chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling of swelling in throat within 30 minutes of vaccine; This is a spontaneous report from a contactable physician (patient himself). A 56-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as COVID 19, brand Pfizer, lot EK9231, expiry date not reported), intramuscularly in the left arm on 02Jan2021 12:00 at single dose, for Covid-19 immunisation. Medical history included seasonal allergy and mild allergic rhinitis. There were no concomitant medications. The patient experienced feeling of swelling in throat within 30 minutes of vaccine, lasted 5+ hours, mostly by 9 hours on 02Jan2021. He took Singulair, Pepcid, Albuterol, Intranasal steroids and Phenylephrine as treatment. The outcome of event was recovering.
Pregnancy; Initial Report Received on 02-May-2022  A health care professional (HCP) reported to the HEPLISAV-B pregnancy registry that a female patient (age, race, and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization while pregnant.  No relevant medical history was reported.  The last menstrual period (LMP), estimated date of delivery (EDD), pregnancy history, and pregnancy risk factors were not reported.    No relevant concomitant medications were reported.    On an unspecified date, received one dose of HEPLISAV-B (date, Lot #, expiration date, NDC #, route, injection site not reported).  On an unspecified date, the patient had a positive home pregnancy test (# of week of gestation unknown).   On 03-May-2022, the HCP reported that the pregnant patient received a dose of the HEPLISAV-B but did not know the dosage the patient took. The HCP was provided information about the HEPLISAV-B pregnancy registry and was informed that her patient would be eligible to enroll in the registry. The HCP did not obtain permission from her patient to pass on any additional information. Permission to follow up with the HCP on the potential patient was not granted.  No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Symptoms - chest pain, shortness of breath, fever, stomach pain, chill   Time course - above symptoms lasted for a week, the severity of symptoms got better after 3 days
Moderna COVID- 19 Vaccine EUA  RECIEVED INJECTION ON 01/28 AND ON 02/02 PATIENT REPORTS THAT SHE DEVELOPED SOME SWELLING IN ARM, DEVELOPED A RED SPOT BELOW INJECTION SITE THE SIZE OF A 50 CENT PIECE THAT WAS BRIGHT RED IN COLOR.  ON 02/08 SHE REPORTS THAT THE COLOR HAS LESSENED BUT STILL THE SAME SIZE. HAS BEEN APPLYING NEOSPORIN TO SITE, NO SWELLING NOW.
Fever, Chills, severe body aches, congestion , headache,  weak/extremely tired, tightening of chest for 2 two weeks
he died while on his routine daily run; medical examiner agreed he should have an autopsy which showed coronary artery disease/likely an acute cardiac event
Employee was fully vaccinated last vaccine on 2/19/21 and she had a household member with Covid and she became infected with the covid 19 virus despite being fully vaccinated but she is asymptomatic
This is in follow-up to report(s) previously submitted on 6/24/2008. Information has been received from a physician concerning a 67 year old male with no known drug reactions/allergies and no pertinent medical history (including no history of chickenpox) who was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included aspirin and NIRVAN. "One month ago", in 15-APR-2008, the patient developed a mild shingles outbreak. Additional systemic symptoms included fatigue. The patient also experienced pain rated 8 on a scale of 0 (least) to 10 (most). The patient was seen by a physician. He was treated with LYRICA. It was noted that the patient had no recent exposure to chickenpox or herpes zoster. Subsequently, the patient recovered from mild shingles outbreak. The product quality complaint unit was not involved. Additional information is not expected.
My wife always gets sick when she gets a flu shot I do not.; Initial information was received on 11-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional via social media.  This case involves a female patient (age unspecified) who got sick while he/she received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient who got sick (illness) (Unknown latency) following the administration of INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE.  The patient always gets sick when she gets a flu shot.  Other relevant laboratory data was not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, event outcome was not reported for illness.   There will be no information available on the batch number for this case.
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about concurrent conditions, medical history or concomitant medication. On an unknown date, the patients were vaccinated with improperly stored dose of VARIVAX (Merck) (lot # L030159 and expiry date 11-AUG-2017) (dosing details unspecified). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Details of temperature excursion: Temperature: 6.7 F. Time frame: 42 Minutes. Data logger: Yes. Previous temperature excursion: No. This is one of the two reports received from the same reporter. Additional information has been requested.
Smallpox scab lasted 9 weeks (longer than the usual 8 weeks).
Patient reports light headed. Dizziness and mild pain  to the injection site. Patient asked to lay down and feet elevated. Water offered, observed  for 30 minutes, felt better and was able to drive home.
This spontaneous report was received from a nurse refering to a 18 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On 16-NOV-2018, 23-JAN-2019 and 20-FEB-2019, the patient was vaccinated with doses of GARDASIL 9 1 dosage form, intramuscular for prophylaxis (strength, frequency, lot number and expiration date were not reported). No adverse effects were reported.
after 30 minutes after administration of vaccine. pt develop red rash completely over body, face, feet, hands. rash was not raised.. pt did not have any difficulty breathing or sob,. pt took 50mg of Benadryl and started Medrol dose pack. after about an hour after Benadryl and Medrol, the rash cleared up.
chills in my left and right Arms; lymph nodes in my injection site arm are in pain; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills in my left and right Arms) and VACCINATION SITE LYMPHADENOPATHY (lymph nodes in my injection site arm are in pain) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.  No Medical History information was reported.  On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced CHILLS (chills in my left and right Arms) and VACCINATION SITE LYMPHADENOPATHY (lymph nodes in my injection site arm are in pain). At the time of the report, CHILLS (chills in my left and right Arms) and VACCINATION SITE LYMPHADENOPATHY (lymph nodes in my injection site arm are in pain) had not resolved.            No treatment information was provided.  No concomitant medication was provided.
Pt developed varicella disease (20-50 pox). She was immunized at 12 months.
hard for him to get up; This is a spontaneous report from a contactable consumer (patient). Report 2 of 2. A male patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 14Feb2021 as single dose for covid-19 immunisation. The patient medical history included Parkinson's disease and was diagnosed 6 or 7 years ago and back problems when he was a kid. The patient concomitant medications were not reported. On unspecified date, the patient experienced hard for him to get up. His wife and him got the first dose of the vaccine on 14 Feb2021. The second shot did not bother him but his wife was in the ER 8 hours later and was on a ventilator and died. The outcome of the event was unknown.  Information about batch/lot number has been requested.
Rapid heart beat on and off for 3 days.   Large hard swelling and redness at injection site continuing to persist (9th day).
My heart just for a second. However about 9 hours later I felt fatigue, headache, chills, sweats and my other arm started to hurt. Everything hurt all my muscles and joints it last about 2 days and then now have a extreme vertigo and fatigue  and brain fog.
sore muscles. arthritis flare up Gout in my foot swelled up like a balloon (extremely painful). all symptoms are receding as of 4/2/2021 8:30
Information has been received from a physician concerning a 53 year old female with rheumatoid arthritis who on 22-AUG-2008 was vaccinated with PNEUMOVAX (lot # 657143/0380U). Concomitant therapy included Tdap. It is unknown if the patient was vaccinated PNEUMOVAX in past or had any reactions in the past. Subsequently, in 2008 the patient experienced pain, redness and swelling at the site, and then stiffness and swelling down the arm to the wrist. The event resolved in a couple of weeks. She recovered, did not die, no antibiotics needed or hospitalized. Additional information has been requested.
2-3 days p/flu began having skin rash on entire body; skin began peeling & had to be seen by dermatologist; Psoriasis had been under control prev; MD feels flu vax exacerbated condition;
Redness and mild inflammation 3/29-CSPI f/u: Caller states that his arm is still painful and red.   He does OT 3 times a week and does arm exercises.  ]ADvised: This is a common effect.  Put ice packs and exercise your arm (move it around).
Woke up with vertigo, nausea and cold sweats. Could not speak for about 10 minutes.  Crawled to bathroom on stomach and vomited.  After laying on floor, was able to speak and crawled back to bed.   Vomited one more time  around 10 am.   Was in bed until 4:00 pm. Symptoms subsided by then, but I did not feel well until the next morning.   The vertigo and nausea were the most severe I have ever had.   At no point was I running a fever..
Patient said she could not articulate words to make sense, said random words without meaning lasting about 10 minutes. Patient had ear pain, throat hurt, and eyeballs hurt for 2 days afterward. Patient had skin sensitivity for a day and a half afterward. Patient had vomiting that lasted 2 days followed by nausea and diarrhea. Symptoms lasted a total of 4 days. Patient was told to call moderna as well.
Painful 8-10 mm, red and raised area on left deltoid within two hour after receiving the vaccine. EPIPEN 0.3mg given in right outer thigh. Dull headache for several hour.
Arm sore, head aches, very tired, restless, lack of sleep, flu symptoms, fever, swollen leg left side, knee swollen and foot, made neuropathy worse, sweat a lot, hard to walk, knee giving out while standing, vision blurry, nose running more, been out of work 2 days a week since shot, body aches, just cough
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. Patients' pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. Since 01-JUN-2017, on unspecified dates, these patients were vaccinated with improperly stored doses of PEDVAXHIB lot # M045206, expiry date 27-JUN-2019, via intramuscular route (strength, dosing details, anatomical location were unknown) for prophylaxis (incorrect product storage). The vaccine was exposed to the temperature of 47 F to 77 F, for a time frame of 10 hours and 42 minutes. Data logger was involved. The vaccines had previous temperature excursion. No adverse effects were reported. No PQC was involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA003783.
Hard swelling and muscle pain at injection site; dizziness, nausea, and weakness (unable to stand for any length of time);  tiredness; muscle aches; possible fever (taking tylenol); headache; general malaise
painful shingles rash; painful shingles rash; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th November 2020, the patient received the 1st dose of Shingrix. On 22nd November 2020, 2 days after receiving Shingrix, the patient experienced shingles and painful rash. On 6th December 2020, the outcome of the shingles and painful rash were recovered/resolved.   It was unknown if the reporter considered the shingles and painful rash to be related to Shingrix.  Additional details were reported as follows: The patient developed a painful shingles rash on her right abdomen which lasted for 14 days. No other information was reported.
1.5 inch x 2.0 inch, warm, red and indurated area on left lateral thigh. Oral CLARITIN or ZYRTEC recommended and OTC hydrocortisone 5-7 days.
Gave the Vaccine at 12:42 client waited 18-20 minutes stood up to walk back to apartment and stated that she was not feeling well and sat back down. Stated that she was feeling short of breath and was not seeing clearling. Writer instructed Office support to call 911. Client continued to have heavy breating and pulse was weak at about 30 beats per minute. Gave epinephrine injection in Right thigh and EMS arrived. Client increased respirations and heart rate increased.
Enlarged lymph node found on left mid-neck region, larger than 1 cm. Additional lymph nodes (2)  felt in right supraclavicular region around 1 cm.
Soreness; Received booster dose before approval; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Received booster dose before approval) and MYALGIA (Soreness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A, 015M20A and 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Hypertension, Chronic kidney disease and Arthritis. Concomitant products included FUROSEMIDE (LASIX M), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), METFORMIN, ATENOLOL, LISINOPRIL, MAGNESIUM OXIDE, AMLODIPINE, ATORVASTATIN and CLONIDINE for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Oct-2021, the patient experienced OFF LABEL USE (Received booster dose before approval). On an unknown date, the patient experienced MYALGIA (Soreness). On 17-Oct-2021, OFF LABEL USE (Received booster dose before approval) had resolved. At the time of the report, MYALGIA (Soreness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information provided.  Company Comment: This is a case of off label use concerning a 76-year-old, female patient, with no relevant medical history, who experienced the non-serious, expected event of myalgia. The event occurred on unknown date after third dose of mRNA 1273 vaccine. The patient was given the booster dose, before it was approved and experienced soreness after the vaccine. The rechallenge is not applicable as there is no additional dose expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-391841.; Sender's Comments: This is a case of off label use concerning a 76-year-old, female patient, with no relevant medical history, who experienced the non-serious, expected event of myalgia. The event occurred on unknown date after third dose of mRNA 1273 vaccine. The patient was given the booster dose, before it was approved and experienced soreness after the vaccine. The rechallenge is not applicable as there is no additional dose expected. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Fever, clingy, whiny, apparent dizzy symptoms when lying flat (when in crib, holding onto the bars, lying, not moving, eyes closed, screaming in pain and fear).  Dizzy signs started around 130pm during nap.  Treating with snuggles, Tylenol, increased fluids, and just relaxing. Holding for sleep for his comfort.  Called dr Office to inform them and get criteria for him to be taken in.
Initial unsolicited report received from a Nurse on 26 October 2015. This case was linked to 2015SA176376 and 2015SA172486 (same vaccine). This case involves a patient (age not reported) who was vaccinated with a dose of Fluzone (batch number, route and site of administration were not reported) and on the same day also received a dose of Pneumovax (batch number- L003188, expiry date- 06 July 2016, route and site of administration, dose, dose in series were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient had experienced nausea, headache, and "terribly achy body", fever, both arms were red and had knot of the size of baseball at the injection site. Laboratory data and corrective treatment were not reported. The outcome of the event was not reported. List of documents held by sender: none. Sender's Comments: Loss of consciousness is unlisted after INFLUENZA VACCINE. Time to onset is not reported. In the current case, there is no information on medical history and complementary investigations. Insufficient information in this report precludes a complete medical assessment.
extreme pain in arm has not gone away. has been made worse by booster I had to get for my union and has spread to my entire shoulder neck and down my arm. have had this pain since april 2021 with first shot.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 06Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative; (Jun2022) Positive. Therapeutic measures were taken as a result of covid-19, drug ineffective included Paxlovid.  Clinical course: Tested negative after 5 days of treatment, tested positive for covid after 10 days. Runny nose came back after 9 days.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Night of vaccination experienced chest and back aches. Following day was achy all over, temp of 100 degrees. Didn't work Friday 10/30, had no energy. Went back to work 11/3. Said has had several cold sores since. Also said knees ached.
no additional information provided; an improperly stored dose of varivax was administered to a patient on 17-FEB-2022; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-FEB-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 ml, lot # U010400, expiration date 01-APR-2023 (formulation, dose number, site and route of administration were not reported) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 9 degrees Fahrenheit for 293 hours and 14 minutes. No previous temperature excursions reported. No additional information provided (no adverse event).; Sender's Comments:  US-009507513-2202USA007938: US-009507513-2202USA008270: US-009507513-2202USA007865:
clinic had administered 16 doses of the Moderna covid-19 vaccine by intramuscular injection; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (clinic had administered 16 doses of the Moderna covid-19 vaccine by intramuscular injection) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (clinic had administered 16 doses of the Moderna covid-19 vaccine by intramuscular injection). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (clinic had administered 16 doses of the Moderna covid-19 vaccine by intramuscular injection) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   It was reported that none of the patients experienced any reported symptoms and no treatments or additional doses was provided.  Treatment information was reported as none.   This case was linked to MOD-2021-413535, MOD-2021-413554 (Patient Link).
VOMITING; SWELLING OF ARM; CHILLS; PAIN ON THE ARM; FEVER; HEADACHE; This spontaneous report received from a patient concerned a patient 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: 203A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced vomiting. On 10-APR-2021, the subject experienced swelling of arm. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced pain on the arm. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, headache, chills, vomiting, pain on the arm, and swelling of arm. This report was non-serious.
Patient was vaccinated with booster 77 days after 2nd dose.  She is not immunocompromised
Pt recv vax on 11/6/98; 2 hr later pt exp cough & shortness of breath
Headache, Arthralgia, Fatigue, chills, injection site pain, arthralgia Narrative:
Local redness and swelling of right thigh. Hot to the touch. Doctor prescribed the patient CHILDREN'S BENADRYL 12.5MG/5mL. Frequency being 4 (four) times daily PRN for allergies, leg rash.