chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Local reaction, erythema, edema  13.5 x 12.5 cm   left shoulder/deltoid. 4.5 yr old male for re checked CBC, nt increase #1 2 mo. starting PACE. Alert,NAD. eating foods high in Fe, but not taking Fe liquid well. n/o anemia. CBC given DTap 0.5ml IM left deltiod. (DTaP) hand given and explained. Consider Fe studies and electrophesis of cont. microcytosis. Reaction to vacc. DTaP possible. Pt with DTaP 09/03/2002 increase swelling and redness today. sl tactile temp at home. Never with r x n  to 1mm in past
0500 on 5/27/2022 patient woke up with 101.5 fever and swelling and redness on r thigh
Client called Health Dept stating she had received flu vaccine w/i last 30 mins and now had headache, and felt numb!! also neck pain.
The patient developed a raised, welted area on the thigh which increased in size for 3 days. The center was white and surrounded by beet red. The patient experienced pain. The patient was treated with ice and Tylenol.
administration of Fluzone HD to patient that incurred a delayed transit / no AE; Initial information received on 17-Sep-2019 regarding an unsolicited valid non-serious case received from a non-hcp (Office Staff).  This case involves a 86 years old female patient who received 0.5 ml vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ242AA) via intramuscular route in the right deltoid, on 16-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to Incorrect product storage.  It was reported that administration of Fluzone HD that incurred a delayed transit time on 16Sep2019. Caller reports product was shipped on 12Sep2019 and was not received until 16Sep2019.  At the time of reporting none adverse event symptoms were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Burning when the medication was injected; Injection was given under the shoulder bone instead of the deltoid muscle; This is a spontaneous report from a Pfizer-sponsored program. A contactable healthcare professional (patient) reported that a 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration under the shoulder bone (arm), on 30Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history included use of multivitamin for a healthy lifestyle. The patient's concomitant medication included ongoing unspecified multivitamin. The patient received the COVID-19 vaccine this morning (30Dec2020) as she works in a COVID unit. The injector put it under her shoulder bone and not in the deltoid muscle; injection was given under the shoulder bone instead of the deltoid muscle. The patient complained of it burning - started when the medication was injected. The patient also asked if this was good enough and if it will it be effective. The patient was recovering from the event.
local swelling @ site of pneumovax w/redness & pain 1 days p/vax tx w/short course of Deltasone & cortisone cream;
Sore, weak, small rash in back spread to side, stomach. Blister on same arm as injection; popped it later 07 - Rash has worsened over days. Right now feels shortness of breath. Has doctor appointment at 3 pm. Took ADVIL for soreness but did not help.
Administered after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a adult female patient who received Herpes zoster (Shingrix) (batch number LG3B4, expiry date 8th April 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 12-Aug-2022 Reporter's comment: The medical assistant stating that refrigerator temperature log indicated out of range temperatures for Shingrix.   The lowest recorded was 3.7 degrees Celsius and the highest was 9.2 degrees Celsius on 7th August 2022 (for 48 minutes).   This case is for 6 out of 10 linked patients reported by same reporter. Additional supportive information: The patient received Shingrix after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022118569:Same reporter. US-GSK-US2022118570:Same reporter. US-GSK-US2022118568:Same reporter. US-GSK-US2022118572:Same reporter. US-GSK-US2022118612:Same reporter. US-GSK-US2022118613:Same reporter. US-GSK-US2022118614:Same reporter. US-GSK-US2022118615:Same reporter. US-GSK-US2022118616:Same reporter.
Arm got extremely swollen, rash, itching, and look like little bubbles om arm.
A few hours after receiving the shots had shaking of his whole body while breastfeeding on 7/12/16. This lasted for 5-6 secs. He was fine the next day however on 7/14/16 had a similar episode while breastfeeding, again each episode lasted 5-6 secs. Mom tried holding his leg/thigh but it continued to shake. No fever.
Local reaction-Red Blotch rash around L deltoid injection site immed after 4-5 cm diameter-not itchy. Ice pack applied
had trouble breathing; Laryngitis; Fatigue; headache; back aches; Coughing; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9264; Expiration Date: 31May2021), via an unspecified route of administration, administered in arm right on 06Feb2021 (at the age of 71-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced coughing on Feb2021, had trouble breathing, laryngitis, fatigue, headache and back aches on an unspecified date. The clinical course was as follows: Reporter is a consumer, asking, should she get the second dose on Saturday? and should she quarantine with these symptoms? She received her first vaccine dose and about 4-5 days later she began "coughing real bad". Also reported experiencing fatigue, headache and back aches and was diagnosed with laryngitis. She went for her first vaccine with several other people, they had some symptoms but nothing like hers. She is supposed to be due for her second dose of the COVID vaccine on Saturday but is coughing and has fatigue and laryngitis and a headache. It was the coughing that really got to her. She did not develop side effects the same day as the vaccine, it was like 4 or 5 days later, and then she had trouble breathing, and that went away and then she got the laryngitis and then the fatigue. She had no other vaccines on the same day. The outcome of had trouble breathing was recovered on an unspecified date while of the rest was unknown.    No follow-up attempts are possible. No further information is expected.
With in 2 weeks developed moderate tinnitus/possible hearing loss, that has since persisted for over 6 weeks.
Mental impairment; Memory impairment; Vision blurred; Pain in extremity; Fatigue; Pyrexia; This case was received via  FDA VAERS (Reference number: 1162631) on 01-Jun-2021 and was forwarded to Moderna on 01-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of MENTAL IMPAIRMENT (Mental impairment) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced MENTAL IMPAIRMENT (Mental impairment) (seriousness criterion medically significant), MEMORY IMPAIRMENT (Memory impairment), VISION BLURRED (Vision blurred), PAIN IN EXTREMITY (Pain in extremity), FATIGUE (Fatigue) and PYREXIA (Pyrexia). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MENTAL IMPAIRMENT (Mental impairment), MEMORY IMPAIRMENT (Memory impairment), VISION BLURRED (Vision blurred), PAIN IN EXTREMITY (Pain in extremity) and FATIGUE (Fatigue) outcome was unknown and PYREXIA (Pyrexia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, Body temperature: 101.5 (High) fever for 48 hours.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient developed 101.5 fever for 48 hours, third day after the vaccination and patient still experience sore arm, tiredness, weakness, inability to focus, forgetfulness, blurred vision, Exhaustion.   patient took cold showers, and iced her arm  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I tolerated the vaccine well?apart from localized soreness, I did not have the fatigue or fever that I felt after my primary vaccine series and the first booster. On June 18, I felt unusually tired and, the following morning, performed an at-home antigen test; it was positive. I felt fatigue, cough, and sore throat. That day, I began a five-day course of Paxlovid, and the symptoms abated on day 6.  On days 7?9, I tested negative, before testing positive again on day 11, with renewed symptoms of fatigue, runny nose, cough, loss of taste, and fever of 101 degrees F. The symptoms abated on day 14, but as of today (day 17), I still feel somewhat fatigue and am still testing positive.
I am experiencing heavy mensuration following the vaccine. I just had my period two weeks ago. This is not normal.
Increased liver enzymes (ALT and AST); positive ANA antibody test; positive smooth muscle antibody test.  Liver disease subsequently ruled out by ultrasound and liver biopsy.
Loss of taste 18 hours post-injection (still has not fully returned 23 days later - I did have COVID in December 2020 and loss taste and smell for many weeks, did not expect it to happen again after my first injection) Swollen lymph nodes in left arm pit 24 hours post-injection (recovered after 5 days of inflammation/pain)
9 weeks pregnant at time of second dose, estimated due date 9/8/2021 12+ hours of body aches, fatigue, feeling feverish
Two right MCA ischemic strokes occurring 3-5 days after each dose of Pfizer vaccine. Both episodes he presented with by waking up with acute left arm weakness, numbness and dysarthria. Both episodes happened a few days after COVID vaccine (Covid #2 was administered 4/27). Previous Right MCA stroke from 4/11 was fully worked up. The etiology of this stroke was cryptogenic. TSH from 4/11 was 2.57 and T4 was 0.69.  Hgb A1c on 4/11 was noted to be 5.6%. LDL on 4/11 was noted to be 73. MRI brain 4/11/2021 showed multifocal small acute infarcts in the right cerebral cortical/subcortical and periventricular matter infarcts, favored to be embolic. CTA head and neck from 4/11 showed no evidence of large vessel occlusion. Ultrasound of bilateral lower extremities on 4/12 was negative for DVT. ECHO on 4/12 was positive for PFO with an WF > 55%, mild LVH and no thrombus. He also has an atrial septal aneurysm. Cardiac MRI was negative for thrombus. He was discharged on 4/14 with 30 day Holter monitor to evaluate for AFIB.
Allergic reaction at the injection site: redness, itchy, skin is hot to touch, 3 inches in diameter. Started 1-2 days after the first injection. The redness still remains and a minor rash developed 7-9 days after the first injection. I experience some minor redness and itchiness on my skin throughout the body (face, torso, arms, legs) after excersising when there is increased blood flow.  Sometimes the itchiness occurs even when at rest. I spoke to my mother who also received the Moderna shot, she also has a rash on her arm, so it might be genetic.
General body ache, headache, lethargy. Took Tylenol, felt better after 24 hours, completely recovered after 48 hours
lots of headache; Had a bit of nausea too; headache is a bit strong; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (lots of headache), NAUSEA (Had a bit of nausea too) and HEADACHE (headache is a bit strong) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-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 HEADACHE (lots of headache), NAUSEA (Had a bit of nausea too) and HEADACHE (headache is a bit strong). At the time of the report, HEADACHE (lots of headache), NAUSEA (Had a bit of nausea too) and HEADACHE (headache is a bit strong) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant included no treatment included
I had severe abdominal pain that started on March 25, 2023. I called and made an appointment to see the gastrointestinal doctor, once I arrived since I was a new patient, they sent me to the emergency room. Once I arrived at the emergency room I had a CAT scan, a lot of blood work, and urinalysis that came back positive for inflammation negative for infection. I was given CIPRO and FLAGYL and so far, I am feeling much better.
administration of expired Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine) in a 37-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   No treatment was given to the patient.   The vaccines were stored in freezer, were taken out one to two vials and placed in fridge each day as needed.
Headache, chills, fatigue,-2nd vaccine, .injection site pain with 1st vaccine Narrative:
The day after the shot, my arm was sore like the first shot but not bad. I did have a 101.8 fever, sore throat, runny nose, headaches all day on and off, extreme fatigue. The following day (today; April 28, 2021) the symptoms all went away except my arm started itching and was very hot and hard to the touch. I looked in the mirror and it was bright red and a big red circle had appeared. As the day has gone on, it has gotten larger and hurts so bad and is so itchy and my arm is swollen in the entire circle. It is now as big as my fist.
sudden onset of guttate psoraisis; diagnosis confirmed via biopsy Feb 2022; oral andtopical treatments unsuccessful. Prescription of COCYNTEX in March 2022 successful in treating.
Case number PHEH2013US008351 is an initial spontaneous report received from a nurse on 10 Apr 2013. This report refers to an 18-years-old female patient whose medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number :M102006, expiry date: Oct 2014) at a dose of 0.5 ml intramuscularly on 22 Mar 2013. It was reported that the vaccine had been at 33 to 36 F for 19 days and it was not frozen. No adverse events were reported following the administration error.
hives on her side, back and arms; Initial information was received on 11-May-2020 regarding an unsolicited valid non-serious case from an other health professional.  This case involves a 63-year-old female patient who experienced hives on her side, back and arms (urticaria), while she received RABIES (HDC) VACCINE [IMOVAX RABIES].  In 2003, a patient had received the Imovax 3 series vaccine. Medical history, medical treatment and family history were not provided.  On 29-Apr-2020, the patient received a first dose of RABIES (HDC) VACCINE [lot R1C71, expiry date: 30-Apr-2020] via unknown route at the right deltoid and on 06-may-2020, the patient received a second dose of same vaccine [lot R1713M, expiry date: 30-Apr-2020] via unknown route at the left deltoid for prophylactic vaccination.  On an unknown date, the patient developed a non-serious hives on her side, back and arms (urticaria) (unknown latency) following the administration of RABIES (HDC) VACCINE.  Details of laboratory data not reported.  Final diagnosis was urticaria.   The patient was treated with PREDNISONE.  The event outcome was unknown for urticaria.
Onset 2 days post vac mild fatigue, arthralgia & myalgia. Slight elevation body temperature. Day 3-7 mod fatigue, myalgia & arthralgia headache moderate temperature elevation some lessening of above symptoms.
SIDE EFFECTS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced side effects. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from side effects. This report was non-serious.
Pt presented with a grapefruit size whelt on her arm - it was red and warm to the touch with mild swelling. She said that if it was no better or worse by the morning that she would see her doctor. It was after office hours when she came to the pharmacy
COVID-19; Teeth pain; Terrible taste disturbance; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), TOOTHACHE (Teeth pain) and TASTE DISORDER (Terrible taste disturbance) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sarcoidosis and Drug allergy (Unknown historical drug). Concomitant products included SIMVASTATIN from April 2022 to 12-May-2022 and BUPROPION HYDROCHLORIDE (WELLBUTRIN XL) from April 2022 to 10-May-2022 for an unknown indication.    On 20-Apr-2022 at 9:30 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2022 at 10:00 AM, the patient experienced TOOTHACHE (Teeth pain) and TASTE DISORDER (Terrible taste disturbance). On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown and TOOTHACHE (Teeth pain) and TASTE DISORDER (Terrible taste disturbance) had not resolved.            The patient received unspecified Pfizer drug as treatment for COVID-19. Treatment started on 10-May-2022 and ended on 13-May-2022. Batch number was reported as FY7031.  Device date was reported as 16-May-2022.  Company Comment: This spontaneous case concerns a 55-year-old female patient, with relevant medical history of Sarcoidosis, who experienced the unexpected events of COVID-19, Toothache and Taste disorder. The events occurred approximately 23 days after receiving the fourth dose of mRNA-1273 Vaccine. The patient also received unspecified Pfizer drug as treatment for COVID-19 on the same day as the occurrence of the events. The outcome of the events was reported as not resolved. The patient's medical history of Sarcoidosis and the unspecified Pfizer drug  for COVID-19 treatment, remain as confounders for the occurrence of the event Taste disorder.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 55-year-old female patient, with relevant medical history of Sarcoidosis, who experienced the unexpected events of COVID-19, Toothache and Taste disorder. The events occurred approximately 23 days after receiving the fourth dose of mRNA-1273 Vaccine. The patient also received unspecified Pfizer drug as treatment for COVID-19 on the same day as the occurrence of the events. The outcome of the events was reported as not resolved. The patient's medical history of Sarcoidosis and the unspecified Pfizer drug  for COVID-19 treatment, remain as confounders for the occurrence of the event Taste disorder.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
This retrospective pregnancy case was reported by a nurse and described the occurrence of cystic kidney disease in a neonate male patient exposed to FLUARIX Quadrivalent 2015-2016 season (batch number 25L53, expiry date 30th June 2016) in utero. The mother received the product. The parent's medical history included previous pregnancies included 1 normal birth. On 11th January 2016, the 21-year-old mother received FLUARIX Quadrivalent 2015-2016 season (intramuscular) .5 ml. The mother's last menstrual period was on 17th September 2015 and estimated date of delivery was 17th June 2016. The patient was exposed to FLUARIX Quadrivalent 2015-2016 season at week 16 of gestation and during the second trimester of pregnancy. At 35 weeks and 3 days, the patient was born via vaginal delivery and weighed 2830 grams (6lbs 4oz) at birth. APGAR scores were 8 and 9. The patient was diagnosed with cystic kidney disease (serious criteria GSK medically significant) and maternal vaccine exposure. On an unknown date, the outcome of the cystic kidney disease and maternal vaccine exposure were unknown. It was unknown if the reporter considered the cystic kidney disease to be related to FLUARIX Quadrivalent 2015-2016 season. See case US2016GSK003242 for details regarding the mother case. Additional details were provided as follows: The patient was born with left cystic kidney disease. The birth defect was evident from prenatal test.