chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 6OCT95 & 22APR97 pt devel chickenpox described as hardly noticeable;
This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she does not feel good), PAIN IN EXTREMITY (arm hurts really bad/arm feels sore) and DIARRHEA (diarrhea couple times a day) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Dec-2021, the patient experienced FEELING ABNORMAL (she does not feel good), PAIN IN EXTREMITY (arm hurts really bad/arm feels sore) and DIARRHEA (diarrhea couple times a day). At the time of the report, FEELING ABNORMAL (she does not feel good) had not resolved and PAIN IN EXTREMITY (arm hurts really bad/arm feels sore) and DIARRHEA (diarrhea couple times a day) outcome was unknown. No Treatment information was provided. No Concomitant medication was provided. The patient weight is provided as 160. Reporter did not allow further contact.
Fever 102.3, massive headache that made Tylenol ineffective. Vomiting, nausea and itching all over the body with no visible rash
administration of improperly stored vaccines; This spontaneous report was received from a medical assistant, referring to a 5-years-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions and previous drug reactions or allergies was not provided.   On 27-AUG-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (dose was unknown by the reporter; strength, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number S021326 has been verified to be valid, expiration date reported and validated as 05-JAN-2021) as prophylaxis (product storage error). The use of a sterile diluent was reported (dose, lot number and expiration date were unknown by the reporter).  The administered dose of the vaccine experienced a temperature excursion of 6 degrees Fahrenheit (F) to 14 degrees F (10.56 degrees F) for 50 minutes, as recorded by a data logger. The previous temperature excursion reported was of 6 degrees F to 14 degrees F (8.47 degrees F) for 30 minutes.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA000777: US-009507513-2009USA000747: US-009507513-2009USA000676: US-009507513-2009USA000699:
Hospitalization - acute respiratory failure with hypoxia; ESRD on dialysis; COVID-19; T2M with diabetic polyneuropathy with long-term current use of insulin
Immediate paiN, Moderate soreNess, swelliNg, redNess aT siTe of injecTioN - lasTed 3-5 days. Approx 6 hous laTer, 12:30 AM. MidNighT - awoke froM sleep by exTreMe shiveriNg - freeziNg - cold; Took 30-45 MiNuTes To calM dowN. Really FrighTeNiNg, uNprecedeNTed!
Pt developed mild varicella with less than 100 lesions and moderate pruritus subsequent to receiving one dose of varicella virus vaccine live.  the rash lasted over three weeks.
depressed feeling/had before but then it enhanced; had before but then it enhanced; Lack of energy; Hard to breathe; This is a spontaneous report by a contactable consumer (patient) from a Pfizer-sponsored program. This 56-year-old male patient received dose 1 of BNT162B2 (lot number EN6202) via an unspecified route of administration on 24Feb2021 (at the age of 55-years-old) as a single dose for COVID-19 immunization. Medical history included depressed feeling, lack of energy, hard to breathe, suicidal thoughts and blood clot in lungs. Concomitant medications were none. On an unspecified date the patient experienced having depressed feeling, lack of energy, and hard to breathe. He had before but then it enhanced after he got his first shot. The patient did not receive any treatment for the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101366714 same patient, different dose/events
Rec'd 11yo vaccines (see above) next morning C/O not feeling well "felt fuzzy" C/O nausea no vomiting remain afebrile. Played basket ball in eve outside temp 50 degrees. C/O top hands felt tingle, numb, pins and needles. Mom chked fingers mottled; white in areas gently warmed color returned. This reoccurred again at soccer practice on Thursday 3/28, unwitnessed by parents. It was cold outside at that time. No further episodes since 3/28.
RIGHT SUBCLAVIAN STEAL SYNDROME 4/18/2023 ADVANCE DIRECTIVE ON FILE HYPOXIA 4/18/2023 ADVANCE DIRECTIVE ON FILE
DTaP, IPV and MMR given on 4/25/05. Mom calls clinic AM of 4/29/05 and reports child has welt-like rash all over body. Not acting like himself since getting shots; no breathing difficulty, up and active. Now started Benadryl 3/4tsp but discharge and started Orapred 2cc today. Mom is MD.
Nausea, fever & body aches within 24 hours also bright red rash across chest & bilateral axilla neck & abdomen.
Covid19 breakthrough.  1st vaccine 05/12/2021.  45y/o with PMHx of brain tumors with resection as child, seizures, developmental delay, HTN, DM, and hypothyroid presents to ER due to generalized tremors x1 day and a 2 day hx of emesis/diarrhea.  Pt found to be dehydrated, tacycardic and while in ED fell and hit her head, stroke alert called and teleneurology felt r/t seizures.  Admitted to ICU and loaded with Keppra/IV steroids and IV abx.
Pregnant; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 30-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 041B21A) for COVID-19 vaccination.  The patient's past medical history included Sepsis (sepsis following birth for mother) on 04-Sep-2019 and Alcohol use (one mixed drink/month) on 28-Feb-2021. Concurrent medical conditions included Food allergy (nuts, some fruits and vegetables), Allergy to animal, Allergy (nature), Asthma and Drug allergy. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Allergy, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 01-Mar-2021 and the estimated date of delivery was 06-Dec-2021. On 27-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  On 27-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Pregnancy test: positive (Positive) Positive.         No treatment information provided by Reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Internal review on 28 JUL 2021, resulted in the update of pregnancy details(birth type, fetal outcome, LMP, para and dravida) , pregnancy test, history(alcohol use), route of administration of concomitant medications.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this30-year-old female. The event of exposure during pregnancy remains as not applicable
chest pain, non-sTEMI, D-Dimer, leukocytosis
1st shot was on 12/29/20. One week later had a rash at the injection site. After 2nd shot, I got a massive migraine with a large amount of pressure., which made me Miss 2 days of work.
This child received Prevnar on 02/23/01. On 02/24/01, he had a temp of 104.3,and "body shaking". he was sent to the ER with a febrile seizure. On 02/26/01, the patient was seen by PCP fever down, giving Tylenol/Motrin alternating. No other sickness, positive coryza, slight cough, TM's nml, throat nml, A/P URI, febrile seizure.  Hold future Prevnar.
Red, swollen area around injection site (left upper arm). Measuring 14cm (length) x 12cm (width). Tender and warm to touch. Instructed to take 1 tsp Benadryl tid.
High pitched cry started 2 hrs past immunization. Lasted for 7-8 hrs w/a fever of 101, very irritable. Rx: Tylenol, no more Pertussis vax.
J96.00 ACUTE RESPIRATORY FAILURE 5/7/2021 OBESITY, BMI 30-34.9, ADULT
p/ pt recv vax approx 3yr later pt exp chickenpox. rpt MD noted to many vesicles to count
None of the patients reported symptoms. No Additional AE's/PQC's were reported.; Improperly stored PEDVAXHIB has been administered to patients; This spontaneous report was received from a staff from an outpatient care, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent condition and concomitant medication were not provided.  From 24-MAY-2021 to 25-MAY-2021, a temperature excursion occurred as haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # T026067 has been verified to be a valid lot number, expiration date was reported as 01-APR-2023) was stored under 54.3 Fahrenheit (F) for 1 hour and 20 minutes, 55.0 F for 7 hours and 10 minutes and 56.8 F for 2 hours and 35 minutes. The temperature excursion was recorded by digital data logger. There was no previous temperature excursion. On 17-JUN-2021, the patient was vaccinated with the improperly stored vaccine (strength and route were not reported) 1 (unit not provided) for prophylaxis. The patient did not report symptoms. No additional adverse events (AE) or product quality complaints (PQC) were reported.  This is one of several reports received from the same reporter.
Adverse drug reactions (including pain) after human papillomavirus (HPV) vaccine; Adverse drug reactions (including pain) after human papillomavirus (HPV) vaccine; product origin unk; This spontaneous social media report was received from an other health professional and refers to a female patients in age between 12 to 24 years old. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an unknown date, the patient was vaccinated with human papillomavirus (HPV) vaccine (manufacturer unknown) (dose, route of administration, lot #, expiration date were not reported) for prophylaxis. On unknown day, the patient experienced undesirable drug effects (including pain). The outcomes of the events were not reported.  The events were considered as related to human papillomavirus (HPV) vaccine (manufacturer unknown).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2107USA001853: US-009507513-2107USA008731: US-009507513-2107USA008732: US-009507513-2107USA008729: US-009507513-2107USA008733: US-009507513-2107USA008728: US-009507513-2107USA008727:
pt recv vax & mom noted pt eyes rolling in head;pt taken to MD had sz for 4hr;did spinal tap;pt taken to another hosp-febrile sz d/t fever pertussis may have caused this;T103;pt exp rhinorrhea;dx febrile sz, R otitis media, starring spells;
Severe vomiting and massive swollen hot injection site with a large raised red rash on arm, spreading nearly from shoulder to elbow. Lasted for 5 days.
Patient moved from where he had not gotten any vaccines.  He came in to get started on the required vaccines he needed for school but was to old for Quadracel.  Patient did not have any adverse reaction, was just advised to submit VAERS by Department of Public  Health
No known adverse reactions. Aunt reports infant died of SIDS on 8/9/09.  12/29/09 Autopsy report received. DOD 8/09/09. Cause of Death: Consistent with Sudden Unexplained Death in Infancy. Additional Information Abstracted: A. Co-sleeping male infant with parental caregivers. B. Petechia of heart. C. Pulmonary edema. D. No evidence of congenical anomaly. E. No evidence of trauma. F. Postmortem toxicological screen of the postmortem blood negative for drugs and ethanol. II. History of Colic and Thrush per family. A No gross lesions of mouth.  III. Therapeutic Procedures. A. Endotracheal intubation. B. Intravascular and intraosseus catheters.
24 hours later after injection started feeling achy; upset stomach; felt feverish; sweating; chilled; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Jan2022 18:30 (Lot number: 33036BD) at the age of 45 years as dose 3 (booster) single for covid-19 immunisation. Relevant medical history included: "Thyroid problem" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product:COVID 19,, prev dose brand:Pfizer,, prev dose brand unknown:False,, prev dose lot number:Er8731,, prev dose lot unknown:False,, prev dose administration date:22Apr2021, prev dose number:2,, prev dose vaccine location:Right arm), administration date: 22Apr2021, when the patient was 44 years old, for COVID-19 immunization; Bnt162b2 (prev dose product:COVID 19,, prev dose brand:Pfizer,, prev dose brand unknown:False,, prev dose lot number:SR8733, prev dose lot unknown:False,, prev dose administration date:10Apr2021, prev dose number:1, prev dose vaccine location:Left arm), administration date: 10Apr2021, when the patient was 44 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 01Feb2022 10:00, outcome "recovering", described as "24 hours later after injection started feeling achy"; ABDOMINAL DISCOMFORT (non-serious) with onset 01Feb2022 10:00, outcome "recovering", described as "upset stomach"; PYREXIA (non-serious) with onset 01Feb2022 10:00, outcome "recovering", described as "felt feverish"; HYPERHIDROSIS (non-serious) with onset 01Feb2022 10:00, outcome "recovering", described as "sweating"; CHILLS (non-serious) with onset 01Feb2022 10:00, outcome "recovering", described as "chilled". The events "24 hours later after injection started feeling achy", "upset stomach", "felt feverish", "sweating" and "chilled" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of pain, abdominal discomfort, pyrexia, hyperhidrosis, chills.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200204856 same patient and drug, different event separated in time
10 days after Varivax pt developed generalized pruritic rash of clear vesicles and erythematous papules which progressed to open lesions. Treatment was symptomatic only w/ topical Calamine lotion, Aveeno baths, and oral Benadryl.
On 10/20/10 the patient called to report soreness at the vaccine site.  She denied redness and had a temp of 100 degrees that had since resolved.  The patient was instructed to seek medical attention for fever, redness, or difficulty moving her arm.  On 10/22/10 the patient presented to her local ED with c/o fever to 102 and redness at the vaccine site.  She was diagnosed with a vaccine reaction and treated with NSAID's.  On 10//24/10 she returned to the ED with persistent symptoms.  She was treated with a single dose of IV antibiotics and a course of oral antibiotics for cellulitis.
Went home after vaccine was administered to the left arm. Just had a sore arm until around 8pm when i started to feel like everything started to hurt like muscle aches and joint pain. Fell asleep and woke up feeling the same as the night before but a little more amplified. Soreness in joins, muscle aches, fatigue but not serious side effects. Just joint and muscle pain like right before you catch a cold.
Intense Injection site pain.  Much worse than first does (in left arm).  Fever and feelings of overheating.  Chills to the point of not being able to get warm.  Sleeplessness and fatigue.  Headache and fogginess.  All symptoms occurred overnight while in bed.  Arm pain remains as well as headache and fogginess after attempting to sleep for 7 hours.
Within 15 minutes of administration the person stated that she was having lite headedness.  Person was refusing any assessment or care and wanted to go outside to take her face covering off.  After going outside the person seemed to be feeling less lite headed, but do to language barrier the person was hard to understand.  An assessment was attempted but person refused any care.
Initial unsolicited report received from a pharmacist on 23-Oct-2017. This case involves 67 year old female patient who was vaccinated with a 0.5 ml once dose of FLUZONE HIGH-DOSE intramuscularly in right deltoid (batch number- UI870AA, expiry date - 13-May-2018 (Dose in series were not reported) on 19-Oct-2017. Medical history and concomitant medications were not reported. On an unknown date, 3 hours following vaccination patient developed fever, chills, yellowish discharge from eyes, congestion, headache, sore throat. It was unknown if patient was going to seek treatment. Laboratory investigations and corrective treatment were not reported. Patient was not recovered from all the events. List of documents held by sender: none.
Information has been received on 14-MAY-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a free clinic as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. During June 2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Tdap, Menactra, Varicella#2 given 10/15/2007 10/16/2007 temp 101.6, drowsy, swelling at injection site
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 20-JUL-2015, the patient was vaccinated with an improperly stored VARIVAX, lot # reported L010148, expiration date 20-JUL-2017. There was not concomitant medication reported. No adverse symptoms were reported. Lot number L010148 has been verified to be a valid lot number for VARIVAX. Additional information has been requested.
Blood in stool; Diarrhea; Severe weakness; Dizziness; Slurred speech; This is a spontaneous report from a contactable consumer (patient's daughter). An 83-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 25Feb2021 at a single dose for covid-19 immunization. Medical history included ongoing high blood pressure and enlarged prostate. Concomitant medications included lisinopril taken for high blood pressure from an unspecified date and ongoing; tamsulosin taken for enlarged prostate; and amlodipine taken for high blood pressure. The patient had side effects: blood in stool, coupled with diarrhea on 02Mar2021, severe weakness and dizziness on 01Mar2021, and slurred speech in2021. The patient felt fine during the day and was able to exercise and it was in the evening of 01Mar2021, that he started to feel the weakness and dizziness. It was followed by diarrhea and he started to get some blood in his stool. The patient's daughter took him to the hospital on 07Mar2021. They were still diagnosing him now. The patient's daughter said that he was still having the weakness, but he has not really eaten anything. Outcome of events blood in stool, severe weakness and diarrhea was not recovered, reported as ongoing; event dizziness was recovered on 04Mar2021; outcome of other event was unknown. The patient was hospitalized from 07Mar2021 and ongoing for the event blood in stool.  Information on lot/batch number has been requested.
Received injection of ZOSTAVAX on 10/26/2006 after 12 hours had reaction at injection site, red and anger with pain. Now after 72 hours have enlarged reddened area with some bruising at the site the area is about 3 1/2 inches by 1 1/2in. Site has begun to itch am looking for a healing as an RN this is the first time I have ever had an injection reaction.
rash, high temp;temp started @ 12:00AM on 9SEP98;rash started 14SEP98;
arm turned red and sorta swelled up a little bit and got kinda hot; some kind of reaction; arm turned red and sorta swelled up a little bit and got kinda hot; arm turned red and sorta swelled up a little bit and got kinda hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (arm turned red and sorta swelled up a little bit and got kinda hot), VACCINATION SITE REACTION (some kind of reaction), VACCINATION SITE SWELLING (arm turned red and sorta swelled up a little bit and got kinda hot) and VACCINATION SITE ERYTHEMA (arm turned red and sorta swelled up a little bit and got kinda hot) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE WARMTH (arm turned red and sorta swelled up a little bit and got kinda hot), VACCINATION SITE REACTION (some kind of reaction), VACCINATION SITE SWELLING (arm turned red and sorta swelled up a little bit and got kinda hot) and VACCINATION SITE ERYTHEMA (arm turned red and sorta swelled up a little bit and got kinda hot). At the time of the report, VACCINATION SITE WARMTH (arm turned red and sorta swelled up a little bit and got kinda hot), VACCINATION SITE REACTION (some kind of reaction), VACCINATION SITE SWELLING (arm turned red and sorta swelled up a little bit and got kinda hot) and VACCINATION SITE ERYTHEMA (arm turned red and sorta swelled up a little bit and got kinda hot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported using multiple medications (unspecified) and 3 Tylenol(paracetamol) every day regularly. Patient placed damp cloths on the affected area as treatment.   Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: A telephone contact was attempted and the consumer denied email information.
From telephone contact with reporter it was stated that an 18 year old male patient received a Menomune A/C/Y/W-135 vaccination and a PPD Tubersol skin test on 19-Jun-2001. Within one hour after vaccination, the patient developed pain in neck and shoulders radiating down back. Patient took Motrin and the symptoms completely resolved.  From additional correspondence received on 22-Oct-2001, additional patient, responsible physician, vaccine and vaccine administrator information was provided.
Erythema and induration to anterior, lateral and medial aspect of thigh.  Very significant local reaction.  Analgesic and cool compresses.