chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial COVID-19 Infection after vacciantion/ Rebound COVID-19 Infection; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Initial COVID-19 Infection after vacciantion/ Rebound COVID-19 Infection) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066H21A, 052E21A, 030M20A and 013L209) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Coronary artery disease and Drug allergy (Unspecified Drug).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (Initial COVID-19 Infection after vacciantion/ Rebound COVID-19 Infection). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) from 22-May-2022 to 26-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Initial COVID-19 Infection after vacciantion/ Rebound COVID-19 Infection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  It was reported as, the patient was treated with Paxlovid for COVID-19 and experienced rebound COVID-19 Infection even after treatment. The device date was reported as 01-Jun-2022.  Company comment- This spontaneous case concerns a 68-year-old male patient with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 which occurred at an unknown time with regards to the mRNA-1273 vaccination. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 68-year-old male patient with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 which occurred at an unknown time with regards to the mRNA-1273 vaccination. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Information has been received from a physician concerning a 49 year old male financial officer with no medical history who on the morning of 11/19/05 was vaccinated in the right arm with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant vaccine therapy given in the left arm included a dose of influenza virus vaccine and a dose of diphtheria toxoid/tetanus toxoid (lot # Td143). There was no illness at the time of vaccination. Subsequently the patient developed a temperature of 104, shaking chills, malaise, and a rash area about the vaccination site. Subsequently, the patient recovered. The physician felt that temperature to 104, shaking chills, malaise and a rash area about the vaccine site were considered to be other important medical events (OMIC) because the patient missed a couple days of work. No further information is expected.
Disseminated VZV including meningitis (CSF +) 10 days after Pfizer vaccine
Initial unsolicited report received from consumer via social media on 13-Sep-2016. THIS CASE IS LINKED WITH 2016SA188144, 2016SA188556, 2016SA188804, 2016SA188805, 2016SA188806, 2016SA188807, 2016SA188808, 2016SA188809, 2016SA188810, 2016SA188811, 2016SA188812, 2016SA188813, 2016SA188814, 2016SA188815, 2016SA188816, 2016SA188817, 2016SA188818, 2016SA188819, 2016SA188820, 2016SA188821, 2016SA188822, 2016SA188833, 2016SA188834, 2016SA188835, 2016SA188836, 2016SA188837, 2016SA188838, 2016SA188839, 2016SA188840, 2016SA188841, 2016SA188842, 2016SA188843, 2016SA188844, 2016SA188845, 2016SA188846, 2016SA188847, 2016SA188848, 2016SA188849, 2016SA188850, 2016SA188851 (same site, same vaccine). This case involves a patient (age and gender: not reported) who was vaccinated with dose of INFLUENZA VACCINE (batch number, expiry date, route, dose and site of administration: not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, post vaccination, the patient had always got flu. Lab data and corrective treatment was not reported. Outcome of the event was not reported. List of documents held by sender: none.
A 17 year old patient was administered the First dose of the Moderna Covid 19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old patient was administered the First dose of the Moderna Covid 19 Vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No medical history were reported. .     On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old patient was administered the First dose of the Moderna Covid 19 Vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old patient was administered the First dose of the Moderna Covid 19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication not provided.  Treatment information not provided. No lab data has been provided by the reporter.
Vaccine administered after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 11:43 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 11:43 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 40.22.  No concomitant medications were reported.  The vial was initially stored in the fridge on 09-Mar-2021, moved to the clinic on 20-Mar-2021 and proposed beyond use date was 08-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  On the date of administration, at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit and at 10:00 A.M., the temperature recorded was 30 degree Fahrenheit that has been reached by the vial.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in Jun2021 as dose 2, single (Batch/Lot number: unknown) and in Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 65 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESYLATE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Information: No known allergies. The patient took anti-viral product Paxlovid on 11Jul2022 for COVID 19 Treatment and ended on 15Jul2022. She  had a rebound beginning 21Jul2022. No treatment received. The event was not recovered.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
PATIENT HAS RED WELT 3X2 INCHES ON LEFT UPPER ARM RED, HOT, AND PAINFUL TO THE TOUCH
Upper arm felt swollen about a week after injection, rash began to appear and area felt hot starting 5/3. Rash still visible but is reducing when icing the area.
malaise evening on next day w/fever of 104.5 & nausea & malaise a few hrs later (3) fever broke next day;
Administered Kinrix to a 8 month old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-month-old male patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st April 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 21st April 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-May-2022 Reporter's comments: Clinical Assistant inquired about any information available about the administered dose was okay. They inadvertently administered Kinrix to a 8 month old patient. The reporter did not consent to follow-up. Additional Supportive Information: The patient received Kinrix dose inadvertently, which led to inappropriate age at vaccine administration.
This spontaneous report was received from a registered nurse refers to a 12-year-old male patient. On 05-JUN-2013 the patient was vaccinated with dose 1, 0.5 milliliter (ml) GARDASIL (lot#, expiration date not reported), intramuscularly. On 06-JUN-2013, patient had a syncopal episode and sought medical attention at the physician's office. Patient had no history of previous syncopal episodes. No injuries occurred and no other syncopal episodes have occurred. Treatment was not rendered for the event. The outcome of syncopal episode was reported as recovering/resolving. Causality was not reported. Additional information is not expected.
Red itchy area about 1.5 inches long, 1/2 inch wide at site of injection. Not sure when it started- patient reported it to us 2 days after vaccination. No other symptoms. She also told us she was allergic to Band-Aids and a Band-Aid was used. We were not aware of this at the time of vaccination. Not sure if reaction is due to ZOSTAVAX or Band-Aid.
stiff knees/ stiff elbows; COULD NOT CURLE MY FINGERS; SOME REACTION WITH MY IMMUNE SYSTEM; PAIN/ hurt; hands swollen/ fingers swollen; wrists swollen; This case was reported by a consumer via call center representative and described the occurrence of hand swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced hand swelling, swelling of wrists, stiff knees, stiff fingers, immune system disorder and pain. On an unknown date, the outcome of the hand swelling, swelling of wrists and pain were recovered/resolved and the outcome of the stiff knees, stiff fingers and immune system disorder were unknown.   It was unknown if the reporter considered the hand swelling, swelling of wrists, stiff knees, stiff fingers, immune system disorder and pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix injection at physician office. The patient stated that next day the patient wrists hands and fingers were swollen, they hurt.  The patient knees and elbows were stiff and the pain and swelling lasted to 1 week, and the swelling lasted for 2 weeks. The patient could not curle fingers to make a fist. The patient asked that will this happen again with the 2nd injection. The patient stated that this must be some reaction with immune system. The reporter can be contacted by phone.
patient stated he has been experiencing pain since the date he got the vaccines administered. He stated it's difficult to lift his arm that the vaccines were administered in.
Great pain on both shoulders and neck; bones and muscles. I can't write continuously with my right hand. Objects fall from my right hand (pencils, pens, papers, etc). Left shoulder muscles at rotator cuff feel like falling apart from bones and trembles. My eye view blacks out, and hazy frequent. Lumbar area hurts, eyes itches and gets red;aphyxiation.  7/18/07-records received-DX hypertriglyceridemia. GERD. Caridac Arrhythmia, Left shoulder tendinitis. Depression. Diverticular disease. DDD of cervical spine. HX of trauma when on active service on right shoulder that requires surgery. 1/11/2010 I still suffering of great pains on my shoulders, specially the left one, my cervical 5 and 6 are clogging my spinal cords. Continues super strong heachaches, my muscles sores everday, flips and strains frequently. Many problems with my stomach, my intestine do not work properly. Hospital discovers that my left floot grown 1 1/2" and my back hurts. Due to this I am not walking straight. My eyes are red, and the itch drives me crazy. Allergies swell ups my eyes. Special allergy to seafood (shrimps, craps, etc) which I have never had it before. Left eye frequently swells up including the left cheek. Bones and muscles deep pain when waling up and during the day-back pain. Lumbars and cervical extremely painful sometimes loosing my sight, everything gets dark for a few minutes, continuous headache, extreme itch on both eyes everyday.
pt brought to ED with c/o SOB and altered mental status; tested positive for COVID; on 15LO2 via NRB saturating  @ 75%; intubated; waiting to transfer to another hospital since there are no isolation bed; severe sepsis secondary to COVID pneumonia; suffered cardiac arrest while waiting to transfer; ACLS started; pt remained in asystole x 20mins where she was declared dead in the ED
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. On unknown dates the patients were inadvertently vaccinated with GARDASIL (lot#, strength, dosage, frequency and route unspecified), which had been improperly stored. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a Nurse Practitioner, for varicella virus vaccine live, a Pregnancy Registry product concerning a female patient of unknown age with none of pertinent medical history and none of drug reactions/allergies. The patient's history of previous pregnancies and live birth was not known. On 09-JUL-2012 the patient was vaccinated with VARIVAX (Merck) (dose and lot # were not provided) while pregnant (the gestation was 20 weeks). Concomitant therapies included vitamins (unspecified) (prenatal vitamins). The LMP was 19-JUN-2012 and EDD was 26-MAR-2013 (also reported as "20-MAR-2013"). The patient was exposed to VARIVAX (Merck) during trimester 2. No adverse effect reported. Routine ultrasound test on 01-NOV-2012 and Route prenatal labs were performed which result not provided. The patient saw the Nurse Practitioner to seek medical attention. Follow up information was received from a Pediatrician. On 16-MAR-13 at 39 weeks gestation, the patient delivered a normal male infant (weight: 15 oz. The pregnancy outcome was live birth-full-term. Standard DB tests were performed which showed all of which were with normal limits (WNL). Additional information is not expected.
A VERY, VERY minor neck ache started the day after my 2nd Pfizer injection (4/30/21), on right side of neck, below right ear.    Ache continued to get worse VERY slowly on almost a daily basis.    About 2 weeks after that 2nd injection, my neck started popping/cracking when I moved it around.  Pain continuing to get worse (but very slowly).  On 6/10/21, (with pain continuing to slowly get worse, but at a pretty high level by now) I finally went to see a doctor.  He checked for serious conditions and concluded it wasn't anything 'serious' and suggested a few sessions of physical therapy.  The earliest I could get physical therapy would be almost 2 months away, so I have not had physical therapy yet.  On 6/11/21 I took an Ibuprofen and played  racquetball.  The neck pain was completely gone for about 11 hours and then slowly came back.  I have been taking 2 Ibuprofens a day since then and even if I don't take an Ibuprofen for a day the neck pain seems to be easing.  It feels like it may be slowly getting better, although there is still some pain and cracking/popping when I move my neck.
Left arm swollen and warm. Itching and painful. Pt to use ice packs and Advil.
pt recvd vax 5APR94 & exp hives 24 hrs p/vax chiefly, arms, trunk, face; no edema; no asthma; lasted 3-4 hrs;
In the evening post first Hepatitis B vax, this 14 day old pt developed diarrhea and was fussy overnight. In the following morning, the child had a fever of 102 rectally and was treated with acetaminophen 0.8 ml PO. Lab tests were conducted. The pt was seen for evaluation. On 12/26, the pt recovered from his experiences. No further information is available.
Left eye became blood shot and smaller and shrunk; Left eye became blood shot and smaller and shrunk; This is a spontaneous report from contactable consumer(patient) reported for herself. An unknown age female patient received 1st dose of BNT162B2 (Pfizer COVID-19 Vaccine) on 22Feb2021 at single dose for COVID-19 immunization. Medical history and concomitant drug were not reported. She got the first vaccine on 22Feb2021 and shortly after that her left eye became blood shot and smaller and shrunk and it has not changed since then. And she was due for the second dose on 15Mar2021 and she was wondering if she should take it. Outcome was the event was not recovered.  Information on lot/batch number has been requested.
Extreme chills, Right leg pain / jumping within 3 hours of getting vaccine,  shortness of breath / Heart racing started around 11:00 pm,  fever 101.3,   Started over night, severe headache.  Had a seizure during the night and the following day.   Symptoms continued for a few days.  My arm pain lasted for a couple weeks.
Jan 7, around the size of a half dollar. Itchy, red, very warm to touch, slightly hard.  Jan 10, less itchy more of a burning feeling, not hard, not as red. Jan 12, no burning but itches slightly when touched, not hard, more pink.
RN gave DTAP, IPV, Varicella. Child became limp and unresponsive. Ammonia ampule given. Child cried became limp. Child laid on table with legs elevated Pulse 70 color WNL. Appeared child was trying hard to get air. Epi .15 given paramedics called.
Pt recv vax on 12/1/98; on 12/3/98 pt exp hives, tight chest, face & throat swollen; tx=Epinephrine, Benadryl, Hydrocortisone injections; pt to allergist
Today she is here for adverse reaction she had to shingles shot on 7/3/2023.  About 2 weeks after that she noticed stiffness in hips and knees. Stood and almost fell. 5 weeks later we talked on 8/10/2023.  She states she is staggering. Unable to walk the way she used to. Loss of appetite, and major fatigue. She is really angry because she had joint pain before, but things are worse now. She has to hold on to things all the way to the bathroom when she first gets up. The longer she sits the stiffer she gets, then she takes minutes to be able to walk smoothly. Denies dizziness or headache. No tremor. Severe fatigue, no energy past 4pm.  Coming off Lyrica for sciatica, did not find it to be helpful.  Going to accupuncture.
L deltoid erythema (6.5m x 7cm) with sore/itching to site at L deltoid. Neuromuscular weakness and parasthesia to L lower leg extending just above knee, mild weakness on exam. Parasthesia L forearm.
The vaccine expiration date was identified to expire on June 22, 2021, but the manufacturer expiration date was February 25, 2021. Based on the information learned, County Health took the following steps: Covid-19 Response Unit Pharmacists contacted Moderna for guidance and based on Moderna data, the Moderna Medical Information team provided the following information: The vaccine administered on March 4, 2021 through March 10, 2021 from lot number 025J20-2A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.  A county medical director was contacted and based on this information from Moderna, no re-vaccination is needed.
Fever to 104 27FEB91 & 105 28FEB91; To ER 28FEB91; No apparent infect; Had red blotching on face 1MAR91 p/taking Augmentin  was discontinued due to poss allergy; continues to have low grade fever & has clear nasal discharge.