chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 28-NOV-2018, the patient was vaccinated with improperly stored PNEUMOVAX 23(lot # R018731, expiration date: 27-FEB-2020, strength, dose, frequency and route unknown) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. Sender's Comments: US-009507513-1901USA004786.
This was second one. I had adverse reaction to first one as well -- same pharmacy, on Dec. 27, 2019. First reaction started morning after a late afternoon shot. This one started a few hours after shot, with trembling. Ended up being much worse than first time, with trembling, weakness, intense muscle and joint pain. So much pain I couldn't sleep or even move. Headache, and I never get headaches. Just felt incredibly awful. It was as bad as chemo, except without sweating. (My last chemo was almost a year ago, but this brought back all those feelings.) I was better about 30 hours after the second dose.
Shingles at age 28 months, with no known exposure to varicella except vaccine at 12 months.
Received Expired Dose; Initial Report Received on 10-May-2023  A registered nurse reported that a male patient (age, race, and ethnicity unknown) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Medical history and allergies at the time of vaccination were not reported. Medications at the time of vaccination were not reported.  On an unknown date, the patient received an expired dose of HEPLISAV-B vaccine (Lot # T035865, expiration date and NDC # unknown) intramuscularly in the left deltoid. The reporter insisted it was HEPLISAV-B given to the patient. No adverse effects to the patient were reported.  No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
elderly mother caught covid, was then vaccinated with Pfizers comirnaty, and then passed away a week later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly female patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "elderly mother caught covid, was then vaccinated with Pfizers comirnaty, and then passed away a week later". The date and cause of death for the patient were unknown.  Clinical information: On 08Jan2023, reporter took an Uber ride in (city withheld) and the Uber driver (who I do not know personally outside of this interaction) told me that his elderly mother caught covid, was then vaccinated with Pfizers comirnaty, and then passed away a week later (in that order). I do not have additional details.  The information on the batch/lot number for [Comirnaty] has been requested and will be submitted if and when received.; Reported Cause(s) of Death: elderly mother caught covid, was then vaccinated with Pfizers comirnaty, and then passed away a week later
This spontaneous report as received from a physician refers to an approximately 83 year-old female patient who is allergic to 12 medications. Approximately on 22-NOV-2012 (reported as 4 weeks ago), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, route and dose were not reported). No concomitant medications were reported. Approximately on 25-NOV-2012 (reported as 3 days later after vaccination) the patient experienced left shoulder pain and vesicular rash in that area. The patient was found to have C4 and C6 dermatome (hospitalization) and was diagnosed with shingles (hospitalization). Standard Laboratory tests were performed on an unspecified date and the results were not reported. The patient sought medical attention (was admitted to the hospital on an unspecified date in 2012) and was treated with VALTREX and after the course was done, the patient developed a rash on the hands and was given another course of VALTREX. On 13-DEC-2012 (reported as about 1 week ago), the patient recovered from all the reported events. The physician also reported that he had seen the patients 60 year old daughter who had has a history of chickenpox early in childhood had developed a vesicular rash on the right side of the face involving the nose 10 days ago. The patient's daughter had multiple unspecified antibiotic allergies, rheumatoid arthritis and was on steroids. The patient was treated with VALTREX and additional lesions were found on the left side of the face. There were multiple lesions that were small. The lesions were now crusted and the patient was being treated with VALTREX. Additional information has been requested.
Pharmacist administered the vaccination and went to engage the safety mechanism on the needle but accidentally poked the side of her finger with the used needle.
Pt had swelling and tenderness on left upper arm which occurred 2 days, post vax. Pt given Keflex, Naprosyn and Ace wrap. Dx'd with cellulitis along triceps left upper arm. Follow-up on 6/2/2000, still with swelling and tenderness of left upper arm, cellulitis worsened last night but improved today and is recovering.
5.5 x 5.5 inch area of erythema and warmth with mild edema left thigh. Instructed to monitor, apply cool compresses and give BENADRYL q 6 hours.
left arm and back were a little achy; sinuses were slightly stuffy; felt fatigued; had mild vertigo; left arm was slightly sore /left arm and back were a little achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 26Mar2021 11:30 (Lot number: EL3248) at the age of 53 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "latex" (unspecified if ongoing); "betadine allergy" (unspecified if ongoing); "seasonal allergy" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE; ZOLOFT; D3 VITAMIN; EXCEDRIN MIGRAINE. Vaccination history included: BNT162B2 (lot number:EN6203, administration time:11:30 AM, vaccine location: Left arm, dose number :1), administration date: 02Mar2021, when the patient was 53 years old, for COVID-19 Immunisation, reaction(s): "slightly stuffy nose", "fatigue", "Earache", "mild vertigo". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 26Mar2021, outcome "recovered" (Mar2021), described as "left arm was slightly sore /left arm and back were a little achy"; BACK PAIN (non-serious) with onset 27Mar2021, outcome "recovered" (Mar2021), described as "left arm and back were a little achy"; VERTIGO (non-serious) with onset 26Mar2021, outcome "recovered" (Mar2021), described as "had mild vertigo"; SINUS CONGESTION (non-serious) with onset 27Mar2021, outcome "recovered" (Mar2021), described as "sinuses were slightly stuffy"; FATIGUE (non-serious) with onset 27Mar2021, outcome "recovered" (Mar2021), described as "felt fatigued". Therapeutic measures were not taken as a result of pain in extremity, back pain, vertigo, sinus congestion, fatigue.  Additional information: The patient was not pregnant at time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. The vaccine was administered in a workplace clinic.  No follow-up attempts are possible. No further information is expected.
I got 2 doses of Pfizer previously and on Nov 18, 2021, I opted for Moderna booster. After booster, immediately I experienced blurred vision and a slight dizziness. After that i was ok and just had body aches the entire day. Next morning when I woke up i experienced tingling and numbness in my left hand and pink finger and right thumb. I called Hospital and spoke to a nurse practitioner and she advice to give it few days and see if they go away.  The symptoms were persistent until last night ( Nov 28, 2021) when I experienced tingling in all my limbs ( feet and hands, plams ). The tingling is intense but numbness comes and goes. This morning Nov 29, 2021, my palms are numb and tingling in my feet and face.
congestion; but believes it to be allergies; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "but believes it to be allergies". Additional information: The reporter was a patient who was scheduled to receive her booster dose of the Pfizer-BioNTech COVID-19 vaccine, the day after the initial report. The patient reported having had "congestion for a couple of months" but believed it to be allergies. The patient noted that her daily activities were not limited, "I still go golfing and go to work".  The patient wanted to know if she could still receive the booster dose with the symptom. The patient noted that her original vaccination series was also Pfizer.  The lot number for bnt162b2 was not provided and will be requested during follow up.
a couple of nosebleeds here and there 3 weeks after receiving the second dose of the Pfizer Biontech Covid-19 Vaccine; cough every now and then; This is a spontaneous report received from a contactable consumer (the patient). A 26-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that he seemed to be having a couple of nosebleeds here and there 3 weeks after receiving the second dose of the Pfizer Biontech COVID-19 Vaccine. He seemed to also be experiencing cough every now and then. He suspected that wearing the surgical mask with wire lining could be the cause but wanted to get more information from Pfizer. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
I now have COVID-19 but thanks to the vaccines that I took earlier I will come through this with my life; now have COVID-19 but thanks to the vaccines that I took earlier I will come through this with my life; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A 65-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "heart problem" (unspecified if ongoing), notes: I'm 65 with heart problems and controlled blood, pressure problems; "Blood Pressure" (unspecified if ongoing), notes: I'm 65 with heart problems and controlled blood, pressure problems. The patient's concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "I now have COVID-19 but thanks to the vaccines that I took earlier I will come through this with my life"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "now have COVID-19 but thanks to the vaccines that I took earlier I will come through this with my life". Clinical course: Patient would like to take this opportunity thank for what patient believed was a life-saving vaccine. The patient was 65 with heart problems and controlled blood pressure problems, patient believed patient would not have survived without wonderful vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Two minutes post vax pt developed an anaphylactic reaction with airway blockage and swelling. Pt was given 3 doses of epinephrine and taken to ER. Pt was placed on a cardiac monitor and received sustained release epinephrine. Pt recovered one day later and was discharged. Pt experienced a similar event following receipt of Depo Provera.
bright red rash and swelling at site of injection given doxycycline hyclate 100 mg bid x7 days by PCP
Cellulitis-left arm 2 hours after I received vaccine.  I noticed that my arm was swollen.  I went to Doctor's office and showed it to her.  She felt that it was nothing to worry about 24 hours later was given 500 mg of LEVAQUIN-to be taken for approximately 8 days.  5 hours after I received LEVAQUIN I noticed I was running a slight fever and I had trouble standing my husband took me to the hospital ER. There they diagnosed cellulitis cause preservative used in the vaccine.  They gave me a giant antibiotic took x-rays took blood from me and did numerous blood screening.  They released me after about 5 hours.  This was 09/12/06-one day after I received the vaccine.  To keep taking the LEVAQUIN.  09/19/06 I'm still feeling rotten and had a hard time navigating felt very weak and had been suffering from vertigo/dizziness.  My husband took me to the ER at hospital again where they took more blood and did more blood studies-they discharged me after about 6 hours.  My instructions were to go and see my primary care physician.  I did the next day.  Doctor denied that I had, had cellulitis but did take a sample of my urine.  I went back again for further treatment.  My husband and I were escorted out of their office.  I had to go and get a new primary care physician since 09/26/2006 he has been very helpful in directing the medical care I needed.  I now have vestibular labryinithis diagnosed by an ENT (ear, nose and throat) man: doctor name reported. He said that it was caused by a trauma: the vaccine  I received 09/11/06.  I now have to have therapy for this disorder-don't known how long I will have to go. 10/26/06-ER records for DOS 9/12/06: DC DX: Cellulitis and amp; ABSC upper arm. Presented for evaluation of erythema of left upper arm. Onset gradual. HX of cardiac disease with stent placement. Hypertension. HX of anxiety, panic attacks. Historian reports dizziness. No gait changes, lethargy, sensory changes, speech changes. RX with Septra. ER visit 9/19/06-DC DX: fatigue and weakness. C/O not feeling well, tearful, concerns regarding recent loss of weight of 10 pounds. Daughter recently DX with uterine cancer. Hasn't felt well in weeks not sleeping well. Patient states has been seen by cardiologist and Dr. for these complaints. PE: WNL. Psychiatric: anxious affect anxious with pressured speech. Workup discussed with Dr, states he had been getting calls from several other physicians about her showing up in ED and offices with similar complaints. Requested social services consult. DC home.  10/31/06-records received from the Doctor. for DOS 9/11-for arm swelling post vaccine. Exam revealed edema secondary to allergic response but cannot totally rule out cellulitis. Rx with antibiotics.  I was released from rehab Dec 2006 I am now able to drive and don't need a cane. It was 3 months of hell.
This spontaneous report has been received from a nurse referring to an unspecified number of patients of unknown age. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL 9 (strength, dose, lot #, expiration date and anatomical location were not reported) intramuscularly for prophylaxis; which experienced a temperature excursion at 1 Celsius degrees for 15 hours. No previous temperature excursions were reported. Data logger was involved. A product quality complaint was not involved, no adverse events were reported and no additional information was provided. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA004670.
Pin and soreness after receiving the booster; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (Pin and soreness after receiving the booster) in a  patient of an unknown age and gender 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Pin and soreness after receiving the booster). At the time of the report, PAIN (Pin and soreness after receiving the booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
received dose 1 at 8:40am and woke up the next morning at 7am with hearing loss in left ear and constant ringing in the left ear.  have never had this issue before.
Since 5/10/21 (through today 5/29), Left Shoulder / Arm soreness and swelling especially in left elbow which spread to lower left leg especially in left knee.
I have developed partial LBBB on EKG.  No other symptoms - could be coincidental
Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was administered an invalid dose of Moderna COVID-19 bivalent booster/ Recipients received underdose of 0.25 Moderna Bivalent Booster).    No concomitant product reported by reporter. It was reported that 100 patients were administered an invalid dose of Moderna COVID-19 bivalent booster. The nurse had no standing order other than what they had for second booster, when administering bivalent boosters, so they assumed same dose as second booster and administered 0.25mL to uncompromised adults.  This case was for one of the patient among the 100 patients who were administered an invalid dose of Moderna COVID-19 bivalent booster.   It was reported that CDC had recommended to revaccinate the patients with full dose of 0.5mL.  No treatment medication reported by reporter.
Recurrent myocarditis; Disease recurrence; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Recurrent myocarditis) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE:  The patient's past medical history included Myocarditis (vaccine-associated myocarditis).    In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Recurrent myocarditis) (seriousness criterion medically significant) and DISEASE RECURRENCE (Disease recurrence). At the time of the report, MYOCARDITIS (Recurrent myocarditis) and DISEASE RECURRENCE (Disease recurrence) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Recurrent myocarditis) and DISEASE RECURRENCE (Disease recurrence) to be related.    Concomitant and treatment medications were not reported.  The study was conducted among 431 patients with a prior history of vaccine-associated myocarditis,  pericarditis, or myopericarditis. Out of this 171 received COVID-19 vaccine in the year 2021 with median age- 39 years (range 21-67 years).  From the vaccine recipients, 11 patients experienced cardiac-suggestive symptoms (chest pain, palpitations, or dyspnea) within 30 days of COVID-19 vaccination. Four patients met the criteria for recurrent. All 4 COVID-19 recurrent cases fully recovered with minimal supportive care within weeks (myocarditis) to months (pericarditis).  This case describes the patient who developed recurrent myocarditis within 3 days of receiving Moderna vaccine.  Company Comment: This is a literature non-study case concerning a 50-year-old, male patient with a reported medical history of Myocarditis (vaccine-associated myocarditis), who experienced the serious (due to medically significant) expected event of MYOCARDITIS (reported as Recurrent myocarditis) and the non-serious unexpected adverse event of disease recurrence. The clinical presentation was mild. The event occurred within 3 days after receiving the second dose of mRNA-1273 vaccine. The events were reported as recovered. Concomitant and treatment medications were not reported. The mentioned medical history remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-726873 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-726873:49 YO male
Pt given Td left arm by ER staff 10/29/04. Pt noticed she started pain with itching. She noticed hard bump on site.
On 4/12/2021 Patient states that he had itching On 4/13/2021 and 4/14/2021, symptoms escalated On 4/14/2021 Patient states he had a rash on arms, neck, and entire body.  He went to Dr. for evaluation.  Was given a steroid shot at office, and Medrol Dosepak to continue at home.
Morning after Pt received MCV4 vaccine, developed pain, redness and induration surrounding injection site. No necrosis. Improving at time of evaluation.
Chicken pox outbreak on neck AND Measles bumps on back and shoulder and forearm.
Red spots on face after first dose, Immediate gastroenteritis after second dose for 3 days.  A couple of weeks later, shortness of breath and chest pains. Dec 21 diagnosed with mitral valve prolapse. No history of health problems before.