chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The injection site has a cellulitis reaction, three and half inches long. Redness and hot to the touch. Physician states it hurts a lot; Physician states that when pharmacist pulled out the vaccine it dripped some content out of arm; Physician states that she was given the vaccine subcutaneously or intradermally; This spontaneous case was received on 01-Oct-2021 from a physician via agency (reference number: SEQW21-03131) with additional document (being process together) received on the same date and concerned a 42-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications. The patient never had a reaction to flu vaccine.  On 30-Sep-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: subcutaneous or intradermal, anatomical location: deltoid) (explicitly coded as 'Inappropriate route od administration') for influenza prophylaxis. The batch number reported was 309613 and expiry date 25-Jun-2022.  On the same date, after the pharmacist pulled out the vaccine, it dripped some content out of arm. The patient stated she believed the vaccine was given subcutaneously or intradermally instead of intramuscularly. The vaccine was not leaking prior to administration.   On the same day, after receiving Flucelvax Quadrivalent, the patient developed a cellulitis reaction on injection site, three and half inches long which was red, hot and to the touch. Additionally, the patient stated that it hurt a lot. The patient was treated with compresses. At the time of initial reporting, it was warm to the touch.   The outcome of the events was not reported.   The reporter assessed the event of 'vaccination site cellulitis' to be related to Flucelvax Quadrivalent and did not provide causality assessment for the event of 'vaccination site extravasation'   The reporter assessed the case as non-serious.  Company Comment: A 42-year-old, female patient developed vaccination site cellulitis on the same day after vaccination with the suspect product Flucelvax Quadrivalent. Vaccination site extravasation was also reported. Vaccine was administered subcutaneously or intradermally (explicitly coded as 'Inappropriate route od administration'). Causality for this event is assessed as not related as per company specific guidelines. Causality for the remaining two events is assessed as possibly related, although confounded by inappropriate route od administration.; Sender's Comments: A 42-year-old, female patient developed vaccination site cellulitis on the same day after vaccination with the suspect product Flucelvax Quadrivalent. Vaccination site extravasation was also reported. Vaccine was administered subcutaneously or intradermally (explicitly coded as 'Inappropriate route od administration'). Causality for this event is assessed as not related as per company specific guidelines. Causality for the remaining two events is assessed as possibly related, although confounded by inappropriate route od administration.
Pruritic rash, reported by mom 3 days after immunizations. Very itchy.
Got a shot of the PREVNAR 13 drug from my doctor on my annual visit. After that noticed a pain in my upper arm muscle area at the injection site. This pain comes and goes especially if I use the muscles in this area.
Sore arm - started a few hours after the vaccine, lasted about 40 hours. Took Ibuprofen until the pain was gone.   Migraine headache - started about 20 hours after the vaccine. Took prescription imitrex, which usually solves the problem, and 3 hours later when I still had the migraine I took another imitrex. A couple hours after that it went away.   Eye pain/irritation - left eye - started more than a full week after the vaccine. Left eyeball hurt and also appeared slightly red and irritated. The pain was on and off for two days.
Exposed to COVID at school. Symptoms May 25th, to emergency care, given Tessalon pearles, fluticasone, and Tylenol. Progressed, back to ED next day. Given IV acetaminophen and IV saline bolus, decadron and reglan. Discharged with acetaminophen, ibuprophen, phenergan and zofran. Still progressed, found unresponsive on May 28th, to ED. Unresponsive, brain dead. May 28: redesivir, dexamethasone, vancomycin ceftriaxone, and metronidazole.
This is a spontaneous report from a contactable consumer reported for himself. A 77-year-old male patient received the first dose of PREVNAR 13 via intramuscular route in the left arm, for immunization at single dose on 31Aug2017. On the same date the patient received also influenza vaccine via intramuscular route in the right arm, he has had it every year for the past 15 years. He received a pneumonia vaccine perhaps 5 years ago. Relevant medical history included elevated blood pressure and high cholesterol, both ongoing. Concomitant medications included doxazosin. On 01Sep2017 the patient experienced discomfort. The outcome of the event was recovered on 03Sep2017.
Initial report received from a healthcare professional on 03-Sep-2013. A 9-year-old patient of unknown gender was given YF-VAX intramuscular rather than subcutaneous route. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
This spontaneous report was received from a healthcare worker concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. In approximately 2015, reported as "since 01-JUN-2015 on unspecified dates", unspecified patients were vaccinated with doses of PEDVAXHIB (Lot # K009955 Expiration date: 26-MAR-2017), which were exposed to temperatures outside of the recommended range (dose, route and anatomical location of administration were not reported). No adverse experiences has been reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Intestinal discomfort; Ileocecal valve inflammation; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration in the left arm on 07Apr2021 at 13:45 (at the age of 74-year-old), as a single dose for COVID-19 immunisation. Medical history included GERD and overweight. The patient had a history of allergy to sulfa and iodine internal. The patient received unknown medication within two weeks of vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER7835), via an unspecified route of administration in the left arm on 17Mar2021 at 14:00 (at the age of 73-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021, the patient experienced intestinal discomfort and ileocecal valve inflammation probably started the following day and has continued ever since. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken for the events. The clinical outcome of the events intestinal discomfort and ileocecal valve inflammation were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Body aches; Fever; 2 asthma attacks; bitter taste; same date same vaccine; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular (Lot number: FF2587) as dose 1, single and intramuscular, administered in arm left (Lot number: FF2587) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 12Oct2021 10:00, outcome "recovered" (2021), described as "Body aches"; PYREXIA (non-serious) with onset 12Oct2021 10:00, outcome "recovered" (2021), described as "Fever"; ASTHMA (non-serious) with onset 12Oct2021 10:00, outcome "recovered" (2021), described as "2 asthma attacks"; DYSGEUSIA (non-serious) with onset 12Oct2021 10:00, outcome "recovered" (2021), described as "bitter taste"; PRODUCT USE ISSUE (non-serious) with onset 12Oct2021 10:00, outcome "unknown", described as "same date same vaccine". Therapeutic measures were not taken as a result of pain, pyrexia, asthma, dysgeusia.  Additional information: Facility type Hospital, other vaccine in four weeks No, Other medications in two weeks None .Adverse event: Body aches, Fever and 2 asthma attacks and bitter taste  No follow-up attempts are possible. No further information is expected.
pt exp h/a 1hr p/vax;rash, face, chest & back;
Swollen right index finger and joint.  Quite painful - most pain is subsided but swelling is still there on joint.
chills, feeling of passing out, nauseated, lost strength, cold, sweaty, exhausted, no appetite
Information has been received from a licensed practical nurse concerning a 68 year old female with sulfa, amoxicillin and Cephalexin monohydrate allergy and a history of pulmonary embolism who on 10/30/06 was vaccinated with Pneumococcal 23v polysaccharide vaccine (lot 651404/0352F). Concomitant therapy included influenza virus vaccine (manufacturer unspecified). On 10/30/2006, the pt experienced an injection site reaction with fever, swelling, achiness, decreased appetite, erythema and fatigue. The pt had been previously vaccinated with Pneumococcal 23v polysaccharide vaccine in 1995. The pt was treated with antibiotics, antihistamines and steroids. At the time of the report, the pts injection site reaction with fever, swelling, achiness, decreased appetite, erythema and fatigue persisted. Injection site reaction with fever, swelling, achiness, decreased appetite, erythema and fatigue were considered to be other important medical events (OMIC). Additional information has been requested.
On the AM of 2/27 at 4 AM she woke up with eyes swollen shut.  She describes this as it looked like she had been in a fight with  no bruising, just very swollen.  Since the weekend, she did not go to the MD, she just took Benadryl and iced with cold packs.  Today on 3/8/21, she still feels that her eyes are still puffy.  Does not interfere with her vision today.   She states that by Monday on 3/1/21, swelling went down and she did not go to the MD.
pharmacist administered second vaccine on day 18; A spontaneous report was received from a pharmacist, concerning a 19-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the pharmacist administered second vaccine on day 18 (PT: Inappropriate schedule of product administration).  The patient's medical history was not provided. Concomitant medications included erythromycin, promethazine, dextromethorphan.  On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030L20A) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection.   On 15 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: 031L20A) through an unknown route in an unknown arm for prophylaxis of COVID-19 infection.   On 16 Feb 2021, pharmacist reported that the patient received second dose of vaccination on day 18, after his first dose.   Action taken with mRNA-1273 was not applicable.  The outcome of the event pharmacist administered second vaccine on day 18 was resolved on 15 Feb 2021.; Reporter's Comments: This report refers to a case of inappropriate schedule of product administration for mRNA-1273 (lot number 031l20A) with no associated AEs reported.
headache; Chills; Fever; Nausea; Vomiting; Slept the entire 2nd day; Tingling; Itching; Horrible feeleng because Could not sleep; really hit bad/feeling horrible; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced headache, chills, fever, nausea, vomiting, sleep excessive, tingling, pruritus, insomnia and feeling abnormal. On an unknown date, the outcome of the headache, chills, fever, nausea, vomiting, sleep excessive, insomnia and feeling abnormal were unknown and the outcome of the tingling and pruritus were recovering/resolving.   It was unknown if the reporter considered the headache, chills, fever, nausea, vomiting, sleep excessive, tingling, pruritus, insomnia and feeling abnormal to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-JUN-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had shingles vaccine and this really hit bad. The patient had headache, chills, fever, nausea and vomiting. The patient slept the entire 2nd day but tingling and itching were going away. It was horrible feeling because he/she could not sleep. Additional Supportive Information: The follow up would not possible as no contact details were available.
Extreme abdominal pain. Chest pain. Circulation issues. Varicose veins and yet to determined by the doctor what the prognosis is.
Reaction to second Moderna vaccine; 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 VACCINATION COMPLICATION (Reaction to second Moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction to second Moderna vaccine). At the time of the report, VACCINATION COMPLICATION (Reaction to second Moderna vaccine) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.
SUSPECTED CLINICAL VACCINATION FAILURE; GOT COVID; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose not reported, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced suspected clinical vaccination failure and got covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from got covid, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000203270.; Sender's Comments: V0:20211145268-COVID-19 VACCINE AD26.COV2.S-Suspected clinical Vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
This spontaneous report was received from a licensed practical nurse concerning an unspecified numbers of patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with unspecified number of doses of improperly stored LIQUID PEDVAXHIB (dose, frequency, route, indication, lot # and expiration not reported, also reported as PEDVAX). Temperature that the vaccines exposed to was 13.1 C with time frame of 22 minutes. There was a previous temperature excursion of 14C for 22 minutes.  No adverse effects were reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1708USA013099:
This spontaneous report was received from a medical assistant and refers to a male patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in 2013, the patient was vaccinated with the first dose of ZOSTAVAX subcutaneously for prophylaxis (dose, lot# and expiration date were not reported). On 22-MAY-2018, the patient received a second dose of ZOSTAVAX subcutaneously for prophylaxis (dose, lot# and expiration date were not reported). No adverse effects were reported.
Information has been received from a physician concerning a female with a history of splenectomy prior to vaccination who "last week" (August 2006) was vaccinated subcutaneously with a 0.5 ml dose of Pneumovax 23. The physician reported that a day following the Pneumovax 23, the patient reported that she was not feeling very well. The patient developed cellulitis at the injection site that spread to her lymph nodes and then to her neck. The patient was hospitalized for three days but the physician did not provide dates. The physician felt as though the patient was near death at one point during her hospitalization. At the time of the report, it was unknown if the patient recovered. The physician felt that the patient's not feeling very well, cellulitis at the injection site which spread to her lymph nodes and then to her neck were considered to be immediately life-threatening. A lot check of concern has been requested. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. Additional information is not expected.
I do not know if it is an adverse event symptom etc of vaccine.  I went to my primary care physician  today because I had a rash and the left side of my torso was in pain.   He diagnosed me as having shingles.  When I got home I decided to report since I see there have been some reports which appear to be rare according to what I read.  I also had one day of illness fatigue overall just felt cruddy about 3 days after the shot.  I was scheduled to get the second shot today but do to this development I did not take second shot today.
Pt complained of dizziness 20 minutes after injections. 2 hrs later hives appeared and pt complained of heaviness in chest, like someone sitting on chest. Pt sent to ER - later that day @ 4pm Pt again went to ER with heaviness in chest. Next day complained of fever 101F, thick swollen tongue, itchy eyes that hurt and joint aches.
04/12/13 - Donor called at 10:27 AM to report sx. Onset of aching started 4/11/13 @ 6PM to joints, wrist, elbows, shoulder, and neck and hasn't resolved. Weakness to hands w/onset starting 3:30 AM, low grade fever 99.5 at 03:30 AM, woke up at 01:00 AM with nausea, cold/chills & diarrhea off/on since. States, feels exhausted and dizziness off/on when sitting or standing since 01:00 AM and that she received the Tetanus shot 04/11/13. Husband w/her and has been assisting her d/t sx.
pt devel fever that evening & had a sudden onset  of a generalized sz according to parents;pt had spontaneous resolution p/several minutes;no prior hx of febrile sz in child;dry cough;eyes rolled back & mild shaking;sz w/fever;
Pt exp high fever x 24 hrs, seizure & encephalitis 5th day;
Severe migraine, 103 degree fever, severe cough, dizziness, nausea, joint pain and weakness.
Obnoxious ringing in the ears, started approximately 1.5 days after the vaccine. Getting worse.
Having trouble eating, diarrhea, nausea called her Oncologist and a blood clot of found in her pelvic
Patient received his 3rd primary dose as his 1st booster dose; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his 3rd primary dose as his 1st booster dose) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071B22A) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his 3rd primary dose as his 1st booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his 3rd primary dose as his 1st booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his 3rd primary dose as his 1st booster dose). No concomitant medications were provided. At that time Moderna had not released Bivalent vaccine, as result patient received his 3rd primary dose as his 1st booster dose. HCP would like to know how to have Bivalent dose administered because patient was not immunocompromised. No treatment medication was provided.
soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (soreness at injection site) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBUPROFEN (ADVIL [IBUPROFEN]) for Muscle soreness.    No medical history was provided by the reporter.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started IBUPROFEN (ADVIL [IBUPROFEN]) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INJECTION SITE PAIN (soreness at injection site). At the time of the report, INJECTION SITE PAIN (soreness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Almost immediate pains all over; hallucinations and irrational behavior the next couple of days and continuing pains, inability to speak. Went to doctor, but declined MRI. Pain was later confined to right arm, where the 2 vaccines were given. Pain has never gone away.
Rash began on right thigh on 7-25-07, has extended to back, none on arm/site of injection. Some blistering, dime sized, some coalesced.
1st sx was pain when inhaling back of lungs, 02 sats 94-98%, elevated BP, feeling SOB when prone
4Pm pt was in car seat waiting in car w/sibling while father was in a building;pt began jerking & eyes rolled back in head;sibling removed pt & ran into store, cold water put on pt & immed broke out of it;paramedics stated feb sz & to ER