chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feels sore; injection site itchy; injection site raised; vaccine caused flu like symptoms; vaccine made sick; very fatigued; Vomiting; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (vaccine caused flu like symptoms), IMMUNISATION REACTION (vaccine made sick), FATIGUE (very fatigued), VOMITING (Vomiting) and PYREXIA (Fever) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. In 2021, the patient experienced INFLUENZA LIKE ILLNESS (vaccine caused flu like symptoms), IMMUNISATION REACTION (vaccine made sick), FATIGUE (very fatigued), VOMITING (Vomiting) and PYREXIA (Fever). On an unknown date, the patient experienced PAIN (feels sore), INJECTION SITE PRURITUS (injection site itchy) and INJECTION SITE PAPULE (injection site raised). At the time of the report, INFLUENZA LIKE ILLNESS (vaccine caused flu like symptoms), IMMUNISATION REACTION (vaccine made sick), FATIGUE (very fatigued), VOMITING (Vomiting) and PYREXIA (Fever) had resolved, PAIN (feels sore) had not resolved and INJECTION SITE PRURITUS (injection site itchy) and INJECTION SITE PAPULE (injection site raised) was resolving.            Concomitant product use was not provided by the reporter.  Action taken was reported as unknown for the co-suspect ADALIMUMAB (HUMIRA) with respect to all the events.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of vaccine made sick, feels sore, injection site raised, injection site itchy, vaccine caused flu like symptoms, very fatigued, vomiting and fever was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Live follow-up received additional event injection site raised, injection site itchy, vaccine caused flu like symptoms and fever were added. the event of sick was updated to vaccine made sick. As reported term of event fatigue were updated. causality of events were updated. start date of suspect vaccine were updated.
Hidradenitis suppurativa flare during COVID vaccination; This spontaneous case was reported by a consumer and describes the occurrence of HIDRADENITIS (Hidradenitis suppurativa flare during COVID vaccination) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced HIDRADENITIS (Hidradenitis suppurativa flare during COVID vaccination). At the time of the report, HIDRADENITIS (Hidradenitis suppurativa flare during COVID vaccination) was resolving.            No concomitant medication provided. No treatment information mentioned.  Patient reported a flare up after COVID vaccine of hidradenitis. Was tender and broke out under arms, breast and groin area.   The reporters causality for events with HUMIRA was considered to be no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
1132 V.S. 108/74 66 20 O2 Sat 100% on R.A.. No difficulty swallowing. ?Sort of like a rock/bump in throat. No rash, no itching, no SOB or difficulty breathing. States he is feeling better. 1142 V.S. 118/80 64 20, O2 Sat 99% on R.A.. Patient without complaints @ this time. No c/o SOB or difficulty breathing. Swallowing okay. Drinking water okay. Fiancé here will drive him home. Ambulating okay. Skin color WNL. No distress stated or observed. No further medical attention needed. Patient advised to call 911 if symptoms recur or worsen. 1148, Okay to go home. Patient post vaccine stable. Patient acknowledges understanding of instructions.
Initial unsolicited case received from a physician via other company Pfizer under the manufacturer control number: 2016555849 on 22 Feb 2017. This case involves a patient (age and gender not reported) who was vaccinated with a dose of TETANUS TOXOID (Batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. The patient medical history and concomitant medications were not reported. On an unknown date after the vaccination the patient had Allergy to tetanus. The patient lab tests and corrective treatment was not reported. The outcome of the event was not reported. List of documents held by sender: none.
I use Kardia device with my cellular device which checks my heart's sinus rhythm. On 01/08 it was noted I had a Afib issue and this is the 3rd of 3 instances that my device alerted me to. The others in July and September and I talked to members of the cardiology dept. at the clinic. After the second in Sept. It was suggested a 2nd ablation treatment which was performed in Nov. This time the cardiology team suggested a Cardioversion. Scheduled for this Friday 01/21.
I had an odd reaction on deltoid muscle several weeks after booster shot, looks like there is a (dent) indentation, looks like some atrophy in my shoulder. The width of a golf-ball, on the bottom of the deltoid muscle. The PA said there is some muscle atrophy. I have an appointment to talk to my doctor this week. I do not have any pain nor disability in my joints. I also came down with Covid few days ago. I do not know if it is related to Covid. I have not recovered yet. Lot# was not provided
Patient became very dizzy and lightheaded immediately after receiving the vaccine. Patient recovered after 15 min. Put head between legs, gave water, cool rag, and food. Pt left under care of husband.
Approximately 20 minutes after administration of the second in a three immunization series for the Hepatitis B vaccine, I experienced severe itching on my front and back upper torso region and neck. I did not notice if there were hives associated with this itching. The itching lasted for approximately 10-15 minutes. It did not occur to me that the Hep B vaccine could be causing the itching. When I went to my employer's Occupational Health Department to inquire if I should get the third vaccine in the series, the Occupational Health nurse suggested that I fill this form out and submit it to you.
Redness and swelling of the injection site and surrounding area of the upper arm. Pain and tenderness of the injection site. This occurred several hours after the injection was given.
acute wheezing non-responsive to Ventolin inhaler; sent to hosp ER for eval tx;
Started with fever then by 10:30pm became delirious, had aphasia, and right sided numbness/weakness Went to ER - had CT scan and MRI Given stress dose of hydrocortisone, given tylenol, and given aspirin Diagnosed with TIA
soreness; pain in his shoulder; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiration Date: was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included, diabetes mellitus from an unknown date and unknown if ongoing, parkinson's disease from an unknown date and unknown if ongoing. Concomitant medication(s) included dabigatran etexilate mesilate (PRADAXA) taken for an unspecified indication from an unspecified start date and ongoing; dabrafenib mesilate (TAFINLAR) taken for an unspecified indication from an unspecified start date and ongoing; ramipril (RAMIPRIL) taken for an unspecified indication from an unspecified start date and ongoing; levodopa (LEVODOPA) taken for parkinsons disease from an unspecified start date and ongoing; carbidopa (CARBIDOPA) taken for parkinsons disease from an unspecified start date and ongoing; primidone (PRIMIDONE) taken for parkinsons disease from an unspecified start date and ongoing. Patient previously received Flu shot for Flu prevention on an unspecified date. It was reported that patient asking if he can take Pradaxa and Tafinlar with the second dose of Pfizer's COVID vaccine. Male consumer stated after his first dose of Pfizer COVID vaccine, he only had soreness on the 2nd day. On the 3rd day, there was nothing. He only had minor pain in his shoulder for a day. No swelling, no redness, nothing. Caller is on Pradaxa, Tafinlar (2 capsules twice daily), Ramipril 10mg, and Carbidopa/Levodopa for Parkinson's and he has diabetes. Patient states he was discontinued from Xarelto because it interacted with his Parkinson medication Primidone. He had always had flu shots and passed with flying colors. The outcome of the soreness was recovered on an unspecified date and event pain in his shoulder outcome was unknown.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
02/03/2022 individual received correct first dose . Today 02/24/2022 individual received undiluted 0.2 ml of Pfizer Covid 19 Vaccine (orange cap, 5-11 years old).
Woke up the day after her vaccines, walked to the bathroom, was not feeling well, Mom witnessed her pass out briefly and fall to the floor. no head trauma. Awake within seconds. Shaking of her arms for 2 seconds. Went to the ER. ECG performed, showing sinus tachycardia. Symptoms were improved, so no further work-up or treatments were needed. Back to baseline now.
Administered DTAP/IPV/MMR/VARICELL left arm swollen red, painful.
CHEST PAIN; LEG NUMBNESS; HIGH PULSE RATE AT MIDNIGHT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced chest pain, leg numbness, and high pulse rate at midnight. Laboratory data (dates unspecified) included: Pulse rate (NR: not provided) 192 {beats}/min. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pain, leg numbness and high pulse rate at midnight was not reported. This report was non-serious.
Patient sat down and in under 5 minutes of receiving the vaccine the patient's eyes rolled back in head and he passed out. Patient was placed on the floor where he regained conscienciousness  quickly. Said he had been in er previous week with low blood sugar possibly dehydrated. Checked his BP was close to normal ...and HR. His HR was 96. Patient was given a glucose tablet and sugar checked by ems once they arrived and it was normal. The ems evaluated his vitals stood him up and he began to look pale and light headed again. He was placed on gurney and taken to hospital. No further info on treatment available other than his grandfather a couple days later said he was doing ok and having someone check his heart.
Hives rash on legs, trunk and face with red splotches. No erythema. Rash is papular, macular: no fever.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021 at 4:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021 at 4:30 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 20.96.  Concomitant products were not provided.  On 19-Apr-2021, Vaccine was moved to fridge. On 29-Apr-2021, 5 vial was moved to clinic and temperature excursion reported as 33 degree fahrenheit at 10 AM. Vaccine BUD date reported as 19-May-2021  Condition of vaccine prior to administration was not frozen. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.   Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Purpura - treated with prednisone 3 times now on dapsone. Biopsy determined vasculitis.
Signs and Symptoms: Tender, Itchy, Redness, Pain in the area, and Swelling. Sx and Sx start on Saturday night until today.
Seasonal influenza vaccine administered prior to minimum recommended age. Administered to a 4wk 4 day old. Vaccine indicated for 6 months and up. Patient remained in clinic for 30 minutes following administration. No adverse reactions noted prior to departure from clinic.
Irritability 1 day later, slight fever 6 hours after, CBC 20,000, 56 % lymph, Spinal fluid 8 WBC. 82% lymphs, not eating, IV Antibiotics, R/O meningitis.
Strange; Vivid dreams; Occasional anxiety; Overdose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14Mar2021 11:00 (Lot number: EP7534) at the age of 42 years as dose 1, 1.3ml single for covid-19 immunisation. Relevant medical history included: "known allergies-Sulfa" (unspecified if ongoing), notes: known allergies-Sulfa; "ADD" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: High blood pressure. Concomitant medication(s) included: LISINOPRIL; ADDERALL; ALLEGRA. Past drug history included: Amoxicillin, reaction(s): "Drug allergy". The following information was reported: FEELING ABNORMAL (non-serious) with onset 15Mar2021, outcome "not recovered", described as "Strange"; ABNORMAL DREAMS (non-serious) with onset 15Mar2021, outcome "not recovered", described as "Vivid dreams"; ANXIETY (non-serious) with onset 15Mar2021, outcome "not recovered", described as "Occasional anxiety"; OVERDOSE (non-serious) with onset 14Mar2021 11:00, outcome "unknown", described as "Overdose". Therapeutic measures were not taken as a result of feeling abnormal, abnormal dreams, anxiety, overdose.  Additional information: Prior to the 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 vaccination. He believed this was the result of an overdose because the first dose received was 1.3mL (shown to him by the clinician after they did three preparations and admitted it was their first time administering the vaccine). He only realized the anomaly yesterday when he received his second dose of 0.3mL. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
Rash in various parts of the body. Mostly around joints. A lot of itching. It?s lasted several days. It hasn?t gone away.
Child immunized with Pfizer pediatric COVID-19 vaccine at only 4 years of age. Will not be 5 until January 2022. Discussed with parent. Child had no adverse effects per mother whom I spoke with today.
devel rash on arms, started 15 mins p/inject of MMR & got worse over the next 2-3 days, sx improved w/DPH;
sore on her left arm (especially the left hand). Soreness later crafted the right hand and could not move it well.; sore on her left arm (especially the left hand). Soreness later crafted the right hand and could not move it well  and struggles rolling over her bed.; trouble with breathing; headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: not reported), via an unspecified route of administration on 15Jul2021as dose 1, single for covid-19 immunization. Medical history included migraine, asthma, allergies, Epstein-Barr, all were ongoing (pre-existing conditions). She has never been free from Epstein-Barr and this EBV was recurring and never goes away. The patient concomitant medication was not reported. The patient previously took Allegra once (20 years ago) and had been suffering from migraine since then. The patient said that she was not the type of person who usually took drugs. The patient was saying that on 15Jul2021, she received the 1st dose of our COVID-19 vaccine. On an unknown date in 2021, the patient was experiencing a sore on her left arm (especially the left hand). Soreness later crafted the right hand and could not move it well. She was also having trouble with breathing and struggles rolling over her bed also mentioned experiencing a headache. The patient was scheduled for the 2nd dose on 12Aug2021. The outcome of the events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
21 y/o male SM developed aching shoulder, sluggishness, flu-like symptoms, progressing to nausea, and recurrent vomiting over the next few days. Symptoms development is temporally associated with receipt of Typhoid IM on 9/7/07. Flu-like symptoms <96 hours Start: 09/07/2007 Comment: Started the day following Typhoid IM. His sxs were mostly 'overall' body aching (muscle and joints). Chills Start: 09/08/07 Comment: Noted first on 9/8 associated with flu-like symptoms. Joint Pain, multiple joints Start: 09/08/2007 Comment: Noted on 9/8 associated with muscle aches. Anorexia Start: 09/08/2007 End: 09/12/2007 Comment: Appetite gone on 9/8. Nausea w/vomiting Start: 09/10/2007 End: 09/12/2007 Comment: Started on 9/10, ~ 6-7 times before admission to the medical ward.  03/03/2008 MR received from VHC for DOS 9/10-15/2007 with DX: Adverse Effect; Typhoid vaccine.  Pneumonia-due to other organisms. Nausea and Vomiting resulting in dehydration. Pt developed sluggishness, aching, flu-like symptoms and chills on the day following typoid vax.  Later developed loss of appetite, decreased po intake, and pt "passed out".  Taken to ED and found to be febrile (101.9'F) and dehydrated. Fluid bolus given and D/Cd. The next day pt began vomiting and returned to the ED on 9/11/07 where pt was found to be dehydrated and hypokalemic.  Cough developed and was Dx with RUL pneumonia. Tx with abx and IVF.  Feeling better at F/U 9/20/07.
SHINGLES, PAIN AT INJECTION SITE, CHILLS, DIZZINESS
5cm x 6cm erythematous lesion w/o distinct borders tot he (R) thigh. No pain or streaking. Abx Rx given PRN worsening Sx. Antihistamine PRN itching.
Patient came in today for an additional dose of Moderna vaccine (had previously received two from us). Confirmed patient had mast cell disease and was taking CellCept (hence eligible for the additional dose). Patient laid out her own EpiPen prior to injection as a "just in case" because she has to use it a lot. Confirmed again with patient she did fine with the first two injections. She said she had a little bit of tingling in her lips with the first dose, but no problems whatsoever with the second. Administered the vaccine. I told her I would sit with her since she had the propensities for allergic reactions (has used EpiPen 12 times in the past 4 months). She started wheezing slightly and did two puffs of her albuterol inhaler she had in her purse, maybe one minute later she said "I need my EpiPen" and she self-administered. Told my tech to note the time. I called EMS and monitored her blood pressure (two readings of 143/90 and then 139/70 after EpiPen administration). Patient stated she can only take IV Benadryl (allergic to oral). EMS arrived. Patient had a signed medical protocol on her phone. She emailed to me so I could print off for the EMS. I provided it to them so they could administer IV Benadryl. She seemed much better when EMS initially arrived, but then had to keep clearing her throat due to tightness. EMS took her to a local hospital for further evaluation.
After 2nd shot within an hour I started to feel a cold sensation flow through my body and my right arm and hand felt numb.
Child had difficulty moving left leg; was not paralyzed but slower reflexes and not able to kick as with the right.