chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 hrs after vaccinations patient seemed sleepy and when awoke for next feeding, cried inconsolably, no fever, both thighs were pink slight STS and slight bruise noted on right thigh.  Patient cried for 2 hours on and off then fell asleep, ate, then cried again.  2/5/08 doing well.
Patient presented for first COVID vaccine and was given Moderna. Patient was 17 at time of vaccination so should have received Pfizer. No adverse reaction noted
Patient subsequently had a miscarriage and therefore got the second dose of the vaccine today, 17Mar2021 (61 days after first dose); This spontaneous retrospective pregnancy case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient subsequently had a miscarriage and therefore got the second dose of the vaccine today, 17Mar2021 (61 days after first dose)) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 17-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient subsequently had a miscarriage and therefore got the second dose of the vaccine today, 17Mar2021 (61 days after first dose)). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. On 17-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Patient subsequently had a miscarriage and therefore got the second dose of the vaccine today, 17Mar2021 (61 days after first dose)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to events was not applicable.   This case was linked to MOD-2021-048004 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up received contains:- No new information received.
21 days after vaccines pt had several vesicles all over body, Fever to 103 degrees, and became limp x 30-60 seconds.
Information has been received from a 69 years old female patient who in 2007 was vaccinated with a dose of PNEUMOVAX 23 (manufacturer unknown). Concomitant therapy included influenza virus vaccine (unspecified). The patient stated that on 2007 after receiving the vaccines, she had severe reactions such as racing heartbeat, redness in the face, tiredness and feeling unwell. At the time of reporting the patient had recovered. Additional information has been received from a physician concerning a 69 year old female patient who on 2007 was vaccinated with PNEUMOVAX 23. The physician reported that the patient did not report any reaction of the vaccine to his office. This was the first time they have learned of this. No additional information is expected.
Chills, fever, weakness, body aches, sharp shooting pain to (B) lower extremities, chest pain severe headaches, soreness at injection site.
pt recv vax 1OCT96 & over the 5OCT96 weekend pt exp body aches, urinary tract infect, chills, fever, back pain, & blurred vision;seen by MD who prescribed pyridium, bactrim, APAP w/codeine & another ATV p/finished bactrim;flu like sx;
Pt's mother called am of 02/11/2002 to inform us of behavioral change and fever since afternoon of Varivax injection. She states fever of 99-102 deg. F. and pt thowing tantrums, biting, kicking, not acting normal self. Saw pt that morning and the doctor found otitis media and started pt on antibiotic with follow up in 10 days. Called mother in the morning of 02/13/2002, child and mother have pretty good colds and coughs but pt is still on antibiotic and is back to his regular personality.
Right arm swollen, hot to touch, erythema and itching starting 22 hours after injection.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021 at 1:45 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Feb-2021 at 1:45 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature 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, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (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 44.51  Concomitant products were not provided.  On 27-Feb-2021, Excursion time was 09 AM, 11 AM, 12 PM, 1 PM, 2 PM, 3 PM, 4 PM, 5 PM, temperature was 33, 35, 35, 35, 35, 34, 34, 35, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.  Vial was stored on cooler 1, on 27-Feb-2021, Excursion duration at 9 AM: 33, 10 AM: 36, 11 AM: 35, 12 AM: 35, 1PM: 35, 2 PM: 35, 3 PM: 34, 4 PM: 34, 5 PM: 35  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Pt. presented to the family practice clinic on 1/27/09 with complaints of fever x1 day. Infant was fussy and difficult to console, and was refusing breastfeeding.  Temperature was up to 102F, symptoms were associated with abdominal pain.  She demonstrated guarding of her stomach.  The pt. was admitted to the local hospital for observation.  She was followed throughout the day and her condition resolved spontaneously and was discharged on the same day she was admitted.  2/20/09 Received hospital medical records of 1/27/2009. FINAL DX: fever & irritability Records reveal patient experienced decreased appetite, fever & irritability.  Admitted observation, improved throughout the day & d/c to home.
Redness and swelling for one week. Vesicles one week later. Rotated TYLENOL and Ibuprofen.
Arm  pain and burning in left deltoid where vaccine was given two weeks after. Left breast pain and swelling and swollen lymph node under armpit.
presenting today for Sore Throat. Got vaccine on 1/22. Started with sore throat. The started with chills, chest pain, abdominal pain, swollen lymph nodes.
itchy, red & swollen @ inj site;started about 3-4 days p/inj
Localized redness, swelling, and warmth to left deltoid - area where vaccine was administered. Placed on antibiotic tx.
1700 felt increase in HR (120), warm feeling, B/P 132/80  Upper chest and facial cheeks along with ears flushed 1715 nausea, no vomiting, light headedness, mouth dry, tolerated apple jice and crackers 1830 felt normal
Information has been received from a medical assistant referring to an unspecified number of patients (age and gender unknown). The patient's concurrent conditions, medical history and concomitant therapies were not reported. The patients received unspecified doses in PROQUAD (lot # M029595 with expiration date of 10-DEC-2017, and lot # M004892 with expiration date of 25-JUL-2017, dose and route unknown) immunization series that were improperly stored. The vaccines were exposed at minus 10 degrees Celsius for 24 hours. The excursion occurred on 08-JUN-2016 and the vaccinations occurred from that point through 07-OCT-2016. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
patient called today (July 1, 2021) stating her vaccine site was red, swollen since Saturday. She states no fever, no pain. She didn't even know it was red,swollen until she noticed it while looking in the mirror. She states it is much better this morning than previous mornings but still noticeable.
rapid heartrate; metallic taste in her mouth; This spontaneous case was reported by an other health care professional and describes the occurrence of HEART RATE INCREASED (rapid heartrate) and DYSGEUSIA (metallic taste in her mouth) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Jan-2021, the patient experienced HEART RATE INCREASED (rapid heartrate) and DYSGEUSIA (metallic taste in her mouth). On 02-Jan-2021, HEART RATE INCREASED (rapid heartrate) and DYSGEUSIA (metallic taste in her mouth) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication was not reported.   Treatment information was not provided.    This case was linked to MOD-2021-085398 (Patient Link).   Reporter did not allow further contact
Pain, itch, heat, swelling, hardness and redness,  from vaccination site down 4/5 inches. Width about 3 inches.Irregular borders.
BODY ACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch no. was not reported but it has been requested.  No concomitant medications were reported. On 13-MAR-2021, the subject experienced body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of body aches was not reported. This report was non-serious.
severe chills, lasting 6 hours; followed by heavy sweating;  unable to sleep the whole night; very tired next day; took acetaminophen every 4hours;  went to bed next day at 8PM and slept until 7am next morning. the was 100% recovered.
tender; Sensitive; Rash feels tender and sensitive; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (tender), SENSITIVE SKIN (Sensitive) and RASH (Rash feels tender and sensitive) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00HC21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN and AMLODIPINE for an unknown indication.   On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 07-May-2021, the patient experienced TENDERNESS (tender), SENSITIVE SKIN (Sensitive) and RASH (Rash feels tender and sensitive). At the time of the report, TENDERNESS (tender), SENSITIVE SKIN (Sensitive) and RASH (Rash feels tender and sensitive) outcome was unknown.        Action taken with response to the events were not applicable.
Case number PHEH2015US000655 is an initial spontaneous report from a pharmacist received on 05 Jan 2015. This report refers to a 65-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 145205) at a dose of 0.5 ml intramuscularly on 10 Oct 2014. It was reported that the patient received FLUVIRIN which reached below 36 F for 3.5 non-consecutive days and the vaccine reached 33.1 F for less than 12 hours. The pharmacist did not believe that the vaccine was frozen and thought it was a thermometer mal-function. No adverse event reported following this medication error.
Local muscle pain at injection site. Approx 8 hours after injection started to develop low grade fever and nausea, Approximately 15-16 hours after injection fever at 101.5 F. Following day low grade fever (99-100 F) remained. Symptoms dissipated by 48 hour mark.
Presents w/c/o frequent falls, gen weakness, SOB X 3-4 days, COVID was suspected for which she did test positive and was tx w/steroids, zinc, Vit-C, Singulair. Remained extremely weak and dc'd to SNF.
This case was reported by a pharmacist via call center representative and described the occurrence of hand swelling in a 56-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020). Co-suspect products included Nystatin and Triamcinolone Cream for vaginal infection. Concomitant products included amlodipine, fluconazole and Miconazole. On 28th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml and Nystatin and Triamcinolone Cream (vaginal) at an unknown dose and frequency. On 28th March 2018, less than a day after receiving SHINGRIX, the patient experienced hand swelling. Nystatin and Triamcinolone Cream was continued with no change. On an unknown date, the outcome of the hand swelling was not recovered/not resolved. It was unknown if the reporter considered the hand swelling to be related to SHINGRIX. Additional details were reported as follows: At 13:00 hours, the patient received SHINGRIX in unknown deltoid. The pharmacist reported that, the patient might had experienced swelling of her hands for not using the vaginal cream with gloves, but was not sure. The patient went to the emergency room and was discharged home and to follow-up with her physician on an unknown date.
A 98 year old female received RSV vaccine or Placebo and Influenza Vaccine on 11/4/02 and 212 days later died. Records have been requested and will send follow-up when more information received. The Investigator assessed the event as unrelated to the study product. Follow up information received 7/11/02. Subject expired 5/6/03 at nurse home. Diagnosis: Respiratory failure, chronic obstructive pulmonary disease, congestive heart failure, myocardial infarction, pneumonia, acute coronary syndrome, esophageal stricture. Follow up on 08/22/2003: "Hospice Services RN Admission Assessment 05/06/03: DNR signed: Yes; Terminal Diagnosis: ES, CHF; Other Diagnosis: Acute Coronary Syndrome, Esophageal Stricture, Dyspnea, COPD; Radiation TX: None; Functional Limitations: Bowel/Bladder Incontinence, Ambulation, Speech; Activities permitted: Total bedrest; Mental Status: Unresponsive; Physical Assessment: Skin: Cool, Dry, Skin tugor: fair; Wound Care Record: Cleanse skin tear to R arm with NSS, apply triple antibiotic ointment, cover with dry dressing BID, D/C when healed; Sensor: hearing unknown, speech: nonverbal; Cardiovascular: Pulse-weak, Pedal Pulse-absent left and right.  Fingers and feet cyanotic; Respiration: shallow at rest, cough: non, non-smoker; Lung sounds: diminished, crackles.  Oxygen 4 L/min; Nutrition/Hydration: No intake; Gastrointestinal: Abdomen soft.  Bowel sounds: x4 Quadrants, Hypoactive, Bowel incontinence; Genito-urinary: Urine amber, clear, indwelling catheter; Abuse screen: no suspected abuse/neglect; Pain assessment: "no indication of pain"; Additional Assessment: no labwork scheduled; Activities of Daily Living: unable to ambulate, transfer, dressing, eating, toileting, bathing; Psycho social status: Caregiver understands illness is terminal: Yes; Care Needs: Symptom management; Caregiver's emotional response to current health status: continue with plan for symptom managment; Spiritual issues: last rights given 05/06/2003.  Interval History and Physican Exam: 06/01/2003.  History of Present Illness: 98 year old female treated for Resp. Failure, and DJD and now here for further managment.  Past Medical History: CHF, DJD, Pneumonia, Dysphagia, Dementia; We are unable to obtain a death certificate for subject.  Our site has made several phone calls to the son of the deceased subject referenced above and have received no response to our calls for a death certificate.  We have no other contact person and we are not aware that an autopsy was performed.  The only information that we have was received from the Health Center and was faxed to you on 07/11/2003.  The note written by the Dr. states that the subject expired in this facility on 05/06/2003.  You should already have this for your file.  If you need us to fax it again, please let us know.
Severe vertigo; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 51 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) for 1 day as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VERTIGO (non-serious), outcome "recovering", described as "Severe vertigo".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
10 minutes into 30 minute observation post vaccination client reported feeling warm with erythema developing on her chest.
her face flushed out; she got hot and sweaty; she got hot and sweaty; for three days following getting the vaccine, she felt like she had been punched in the arm; she is losing her voice; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL1283 and expiry date was unknown) via an unspecified route of administration, into left arm on 15Jan2021, as single dose for COVID Prevention. Medical history and concomitant medications were not reported. Patient stated that quickly after getting the vaccine, her face flushed out, and she got hot and sweaty. For three days following getting the vaccine, she felt like she had been punched in the arm, she was not just sore, but it felt like she had been punched. Stated that she was losing her voice. Patient received no other vaccines on the same day as the COVID vaccine. Patient wondering if other people are having the problem with the face flushing from the vaccine. Outcome of the events was unknown.
Information has been received from a healthcare worker (certified medical Assistant (C.M.A)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On 18-JAN-2015, the patient was administered with a dose of improperly stored ZOSTAVAX (lot#, expiration date and dose not provided), subcutaneously. No adverse effects were reported. This one of several reports received from the same source. Additional information has been requested.
Swollen armpit/ lymph node(s) in same right arm of injection, 1.5-2 days after booster.
No known adverse effects.; An administered dose of GARDASIL 9 underwent a temperature excursion prior to being administered to 1 patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications and previous drugs reactions or allergies were not provided.  On 15-JUL-2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; reported lot number R027946 and expiration date 27-APR-2021). No adverse effects were reported for the patient.  According to the reporter, the temperature excursion was 52.6 degrees Fahrenheit for a time frame of 7 days on an unspecified date (product storage error), without any previous temperature excursion; which was detected by a digital data logger. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: R027946; expirationdate: 27-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
This spontaneous report was received from a pharmacist concerning a 69 year old patient of unknown gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 24-APR-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot number M037013, expiration date 22-NOV-2017 (dose and route were not reported) for prophylaxis.  The temperature involved was 7° F, for 45 minutes. It was not previous temperature excursion, and a data logger was involved. No adverse effects were reported. Additional information has been requested.
FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 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 08-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Presented to ED with UTI symptoms with apparent septicemia. COVID-19 test upon hospital admission was (+). Patient had low O2 sats on RA at 88%. She also reported chills, fever and myalgias and cough. Denied SOB.
Redness around inj. site  Lt. arm (about size of softball) warm to touch. Hives down left leg. BENADRYL 25 mg at bedtime and TYLENOL for inj. site discomfort.
Client c/o a headache, feeling lightheaded, client turned pale and began to vomit. V/S 97.2, pulse was thread, respiration 28, blood pressure 92/64.
Patient received pediatric dose. Patient called and advised will need to return to start over with adult dose.
Within a few hours I felt nauseous. By the next morning my arm at the injection site was swollen and the armpit (gland) was swollen on the same arm. I was nauseous and didn't eat much for several days. I felt like I had been hit by a truck, felt very achy and weak. By the third day I realized I probably had a reaction to the shot and let my doctor know the symptoms and effects. It was a week before I began feeling better.
PATIENT CAME IN FOR DOSE #2 OF PRIMARY SERIES AND WAS GIVEN THE PFIZER BIVALENT (BOOSTER) IN ERROR.  PATIENT WAS INFORMED AND NO ADVERSE EFFECTS WERE REPORTED.