chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna vaccine was given beyond its use by date; Moderna Covid-19 vaccine that was beyond its use-by date was given; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond its use-by date was given) and PRODUCT STORAGE ERROR (Moderna vaccine was given beyond its use by date) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond its use-by date was given). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine was given beyond its use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond its use-by date was given) and PRODUCT STORAGE ERROR (Moderna vaccine was given beyond its use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  Patient was administered with the booster dose (1/2 dose). No treatment medications were provided.   This case was linked to MOD-2022-516081 (Patient Link).
Left outer thigh with induration, red and warm area 3x3cm in size, ice?Motrin.  Augmentin 400mg, 4cc by mouth, 4 times a day for 10 days.
Very hot and hard spot on the back of her arm that is two inches long, starting at the point of injection, and one inch wide.
pt recv vax MAY, JUNE, or JUL96;pt devel spots on face on 5DEC96 & was dx w/shingles 2wk later;it was also reported that the pt face is scared, but resolved;
Information has been received from a physician concerning an 8 year old female patient who on 03-Dec-2008 was vaccinated with the second dose of VARIVAX (Oka/Merck) (lot#551977/1275X). On 05-DEC-2008 the patient developed cellulitis. Patient sought medical attention by calling the nurse. At the time of the report the patient had not recovered. Follow-up information received from a licensed practical nurse that reported the patient  weights 81 pounds and is 5 feet 1 inch tall. Second dose of VARIVAX (Oka/Merck) (lot#661977/1275X) was administered subcutaneously on the left arm at 18:00. Unspecified medical attention was sought. Increased redness, edema and warmth at injection site were experienced by the patient on 5-DEC-2008 at 17:50. After patient was diagnosed with cellulitis she was treated with CEPHALEXIN (unspecified) 500 mg every 6 hours for 10 days with effect. Patient recovered on 15-DEC-2008. A standard lot check investigation was performed for lot#661977/1275X. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the government and was released. This is one of several reports from the same source. No further information is available.
The next day after receiving the shingles vaccine, she developed a red blotch on the area of the vaccine about the size of a 50-cent coin that was warm to the touch. She also developed a rash on top of her hand. She wasn't sure if that was related to the vaccine or if it was coincidental. Both resolved in about 3 days.
This case was reported by a dentist and described a 30 year old female pt who did not respond to the hepatitis B vaccine recombinant (Engerix-B) immunization series.  On 11/02, the pt received her second injection of Engerix-B. Approximately 6 months post-immunization, in May 2003, the pt had "no antibodies".
started screaming about 5hrs p/vax; screaming spells lasted 4-5hrs over 48hrs period w/some very irritability & restless sleep between screaming episodes
Patient admitted with HSV encephalitis with non-convulsive status epilepticus on 1/30/21
On the same day that the flu and Tdap vaccines were received, the patient developed a erythematous, maculopapular, pruritic rash to her upper chest and felt feverish. Symptoms lasted for 3 days before the patient returned to the clinic. Denied history of reactions after vaccines, anaphylaxis, dyspnea, wheezing, difficulty breathing. Patient had taken Tylenol on the day of vaccination and each day after before returning to the clinic. Symptoms did not change since onset. Oral temperature when the patient returned to the clinic was 100.4F. Patient was advised to continue to take Tylenol as needed for fever, apply hydrocortisone 1% cream 2-3 times daily to the affected area, Claritin 10 mg by mouth once daily, and Benadryl 25 mg by mouth at night as needed for itchiness. Advised to return to the clinic in 1 week or sooner for non-improving or worsening symptoms.
ringing on his ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing on his ear) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 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 TINNITUS (ringing on his ear). At the time of the report, TINNITUS (ringing on his ear) outcome was unknown.            No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Arm swollen and red, not at injection site, but rest of arm.  Fever, chills, and generalized malaise.
She felt hypotensive. She states that she felt that her BP was increasing. Average range is 160/170 systolic. Felt anxious prior to vaccine. Denied SOB, difficulty breathing, denied chest pain or dizziness. 15:35 VS 187/72 and HR 69. 16:17 VS 212/94 HR 71 RR 14 and o2 sat 100%. Brought patient to our express symptom management unit.
Has not received the 2nd Moderna vaccine; Loss of appetite; Lost 20 pounds; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of DECREASED APPETITE (Loss of appetite), WEIGHT DECREASED (Lost 20 pounds) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Has not received the 2nd Moderna vaccine) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Broken hip since 16-Jan-2021 and Dementia.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced DECREASED APPETITE (Loss of appetite) and WEIGHT DECREASED (Lost 20 pounds). On 26-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Has not received the 2nd Moderna vaccine). On 26-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Has not received the 2nd Moderna vaccine) had resolved. At the time of the report, DECREASED APPETITE (Loss of appetite) and WEIGHT DECREASED (Lost 20 pounds) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided/unknown. Patient originally weighed 100 pounds and is now 80 pounds.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
We became aware recently (2/4/15) of arm pain and swelling at site of HPV vaccine. Please see enclosed records for subsequent symptoms, with most recent evaluation by rheumatology consistent with SLE or mixed connective tissue disease.
Developed pinpoint rash on back 24 hours after vaccines.  Then developed macular papular rash on arms.  Slightly fussy but was feeding well.  No fever.  Emesis x 1 morning of 11/3/06.  Per ER report.
Clinical Summary Patient is a 88 y.o. male with a history of HTN, HLD and TIAs who presented to RMH 8/5/2022 with generalized malaise/weakness and subjective fevers s/p positive COVID home test found to be septic and hypoxic. Discharged on 8/7/2022   1. Sepsis 2/2 COVID Infection: Confirmed PCR 8/5/22, unclear exact duration of symptoms but reported ~ 5 days. Admit CXR nonfocal. CRP 3.2. LFT WNL. Required 2-3L NC on admit. Initiated on decadron and remdesivir. Off O2 8/8/22. Plan to complete 10 day course of steroids. 2. Acute hypoxic respiratory failure: Secondary to above, CXR nonfocal. D-Dimer normal. Wean O2 as able. Intermittent lasix prn. Resolved.  3. Acute on chronic encephalopathy: baseline cognitive impairment with poor memory per wife. Suspect concurrent acute metabolic encephalopathy in setting of above. VBG WNL. Delirium precautions. Appears to be at baseline.  4. HTN: Known history, continued home meds with parameters 5. HLD: Known history, continued home statin  6. TIA: per hx, continued plavix   Discharge Medications   Medication List     START taking these medications    dexAMETHasone 6 MG tablet Commonly known as: DECADRON Take 1 (one) tablet (6 mg total) by mouth daily with breakfast for 6 days Start: 08/09/22. Start taking on: August 9, 2022
the patient received PROQAD and VARlV AX, the patient was supposed to get MMRII and V ARlVAX.; the patient received PROQAD and VARlV AX, the patient was supposed to get MMRII and V ARlVAX.; This spontaneous report was received from a Licensed Practical Nurse (LPN) and refers to a 12 month old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 28-OCT-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # U009260 with expiration date of 19-SEP-2022) and with varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T024285 with expiration date of 15-JUL-2022) for prophylaxis (doses, routes of administration, and anatomical location were not reported). The reporter stated that the patient was supposed to get Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMRII) and varicella virus vaccine live (oka/merck) (VARIVAX) (inappropriate schedule of product administration and wrong product administered). No other issues or concerns were noted. No product quality complaint (PQC) was reported.
Severe migraine,  dizziness, nausea vomiting for 3 days
Redness; Swelling; Hot to the touch; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) (batch number G45LN, expiry date 30th November 2019) for prophylaxis.   On 1st April 2019, the patient received the 1st dose of Shingrix. On 1st April 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and injection site warmth. In April 2019, the outcome of the injection site erythema, injection site swelling and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Later the same day after receiving Shingrix, the patient had large area of redness, swelling and hot to the touch, at the injection site. The reported reported that this was a pretty significant, severe reaction to vaccine which lasted for about 3 days to several days. The healthcare professional (HCP) did not want to provide the patient demographics without speaking to patient first. The HCP did not consent to follow up.
Skin itching, reddened skin whelps, increased pulse, skin flushing, treatment BENEDRYL 2.5 mg by mouth.
Parents report crying of longer than 3 hours, wakefulnesss and continuous crying over the past 2 days, post vax. On 2/16/2000, approximately 15:00, parents report temperature of 102F (orally) and seizure-like actively the night of 2/17/2000. Referred to MD at clinic. Presently, irritable and tearful with a staring expression.
Approximately 10 minutes after receiving the vaccine she became anxious. She stated, " I am nervous about the unknown. I wanted to get it." " I always get like this." 8:50am she was placed on vs monitor, BP 138/82, HR 115, O2sat 100%. 8:55am HR up to 124. She was tearful and trembling. 8:58am 133/92, HR 149, O2sat 100%, R 24. Code green was called. 9:05am She was taken by stretcher to ED for evaluation. BP 131/94, HR 132, O2 sat 100% when leaving the vaccine clinic area. She remained awake and alert throughout.  1/7/21 Followed up with her via phone conversation. She states she was discharged from ED yesterday. She was at work. She had a slight headache today, but had taken Advil and it was improving. Stated that last night the headache was worse. No other complaints today.
Product storage error; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No Treatment medications were reported.
Red, hard, feverish, sore injection site on left arm approximately 4 inches x 3 inches.  It began on February 13, 2021, which was 2 days after injection.  Redness subsided some, but on day 8 after injection, area became more red, hard, feverish and sore.  Also, I have  soreness under arm near lymph nodes.  I visited my Primary Care Physician today and was prescribed a steroid pack.
Delayed reaction.  on 7/22 started getting dull arm pain in the evening that ran down my arm into my hand.  Then I noticed the injection site was warm to the touch and started to feel itchy.  There was also a hard lump and the area around it was hard.  Arm started to feel heavy and feel like it was burning on the inside.  I took ibuprofen and applied an icepack and that helped.  The next morning very itchy and a red patch about 2 inches in diameter. Dull pain in arm.
Information regarding PREVNAR was received from a healthcare professional regarding an 18-month-old female patient who developed temperature ranging from 103 degrees to 104 degrees.  The patient received a dose on 18-Jun-2007.  The patient has a twin brother who experienced a febrile seizure with PREVNAR on the day (HQWYE727521JUN07).  Product was administered on 18-Jun-2007.  Dose regimen was 1 dose 1 time per day (intramuscular).  Concomitant medications were not reported.  On 18-Jun-2007 the patient was taken to the emergency room with a temperature ranging from 103 degrees to 104 degrees.  The patient recovered.  Body temperature (results: ranging from 103 degrees to 104 degrees) was done on 18-Jun-2007.  No additional information was available at the time of this report.
hives on thigh, hand and abdomen; sore arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore arm) and URTICARIA (hives on thigh, hand and abdomen) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 15-Jan-2021, the patient experienced URTICARIA (hives on thigh, hand and abdomen). At the time of the report, VACCINATION SITE PAIN (sore arm) and URTICARIA (hives on thigh, hand and abdomen) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   The patient took Benadryl and Aleve to try and relieve her symptoms.
pt. received her booster Covid vaccine today, she was waiting in the car waiting area for 15 minutes. During her wait time she started to feel "funny," sweaty,  and dizzy. She opened the car door and stood up, at which point she felt an aura and saw darkness. Her husband was with her and stated that he walked around the car and found the pt. on the ground sitting on her bottom. Pt. was alert and oriented when this RN arrived and was able to provide a history of events that lead to her sitting on the ground. Pt. was assessed and vitals taken. Pt. was given fluids and cookies and brought back into facility. Pt. recovered for another 15 minutes and reported feeling better. Pt. denied EMS/ER services. Final Blood Pressure: 111/76 Pulse 76
Symptoms began 5 hours after the vaccines were given and lasted 18 hours. Symptoms included fever, coughing, sneezing, body aches, fatigue, itching & mattering eyes, difficulty breathing.
Lightheadedness; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Lightheadedness) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced DIZZINESS (Lightheadedness). At the time of the report, DIZZINESS (Lightheadedness) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
full neck is stiff, hurts on movement; full neck is stiff, hurts on movement; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old male patient received BNT162B2, administered in arm right, administration date 10May2021 10:30 (Lot number: EW0151, Expiration Date: Unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (Product=COVID 19 , Brand =Pfizer, Lot number= EW0151, Lot unknown= False, Expiration Date: Unknown, Administration date=19Apr2021, Administration time=03:45 PM, Vaccine location=Left arm, Dose number=1), administration date: 19Apr2021, when the patient was 41 years old, for Covid-19 Immunisation, reaction(s): "stiffness in the neck", "painful movement". The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), NECK PAIN (non-serious) all with onset 10May2021, outcome "not recovered" and all described as "full neck is stiff, hurts on movement". Therapeutic measures were taken as a result of musculoskeletal stiffness, neck pain.  Additional Information: Facility type vaccine for vaccination Pharmacy or Drug Store. Patient did not took other vaccine in four weeks. Patient did not took other medications in two weeks. 3 days before second does on 10May, stiffness in the neck, left side. Motion of the next obstructed and painful movement. (Left arm). Second dose on 10May, right arm, it's been 10 days now and full neck is stiff, hurts on movement. Taken pain killers but now does not help. Now both right and left side of the neck is impacted. Adverse event start date: 07May2021 12:00 PM. Patient received treatment as Pain Killer medication self prescribed. No covid prior vaccine administered to the patient. Patient did not tested post vaccination. No Known allergies or other medical history.  Follow-up attempts are completed. No further information is expected.
03/14/04 had chickenpox breakout, one on nose, more on trunk, few on legs, no fever, called office to report it on 3/18/04.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 25-JUN-2007, the patient was inoculated with ZOSTAVAX for routine adult health maintenance for the prevention of shingles (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 12-DEC-2015, the patient was treated at the hospital for the onset of a severe vesicular rash, which was diagnosed as herpes zoster. The patient was prescribed VALTREX, VICODIN and gabapentin for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
I had bruising and water retention in right arm and breast for 2 weeks.   This turned into flu like symptoms and a baseball size hard mass developed in right armpit.  Fever of 102*.   Loss of muscle mass throughout the body.  Extreme sickness, bleeding gums.
Mom called eighth day after receiving VARICELLA-child ill with rash with white centers in groin, face, hair, eyes. Instructed mom to talk to doctor. No immune deficiencies noted-no chicken pox contacts. Did not respond to phone message left.