chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Persistent fever which reached 103.5; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Oct2021 17:00 (Lot number: 301558A) at the age of 33 years as dose 3, (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8727, Location of injection: Arm Left), administration date: 27Mar2021, when the patient was 33 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8731, Location of injection: Arm Left), administration date: 17Apr2021, when the patient was 33 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "Persistent fever which reached 103.5". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia.  Additional information: On an unknown date patient underwent lab tests and procedures which included body temperature: 103.5. Patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID since the vaccination. Patient had no known allergies. Patient was not hospitalized due to event.  No follow-up attempts are possible. No further information is expected.
Developed oval swollen lump (approx 3" long by 2.5" wide) at injection site within 7 hours after shot.  Area was warm, itchy and slightly tender to the touch and remains so 24+ hours later.  No side effects were experienced with the first shot nor have i had any reaction to other vaccines such as FLU, Shingrix, DTAP, MMR, etc.  Periodically iced area and have taken antihistamines.
Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No adverse event; Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (Bivalent booster was given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    This case included information of patient 66th out of 100 patients.  No concomitant medication was provided by reporter.  Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients are involved, date of administration 11 Jan 2023, lot numbers unknown to the HCP.  No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:case
Pt had Td and PREVNAR on 4/30/14. Called on 5/5/14 stating she had stiffness in both arms and legs but is feeling much better now. 5/8/14 Patient calls to state she has had stiff neck for 3 days and arms are still sore. OV on 5/8/14 -> (R) arm soreness, right leg weakness and muscle aches 4 days now. Feels warm and having chills, T 98 degrees. Appetite decreased. Aching and swelling over (R) foot last 4 days and using cane. Exam -> (R) upper arm pink, tender, warm to touch, (R) foot warm, tender with non-pitting edema. 5/16/14 - OV - (R) upper extremity full ROM. Able to get out of chair without difficulty.
it was very sore; there was a rash there; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (it was very sore) and VACCINATION SITE RASH (there was a rash there) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included SULFASALAZINE for an unknown indication.    On 27-Feb-2019, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE PAIN (it was very sore) and VACCINATION SITE RASH (there was a rash there). At the time of the report, VACCINATION SITE PAIN (it was very sore) and VACCINATION SITE RASH (there was a rash there) 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.   Treatment details include paracetamol.  Concomitant medications include Sulfasalazine, Hormonal medicine and cholesterol medicine.
8/9/11 received Meningitis, Tdap & Varicella - Varicella site, red, warm, painful & swollen.
It was itchy and hot; Overall itching in her body; got larger before smaller, size of a golf ball/it came back; red at the injection site/got larger before smaller; red at the injection site; Injection site, it was itching; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (It was itchy and hot), PRURITUS (Overall itching in her body), VACCINATION SITE PRURITUS (Injection site, it was itching), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE SWELLING (got larger before smaller, size of a golf ball/it came back) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypertension since an unknown date and Thyroid disorder since an unknown date. Concurrent medical conditions included Allergy multiple (It is reported that patient has lot of allergies).  On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site, it was itching), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site).   On 24-Jan-2021, the patient experienced FEELING HOT (It was itchy and hot), PRURITUS (Overall itching in her body), VACCINATION SITE SWELLING (got larger before smaller, size of a golf ball/it came back) and VACCINATION SITE ERYTHEMA (red at the injection site/got larger before smaller). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency.   On 19-Jan-2021, VACCINATION SITE PRURITUS (Injection site, it was itching), VACCINATION SITE SWELLING (swelling at the injection site) and VACCINATION SITE ERYTHEMA (red at the injection site) had resolved.   At the time of the report, FEELING HOT (It was itchy and hot), PRURITUS (Overall itching in her body), VACCINATION SITE SWELLING (got larger before smaller, size of a golf ball/it came back) and VACCINATION SITE ERYTHEMA (red at the injection site/got larger before smaller) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.
This spontaneous report was received from a registered nurse concerning a multiple unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD subcutaneous injection (strength and dose were not reported) (lot # M007964, expiration date 15-AUG-2017; lot # L046508, expiration date 17-MAY-2017). According to the reporter, PROQUAD doses were exposed to the following temperatures excursions: 2 hours and 12 minutes between more than 5 degrees Fahrenheit (F) but less than 14 F, for 48 minutes more than 14 F and  less than 46 F, and for 8 hours and 15 minutes more than 5 F and less than 14 F. No adverse effects were reported. A digital data logger was involved. There was no product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA005005: US-009507513-1702USA001693.
Vaccine were drawn up on August 4 and instead of "wasting" the remaining doses CMA placed the vial back in the refrigerator to be utilized the next day.  This does not follow our clinic policies or protocol. The next day, August 5, 2022 -  another CMA went to give a Peds COVID vaccine and utilized the remaining vial from the previous day's doses.  Another nurse later that morning went to give another Covid vaccine and identified that the previous day's supply had been placed back in the refrigerator. Our clinical pharmacist was contacted. The pharmacist contacted the Pfizer Medical Information team and received the following information:  Within the supported 24 hours post-dilution at 2°C to 30°C (35ºF to 86ºF):  o Data supports up to 24 hours storage of diluted vaccine in vials at 2°C to 30°C (35ºF to 86ºF) (this includes 6 hours labeled time described in the Prescribing Information + additional 18 hours excursion time)  o Data supports up to 24 hours storage of diluted vaccine in syringes in the refrigerator (2°C to 8°C [35ºF to 46ºF])  o Data supports up to 6 hours storage of diluted vaccine in syringes at room temperature (8°C to 30°C [46ºF to 86ºF])  o Total cumulative time post-dilution cannot exceed 24 hours, regardless of container.   The error was reported to myself and our policies and procedures will again be reviewed regarding the vaccine storage.
04/2021 I started to have swollen ankles and bad arthritis. I could hardly walk for about three weeks. I went to the doctor on 05/17/2021. The doctor did test to rule out Lyme Disease. Shortly after I ended up having bronchitis. I went to urgent care and they prescribed prednisone and an inhaler for asthma. Before the vaccine I had some allergies, but never had a full-blown asthma. The bronchitis last 3 weeks. On 07/09/2021 I had shortness of breath. I went to urgent care 07/11/2021 and was diagnosed with severe Bronchitis. They prescribed prednisone. They also tested for COVID which was negative. 09/03/2021 I went to urgent care because I was feeling shaky for a few days. My BP was 165/92 and my heart rates at rest was 90-100. 09/07/2021 I had a follow up visit with my doctor and he ordered an echocardiogram. I had to wear a heart monitor from 09/17/2021- 10/01/2021. The monitor showed abnormal short bursts of fast heart rate. Longest episode was for 10 seconds. 253 nonsustained supraventricular tachycardia with max heart rates of 184. 09/2021 I went to urgent care for bronchitis and was treated with Dexamethasone. Also, in 09/2021 I went to urgent care for bronchitis and was treated with Dexamethasone. After my last round of Steroid treatments my asthma is now stable. I am still taking medication for high blood pressure.
10-6-10 2 x 3/4 red and slightly raised area at site of flu vaccine. BENADRYL prn.
CHEST PAIN, EXTREME FATIGUE, PALPATATIONS. AFTER SEVERAL WEEKS OF CHEST PAIN AND EXTREME FATIGUE, DR. ORDERED A BLOOD TEST TO CHECK FOR INFLAMMATION AFTER I DISCUSSED WITH HIM ABOUT THE SIDE EFFECTS OF THE VACINE WITH HEART INFLAMMATION. THE TEST CAME BACK SHOWING INFLAMMATION AND HE PUT ME ON 600 MG IBUPROFEN 3 TIMES A DAY AND COLCHICINE 5 MG 1 TIME A DAY. I AM CURRENTLY STILL TAKING THESE MEDS. BUT I AM FEELING MUCH BETTER.
Received phone call from client's husband 1/29/2010. Husband reports client took first capsule of typhoid vaccine at 8:00 AM 1/27/09. Husband reports client began experiencing redness and swelling of the lips around midnight. Symptoms persisted for approx. 4 hrs and were completely resolved at the time of report.
Boostrix was administrated to 1 day baby; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-day-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 16th April 2021, the patient received Boostrix. On 16th April 2021, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The Boostrix vaccine was administrated to 1 day old baby ,which led to inappropriate age at vaccine administration.  No adverse event was reported .  No patient's identifiers provided, no lot number nor expiration date provided. The reporter consented to follow up.
This spontaneous report was received from a physician via company representative and refers to a male patient of unknown age. His concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in 2018 (reported as within the last year), the patient was vaccinated with GARDASIL 9 intramuscular (dose, lot# and expiry date were not reported) for prophylaxis. On an unknown date (reported as afterwards), he developed dizziness. The outcome of dizziness was unknown. The causality was not reported.
Continuous crying for @ least 5 hrs following vax administration; no fever; no neurologic abnormalities noted;
Within a couple minutes, I had a shooting pain in my left ear - that went away in 30 seconds. And then that evening, about 6 hours after, I was achy, had the chills, I had sweats and I was incredibly tired. That lasted for about 36 hours. My headache didn't go away - it wasn't on my forehead, it was on the back of my head. That headache didn't go away for two weeks - four weeks. It was really painful. Around that Monday or Tuesday,  after the vaccine, I started getting the ringing in my ear. If you go to a concert - loud music venue - and you come home and your ears are ringing. That is how it is all the time/consistent ringing and it's only in my right ear.  My head hurt so badly, I don't know if it was Monday or Tuesday for when it started. I had a virtual appt with Primary Care Doctor - he said that there had been reports of Tinnitus from after the vaccine. He recommended not to do J&J again - if they do a booster. If you make a line from  top of one ear to to top of other ear - all that area was excruciating pain on the back of my head. I had massages for it and had them work on my head to help the pain.
throwing up; Itchy; Dizzy; This is the spontaneous report received from a contactable consumer (patient' wife). A male patient of an unspecified age received BNT162B2, dose 1 via an unspecified route of administration on 28Mar2021 11:00 AM (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included cancer. The patient had cancer and his chemo was done three weeks ago, it was his third chemo. The patient's concomitant medications were not reported. The reporter was calling about the covid vaccine. The reporter received the first dose of the vaccine a week ago with her husband, same place and same time. Her husband had been throwing up all day yesterday but then he was feeling good today. The patient had cancer and his chemo was done three weeks ago, it was his third chemo. At first the caller thought the patient was throwing up because of the chemo. The patient had also been itchy and dizzy. The event onset date was not reported. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected. Information about batch number cannot be obtained.
shot was given with moderna that had been at room temp for 24 hours. pt had similar side effects  as those receiving a shot not over exp. time
I woke up this morning (5/4/21) with a very swollen,  sore and achy left arm with a large red rash on swollen area. The swelling is at the vaccine site. I also have had a headache since waking up. My left arm feels weak all the way down to my hand. I felt heart palpitations this morning which is very unusual, not sure if that?s related.
After the first shot in my left arm I had occasional numbness from that shoulder all the way down to my pinky and ring finger.  EVER SINCE MY 2ND SHOT IN MY LEFT ARM I NOW HAVE CONSTANT NUMBNESS ALL THE WAY DOWN FROM MY LEFT SHOULDER TO MY PINKY AND RING FINGER, IT NEVER GOES AWAY!  Also, after the 2nd shot i was sick for 5 days.
Notice the swelling the next day after vaccine was administered (09/23/09). Red and hard, swollen 4 cm x 4 cm, but as per mom has reduced from 9/24/09.
Modern a COVID-19 Vaccine EUA  Swelling,hardness,redness, itching
Had tiredness; Arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Had tiredness) and VACCINATION SITE PAIN (Arm was sore at the injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A, 044B21A and 051F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced FATIGUE (Had tiredness) and VACCINATION SITE PAIN (Arm was sore at the injection site). At the time of the report, FATIGUE (Had tiredness) and VACCINATION SITE PAIN (Arm was sore at the injection site) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-384074, MOD-2021-384392 (Patient Link).
This non-serious initial spontaneous case, was received on 06-Sep-2017 from pharmacist (pharmacy technician), concerning a 21-year-old adult male patient. On 06-Sep-2017, the patient was administered FLUVIRIN THIOMERSAL (dose: 0.5 ml, batch number: 1720801 (as reported), expiry date: Apr-2018, dose, route of administration: intramuscular and anatomical location: not reported). On an unspecified date, the vaccine underwent temperature excursion, which was considered as incorrect product storage. On 06-Sep-2017, the patient was administered with vaccine, which underwent temperature excursion instead of storing at 36-46 degree F (2-8 degree Celsius), which was considered as drug administration error. The outcome of the events was not reported. The reporter assessed the report as non-serious.
I have received my 2nd dose of Moderna vaccine on 2/12/21. On 2/23/21, I noticed Shingles on my left side of the face, ear, lymph nodes swollen. I never had chickenpox in the childhood. I am 46 years old. I am from India. I hope my information will help prevent in the future not many people suffer in the same way.
This spontaneous report as received from a health care worker refers to multiple unspecified patients of unknown demographics. The concurrent condition, medical history and concomitant medication was not reported. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (Lot# L029472, Expiry: 06-SEP-2017; Lot # L040422, Expiry: 15-OCT-2017, Lot# L035124, Expiry: 14-SEP-2017, Lot# L034367, Expiry: 08-SEP-2017, Lot# L043622, Expiry: 03-NOV-2017). The vaccine was stored at 16 F for a duration of 1 hour and 11 minutes. There were no previous excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Chest pain, tachycardia, severe head pain, dizziness, loss of vision, and continued headaches/migraines.
Fatigue/severe body aches Fever of 100-101 degrees Chills/sweating Headaches Intermittent sore throat Intermittent nausea Elevated HR   Has lasted two days after vaccination and caused me to miss work
hard swelling arm which feels warm to the touch at the injection site; itching; swelling; hardness; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events itching, swelling, hardness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 032L20A) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) itching, swelling, hardness.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), itching, swelling, hardness was unknown.
Got out of bed, after a few minutes of standing vision became  white, sudden onset of severe diaphoresis, then unable to stand, fell to the floor then could not see at all, everything was black, also unable to speak, sudden onset of shortness of breath, central chest pain, pain to shoulders and neck. Ears ringing, pain to back of head. Approximately 15 min later was able to speak and crawl to edge of bed. Sweating remained at this time along with extreme weakness, lightheaded and nausea. Heart rate 118, oxygen was 96% by finger oximeter.  10 minutes later dressed with assistance and able to ambulate independently but slowly to truck to be taken to ER.
Patient c/o site reaction that occurred 8 days post vaccination.  Site is approximately 1.5" in diameter, raised and area is red.  The site is not "hot" to touch and patient denies any pain.  She does complain of itching and irritation.  On day 10 post vaccination the site is approximately 2.75" in diameter.  The area is still raised and red.  Patient still complains of itching and irritation but denies any pain.