chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On unknown dates, it could not be could out that the patients were vaccinated with improperly stored ROTATEQ orally, lot # M040270 with expiration date: 29-APR-2018 (dose was not reported). Temperature ranged to 1.6 degrees Celsius for the time frame of 8 hours and 30 minutes. There was previous temperature excursion with temperature of 1.3 degrees Celsius for 8 hours and 20 minutes. Digital data logger was not used. No adverse effects were reported. Product quality complaint was not involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA006252.
Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022; Vaccine administered 30 days after beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 30 days after beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a22b) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 30 days after beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 30 days after beyond use date) and PRODUCT STORAGE ERROR (Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Patient had received second booster on 18-Jul-2022. Number of doses and vials were reported as 6 doses from the same vial 3. The vials were stored in refrigerator on 16-Jun-2022. The vial did not undergo any temperature excursions.  No treatment medication was reported by reporter.  Vaccine administered 30 days after beyond use date.  Vial was stored in refrigerator on 16-Jun-2022 and administered on 18-Jul-2022
03/13/2021: Presented to the emergency department for profuse diarrhea, tachycardia, and diffuse wheezing.  Patient hypoxia was most likely secondary COPD exacerbation was started on IV steroids and transition to p.o. prednisone. Medication changes led to better heart rate control.
A non-serious, spontaneous report of root canal, ear infection, sinus infection and nasal congestion was received from a nurse/parent, concerning a 19 year-old male subsequent to FLUMIST.  The patient's past medical history includes IgG two deficiency, asthma, otitis infections and skin granuloma.  No concomitant medications have been reported for this patient.  The patient received a first dose of FLUMIST, intranasal for flu vaccination on 24-Oct-2008.  On 26-Oct-2008 the patient experienced nasal congestion which progressed to a sinus infection on 31-Oct-2008.  The patient was seen by a dentist on 01-Nov-2008 and was given AMOXICILLIN 500 mg for one week.  On 19-Nov-2008 the patient experienced ear infection and was given AMOXICILLIN/clavulanic acid combination 875 mg for one week.  The patient recovered from the nasal congestion, sinus infection and ear infection on 26-Nov-2008.  The patient recovered from the root canal procedure on 13-Nov-2008.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. The patient was vaccinated with dose 1 GARDASIL (lot # not reported) on 20-JAN-2011, dose 2 on 31-MAR-2011. The patient was in the office on 27-JUL-2012 to get the third dose. No adverse effect reported. Additional information has been requested.
Watery eyes. Red, puffy skin around the eyes and on the cheeks. Redness on the chest. Fever of 101.5, although possibly higher (taken with an ear thermometer, which tends to read about one degree (F) cooler than actual body temperature). Infant Tylenol (suspension) was administered, but she vomited due to gagging. Cold, wet rags were then placed on her torso, and that brought the fever down.
Weakness, fogginess in head - not thinking clearly, chills even a week later, no energy, exhaustion, funny feeling on left side of face, loss of appetite, general feeling of unwell and not feeling like myself.
Fatigue; Pain in arm; Pain under arm pits; Breast swollen with pain; Breast swollen with pain; Thirsty; Loss appetite; Couldn't do daily activities; Booster dose; This is a spontaneous report from contactable other healthcare professional. A 45-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 05Oct2021 at 11:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included pre-diabetic, asthma and allergic to bananas and latex (Known allergies: bananas and latex). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included unspecified daily vitamins from an unknown date and unknown if ongoing for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730) via an unspecified route of administration in the left arm on 04Jan2021 at 11:15 (at the age of 45-year-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246) via an unspecified route of administration in the left arm on 25Jan2021 at 12:00 (at the age of 45-year-old) both as a single dose for COVID-19 immunisation. On 06Oct2021 at 09:00, the patient experienced fatigue, pain in arm, pain under armpits, breast swollen with pain, thirsty, loss of appetite and couldn't do daily activities. The events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, pain in arm, pain under armpits, breast swollen with pain, thirsty, loss of appetite and couldn't do daily activities were not resolved at the time of this report.
Child woke up with erythema and swelling, "4 inches down his arm" per his father.
2021.05.20, 11:30PM felt unusually tired after my daily evening 3-mile walk. Muscles all over my body ached. 2021.05.20 12 midnight - 2021.05.21 8:00AM - slept very poorly with several interruptions, lots of sweating, mattress and bedding damp by the morning. I did not feel hot like when I have a fever. 2021.05.21 - 8:00AM - 9:00PM - Felt weak and lethargic. Muscle pain all over body continued. I needed to nap for two hours during the day. My heart rate was elevated about 15 percent above normal. After the nap I still felt tired. Food helped a little, but I went to be early, at 9PM. 2021.05.21 - 9:00PM - 2021.05. 22 - 8:00AM - Slept poorly with several interruptions, chills, and night sweats. Again awoke with damp mattress and bedding. For the first 10 minutes after rising I felt a little better, but then the muscle pain intensified and the lethargy too. I spent several hours of the day lying down in bed. Ate normally, which improved my overall feeling and energy level. Also consumed electrolytes and water. In the evening I started to feel not fully recovered, but a lot better than 24 hours prior. I went to bed at 11PM. 2021.05.22 - 11PM - 2021.05.23 - 10AM - I had some chills on preparing my bed, but overall slept better. Some sweating still.  2021.05.23 10AM - present 8PM - Felt much better. 95 percent of normal.
Pt presented w/rash & said limb was extremly painful. She said it occurred after 1 day. She was 2 days post vaccine when reported.
Patient states that his arm is still very sore and hurts to lift his arm.  It has been 17 days since he recieved his flu shot. He says that it is still sore to the touch and it hurts to sleep on it.
Severe fever with rapid onset accompanied with chills. At least 103.4 F measured with a very precise thermometer.  Resolved in 3-4 hours with bedrest, Tylenol and ibuprofen.
Pt developed a red raised area about the size of a quarter.  Area was warm and painful.  It is resolving but still present as of 03/26/21
HURTING IN LEGS; MUSCLE ACHE; FATIGUE; BODY ACHES/BODY FELT SORE; JOINT PAIN/HURTING IN JOINTS; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's past medical history included: spinal fracture. On an unspecified date, the patient previously received covid-19 vaccine ad26.cov2.s vaccination from an unspecified manufacturer (dose number in series: 1) for prophylactic vaccination and it was unknown whether patient had any adverse events. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: UNKNOWN) dose was not reported, (dose number in series: 2),1 total, administered on 19-NOV-2021 09:15 to left arm for prophylactic vaccination.  Concomitant medications included paracetamol occasionally and ice packs for spinal fracture.  On 19-NOV-2021, the patient experienced body aches/body felt sore, joint pain/hurting in joints, muscle ache and fatigue. The hurting in joints and legs felt like beaten up (all events dose number in series: 2).  On 20-NOV-2021, the patient experienced hurting in legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches/body felt sore, joint pain/hurting in joints, muscle ache, and fatigue on 20-NOV-2021, and the outcome of hurting in legs was not reported. This report was non-serious. This case, involving the same patient is linked to 20210421085.
severe from 6/12 - 6/15 intense lower back pain 6/15 - present (6/21) intense abdominal pain 6/15 - present (6/21)
6-8 hours after injection, patient complained of 10/10 pain at injection site and R upper arm, with nearly circumferential erythema, swelling, and induration around bicep region. He was febrile to 39.1C R axilla and 38C L axilla at the time. Pain on adduction of shoulder, flexion of elbow, and flexion of wrist. Neurovascularly intact distal to affected area. Patient was treated with multiple doses of diphenhydramine, acetaminophen, and ibuprofen. Swelling began to slowly subside after 24 hours, though remained intensely tender to palpation.
I was fine for 7-10 days after the jab.  No reactions other than minor soreness.  Then the digestive and neurological conditions emerged.  Never had anything like them previously.  PLEASE NOTE:  I am not claiming that the second vaccine caused either or both of these conditions.  I'm ask if you have received similar incident reports.
Approximately five minutes after vaccination patient began to appear sleepy while in observation area.  I walk over to the patient and by the time I got to him the patient was unresponsive.  His body was rigid and breaths were erratic.  He regained consciousness after about a minute or so and appeared to be alert.  EMT's then arrived and took over.
Headache for 5 days. Extremely sore arm for 5 days. Unusual Fatigue  3 days.
Severe headache fever 102.4 (L) arm injection swelling 5x5 cm redness 10x10 cm tenderness 2+ 24-36 hours. Vomiting x2 to 24 hours. Rx TYLENOL fluids.
pain and spasms intensified 2days after vaccine 2; pain and spasms intensified 2days after vaccine 2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 19Mar2021 12:00 (Lot number: EN6205) at the age of 45 years as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESCITALOPRAM. Vaccination history included: BNT162B2 (lot number=EN6201; administration time=01:30 PM, vaccine location=Left arm, dose number=1), administration date: 26Feb2021, when the patient was 45 years old, for COVID-19 immunisation, reaction(s): "Upper back and Right sided neck pain and stiffness", "Upper back and Right sided neck pain and stiffness", "Upper back and Right sided neck pain and stiffness". The following information was reported: PAIN (non-serious), MUSCLE SPASMS (non-serious) all with onset 21Mar2021 12:00, outcome "not recovered" and all described as "pain and spasms intensified 2 days after vaccine 2". The event "pain and spasms intensified 2 days after vaccine 2" and "pain and spasms intensified 2days after vaccine 2" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pain, muscle spasms.  Additional information: The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient had no known allergies. The patient did not receive other vaccine in four weeks. Treatment for the events today 22Mar2021.  No follow-up attempts are possible. No further information is expected.
A spontaneous report was received from a consumer [United States] concerning 60 years old female patient who received Moderna's COVID-19 (mRNA-1273) and experienced worsening of meniere's disease symptoms/meniere's disease, scratchy throat/oropharyngeal discomfort, sinus pressure/paranasal sinus discomfort, dry cough/cough, phlegm/productive cough, vomiting.   The patient's medical history was not reported. Concomitant product use was not provided by the reporter.   The patient received their first of two planned doses of mRNA-1273 (Batch number: 046A21A) on 18 Mar 2021 intramuscularly in the unknown injection site for prophylaxis of COVID-19 infection.    On 18 Mar 2021 the patient developed a dry cough, scratchy throat, sinus pressure, phlegm, vomiting x1, and worsening of her Meniere's disease symptoms. The medically significant event is meniere's disease. Treatment of the event was not provided.   Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the events worsening of meniere's disease symptoms, scratchy throat, sinus pressure, dry cough, phlegm, and vomiting was not reported.; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the events, a causal relationship cannot be excluded.  Vomiting is consistent with the product known safety profile.
Case number PHEH2013US017053 is an initial spontaneous report received from a nurse on 08 Aug 2013: This report refers to a 12-year-old male patient. He was vaccinated with MENVEO (batch number: M12123) intramuscularly in to the right arm at 0.5ml and with Dtap (other manufacturer, batch number: unknown) in to the left arm on an undetermined date. On an unspecified date after vaccinations, he experienced a circle around the shot that felt hard and was warm to touch. No further information about seriousness, outcome and causality was reported.
At 8pm the same night of receiving vaccinations, he was warmer than normal at bed time. The next morning he had a fever of 102; he seemed unusually cranky though the day, and the leg that received the injection was sensitive. His fever rose to 103 by 4pm; we gave him a warm bath at 4:30pm in hopes of helping his body manage the fever better. Immediately after the bath his temp had dropped a degree. He still had a fever of 102 at bed time that night (4/30; 8pm). The next morning his temp was 100, and was normal by lunch time.
contracted covid-19, tested positive to COVID; contracted covid-19, tested positive to COVID; This is a spontaneous report from a contactable consumer. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose on 21Mar2021 (batch/lot number: unknown) and first dose on an unspecified date (batch/lot number unknown), both via unspecified routes of administration on an unspecified dates as single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported.  The patient experienced contracted covid-19, tested positive to COVID (drug ineffective and COVID-19) on 08Apr2021 with light headaches and cough for 3 days. The patient underwent lab test which included COVID test: positive on 08Apr2021. Patient received her vaccine in Dubai (2nd dose on 21Mar2021), she tested positive to COVID on April 8th (light headaches and cough for 3 days). The outcome of the events was unknown.  Information about lot/batch number has been requested.
Large, red spot 4 inches diameter at site. Golf ball size lump with pain at site. Bone/ joint pain, lethargy for 2 days.
Pt reported symptoms of dizziness, light headed. Onset after receiving vaccine. Pt reports last food/liquid intake last night. Assisted patient to stretcher. Provided juice, water, crackers.
I noticed I was having dizzy spells when I would try to get out of bed and when I would bend over to tie my shoes.  I was tested laying down and standing up my and I would get dizzy.  The neurologist diagnosed me with positional vertigo.  The dizziness stopped in December.  The ENT said it may have been bouts of vertigo.  I had a CT Scan of my bran.  I also tested positive for COVID-19 at the end of December.  My symptoms began as a sore throat.  On December 28, 2022, I tested negative.  On December 30, 2022, I tested positive.  I had sinus congestion and a sore throat for a two weeks.  I took Tylenol and Mucinex.
Inflamation on underarm glands and excruciating pains as if something was chewing all of the glands under my arm. I was seen an the ER Hospital on 11/4 because I was worried as to what was happening to me.
Menstrual bleeding the day after the vaccine, the flow was heavy; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 06Apr2021 at 15:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had allergies to penicillin, peppers, birch and grass pollen. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. On 07Apr2021 at 23:30, the patient experienced menstrual bleeding the day after vaccine, flow was heavy. The patient was in the middle of menstrual cycle and takes birth control (unknown medications). The patient had never experienced bleeding in the middle of menstrual cycle in the three years, the patient had been on birth control. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event menstrual bleeding the day after the vaccine, the flow was heavy was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
2/29/08 - Mom states last night child had high fever and had seizures and was taken to hospital after receiving immunizations here earlier that afternoon. Child stayed overnight - Mom states ER doctor - states that immunization did cause fever and seizure. 3/01/08 Mom states child was discharged on 2/29/08 and child is much better.  4/1/08 Reviewed hospital ER medical records of 2/29/2008. FINAL DX: febrile seizure Records reveal patient experienced shaking & blank stare for approx 1 hour.  Fever x 1 day s/p vaccines despite antipyretics.  No further seizure activity in ER & d/c to home to f/u w/PCP.
Information has been received from a registered nurse concerning an 81 year old female with allergy to antibiotics, NEURONTIN, MORPHINE and iodine, who in October 2007 , was vaccinated with a dose of ZOSTER (lot no. 658207/0883U). Last week, on approximately 24-SEP-2008, the patient developed shingles on her face and head area after administration of ZOSTER. The patient reported that she is in a lot of pain. The nurse is not interested in VZV analysis by PCR. The patient sough medical attention, via telephone. At the time of the reporting, the patient was recovering. This is one of several reports received from the same source. No further information is available.
Two days after receiving vaccine, chest tightness, pain, shortness of breath, heart palpitations, dizziness, blurred vision lasting 5 days.
18 yo female received her vaccine booster of Pfizer Covid19 Vaccination (LOT # FK9896 EXP: 03/2022) on 2/01/2022 around 3:35 PM. Patient reported no allergies, no current medications, and had a meal today before her vaccine booster. Patient reported at 3:35 PM that she had chest pressure and feeling drowsy and placed in a gravity chair during observation. Patient reported that similar symptoms occurred her first and second doses of Pfizer and did 30 minutes of observation her second dose of Pfizer. At 3:35 BP of 140/82, HR 55, and 02 of 100 RA and Respirations 16. At 3:45 Patient reported "feeling drowsy, chest pressure, and a little nauseas". At 3:42  Patients Vital Signs: BP of 130/72 , HR 55, and 02 of 98% RA. At 3:52 PM patient reported feeling "pressure around her chest and tightness in her throat. At 4:03 PM Patient was reevaluated and reported " No nausea, no chest pressure, and slight throat pressure with no troubles breathing". At 4:07 Patients Vital Signs: BP 128/76, 02 of 99% on RA, and HR of 52. At 4:10 PM the patient reported " no pressure on throat or chest pressure" and at 4:15 PM reported " no more pressure". At 4:13 PM BP was 132/76, O2 of 98% on R, and HR of 55. At 4:20 the Patient was informed and educated by Vaccine Site Co-Lead RN to monitor for common side effects to such as muscle soreness and fatigue and to Call 911 or go to nearest emergency room if any severe adverse reactions occur such as shortness of breath, chest pressure, throat closing, and generalized rash. At 4:20 Patient left observation with no reports of chest pressure, nausea, drowsiness, and throat tightness.
Heart pain, racing heart, dizziness, shortness of breath, seeing stars, almost feinting.  Since then my energy level is less than half of what it was, I end up spending almost every non -working hour in bed and colds have been more frequent as well as a constant clammy feverish feeling.  Night sweats are common.
Developed chicken pox several years after he got the shot. Vaccine didn't prevent from getting the disease.
A few minutes after administration of the vaccine, the patient became light headed followed by loss of consciousness for several seconds.