chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen lips; Dizziness; Itchy arm; Hives in the arm; Bumps; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen lips), DIZZINESS (Dizziness), PRURITUS (Itchy arm), URTICARIA (Hives in the arm) and SWELLING (Bumps) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced LIP SWELLING (Swollen lips), DIZZINESS (Dizziness), PRURITUS (Itchy arm), URTICARIA (Hives in the arm) and SWELLING (Bumps). At the time of the report, LIP SWELLING (Swollen lips), DIZZINESS (Dizziness), PRURITUS (Itchy arm), URTICARIA (Hives in the arm) and SWELLING (Bumps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up information received and AE contact information updated.
2nd dose 8 days before a month from 1st dose; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 4-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number T030710, expiry date 15th April 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DIPHTHERIA TOXOID, HEPATITIS B VACCINE, PERTUSSIS TOXOID, POLIOMYELITIS VACCINE, TETANUS TOXOID (PEDIARIX).   On 15th October 2021, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 15th October 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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 was provided as follows: The patient received 1st dose of Pediarix on 23rd September 2021. The patient received 2nd dose of Pediarix 8 days before a month from 1st dose, at an interval shorter than the recommended, which led to shortening of vaccination schedule. The reporter did not consent to follow up.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the current condition, medical history and pertinent drug allergies of the patient were not reported. On 26-NOV-2015 at time- 13:52, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 2.9 and 2.4 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Following vaccination, the pt had a high fever of 105.8, then experienced a seizure. He seized for 35 minutes. Received O2, Lorezepam, IV Rocephin. Transported and was hospitalized for 4 days. Information has been received from a pediatrician concenring a 12 month old healthy male with no previous history of febrile seizures and a Cefzil allergy. It was reported that the pt began posturing and was given a second dose of lorazepam and IV phoenobarbital. The pt was transported to another hospital's pediatric care unit for four days. During this time th ept had a neurological examination and a spinal tap with unspecified findings. Diagostic and lab tests were reported as CXR: negative; CT head: negative; throat c/s: negative; WBC: 6.0; Hbg: 12.3; Ne: 135; K: 4.2; Cl: 97; CO2: 18; hematocrit: 36.1; plt: 392K; bands: 4; seg: 31, BUN: 10; creatinine: 0.6; Ca: 9.2; U/A: normal. The pt was discharged with rectal diazepam prn, if needed. The pediatrician at a follow-up visit described the pt was "recovered and looks great," and told the mother that her child may have had a viral infection. It was also noted that the pt, and sibling, did not have any adverse events following prior vaccinations. Additional info is not expected.
Vaccine administration error.  The Moderna COVID 19 vaccine Lot# 048F21A  expiration date: 01/22/22.  The vaccine was administered on 01/24/22.  Two days past the expiration date.
pt recvd vax;w/in a couple of days,difficulty walking,stiffness in ankles,numbness in feet;forearms painful;generally felt sick;called MD who felt mild rxn to vax;tests done, all neg;x-ray neg;referred to neurologist;pt better,coughing less
Patient received Moderna instead of Pfizer based on age, no problems reported as far as we know as of 1/27/22.
approx. 10hrs after shot suddenly shaking uncontrollably,feeling bad,overcome with exhaustiontion.able only to lie down-freezing under blankets,in hoodie and sweats and heated room.nauseas, terrible headache, middle of chest hurting/aching,heart racing periodically.muscles in neck espec. but all over tender and painful.miserable.not able to get up for near 12hrs.when I had to.wen I did I threw up 3-5times like out of a firehose.began to improve slightly 3-4rs.later.still slept or lay with no energy and headsplitting pain through 3/14 and into 3/15.better with a headache and around 2:00pm felt noticeably better.arm still red and sore and I am not near 100% but feel like I will be. Forgot to say also 3/13 when I slept I would wake up gasping for air as if I were not breathing. that happened several times and I was afraid I may not wake up to breathe
dizziness/for more than 24 hours he was dizzy; Could not stand up; diarrhea; Felt really very sick; nausea; fever; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness/for more than 24 hours he was dizzy), DYSSTASIA (Could not stand up), DIARRHOEA (diarrhea), VACCINATION COMPLICATION (Felt really very sick) and NAUSEA (nausea) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Open heart surgery in 2001. Previously administered products included for an unreported indication: Flu vaccine. Concurrent medical conditions included Diabetes and Heart disorder.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness/for more than 24 hours he was dizzy), DYSSTASIA (Could not stand up), DIARRHOEA (diarrhea), VACCINATION COMPLICATION (Felt really very sick), NAUSEA (nausea), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). At the time of the report, DIZZINESS (dizziness/for more than 24 hours he was dizzy), DYSSTASIA (Could not stand up), DIARRHOEA (diarrhea), VACCINATION COMPLICATION (Felt really very sick), NAUSEA (nausea), PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that the doctor then suggested him to take flu vaccine in half dose which worked for him since he got sick after the flu vaccine  No relevant concomitant medications were reported.  Treatment information was not provided.
The cases were received on 21 March 2014. Initial misuse report received from a healthcare professional on 20 February 2014. A 40-year-old patient had inadvertently administered FLUZONE HD. It was an inappropriate age at vaccine administration. No adverse event was reported. List of documents held by sender: none.
her neighbor got spina bifida after COVID vaccine; her neighbor got spina bifida after COVID vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: SPINA BIFIDA (medically significant), IMMOBILE (medically significant), outcome "unknown" and all described as "her neighbor got spina bifida after COVID vaccine". Clinical course as follows: reporter reported her neighbor got spina bifida after COVID vaccine. he had the vaccine, and he got the second one and it made him immobile. That's pretty rare for people. He's got Spina bifida maybe.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on information provided, the events more likely represent intercurrent illnesses which are unrelated to BNT162b2 (BNT162B2). The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Erythema (R) thigh 2cm X 1cm, 3 1mm- 2mm red papules.
Usual resting heart rate is 55 bpm. Staring the night of 2nd dose and continuing into the 2nd day, it is 80 to 85 even when lying in bed. Just walking to the bathroom makes it increase to over 100 to 115; Also feeling very drained of energy.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 08May2021 at 10:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included cetirizine hydrochloride (ZYRTEC) daily 24-hour and daily multivitamin (MANUFACTURE UNKNOWN); both for unknown indications from unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0189) via an unspecified route of administration in the left arm on 17Apr2021 at 00:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient usual resting heart rate was 55 bpm. On 08May2021 at 23:30, starting the night of second dose and continuing into the second day, the patient heart rate was 80 to 85 even when lying on the bed and any activity including just walking to the bathroom increased the heart rate to over 100 to 115. (Based on a fitness tracker that was worn constantly) and also felt very drained of energy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events heart rate was 80 to 85 even when lying in bed and any activity including Just walking to the bathroom makes it increase to over 100 to 115 and  felt very drained of energy was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Symptomatic patient with muscle aches and SOB. Tested for COVID-19 on 1/12/2022. Hospitalized on 1/12/2022 for 2 days. Patient had an abnormal chest X-ray.
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (merck) Injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (merck) (injection strength, dose, frequency, route of administration and indication were not provided) (lot # J012817, exp date: 10-OCT-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
Starting on 01/25/2021, I started feeling dizzy, body aches, chills (no fever), headaches, and bad fatigue. It has continued until last night (02/03/2021) when I had body aches. Today (02/04/2021)  I feel fine for the first time.
Patient is reporting shoulder pain since first vaccination that has not resolved or been diagnosed by providers he has seen.
sore arm; chest and some back pain; chest and some back pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), CHEST PAIN (chest and some back pain) and BACK PAIN (chest and some back pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     medical history is not provided and concomitant drugs are provided.  Concomitant products included MELATONIN and CALCIUM for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), CHEST PAIN (chest and some back pain) and BACK PAIN (chest and some back pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), CHEST PAIN (chest and some back pain) and BACK PAIN (chest and some back pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
On 8/11/99, the pt experienced flu-like symptoms. On the following day, the pt experienced aches, nausea, and vomiting several times throughout the day. On 8/13/99, the symptoms resolved.
I was fine until about 2 AM, roughly 10.5 hours after being vaccinated. The pain in the injection site became unbearable, and the whole area turned red and hot to the touch. Then, the fever began. It started as 101° but by mid Sunday I was up to 103°. I had the cold sweats and periods of intense warmth. I was so nauseous I hardly could eat.  My neck hurt so much along with my head. It hurt to rest my head on a pillow but holding my head up was even worse. My whole body ached and I had intermittent joint and muscle pain. I have basically tried to sleep throughout all of this. As I'm writing this, I'm still curled up in bed, nauseated, fatigued, and in pain with a fever of 101.5°.
A physician reported via a company representative, that a 4 year old child received Flu Shield (2001-2002 formula) (influenza virus vaccine, trivalent, types A & B/2001-2002 formula) vaccine. At a later date, the child tested positive for influenza by an office flu test. The flu immunization was given approx. 2 months prior to dx. The child developed a "high" fever that measured 103-104F, lethargy, cough and runny nose. This is 1 of 6 pts from this office who developed influenza following receipt of Flu Shield (2001-2002 formula) lot 4078033. See case ID numbers: HQ0713214FEB2002, HQ1480125MAR2002, HQ1480225MAR2002 and HQ1480325MAR2002. One pt was not identified; an additional report will be generated when identifying information is provided. No additional information was available as of the date of this report.
Info has been received through the pregnancy registry from a 32 year old female with no past medical history or allergies, who on 06/24/2002 was vaccinated with a 0.5 ml first dose of varicella virus vaccine live (lot #641984/0290M). There was no concomitant medication. The pt had recently found out that she is 3 weeks pregnant. The doctor who administered the 1st dose was her father, and at the time of the report he was unaware that the pt was pregnant. The pt was scheduled to have a second dose of varicella virus vaccine live on 08/24/2002. The pt recently moved and does not have a doctor at this time, therefore she did not seek medical attention. Follow-up info received from the pt indicated that she was not tested for varicella antibodies before vaccination with varicella virus vaccine live and that the vaccination was not given for immigration purposes. The pt identified her last menstrual period as 07/17/2002 and estimated date off delivery as 04/20/2003. On 09/12/2002, an ultrasound, done to check for ectopic pregnancy, showed a normal pregnancy. The pt reported that she had one previous pregnancy which resulted in a full-term delivery with no birth defects. The pt indicated that she had no previous pregnancies resulting in stillbirth or miscarriage. On 08/19/2003 the pt's father (who is a physician) reported that he did not check the pt's immunity before she received the vaccine due to the fact that he knew that she had never had chicken pox. His daughter had problems with this pregnancy and he stated "it had nothing to do with the varicella virus vaccine live". His daughter had an incompetent cervix and on approximately 08/29/2002, at 6 months gestation, she had a cerclage placement (he could not remember the specific date of the procedure). She was released from the hospital and her cervix continued to thin. His daughter was then hospitalized for 8 weeks and discharged on approximately 03/13/2003 at 34 weeks gestation. He also reported that his daughter did not have a history of incompetent cervix, stating at least it was never diagnosed, and she had delivered at term with her last pregnancy. On 03/27/2003 at 36 weeks gestation, the pt delivered a 6 lb., 11 oz., 18.5 inches long female. The infant had Apgar scores of 8 and 9. The pt's father reported that the baby was now 5 months old and had no problems. No further info is available. On 29-Mar-2004 it was reported that a glucose (POC) was noted to be low at 43 mg/dl. No further information is available.
Patient experienced some facial swelling to the left side of her face along the jawline, where her jawline meets her ear. Patient came back to the pharmacy to purchase some Benadryl as she was advised to do by her doctor's office.
High Fever and coughing 02/09/07-records received and reviewed for DOS 01/01-01/05/07 DC DX: acute bronchiolitis/RAD viral syndrome possible reaction to DTAP and flu shot.  Rhinosinusitis Seen in ER for hyperpyrexia. Temp in ER 106 with cough and wheezing. Started one week prior to admission. Cold without fever. Received vaccines 4 days prior admission. One and one half days later developed fever to 103-104. Seen in ER on 12/31/06, treated with Motrin, Tylenol and cough medication and sent home. Temperature spiked to 105 prior to admission. No seizure. No meningeal signs. PE: Temp on admission 98.3. WNL except for Throat injected, tonsils enlarged, nose clear mucus.
Lip swelling 25 minutes post vaccine Patient medicated by MICU prior to arrival. Pt arrived AAO x 3 & appropriate.  Airway intact NAD.
DPT inj. at L deltoid on 22 Nov 99. Seen by Dr. 5 cm erythema & 2 cm induration per MD.
lethargy at 7 ish pm, followed by a runny nose at 7:45 pm,  chills set in around 8:45 pm,  temp at 99.9 F at 9:15 pm,  temp at 101.1 F at 10:30 pm accompanied by severe chills temp up to 102.0 at 11:19 pm Nausea at about 12:15 am temp stayed around 102 for the next few hours (101.8 at 12:30 am then back up to 102.1 a bit later)  fever came down to about 100 at 4 am Headache persisted through the early morning and has not disappeared by 12:04 pm on 3/21/2021
Pt reported Red Raised Itchy Bumps mainly on legs, but was all over. She stated it started on 3/22/23 at around 8pm. She received the vaccine on around 3pm on 3/21/23.
having trouble breathing; breathing problems are getting worse every day; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (having trouble breathing) and CONDITION AGGRAVATED (breathing problems are getting worse every day) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (having trouble breathing) and CONDITION AGGRAVATED (breathing problems are getting worse every day). At the time of the report, DYSPNOEA (having trouble breathing) and CONDITION AGGRAVATED (breathing problems are getting worse every day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported by reporter Treatment information was not provided by reporter
cluster of painful, blanching (with yellow hue), erythematous papules to midline lower chest, upper abdomen with painful skin to left side of chest/abdomen
Narrative: Pt is a 81y male with a h/o CAD with PTCA over 30 years ago, Crohns disease, T2DM, Sleep apnea-no CPAP, Cervical stenosis SP ACDF 3/4-RP abscess on chronic antibiotics & obesity died on on 07/07/2021. Patient was confirmed with COVID-19 on 06/08/2021. MD notes state death was caused by hypoxic respiratory failure secondary to COVID Pneumonia and bacterial pneumonia. Pt received covid vaccines on 01/14/2021 and 02/11/2021. Covid-19 vaccination failure led to patient's covid-19 infection ultimately causing patient's death.
He experienced nausea, vomiting, fatigue and tiredness. He also had clamminess and sweating and pain in the injection site. These symptoms started on the same day. He notified the nurse on the same date, but I was advised on 01/31/2023. He was given prescription strength Tylenol and started to feel better about 72 hours later. He still has some lingering fatigue and tiredness.
This spontaneous report as received from an approximately 78 year old male patient refers to himself, as a part of Post Marketing Active Surveillence. Medical history, drug reactions or allergies were not reported. The patient stated that he was in a study for the "shingles vaccine". The consumer did not have further information about the study. On an unknown date in approximately 2003 (reported as "about 10 years ago") the patient was vaccinated with a dose of ZOSTAVAX subcutaneous (dose, route and lot number were not reported). On an unknown date in approximately 2013 (reported as "recently") the patient was diagnosed with shingles. The outcome of shingles was unknown. Additional information has been requested.
66 y.o. female admitted 1/11/2022 with HO HTN, HLP, hypothyroidism, bipolar disorder, anxiety, GI bleed, and diabetes who presented to the ED 1/11/22 with fever and shortness of breath. Patient has tested positive for COVID 1/10/22. Patient had worsening hypoxia and ill feeling today and was sent to the ED> Upon arrival here she was febrile, hypoxic and admitted for further treatment.