath; I'm not able to exercise like normal; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 27 year-old female patient received bnt162b2 (BNT162B2), administration date 21Sep2021 (Lot number: FC3182) at the age of 27 years as dose 2, single and (Lot number: FF8839) as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid-19" (unspecified if ongoing), notes: Prior to vaccination. The patient's concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious) with onset 01Sep2021, outcome "recovering", described as "intense chest pain"; BLOOD PRESSURE INCREASED (non-serious) with onset 01Sep2021, outcome "recovering", described as "increase in blood pressure"; HEART RATE INCREASED (non-serious) with onset 01Sep2021, outcome "recovering", described as "increase in heart rate especially with exertion"; DYSPNOEA (non-serious) with onset 01Sep2021, outcome "recovering", described as "shortness of breath"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 01Sep2021, outcome "recovering", described as "I'm not able to exercise like normal". The events "intense chest pain", "increase in blood pressure", "increase in heart rate especially with exertion", "shortness of breath" and "i'm not able to exercise like normal" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chest pain, blood pressure increased, heart rate increased, dyspnoea, loss of personal independence in daily activities.  Additional information: After receiving the first and second vaccine, patient started having intense chest pain within 24 hours after the shot. In addition, she also had an increase in blood pressure and an increase in heart rate especially with exertion. Sometimes at rest her heart rate would spike for no reason into the 170s. The chest pain was associated with some shortness of breath. She have never had any cardiac issues prior to receiving these shots. 3 months out she was still having chest pain especially with exertion, elevated heart rate, and not able to exercise like normal. Prior to vaccination, patient diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID19 VACCINE), dose 1 at vaccination age of 55-year-old via an unspecified route of administration in the left arm (reported as upper, bicep of left arm) on 13Sep2021 at  09:20 (Lot Number: FA7485) as dose 1, single for covid-19 immunisation. Medical history included Graves' disease diagnosed in 2010 and had surgery in 2012. The patient's concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect or other vaccines administered on same date of the Pfizer Suspect were none. The patient received the vaccine in a pharmacy. On 13Sep2021 at 10:20, the patient experienced tongue swelling started about an hour later. She feels like it has worsened since it feels like her tongue is wanting to go over her teeth. She added that she can feel it when she is talking. She inquired if this is a normal side effect of the vaccine. The patient was advised to consult with healthcare professional which the patient stated that she already called her doctor and is waiting on a call back. As for the treatment, it was mentioned that the patient declines any and she waiting to hear from her doctor. As of the time of this initial report, the adverse event did not result in emergency room visit or physician's office visit. The outcome of the event was not recovered.
pt called MD office 15MAR96;reports rash & numbness from forehead to lips on the lt side of face,malaise,chills;instructed to take DPH;
pt recv vax 8FEB99 & broke out w/hives & rash to bilat arm pits on 9FEB99 7-8PM;pt c/o tender to touch;welt like areas noted;light red mild rash to underneath arms, tender to touch;
pt recv vax & devel a 1cm knot which remains;mom is school nurse;gave DPH, Ibuprofen, hot compresses, cold compresses;pt is not a complainer;when weight lifted both arms cont to be painful;neither MMR or Td reacted in this way;
The COVID-19 vaccine administered through vaccine administrator, Health, between June 25 and July 30 came from the lot number 039K20A.  It was discovered that this particular lot was beyond its frozen expiration date by five (5) up to forty (40) days.  A case was opened with Moderna (Case #: MOD21-126790).  Please refer to this case number if you would like to contact Moderna directly.  Moderna confirmed that the vaccine doses administered maintained the activity necessary to protect against the COVID-19 virus.  Moderna also confirmed there is no danger to anyone's health from receiving a vaccine past its frozen expiration date.  No adverse reactions were identified.
This report was received from the investigator on 12 April 2010. A 35 year-old male subject received the following vaccines on 15 March 2009:  ACAM2000 (lot number not reported); and anthrax vaccine (other manufacturer and lot number not reported). Nine days after vaccination, the subject reportedly experienced angina pectoris. The subject had a history of high blood pressure, elevated cholesterol, abnormal electrocardiogram, dizziness/fainting spells, shortness of breath, asthma and numbness or paralysis. The outcome was not reported.
COLLEAGUE ADMINISTERED PFIZER VACCINE. PATIENT REPORTED INJECTION SITE REACTION (HIVE) AT SITE OF INJECTION. PATIENT TOOK A DOSE OF CLARITIN WHICH SEEMED TO RESOLVE IRRITATION.
Information has been received from a nurse practitioner concerning a female who was vaccinated with a 0.5 ml first dose of Gardasil. Subsequently, the patient experienced "swelling on her arm". Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Patient called to express concern over pain at the injection site 7 days post injection. She said the area around the injection site was red, swollen, itching and was spreading to a rash on her chest.
Pt received TDAP. He developed fever & headache x 4 days. Per mom they brought him to urgent care. Now he is better.
pt recvd vax & devel local adenopathy; pt tx w/ antihistamine & problem;
11/28/06-9-10pm to 11/29/06 12pm acute hives. Resolve with Claritin. 11/28/06 to present persisting numbness, tingling paresthesias present. No treatment.
chest cold, h/a, conjunctivitis, sore throat; temp not measured, doubts fever was present; 2wks later has dyspnea, tight chest
Believe injection was made into bursus which resulted in SIRVA (shoulder injury related to vaccine administration).  Have been participating in physical therapy.  Range of motion gained = 60% (overhead) and 20% (behind back); shoulder pain, severe loss of range of motion, weakness in arm, some nerve pain.
fever as high as 102, chills, sweating, joint pain, fatigue for about 60 hours -- fatigue continued for about a week with minor joint pain.
Given MMRV vaccine on 3/21/17. Developed rash and fever 4 days later. Seen in office again on 3/31/17 for rash and fever. Treated with antibiotic for pharyngitis on 3/31/17.