chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of injection site tenderness in a 60-year-old female patient who received FLUARIX QUADRIVALENT (batch number 359MH, expiry date 20th June 2017). On 26th September 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 26th September 2016, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced injection site tenderness. On an unknown date, the outcome of the injection site tenderness was recovering/resolving. It was unknown if the reporter considered the injection site tenderness to be related to FLUARIX QUADIRVALENT. Additional details were provided as follows: The patient received a dose of FLUARIX QUADRIVALENT in her left arm and experienced injection site tenderness when laying on it, soreness was 2 inches below shoulder that hurt when she raised her arm. No additional information was provided.
Patient complained of a headache, nausea, clamminess, feeling warm and sweaty. Vitals stable. Laid patient down in Trendelenburg position. Symptoms improved, headache became less severe. Nausea returned when patient sat up. No symptoms of anaphylaxis.
15 minutes post injection, pt. c/o "rash & tightness in chest".  Evaluated by APN & assisted by POD supervisor RN & assistant pod supervisor RN.  Vital signs at 10:52am: 120/80 blood pressure taken manually, heart rate 79 bpm with no irregularity.  Benadryl 100 mg administered IM in right VL by APN at 10:56am.  Within 15 minutes, patient reported symptoms resolved & rash observed to be improving.  Pt. called family member to drive her home.  Pt. instructed to call 911 immediately for any worsening of symptoms or difficulty in breathing.
Chills, fever (101), vomiting, severe body aches, headache/migraine, lack of appetite, nausea, generalized fatigue. Overall felt like I had the flu. Lasted approximately 36 hours at most severe, then fatigued and lack of appetite for another 18 hours.
This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Low grade fever), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain in back, legs, arm) and PAIN IN EXTREMITY (Sore arm, couldn't be touched) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Low grade fever), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain in back, legs, arm) and PAIN IN EXTREMITY (Sore arm, couldn't be touched). At the time of the report, PYREXIA (Low grade fever) outcome was unknown and ARTHRALGIA (Joint pain), MYALGIA (Muscle pain in back, legs, arm) and PAIN IN EXTREMITY (Sore arm, couldn't be touched) had resolved. mRNA-1273 (Spikevax) (Intramuscular) dosing remained unchanged. No concomitant medication were reported. Patient experienced Joint pain, Muscle pain in back, legs and arm which lasted a day and a half. She also experienced Sore arm and could not touched to arm that lasted 5 days. It was reported that patient experienced difficult side effects and scary events. No treatment information was provided by the reporter. This case was linked to MOD-2022-592473, MOD-2022-592474 (Patient Link). Reporter did not allow further contact.
I received the Flu Shot on a Tuesday and the next day I awoke to my muscle being swollen and red and hot.  I also received the Pneumonia Shot in the same arm.  That information is:  Pneumovax 23 Syringe, Manufacturer: Merck Sharp & D, Route: Intramuscular, right arm.
1 1/2hr p/vax pt devel hives along rt jaw & rt neck;persisted 18hr no tx;
After her first dose of the vaccine, her psoriasis started acting up; Some of her rashes look like psoriasis/some of them may look like a rash from an allergic reaction; Some of them may look like a rash from an allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EP7533), via an unspecified route of administration, administered in right arm on 11Apr2021(age at vaccination 58-years-old) as dose 1, single dose for COVID-19 immunization was in hospital sponsored clinic. Medical history included blood pressure (she always had a problem with her blood pressure), coeliac disease from 2004, psoriasis that off and on for 10-15 years, thyroid had for years, Low Vitamin D. There is no family medical history relevant to adverse event. Concomitant medications included bisoprolol fumarate, hydrochlorothiazide (BISOPROLOL HYDROCHLOROTHIAZIDE CRISTERS) taken for blood pressure, levothyroxine taken for thyroid disorder, colecalciferol (VITAMIN D 3) taken for low vitamin D,curcuma longa (TURMERIC) taken for supposed to be good for her and multivitamin had been taking for years. The patient previously took shingles vaccine for immunization and experienced achy, fever, and chills. Past drug included Humira and had instantly got a rash, improved after a while. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine.On an unknown date in Apr2021, after her first dose of the vaccine her psoriasis started acting up. Patient stated that some of her rashes look like psoriasis, but the doctor said some of them might look like a rash from an allergic reaction. Patient clarified the symptoms began in Apr2021 with her hands, feet, elbow, and knee, after her first dose. Caller clarified the blood tests that were done were all related to like Lupus and things like that, like ANA, all kinds of stuff, and the test for inflammation was high, and she states, CRP, or something like that, when queried for test name by agent. Caller confirmed everything else was negative, and states, she was actually going to go to the rheumatologist, she was waiting on the appointment.The patient stated they added a new cream for her feet, just today and also got a shot of Stelara, and provides dose as 45 mg/0.5 ml.  The patient provided cream as Urea that she mixes with another cream, Betamethasone, and applies cream twice a day. The patient underwent lab tests in in Jul2021 which included ANA: negative, Blood tests for Lupus, and things like that: negative and blood test for inflammation, CRP or something like that: high. The patient confirmed the blood tests were done last week, in Jul2021, because she kept getting worse. Outcome of the event psoriasis started acting up was not resolved and rest of the events it was unknown.
Patient was brought in by parents for all to get booster shots of Moderna. After administration, and upon processing the claims, it was noticed that the patient is 17 years old and does not qualify for Moderna or booster.
Rash after dose 1; This non-serious case was reported by a physician via call center representative and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: Rash after dose 1). The outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.     It was unknown if the company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-JUN-2023 The physician asked that if a patient got the 1st Shingrix vaccine and developed a rash before getting the 2nd vaccine, did the patient still needed to get the 2nd vaccine. The reporter consented to follow up.
ZOSTER(ZOSTAVAX): RASH, REDNESS, AND ITCHING; FLUZONE HIGH DOSE REDNESS ONLY.  I RECOMMENDED PT TO TAKE  BENADRYL 25MG (OTC); 1HR 15MINS AFTER, WE CALLED TO CHECK HOW SHE WAS DOING, PT INDICATED THAT SHE FELT MUCH BETTER.
A few minutes after receiving the 1st vaccine shot I started feeling a tingling sensation in my right arm and felling as if both my mouth and nose were moving involuntarily and a sensation of swelling in them. It went away as the day proggresed, but I still feel it sometimes. But most importantly, 25-30 min. upon receiving the vaccine, I started to feel a nagging pain in the left region of my chest. I did not have any pain at all prior to that day.. At first it was worse if I slightly pressed my pectoral muscles.m but it increased immensely without any touch. It left me feeling like I was having a heart attack. My chest felt painful and tight day and night, I couldn't breathe properly and I continously felt my left upper arm and forearm going numb. Any event that caused emotion, movement of my left arm, and even talking  and laughing left me feeling weak, fatigued, and  quite frankly, scared. The pain was felt towards the middle of the chest and between scapula as well. It got so bad that I had to go to the ER, where they did tests on me, only to say that it could be something more muscular skeletal related as my heart seemed without damage. Still I was advised to visit both a cardiologist and a Physiatrist to evaluate further. Upon evaluation the doctor told me that I seemed to have developed a costochondritis and prescribed anti inflammatory meds to deal with the pain. I'm still currently in that treatment and the cardiologist will perform an Echocardiogram, Stress Test and Holter test on me in the next few weeks to further evaluate my heart. I was also advised by him to consult with my Gastroenterologyst to evaluate if it was really safe to have my 2nd vaccine shot. My inmune system is weak and my liver ensymes are high and the cardiologist fears that if my pain is indeed an adverse reaction to the vaccine, I should consult with my gastroenterologyst first before proceeding.
Swelling, tenderness, knotted under skin, erythema, area affected about 3 inches in diameter
After immunization, patient developed paresthesia of all limbs. 8/19/09 Neuro consults received dated 12/15/2008 with dx:  Paresthesias of the hands and feet, likely mild peripheral neuropathy r/t immunization.  Pt presented with c/o onset of sensation of vibration in the hands/feet shortly after receiving flu vax. Pt initially developed flu-like sx then the onset of vibration. PE (+) for diminished reflexes.
Within 2 minutes of vaccination c/o not feeling well pallor observed, full body seizure with unresponsiveness to shake and shout. positive pulse but color quite pale. BP 110/70. Smelling salt with no response. Rescue breathing given and client awoke in 10 minutes. A+0x3. Reported strange dreams. ER/via ambulance CT scan, negative discharged all vaccines.
Pt, age 13, received the Pediatric Pfizer 5yr-11yrs Orange Cap Covid-19 Vaccine as her first booster dose. Pt was offered another dose of the Gray Capp Pfizer Vaccine for ages 12yrs and up, but refused because Pt has already received a Covid-19 vaccine. Pt did not have and symptoms, side effects, or any known complaints.
adult was administered a pediatric 1st dose; adult was administered a pediatric 1st dose; adult was administered a pediatric 1st dose; adult was administered a pediatric 1st dose; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a adult patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B pediatric) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 2nd dose of Engerix B pediatric .5 ml, Engerix B Pre-Filled Syringe Device, the 1st dose of Engerix B pediatric .5 ml and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device and not applicable after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced accidental underdose, adult use of a child product, accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose, adult use of a child product, accidental underdose and adult use of a child product were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2023AMR011504   Additional Information: GSK Receipt Date: 25-JAN-2023 Reporter's Comments: RPH reported an Adult patient was inadvertently administered a Engerix Pediatric dose for a first dose and a pediatric dose for the second dose of Engerix Pediatric last year (2022). RPH unable to provide any vaccine or patient details. The pharmacist inquired how to proceed. The reporter consented to follow up. Additional Supportive Information: The patient received first and second dose as Engerix Pediatric, which led to accidental underdose and adult use of a child product.; Sender's Comments:  US-GSK-US2023AMR011504:same reporter - 2nd dose
Large localized vaccine reaction-swollen, red, mild tenderness and itching. Treating symptomatically with Benadryl and Motrin. Marked borders of erythema. Return to clinic if symptoms persist or worsen. Left upper arm is site of reaction.
pt recv 2 doses of vax 17AUG95 & 20SEP95 & in APR96 lab test revealed that the pt failed to seroconvert;MD indicated that his colleague has been exposed to the virus in practice & therefore may have failed to build titer;
feeling cold/now, feeling extremely cold even through being fully dressed; I received the J&J vaccine on 18May2021 and did have a reaction which lasted almost 2 months. Recently I received the Pfizer vaccine as a booster on 14Dec2021; I received the J&J vaccine on 18May2021 and did have a reaction which lasted almost 2 months. Recently I received the Pfizer vaccine as a booster on 14Dec2021; Pfizer vaccine as a booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 14Dec2021 (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "Ulcer" (unspecified if ongoing); "Anemia" (unspecified if ongoing); "lower back issue" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (Dose 1, single), administration date: 18May2021, for Covid-19 Immunization, reaction(s): "Have a reaction which lasted almost 2 months". The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 14Dec2021, outcome "unknown" and all described as "I received the J&J vaccine on 18May2021 and did have a reaction which lasted almost 2 months. Recently I received the Pfizer vaccine as a booster on 14Dec2021"; IMMUNISATION (non-serious) with onset 14Dec2021, outcome "unknown", described as "Pfizer vaccine as a booster"; FEELING COLD (non-serious) with onset 28Dec2021, outcome "not recovered", described as "feeling cold/now, feeling extremely cold even through being fully dressed".  The lot number for bnt162b2 was not provided and will be requested during follow up.
she had open heart surgery; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6203), on 18Mar2021 as dose 2, single (Lot number: ER2613) and on 30Aug2021 as dose 3 (booster), single (Lot number: FF2587, Expiration Date: 31Dec2021) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC OPERATION (medically significant), outcome "unknown", described as "she had open heart surgery". Therapeutic measures were taken as a result of cardiac operation.  Clinical course: The patient stated that she had open heart surgery and was trying to get better while all this was going on. The patient stated that she and her husband both had all the vaccines and she was thankful that Pfizer came out with something because she was scared she would have got sick or Covid would kill them.
The injection was given with no complication.  After discussing the observation time, he moved to the waiting area.  Approximately 3-4 minutes later he began to sweat and slowly fell to the floor.  He was never seemed to lose consciousness.    He sat up and was monitored for an additional amount of time.  He was able to leave on his own power.
Spontaneous urticaria all over body. Itchiness and redness. Began on February 13th., 14 days after received Moderna Booster. Received booster on January 31st and 3 weeks after testing positive for Covid-19. Taking zyrtec and Benadryl for relief.
Pt received ZOSTAVAX Lot # H011427 in her (R) upper arm 10/26. She was seen for a different issue 11/28 and mentioned she had a reaction which lasted 2 1/2 wks including redness, itching, blisters & swelling.
Nosebleed/blew her nose and it was bleeding; she is starting to get nervous; This is a spontaneous report from a contactable consumer. A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient stated that she took the Covid-19 vaccine on Monday, and woke up this morning and blew her nose and it was bleeding, and it's still bleeding. States that it is not bleeding a lot, like it is not dripping out of her nose, but if she blows her nose, there is blood on the tissue, and if she tilts her head back she can feel it trickle down her throat. The patient asked if this is something that has been reported before, and what does she need to do? Will it go away? Does she need to go to the doctor or the emergency room? States that she always thought that if you can make it past the first 3 days, then you'll be okay, but it's been more than 3 days since getting the vaccine, so she is starting to get nervous. No further details provided. The outcome of the event was unknown.  Follow-up (19Apr2021): 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.
6 hours after Gardasil immunization (second dose) was given, patient had an episode where she felt weak and she felt that she could not move her arms or legs secondary to weakness. This was transient. She then developed severe joint pain in bilateral elbows, hips and knees, severe enough to go to the Hospital ER the following day for it.  Pain improved after patient was given ibuprofen 400mg, and then resolved completely, and has not returned.
With each shot or booster I have muscle aches all over, body weakness, and migraines that can last for days or weeks.  My mother became so weak after her first shot, she fell and broke her back.  That required emergency surgery.   She is now too afraid to take any more shots and is losing protection at age 85.  I am missing time at work and there is very little sympathy.   The boosters seem to trigger whole series of migraines that are debilitating.  Please take the severity of these side effects seriously and consider an inoculation protocol with lower doses more frequently or whatever else may be possible for people like us.
Lymph nodes on (L) side of neck became swollen and very painful. Arthritis like pain in basck of neck. Low grade fever. Rash covering face, torso, arms and thighs. Severe pain in joints of hands, wrists, knees and neck. Right eye inflammed.
complaining of intermittent chest pain and headache; complaining of intermittent chest pain and headache; Initial information received on 22-Dec-2021 regarding an unsolicited valid non-serious case received from a health professional.  This case involves a 15 years old male patient who was complaining of intermittent chest pain and headache, while receiving vaccine IPV (VERO) [IPOL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for Prophylactic vaccination.  On 20-Dec-2021, the patient received a dose of suspect IPV (VERO) (lot U1A452M, expiry date:20-Feb-2023) via intramuscular route in unknown administration site for prophylactic vaccination.  On 22-DEC-2021 the patient developed a non-serious event "complaining of intermittent chest pain and headache" (chest pain) 2 days following the administration of IPV (VERO). On 22-DEC-2021 the patient developed a non-serious event "complaining of intermittent chest pain and headache" (headache) 2 days following the administration of IPV (VERO).  Action taken with POLIOMYELITIS VACCINE (INACTIVATED) (IPOL) was not applicable.  It was not reported if the patient received a corrective treatment for the events (complaining of intermittent chest pain and headache, complaining of intermittent chest pain and headache).  At time of reporting, the outcome was Unknown for the event complaining of intermittent chest pain and headache and was Unknown for the event complaining of intermittent chest pain and headache.; Sender's Comments:  00908756:associated case
1st shot - fatigue for a week 2nd shot - extreme fatigue for a few weeks with depression, major changes in mentrual cycle with very late periods for two cycle so far (3 weeks late).  I hope my period returns to normal as I have had regular periods for years.
headache, fever, nausea...shot done at 4:45 pm on the 7th symptoms started 6 am on the 8th
Received 0.5 ml for 4th shot booster instead of 0.25ml; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (Received 0.5 ml for 4th shot booster instead of 0.25ml) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Jan-2022, the patient experienced EXTRA DOSE ADMINISTERED (Received 0.5 ml for 4th shot booster instead of 0.25ml). On 28-Jan-2022, EXTRA DOSE ADMINISTERED (Received 0.5 ml for 4th shot booster instead of 0.25ml) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.
Moderna COVID-19 Vaccine EUA; Red rash around site of injection. itching.
Pfizer shot at 11:30am, April 1 Reactions 3:30am, April 2: chills, fever, body aches, dry mouth
She started having sharp abdominal pains in the upper right quad and had to have her gall bladder removed and 6 months later had to have her appendix removed. Now she vomits regularly and had daily massive headaches. Her immune system is diminished.