chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 31-JUL-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (MRK INJ) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA001261.
REDNESS, WARMTH, RASH TO UPPER ARM DOWN TO ELBOW, FLU LIKE SYMPTOMS.
BIG TOES COLD; STRESSED OUT; FELT LIKE HEAD 2 TO 3 TIMES NORMAL SIZE; HIGH BLOOD PRESSURE; TINGLING IN BOTH BIG TOES, FINGERS, LEFT AND RIGHT HAND AND THIGHS; TINGLING IN LEFT ARM; LEFT ARM FELT HEAVY; COLD WET SENSATION IN EXTREMITIES; DRY LEFT EYE; POUNDING HEADACHE; WOKE HIM UP; FOGGINESS; MILD HEADACHE/JABS IN THE BACK OF HIS HEAD; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, benign prostatic hyperplasia, gerd, headache, seasonal allergy, diarrhea from peanuts, cramping from peanuts, shellfish when younger itchy rash, skin inflammation, itchy throat, valium-nausea, spinning, non alcohol user, non smoker, and exposure to person with covid infection, and other pre-existing medical conditions included the patient was exposed to a person with covid-19 before 5 days of vaccination, and had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. Concomitant medications included morniflumate for benign prostatic hyperplasia, lisinopril for blood pressure, ergocalciferol for gerd, famotidine for gerd, and lansoprazole for gerd.  On 31-MAR-2021, the subject experienced fogginess. On 31-MAR-2021, the subject experienced mild headache/jabs in the back of his head. On APR-2021, Laboratory data included: Blood pressure (NR: not provided) 180/100 mmHg, 200/90 mmHg, 180/100 mmHg. On 01-APR-2021, Laboratory data included: CT scan (NR: not provided) negative/nothing. On 01-APR-2021 03:00, the subject experienced woke him up. On 01-APR-2021 03:00, the subject experienced pounding headache. On 05-APR-2021, the subject experienced dry left eye. On 17-APR-2021, Laboratory data included: CT scan (NR: not provided) negative. On 18-APR-2021, the subject experienced cold wet sensation in extremities. On 19-APR-2021, the subject experienced tingling in left arm. On 19-APR-2021, the subject experienced left arm felt heavy. On 20-APR-2021, the subject experienced tingling in both big toes, fingers, left and right hand and thighs. Laboratory data included: Blood test (NR: not provided) normal. On an unspecified date, the subject experienced stressed out, felt like head 2 to 3 times normal size, high blood pressure, and big toes cold. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in both big toes, fingers, left and right hand and thighs, and big toes cold, was recovering from fogginess, and high blood pressure, had not recovered from mild headache/jabs in the back of his head, and cold wet sensation in extremities, and the outcome of woke him up, stressed out, felt like head 2 to 3 times normal size, tingling in left arm, left arm felt heavy, pounding headache and dry left eye was not reported. This report was non-serious.
Bones joints and muscle ache, acid reflux, difficulty in concentration, heart arrhythmia, loss of muscular strength, urinary frequency , unable to sleep flat without medication, Migraine, depression.
Fax no. is unknown by me. Vaccinated Ap 1, 2021, noon. The following morning, 6am, I awoke to find pigment changes on the tops of both hands and less on the fingers.  Blotchy, light coffee brown in appearance. (I'm a male, old skin, some blemishes, nothing like this).  Also, on the right, lower areas of my left forearm.   Some of the darkness of the coloring has dissipated overt he past 3 days, but not much. If I didn't know better, I would think a painter, using a cheap  sprayer had painted me with brown stai  I ave no other things . feel fine.
Mom called stating child c/o of joint pain in all joints and headache. Took ibuprofen - improved per following call 9-12/13.
Extreme pain at injection site and anterior to injection site. Unable to move arm without pain. Unable to perform ADLs days later - seen in office on 3/29/16 with extreme pain. Unable to swim (she is a swimmer).
Client reports she had varicella and HPV immunizations given in L arm on 12-28-09. On Tues. approx 9 PM, bandaids removed and noticed redness. Pain in back of upper arm; above elbow is sore also. States has hard knot, size of 3" circle towards back of arm. Itching also in area of bandaids.
approximately 42 hours after receiving the vaccination, the vaccinee developed fever, sweating, aching in arms, legs and chest, and intestinal pain. The intestinal pain was relieved by having a bowel movement, but other symptoms last between 1.5 to 2 weeks. Vaccinee has received "High Dose" flu vaccine in previous years and does not report as severe side effects.
a spot on the medial side of his arm, opposite from the injection site, that is getting bigger; a spot on the medial side of his arm, opposite from the injection site, that is getting bigger; He thinks the MRSA has come back; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 66-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 26Jan2021 as a Dose 1,Single dose for COVID-19 immunization. The patient's medical history included methicillin-resistant staphylococcus aureus (MRSA), rheumatoid arthritis, diabetes and hypertension.The patient's concomitant medications were not reported. The patient reported last night the patient noticed a spot on the medial side of his arm, opposite from the injection site, that was getting bigger. The patient had the same thing on the opposite arm 12 years ago and it was MRSA. The patient thinks the MRSA has come back. He was waiting for the doctor to call him back. The treatment for the events was not reported.The outcome of the events was unknown.   Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Vaccine failure.  Flu shot on 11-7-05. Flu A positive and symptomatic on 01-23-06.
Feverish, chills, nausea, body aches, fatigued, headache,
This spontaneous report as received from a doctor of pharmacy refers to a 4 years old female patient. The patient was vaccinated with, 0.5 milliliters (ml) (Merck) VARIVAX(lot number, expiry date were not reported) intramuscularly. No concomitant medications were reported. On an unknown date, the patient developed mononucleosis after receiving (Merck) VARIVAX. It was unspecified if the patient sought medical attention. Treatment details were unspecified. The outcome of mononucleosis was unknown. Additional information is not expected.
Rash on right arm (same side as flu shot), weakness, fever, exhaustion, labored breathing
Tinitus - high pitch ringing in the ears. It's constant and never stops. I hear this noise 24/7
Mild joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Mild joint pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced ARTHRALGIA (Mild joint pain). In January 2021, ARTHRALGIA (Mild joint pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company Comment - Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded
No adverse event; BUD for vial was on 03/12/2023, dose of same vial was administered 2 two patients as a booster on 03/16/2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (BUD for vial was on 03/12/2023, dose of same vial was administered 2 two patients as a booster on 03/16/2023) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7173B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 16-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (BUD for vial was on 03/12/2023, dose of same vial was administered 2 two patients as a booster on 03/16/2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (BUD for vial was on 03/12/2023, dose of same vial was administered 2 two patients as a booster on 03/16/2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (BUD for vial was on 03/12/2023, dose of same vial was administered 2 two patients as a booster on 03/16/2023).    No concomitant medications was reported.  Dosage text was reported as Initial Booster.  No treatment medications was reported.  This case contains information about Patient 2 out of 2 Patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-717122 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717122: Patient 1 out of 2 Patients
Pt recvd vax & 45 mins p/vax c/o dizziness, nausea, faintness & not feeling well;
The vaccine administrator signed off as administering to vaccine in my Left Deltoid muscle, however, that ws not the case. It was injected into the subcutaneous tissue under the left deltoid muscle. I worked for the area for 19 years, partially as an immunization nurse and it was apparent to me soon after receiving the vaccine that a mistake had been made.) Within tow hours Ithe area around the site began to turn red and painful. By that evening I let nauseated, had muscle aches, headaches and extreme fatigue. The next morning the site had become much redder, larger and somewhat swollen. The same side effect but worse. I could only rest throughout the day and continued to take Ibuprofen BID. Following day same with redness measuring 2 inches by 2 inches, with headache, nausea and fatigue continuing. I began to apply moist warm heat the the area and by Thursday the site was less re and smaller, still painful. I still had nausea. Today, 9/15  I have my appetite back with some redness still but less pain. I did go back to this pharmacy on Thursday 9/14 and spoke with the Head Pharmacist about my side effects as well as showing him my arm. He apologized and stated he would address the matter.
COVID 19 Treatment; COVID 19 Treatment; Dose 4: Moderna; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and in May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Nov2022, outcome "unknown", described as "Dose 4: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (Jun2023) Negative, notes: symptomatic 3 days after initial negative test; (Jun2023) Positive, notes: Rebound COVID-19; positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events interchange of vaccine products, drug ineffective, covid-19 and the suspect drug BNT162B2 cannot be excluded.
This case involves an unknown age female patient who experienced came down with the flu (influenza ), took 4 days before she got sick and got a flu shot (illness). 6 days later she came down with the flu (vaccination failure) after receiving vaccine INFLUENZA VACCINE. The patient's past medical treatments, concomitant medications and family history were not provided. It was unknown if the patient had any concomitant disease or risk factor. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination. On an unknown date,  the patient developed a non-serious came down with the flu (influenza), took 4 days before she got sick (illness), got a flu shot. 6 days later she came down with the flu (vaccination failure) (unknown latency) following the administration of INFLUENZA VACCINE. It was unknown if the patient experienced any additional symptoms/ event. It was unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment for the events. At time of reporting, the outcome of the events was reported as unknown.
Patient had a flu shot in October 2008.  She felt immediate pain in shoulder, radiating down arm.  She felt the flu shot was given higher up on her shoulder than previous flu shots.
shaking chills; fever; severe headache; body aches (muscle / joint); body aches (muscle / joint); nausea; reflux; This is a spontaneous report from a contactable other hcp. A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) , via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced shaking chills, severe headache, body aches (muscle / joint), fever, nausea, reflux on an unspecified date. The patient did not have did not have COVID prior to vaccination. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
when I had it, it was very blood clotty and short; My period went late by 3 weeks; also have had a few minor rashes since the vaccine on my arm around the injection site; battling diaharrea for a few weeks; This is a spontaneous report from a contactable consumer. A 39-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 29Jun2021 11:00 (Batch/Lot Number: EW0161) as dose 2, single (at the age of 39 years) for covid-19 immunisation. The patient's medical history included nut allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient received the first dose of BNT162B2 (lot number: EP7533) via unspecified route in the right arm on 11Jun2021 at 15:45PM (at the age of 39 years) for Covid-19 immunisation. On 06Jul2021, the patient experienced when she had it, it was very blood clotty and short, her period went late by 3 weeks, also have had a few minor rashes since the vaccine on my arm around the injection site, and battling diarrhea for a few weeks. It was further reported that patient typically have regular periods. Her period went late by 3 weeks, when she had it, it was very blood clotty and short. She never had late periods, nor a period like that before. Patient also had few minor rashes since the vaccine on my arm around the injection site and was battling diarrhea for a few weeks after the second shot.  Nothing was major, but felt that any additional information for the vaccine would be helpful for you all- thank you for all your hard work. The outcome of the events was recovered on unknown date.   No follow-up attempts are possible; information about batch number already obtained.
There was no adverse event but, there was a vaccine administration error in getting my vaccine at clinic site on Friday, 2/12. Received call from Pharmacy Manager, at approximately 2:05 pm on Saturday, 2/13.  Was told there was an error in the dosage I received which was less than 1/2 of full dose.  Manager recommended getting revaccinated with 1st dose. Scheduled to get revaccinated with 1st dose again on Monday, 2/15. I was not the only one affected by this vaccination error, which in my opinion, needs to be reported.  Will be notifying local health department to report incident.
Upon the second injection, a hot, metallic taste came into my mouth immediately during the injection. That evening, I became lightheaded, experienced chills,  bone throbbing, and muscle pain.  Since then, all of my autoimmune and chronic symptoms have worsened: bone pain, extreme fatigue, "empty-brain (brain fog)," loss of balance, coordination, and short-term memory, extreme mental confusion, worsening of depression and anxiety, and heightened allergic reactions.
After receiving vaccine client complained of nausea and chest heaviness.  Vital signs obtained:  BP 110/75, HR 92, O2Sat 99%
Tingling sensation, flu like symptoms, chest pain, sore throat, tiredness.  ER visit for chest pains, labs and testing done, heart attack ruled out.  Patient reported that symptoms were result of Covid Vaccine side effects. Onset of symptoms began on 1/11/21, ER visit on 1/13/21 for chest pains, returned home on 1/13/21 after tests were completed.  Patient reports feeling better.
7 cm x 7 1/2 swollen red, notice just 4/3/07 apply ice in office to reduce swelling.
Daughter states that patient has been feeling unwell ever since he got his second post-vaccination.  Has been complaining of difficulty breathing.  There is also been clutching his heart over the past few days.  Patient arrived to ED in full cardiac arrest
ON 12-28-07 PATIENT RECEIVED HEP A #2 AND VARIVAX #2. THEY WERE BOTH GIVEN IN THE LEFT ARM (1-IM, 1-SC). ON 12-31-07 PATIENT RETURNED TO OFFICE WITH LEFT ARM RED AND WARM TO TOUCH. HE WAS TREATED FOR CELLULITIS- KEFLEX 250MG TID X 7 DAYS AND TRIAMCINOLONE CREAM 0.1% TO AREA BID PRN.
Moderna COVID?19 Vaccine EUA After receiving the second dose of the Moderna COVID-19 vaccine on 2/3/2021 I noticed a bump at the injection site that has not gone away as of today (5/1/2021).  At times the bump is itchy.
fatigue, cant sleep, no apetite, abdominal pain, diarrhea, weight loss, confusion
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with an improperly stored doses of GARDASIL 9 (lot# L040054, expiration date: 26-DEC-2017) (dose and route of administration were not reported). There was no adverse effect reported. This is one of two reports from the same reporter. Additional information has been requested.
Patient expired 19 days after receiving her first shot of Moderna.  Patients family is convinced the shot killed her and wants it reported.  patient has a history of vasculitis. Primary provider believes the vaccine could have contributed to her death.  Patient was on the transplant list and was told it was a requirement to receive this shot.
Woke with headache, extremely sore arm, was dizzy upon standing (went away soon after), temperature 99.8
migraines got significantly worse/migraines to go loop crazy and the pain was a 7 to 8 out of 10; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59-year-old female patient received bnt162b2 (BNT162B2), in Apr2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "epilepsy" (unspecified if ongoing); "Migraine" (ongoing), notes: that never go away, they're usually at a 2 or 3 on a pain scale of 10. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: MIGRAINE (non-serious), outcome "not recovered", described as "migraines got significantly worse/migraines to go loop crazy and the pain was a 7 to 8 out of 10". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of migraine. Additional information: after taking her second Pfizer Covid 19 vaccine in Apr2021, it caused her migraines to go loop crazy and the pain was a 7 to 8 out of 10.    The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE HYPOXIA 1/11/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
I had the shingles vaccination and now have an itchy lump on the back of my arm that's lasted 5 days.
I had extreme dizziness to the point that I could not safely stand up. It has been three weeks since my first shot and I still have three swollen glands on my left front collarbone. I went to my doctor, and he confirmed these symptoms were from taking the shot.
P/receiving Typhoid vax, pt exp a systemic rxn consisting of fever (up to 102F), myalgia, nausea, vomiting, diarrhea; This required an ER visit;