chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist via company representative referring to a female patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX, (dose and lot number not provided) and months after, on an unknown date, the patient developed a mild case of shingles. The patient spoke to pharmacist for seeking medical attention. The outcome of the event was unknown. Additional information has been requested.
Patient received vaccine at CVS. With in 5 min developed flushing. Patient given Benadryl and epi at CVS, transported to ER. Patient develops difficulty swallowing and a rash, monitored and Evaluated. D/C home with PO prednisone.
I had a headache that lasted a day, a week later I got tested for covid and tested positive I had a headache again lasting 4 days, and I had a cough I went to a drive through express care for the test
Exactly 1 week after injection, injection site became itchy.  Over the next 12-hour period, the injection site and surrounding area became red and swollen.
Heart inflammation (diagnosis myocarditis from one hospital & pericarditis by the other) Chest pains, trouble breathing, cannot move easily without pain., heart palpitations (those ended).  Started off being told to take Advil every 6 hours. That didn?t help, went to a new ER, they gave me colchicine. It?s helping but I still am pretty much bedridden.
Patient was administered a Pfizer Covid-19 vaccine that was exposed to a temperature excursion. (Vaccine was between 8-14.5 degrees C for 7hrs and 48 minutes). Pfizer was contacted and advised the clinic to consider the dose as invalid and to revaccinate. Pateint was revaccinated 03/19/21 and given 2nd dose 04/09/21
Rash on the injection arm; Retinal bleeding present in the left eye; A spontaneous report was received from a consumer, concerning herself, a 68 years-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced retinal bleeding present in the left eye and rash on the injection arm.  The patient's medical history was not provided. Concomitant medications reported included simvastatin.  On 21 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot # 032L20A), intramuscularly for prophylaxis of COVID-19 infection.  On 21 Jan 2021, following the vaccination, the patient experienced a rash on the injection arm that had lasted for about a week. Additionally, the patient went for a routine eye exam on an unknown date in Jan 2021 and it was determined that there was retinal bleeding present in the left eye. The rash had subsided at the time of the report, but the retinal bleeding remained the same.  Action taken with mRNA-1273 was unknown.  The event rash on the injection arm was considered resolved on an unspecified date in Jan 2021. The event retinal bleeding present in the left eye was considered not resolved at the time of this report.; Reporter's Comments: Very limited information regarding these events of unlisted serious event of retinal hemorrhage and non-serious listed event of injection site rash has been provided at this time.  No further information is expected.
At some time after the vaccination, I started having occasional very sharp pains that instantly abated.  It felt like I was shot or stabbed and instantly cured.  The intense sharp pain immediately disappeared.  This happened most frequently about 1-2 months after the second shot, and then stopped until a few days ago, there was one, and again today, about 1/2 hour ago.  They have been all over my body, head, one back of eye, leg, and just now, in my right upper arm.  Other places also, but I don't think ever in the same place twice.  Also, I have started having slight tremors in my eyes at awakening, and twice in my hands.  I have not had tremors ever before.
headache; fever; chills; body ache; exhaustion/ have continued to be uncharacteristically exhausted for part of each day; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the left arm on 05Mar2021 at 10:30 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, high cholesterol and mild heart murmer. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), clonidine (MANUFACTURER UNKNOWN), hydrochlorothiazide (HCTZ) and pravastatin (MANUFACTURER UNKNOWN) for unknown indications from an unknown date. The patient did not have any known allergy to any medications, food, or other products. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809), via an unspecified route of administration in the left arm on 12Feb2021 at 10:15 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 06Mar2021, the patient had headache, fever, chills, body ache and exhaustion for about 30 hours after the shot. She had ongoing exhaustion and after recovering from the initial 30 hours of side effects from the vaccine she continued to be uncharacteristically exhausted for part of each day, especially after exercise. She was tired when she woke up in the morning, and found that after any form of activity she became physically exhausted. There were times when she could barely stay awake and had to take a nap and after which she was still very tired. This had been going on for a full four weeks after receiving the second dose, which was concerning for her. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the events headache, fever, chills, body ache and exhaustion. The clinical outcomes of the events headache, fever, chills, body ache and exhaustion were not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Received a double dose / pt received 1mL for the dose; A spontaneous report was received from a healthcare professional concerning a male patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a double dose/accidental overdose.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient was given a double dose.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the event patient received 1mL for the dose was recovered.; Reporter's Comments: This case concerns a male patient of unknown age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Accidental overdose without any associated adverse events.
PATIENT EXPERIENCE A BLOOD CLOT IN LEG AND HAD TO BE HOSPITALIZED
This is a spontaneous report from a contactable consumer (office manager) who reported the same event for two patients. This is the second of two reports. A 65-year-old female patient received PREVNAR 13 (lot/batch number M60993, NDC # 0005197102, Expiry Date Jul2017), via an unspecified route of administration on 09May2016 at 0.5 ml, single. The patient had no medical history. Concomitant medications included atorvastatin (unknown manufacturer), HUMALOG, JANUVIA, LANTUS, LIALDA, metformin (unknown manufacturer), omeprazole (unknown manufacturer) and ramipril (unknown manufacturer). The patient experienced cellulitis on 13May2016. The doctor gave her BACTRIM as treatment for the event. No laboratory work was performed. The antibiotic was working, cellulitis was still red and slightly swollen but the pain was gone and it was getting better. The patient was recovering from the event.
Itchy hives (rash) over entire body; took Benadryl and received steroid shot by healthcare provider. Itching resolved, then returned.
Unexplained extremely painful and heavy menstrual cycles ever since receiving the COVID-19 shots. Had OBGYN work-up. Everything is normal and they can find no other change other then getting the COVID-19 shot.
Stiff/hurt neck on side on shot 5 minutes after injection, subsided in about 3 minutes Super sore arm day 1-2 after Fever day 1 about 8 hours after shot Took acetaminophen & felt better Fever broke next morning (day 2) Day 2 muscle fatigue whole day Day 3 mental grogginess but overall okay
Approximately 5 days after vaccination I started experiencing VERY strong heart palpitations, so much so I am able to see my chest move while they're happening and have captured it on my cell phone. The only other time I have experienced heart palpitations was while pregnant, I am not currently pregnant.   So far, the palpitations have continued with less severity approximately two weeks from onset. I have contacted my doctor and he has advised if they do not resolve by the end of this week/this weekend, I should contact him and we will look into an EKG and/or holter monitor.   Often while having the palpitations I am completely at rest. They have occurred randomly throughout the day and evening. They have not woken me during the night if they have happened while I sleep. I wear a smart watch daily and my heart rate appears to be normal. My heart does not race during the palpitations. There is no pain or discomfort felt while it happens. I have been able to work out every couple of days without feeling like something is wrong.
Got varicella shot 2 days ago - 2 days out - arm erythemic 4 inch diameter area - hot and tender. Tx - warm soaks, Cephalexin Cap, Triamicinolone cream and Atarax.
Approximately 24 hours after injection of PNEUMOMVAX 23 in right arm (deltoid) patient experienced significant pain and tenderness in right arm. He states he had a hard time lifting his arm above his head. In the evening he noticed significant swelling and redness above the elbow on the posterior side. He slept with his arm above his heart to reduce the swelling and applied ice packs. On 9/20 he returned to the pharmacy; there was still significant swelling and redness on the posterior side of the right arm. He was instructed to ice the area and to take an NSAID and antihistamine to decrease the reaction and that the reaction should resolve with in a couple days.
6/5/03 Pt reported swelling, pain, redness, warmth at injection site, back of right arm, which started 6/2/03. Severity of symptoms decreased over next few days. Appt booked for 6/6 for evaluation by MD (assessment/outcome unknown). Also complained of muscle soreness right upper arm.
High Fever over 102 for 3 days.  They recommended me to go to the Emergency Room if it lasted longer than 3 days. How embarassing that would have been
After about a week of getting the vaccine my left arm starter a red raised rash around the injection site. It was not itchy. Just red raised rash
Pt recv vax on 1/21/99; on 1/22/99 pt exp rash on neck, left armpit, genitals, left corner eye; tx=Allegra, topical Benadryl
Hard lump under skin at injection site. Site is inflamed, red and warm to the touch. Symptoms appeared 2 weeks following administration of vaccine.
this is 1 of 2 pt from this site to devel inject site rxn w/ more than usual redness and swelling after recv vax; physician stated that the vax may have been above the optimal temp range when it arrived @ the office.
Shortly after administration of Moderna Vaccine, pt. developed lip swelling and circumoral erythema, pt was given Benadryl 50 mg po which resulted in swelling and erythema resolving shortly after.
no adverse event; Expired vaccine used; This spontaneous report has been received from  a nurse regarding a patient of unknown age and gender.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.   On 18-JAN-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)  0.5 milliliter (Route of administration and frequency were not provided; lot # reported as: T001214, expiration date 12-JAN-2022).    It was reported that the vaccine did not experience any temperature excursions prior to administration. No additional information was provided. No additional adverse event (AE) was reported. No PQC reported. The outcome of the event was not reported.
pt. vax'd /w 1st dose of hepatitis B vac in approx 1988 on evening p/inject developed abdominal cramps.
Shingles or HSV1 bilateral systemic rash on back and foot.  swelling and vascular changes in eyes.  Bi-lateral rib pain cough and chest pain that lasted 5 days headache fatigue for more than 5 days
The moderna vaccine knocked her daughter's heart out of rhythm; A spontaneous report was received from a mother who reported on behalf of her daughter, unknown (age and race) female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event the moderna vaccine knocked her daughter's heart out of rhythm.  The consumer's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of the event the consumer received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the consumer experienced the event the moderna vaccine knocked her daughter's heart out of rhythm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event was unknown.  The assessment was not provided for the event.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Critical details such as the exact term for sign, symptom or diagnosis, the patient's medical history, list of concomitant medications, diagnostic findings if any, mRNA-1273 administration date and onset date of the event is lacking. Further information have been requested.
Redness, soreness and hives- like rash to right deltoid at the site of the injection.
No additional adverse events reported; PROQUAD that was administered post expiry; This spontaneous report was received from an administrator referring to a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.     The reporter was inquiring about the potency of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rha) (PROQUAD) that was administered post expiry. The reporter informed that measles, mumps, rubella and varicella (oka-merck) virus vaccine live , rha (PROQUAD) (lot S027463 expiration date 02-MAR-2021) was given on 09-MAR-2021, at a dose of 0.5 milligram subcutaneously for prophylaxis (vaccination scheme frequency and anatomical site of vaccination were not reported). The reporter informed that measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rha (PROQUAD) was stored properly up through administration. No additional adverse events reported.
Vaccine administered 23 days after first dose.  Headache, fatigue, chills, body aches
pain in my hip; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included inflamed swollen hip. The patient's concomitant medications were not reported. On an unspecified date, it was reported that the patient experienced pain in the hip, and it is hurting. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing); "enlarged heart" (unspecified if ongoing), notes: enlarged heart; "anxiety" (unspecified if ongoing); "depression" (unspecified if ongoing); "known allergies: Wheat and dairy" (unspecified if ongoing). Concomitant medication(s) included: STRATTERA; PROZAC. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures Paxlovid were taken from 08Dec2022 as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
nerve pain; numbness and tingling in hands feet; numbness and tingling in hands feet; weakness on legs and arms; burning in face; polyneuropathy increased 10- fold after the Pfizer vaccine for the first 2 days after shot; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 64-year-old female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, dose 1 intramuscular, administered in arm left on 25Jun2021 09:00 (Batch/Lot Number: EW0173) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included breast cancer from Aug2015 to Jul2016 (right mastectomy reconstruction), lung cancer from Jan2020 to Jan2020 (lung resection), guillain barre from Oct1986 to Apr1987 (paralyzed waist down), polyneuropathy from 04Jul2017, muscular weakness from 04Jul2017. Patient is not pregnant at time of vaccination. Concomitant medications included atenolol; ramipril; potassium; and hydrochlorothiazide. The patient previously received tetanus boost on 04Jun2017 for immunization and experienced polyneuropathy and muscle weakness at age of 60 years old, and previously took duloxetine hydrochloride (CYMBALTA), baclofen and gabapentin and none of these medications have been effective. The patient experienced nerve pain, numbness and tingling in hands feet, weakness on legs and arms, burning in face after first dose. Adverse event start date was reported as 14Jun2021 (pending clarify). The patient underwent lab tests and procedures which included mamograme biopsy: positive on Aug2015, Celebro spinal fluid culture imagine: negative on 2017, negative on 2019, negative on 2020, spinal tap: negative on Oct1986, Diagnostic X-Ray: negative on Oct1986, X-Ray biopsy: positive on Jan2020. Patient was considered this event as not serious. Patient developed Guillain barre syndrome in 1986 after her young children had the flu. Patient was hospitalized for 2 weeks. She was unable to walk for several months. She had residual visible weakness on one side of her face which has persisted to the present. Patient developed polyneuropathy after an emergency tetanus shot in Jul2017. Patient had persistent numbness, tingling and muscle weakness in her hand, face, legs, feet, and arms. She had been prescribed Cymbalta, gabapentin, baclofen; none of these medications have been effective in managing the symptoms. She had never taken the flu, shingles, or pneumonia vaccine to avoid the risk of negative reaction. The polyneuropathy increased 10- fold after the Pfizer vaccine for the first 2 days after shot and even worse after the 2nd shot. No treatment was received. The outcomes of events were recovering.
administered expired ACTHIB with no adverse event; Initial information was received on 07-Feb-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 18 months old male patient who received administered expired HIB (PRP/T) vaccine [ACT-HIB] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 7v (CRM197) (Prevnar) and Influenza vaccine for Immunisation.  On 15-Nov-2022, the patient received expired 0.5 ml dose 4 of suspect HIB (PRP/T) vaccine [ACT-HIB] (strength: standard) (lot number: UJ594AAA, expiry date: 26-Oct-2022, formulation: Unknown) via intramuscular route in the right deltoid for Immunization (Immunisation) with no adverse event (expired product administered) (latency: same day)  It was reported that "seven patients were administered ACTHIB that expired on 26-OCT-2022. Wanting to know next steps to take and what information to tell the parents. See related cases and AE reports: Patient 1: 01481406 Patient 3: 01481502 Patient 4: 01481503 Patient 5: 01481505 Patient 6: 01481508 Patient 7: 01481511"   No lab data reported.  Action taken: not applicable.  Outcome: Unknown for the event administered expired acthib with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01481406: 01481502: 01481503: 01481505: 01481508: 01481511:
Pt came to ER c/o abdominal pain and distention onset 1 week prior.
Pt. reported: Had L) upper arm swelling starting 3/8, swollen lymph node under L) arm 3/9, Flu like sx chills, HA, neck ache 3/10, Inj site red, swollen warm 3/10. Confirmed at office: 2" Red/swollen @ inj. site 3-10-09 rx'd KEFLEX 500mg TID X 7d, warm compresses, TYLENOL.
PATIENT BEGAN HAVING REDNESS AND SORENESS ON 08/30/2013. IT WORSENED THROUGHOUT THE DAY AND MOM CALLED AT 5:00PM AND STATED THAT ENTIRE TRICEP WAS SWOLLEN. AT THIS TIME CLINIC WAS CLOSED. PATIENT SENT TO ER. HAD US TO RULE OUT ABSCESS. US NEGATIVE. PATIENT STARTED ON CEPHALEXIN AND ADVISED TO RETURN TO CLINIC 8/31/2013 FOR FOLLOW UP. SWELLING WAS NO BETTER BUT HAD NOT WORSENED. PT AFEBRILE AND FELT FINE. ADVISED TO CONTINUE COURSE OF ANTIBIOTICS.
Fever (103.7) and cough on 10/8/09. Hospitalized with seizure on 10/8/09 - admitted through ER.  10/19/09:  Emergency Department records received for date of service 10/8/09.  Dx:  Complex febrile convulsion. Assessment:  Pt. was ill during the day with a febrile flu-like illness, appearing lethargic.  Began to have a tonic seizure involving the entire body while at home and continued in ambulance for approximately 20-30 minutes.  Medicated with Ativan with no results, so Versed was given.  Febrile with tachycardia upon admission to the ED. O2 sats. remained at 100%.  A lumbar puncture, CT scan and chest x-ray were all done.  Started on IV fluids for possible fluid depletion.  Medicated with Acyclovir, Rocephin and phenobarbital.  Transferred to a higher level of care.   ICD Code:  780.32