chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1st dose given 29 hours after puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1st dose given 29 hours after puncture) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0788C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (1st dose given 29 hours after puncture). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (1st dose given 29 hours after puncture) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. The patient had no known drug allergies and no chronic or long standing health conditions.   Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: significant follow up : patient demographics (age, ethnicity, race) updated and narrative updated
Child had fine red rash on trunk prior to vaccine being given. Rash present all over body next day.
Symptoms began  approximately 6-8 hours after injection and included chills and fever, headache, muscle soreness, nausea, poor appetite. Moderate diarrhea approximately 18 hours after injection.  Fatigue and headaches for a week.
Developed fine, rough rash 2 hrs post vax given developed fever of 105F;
PATIENT FORGOT HE ALREADY RECEIVED A FLU VACCINE AT HIS DOCTORS OFFICE AND CALLED THE FOLLOWING DAY TO INFORM US WE GAVE HIM HIS SECOND FLU SHOT FOR THIS YEAR. STATED HE FELT FINE ONLY EXPERIENCED 'CHILLS '
40 minutes after flu shot I had severe jerking of arms and legs, fever, confusion. Treaded with forced fluids, 400cc 5 hours and Tylenol. Weak, sleepy times 4 days
startles every 15 second while asleep; first noticed 6DEC94 930AM until 330PM; t99.8 R; mom reported events- mom is RN & reliable in observation;
Started feeling light headed at 4am and had syncope x 2, his wife stated he was talking nonsense during this time, at 8am he had a fib, HR went from 40-155s, B/P 116/60, went to  ER with chest pain and SOB, temp. 100.2, spent 3-4 hours in ED. He was sedated and converted.
Information has been received from a registered nurse concerning a male who was vaccinated po with his first dose of ROTATEQ at just over thirteen weeks of age. No symptoms were reported. Additional information has been requested.
Pt recv vax on 10/26/98; on 10/27/98 pt exp lower Rt arm red & know, fever (100) x 1-2 day
On 01/02/2023 I woke up not feeling well, tired, fatigued and was running a fever of 103.5 and my BP was about 140/90.  I took a home test and the result was positive a half hour later I took another test and it was also positive. I contacted the local clinic and was prescribed PAXLOVID for 5 days. I was feeling better within 2 days. 10 days later I tested negative.
No adverse effect reported.; a patient received improperly stored PROQUAD on 10/30/2019.; This spontaneous report was received from a nurse, referring to a patient of unspecified age and gender.   The patient's concurrent conditions and medical history were not reported. Concomitant medications included sterile diluent.  On 30-OCT-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) recombinant Human albumin (rHA), lot # S021617, expiration date 09-JAN-2021 (dose and route of administration were not provided), as prophylaxis; which was reconstituted with a properly stored sterile diluent.  The administered dose of the vaccine experienced a temperature excursion from -14 Celsius degree (°C)  to -10 °C (-11.7 °C), during 2 hours and 35 minutes. No previous temperature excursion was reported. This report was called because of a data logger. There was no adverse effect reported. No product quality complaint was involved.
Information has been received from a health professional concerning a 4 year old male with no pertinent medical history and no known drug reactions or allergies, who on 25-AUG-2005 was vaccinated subcutaneously with 0.5 cc of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live.  Concomitant vaccinations given on an unspecified date included poliovirus vaccine and diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid.  On 27-AUG-2005 the child developed cellulitis on the left leg.  Unspecified medical attention was sought, and the child was treated with amoxicillin (+) clavulanate potassium (AUGMENTIN) and loratadine (CLARTIN).  At the time of this report, the outcome of cellulitis was unknown.  Additional information has been requested.
Swelling, redness, warm mass that progressively became more painful and has limited mobility of patient's arm. The area red and swollen is not about 6 inches in diameter. Also complained of itchy, scratchy throat soon after vaccine administration.
Racing heart, palpitations, shortness of breath, nausea. Went to ER. No treatment, as acute symptoms subsided in several hours. However as of 8 days later, palpitations are still occurring.
light headed, "weird feeling in my body,"  Narrative: About 1 hour after injection employee reports feeling groggy and disoriented. 1/26 - attempted to reach employee 1/25 and 1/26 without success. Will complete this report.
Fever day after vaccines; fussy for a few days and developed rash around nose. Fever again 4/26 -> 4/28/16. Fever again 5/4 -> 5/6/16 associated with vesicular rash - starting in groin, then perianally, posterior neck/upper back, ears, face, elbows, knees, hands, feet. Fever on 5/6/16 close to 106 degrees F.
Had Kinrix on right thigh and within 24hrs had  fever, HA, + swollen right thigh - 6/30/20. Had quarter size red area 7/1/2020 - called again leg more swollen, size of red area has double w/ purplish bruise around perimeter. Improved w/ compress & Ibuprofen 7/25/2020 - seen in office still limping w/ pain in right thigh. Has knot in muscle 1-2 cm on right  site of shot.
Sore arm onset 1-2 hours post "Loopy" feeling immediately post  Fever 99.5 12 hours post with significant body aches, while body skin sensitivity and pain Lack of sleep - only able to sleep 3 hours Headache 19 hours post Continued body aches  Hot flashes 24 hours post
Severe headache making it hard to even move head/neck; constant vomiting and nausea; constant vomiting and nausea; chills/trembling; chills/trembling; sweating/night sweats; sweating/night sweats; lightheadedness; This is a spontaneous report from a contactable Other Health Professional (patient). A 24-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EL3248), dose 2 intramuscular, administered in right arm on 02Feb2021 at 07:45 (at the age of 24 years old) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication(s) included iron (IRON); fish oil (OMEGA 3 [FISH OIL]); vitamin b complex (SUPER B COMPLEX [VITAMIN B COMPLEX]) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EL0142) dose 1 intramuscular, administered in right arm on 09Jan2021 07:45 for COVID-19 immunization. No Allergies to medications, food, or other products. The most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Feb2021 at 23:45, the patient experienced severe headache making it hard to even move head/neck, constant vomiting and nausea, chills/trembling, sweating/night sweats and lightheadedness. The events assessed as non-serious. The patient was not received treatment for the adverse event. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and unknown gender. Since 02-APR-2015, the unspecified patients were vaccinated with PNEUMOVAX 23 (lot # K02130 and expiry date: 22-JUN-2016) single dose vials which were exposed to temperature outside of the recommended range. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
No additional AE information; Reports multiple temperature excursions/administered to patients; Information has been received from a nurse concerning to a patient (age and gender not reported). No medical history, concurrent conditions nor concomitant medications. On 25-JAN-2021, the patient was vaccinated with a dose varicella virus vaccine live (oka/merck)(VARIVAX) (Lot # S032355, exp. date 14-OCT-2021) for prophylaxis, that went through temperature excursion. The patient did not experienced any adverse event.        Temperature: minus 14.00°C for 0.25 hours Call made because of data logger.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2103USA001252: US-009507513-2103USA001024:
This is a spontaneous report from a contactable nurse and a contactable pharmacist reported on behalf of physician. A 3-month-old male patient received the first dose of PREVNAR 13 injection in the right thigh, at 0.5ml (Lot # G73024, Expiration Date 01Oct2014) on 28Mar2013 at 10:24 am. The relevant medical history included acid reflux since an unknown date and on 12Feb2013 switch to Nutramigen due to spitting and frequent stools (4-6x/day) that tested heme positive- after changing to Nutramigen stool decrease to 2x/day and stools were heme neg- until had PREVNAR-13. The patient received previous vaccines first dose of PENTACEL (Sanofi manufacturer) injection in the left thigh, Batch/lot # expiration date: C4372AA, Exp: 13Apr2014 on 28Feb2013. The relevant concomitant medications included ZANTAC syrup at a dose of 0.5ml as needed on 13Feb2013, it was off for few weeks- resumed on 18Apr2013 for acid reflux (GER). On 29Mar2013, the patient developed watery stools, watery, frequent stools with blood at times. Seriousness criteria: very concerning due infants age and nutrition and possible dehydration. The patient has not had solid stool since vaccine. Relevant lab tests included stool test for cold blood on an unknown date in 2013 for the watery stools for which the report was negative, however, results were unknown. On 02Apr2013 stool HEME Test: +positive; on 09Apr2013 stool HEME Test: +positive; on 10Apr2013 stool culture, Fecal FAT, Fecal reducing substance OVA + Parasite, Giardia, IAMBIIA AG, EIA: Trace Fecal reducing substance. On 22Apr2013 stool HEME Test: negative. Therapeutic measures was required. Stool studies, formula changed, Gastroenterologist consult and follow-up, weight checks. Patient had not recovered from the reported event at the time of report. Follow-up (29Apr2013): New information obtained from a contactable pharmacist reported on behalf of physician includes: patient's age updated (3-month-old not 2-month-old); expiration date of PREVNAR 13; anatomical location of the administration; additional medical history; previous vaccines administered (PENTACEL); details of concomitant medication; additional lab data; treatment; event details including new events (blood in stool and dehydration), onset and outcome of the events. Follow-up attempts completed. No further information expected.
Fever to 103F, Severe R arm pain and swelling shortly following injection. Approximately 2 weeks after the initial immune reaction patient reports significant diffuse hair loss that have persisted since that time. No other new medications/illnesses/stressors.
Skin rash. Acetaminophen 650 mg TID, hydroxyzine 10 mg BID.
Swelling under the left arm, swelling and redness in the area where the vaccine was administered, swelling in the chest area, on the left side. Body aches, fever, headache, itchy red spots on the body.
internal shingles; hot burning sensation on my right side around my hip area; feels hot to me; relieve the pain; This case was reported by a consumer and described the occurrence of shingles in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 3rd January 2020, the patient received the 2nd dose of Shingrix. On 3rd January 2020, immediately after receiving Shingrix, the patient experienced shingles, burning hip, feeling hot and pain. The patient was treated with hydrocortisone (Cortisone Topical Cream). On an unknown date, the outcome of the shingles, burning hip, feeling hot and pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles, burning hip, feeling hot and pain to be related to Shingrix.  Additional information was provided as follows: The patient developed hot burning sensation on right side around her hip area, it was not hot to touch but felt hot to patient. Till the time of reporting, the events were constant. The patient wanted to know what measures were taken to relieve the pain. The patient had been using cortisone creams for treatment and has had a CT (Computerised tomogram) scan, MRI (Magnetic resonance imaging) and ultrasound. All of the tests so far had been negative, the patient was wondering if she had a form of internal shingles. The reporter consented to follow up.
immediately following the vaccine I felt tired and feverish. I took ibuprofen and felt mostly fine. The symptoms went away 3 days after the vaccine. On Monday following the vaccine (4 days after the vaccine) I began feeling joint pain / stiffness at night. I thought it was from skiing  for 3 days after the vaccine but it did not go away. It got worse and I began feeling joint / muscle pain throughout my body, especially in the morning and night. When I wake up in the morning it still hurts to roll over. Once I am up and moving for the day and take ibuprofen I start to feel a bit better, but overall I feel very painful joint and muscle pain daily.
A non-serious spontaneous report of runny nose and cough has been received from a consumer concerning a 38-month-old female patient, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither past medical history nor concomitant medications were reported for this patient. On an unknown date, patient received FLUMIST. The patient had runny nose and wet cough for entire month and for two more weeks had dry cough. Patient was currently symptom free. The dose was administered at Dr's office. The outcome of the events runny nose and wet cough was resolved.
Patient called the pharmacy today and she said she could not move  or raise her arm for about 2 weeks  since she got the  Janssen covid vaccine and it is getting worse . She went to the doctor and patient said doctor didn't  give any medicine. She is going  to the doctor again this week.
Fifteen mins after Pfizer dose #1, Pt. noted tingling of tongue.  ARNP noted slight swelling of right lower lip.  Pt. received Benadryl 50 mg IM.  Tingling resolved after 15 minutes.  Pt. felt fully recovered at that time, and later did not have any systemic side effects from the Covid vaccine.  She admits to feeling anxious with injections and venipuncture.
Vaccine given 12/12/03. States on 12/14/03 started with edema under armpit. No redness at site or fever. Edema was 2 inches high and 5 inches long. On 12/16/03, swelling is 1/2 inch high and 2-3 inches long. Muscle is sore.
Chills; Heartbeat at 90 beats a minute an hour; blood pressure went up a bit; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEART RATE INCREASED (Heartbeat at 90 beats a minute an hour) and HYPERTENSION (blood pressure went up a bit) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for an unknown indication.     The patient's past medical history included No adverse event. Concurrent medical conditions included Blood pressure (Patient reported that she is currently on blood pressure medication blood pressure went down as of 5Feb2021.) since 04-Feb-2021. Concomitant products included AMLODIPINE.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced CHILLS (Chills), HEART RATE INCREASED (Heartbeat at 90 beats a minute an hour) and HYPERTENSION (blood pressure went up a bit). On 05-Feb-2021, HYPERTENSION (blood pressure went up a bit) had resolved. At the time of the report, CHILLS (Chills) and HEART RATE INCREASED (Heartbeat at 90 beats a minute an hour) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Heart rate abnormal: 90 bpm a fast heartbeat, and higher than normal blood pressure.Patient reported that she began experiencing  a heart rate of 90bpm..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information were not provided.   Reporter did not allow further contact
belly pain; fatigue; fever; arm pain; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0151), via an unspecified route of administration in the left arm on 05Apr2021 at 11:45 (at the age of 42-year-old) as a single dose for COVID-19 immunization. Medical history included systemic lupus and Hashimoto's disease. Concomitant medication(s) included hydroxychloroquine sulfate (PLAQUENIL); escitalopram oxalate (LEXAPRO); colecalciferol (VITAMIN D), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6208), via an unspecified route of administration in the left arm on 12Mar2021 at 11:45 (at the age of 42-year-old), as a single dose for COVID-19 immunization and the patent experienced back pain after 2 hours, exhausted and headache next day with still pain, itching on 3rd day on an unknown date. The patient previously received intravenous iodine and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Apr2021 17:30 On 05Apr2021 at 17:30, the patient experienced stabbing belly pain within 6 hours, fatigue, fever and arm pain could barely move next day. Belly pain continued for 6 days, really exhausted and gets tired very easily usually the patient was very fit and exercise. No therapeutic measures were taken for the events. The clinical outcome of the event belly pain, fatigue, fever and arm pain was not resolved at the time of report.    No follow-up attempts are needed. No further information is expected.
This spontaneous report was report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unknown demographics. No relevant medical hisotry of the patients was reported. On unspecified dates the multiple unspecified patients were vaccianted with (Oka/Merck) VARIVAX (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It was reported that the multiple unspecified patients were administered with (Oka/Merck) VARIVAX that was stored improperly on unknown dates. There were no adverse effects reproted. It was unspecified whether the patients had sought any medical attention. There was no product quality complaint involved. Follow up infromation has been received from office manager, who stated she may call back or fax infromation as it become available. Also, reported that M-M-R II was not mentioned in the original call, but did experience a temperature excursion. No further infromation was available at that time. Follow-up infromation as received from office manager refers to a 4 years old patient. On 03-JUN-2014 the patient was vaccianted with a dose of improperly stored M-M-R II HSA (lot # reported as J013315, expiration date 18-OCT-2015) (strength, dose, route and site of administration were not reported). This is one of the several reports from the same source. Additional infromation has been requested.
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received her first dose on 23Dec2020 and was subsequently exposed at work to the virus and became symptomatic and tested positive on 31Dec2020. Her next scheduled dose is on Sunday, they may have to reschedule. The patient queried on how long should they delay the next dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 31Dec2020. The outcome of the events was unknown.  Information about Lot/Batch number is requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of suspected Covid-19 infection and suspected LOE due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is 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.
I was really tired after receiving the vaccine for about a day. I had a mammogram on 08/25/2022 and I had a lumpectomy on 02/23/2023. I have been diagnosed with breast cancer of the left breast.
13NOV97 reduction in rheumatoid arthritis sx;17NOV96 lymph nodes (ax) swollen & painful both sides;27NOV96 MD notes hx of pain axillary area poss secondary to vax;
no adverse effect; administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to refers to a 4-month-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 25-SEP-2019, the patient was inadvertently administered improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R026541 with expiration date: 11-JUL-2020) (strength, exact dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced a temperature excursion of 51.62 degrees Fahrenheit for 10 hours. It was reported that digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There were no adverse effects reported. No product quality complaint (PQC) was involved.  This is one of the several reports received from the same reporter.