chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had Moderna booster yesterday. Today I feel weak; This spontaneous case was reported by an other health care professional and describes the occurrence of ASTHENIA (Had Moderna booster yesterday. Today I feel weak) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Nov-2021, the patient experienced ASTHENIA (Had Moderna booster yesterday. Today I feel weak). At the time of the report, ASTHENIA (Had Moderna booster yesterday. Today I feel weak) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Patient was seen in office today to receive the first dose of her Covid vaccination, Approximately 2 to 3 minutes after receiving her dose she began feeling hot all over her body and began feeling swelling and irritation to her neck and throat. Patient was brought back at that time for me to evaluate and was found to have urticaria and erythema from her chest up to her neck and into her face. There was no tongue swelling or dyspnea noted upon initial exam. The patient was initially given 50 mg of p.o. liquid Benadryl. Approximately 5 minutes after receiving Benadryl the patient began stating that she felt as though she could not breathe and became panicking while having rapid and shallow respirations. At that time 0.3 mg of epinephrine was administered into the patient's left thigh and EMS was called. While awaiting the arrival of EMS the patient began feeling significantly better, was able to speak in full sentences, and the rash begin to diminish. EMS transported the patient to the emergency department for further evaluation and treatment.
24 hours post vax, following the rabies vaccine, the pt developed dysphagia, angioedema and urticaria. No other details were reported. This is considered "other medically significant."
RED RASH  FROM ELBOW TO HAND ON RIGHT ARM, RASH ON INSIDE OF ARM/ELBO ON LEFT ARM, ITCHING ALL OVER.  GAVE PATIENT HYDROCORTIOSONE  1% TO APPLY ON ARM, REDNESS WAS BETTER BUT ITCHING WAS WORSE, GAVE EPI-PEN, PATIENT BOUGHT BENADRYL TO TAKE AT HOME
I have very tender sensitive skin around the left side of my midsection [front to back].  It feels like a sunburn.  There is no redness, but a few days ago I had 3-4 small red bumps, like bug bites.
throat closing; tingling immediately in left arm; rapid heartbeat; This is a spontaneous report from a contactable healthcare professional, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL 1283), intramuscular in the left arm on 08Jan2021 at 17:00 (at the age of 47-years-old) as a single dose for Covid-19 immunization. Medical history included migraines. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food or other products. The patient's concomitant medications included minocycline (MANUFACTURER UNKNOWN) for unknown indications from unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 08Jan2021 at 17:00, the patient experienced tingling immediately in left arm following injection, rapid heartbeat and throat closing. The patient was treated for the throat tightness, paraesthesia and heart rate increased which included diphenhydramine (BENADRYL), oral steroids, EKG and blood pressure monitoring. The events did initiate an emergency room visit. The clinical outcome of the events throat tightness, paraesthesia and heart rate increased was recovered with sequel. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "throat closing" and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations.  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.
Swollen tongue, itchy, hive everywhere. neck, back, abdomen, thigh.
Client presented to the vaccination site on 11/12/2021. The client notified PHN that she received a single dose of COVID vaccine (lot A030921 on 4/30/2021. PHN submitted a medical consult via text message to Vaccine Operations Leads, requesting to proceed with the COVID vaccine Pfizer. Per CDC guidance, approval to proceed with COVID vaccine Pfizer dose 1 was obtained from medical consult team via text message, Vaccine Operations Lead. Client received COVID vaccine Pfizer (lot FF8841) on 11/12/2021. The client did not report any symptoms during the 30 minute observation period. Vaccinator Pharmacist educated client on possible adverse reactions and when to seek medical care. The client left the vaccination site at 1415 walking with steady gait.
pt states 930AM 9NOV95 devel soreness lt deltoid inj site (pneumonia vax) approx 2hrs p/inj;has become progressively more swollen & warm to the touch w/tenderness;more swelling & tenderness below inj site to elbow;
Pt presented to ED, 2 - 3 days after receiving a PNEUMOVAX shot at her physician's office. Chills. fever, lightheaded, dizzy, sweating & fell. Pt given IV fluids & monitoring. Later sent home w/daughter.
At 14:48, left deltoid area reddened and swollen to approx. 10cm X 10cm and warm. Temperature 36C.
Patient reported vision changes with flashing lights, squiggly lines, and black spots the evening after receiving the vaccination. This last for approximately 7 minutes. The next day patient reported redness and warm to touch at injection site.
Initial report received on 11 January 2011 from the investigator participating in the post-marketing observational surveillance study under reference number M5A16. This is one case in a series of 11 pertussis cases received during the surveillance period from 01 January 2010 to 11 January 2011. A case of pertussis disease in a 12 month old male subject (initial not collected), was identified by the investigator based on review of data from the Electronic Disease Surveillance System. The subject's vaccine history included 3 doses of PENTACEL: lot number C3469AA received on 23 November 2009, lot number C3502AA received on 18 January 2010, and unknown lot number received on 23 March 2010 (route and site of administration not reported). Approximately 6 months after the last dose, on 05 October 2010, the subject developed cough. Other symptoms included cold-like symptoms and posttussive vomiting. Chest x-ray findings were negative for pneumonia. Corrective treatment  consisted of azithromycin started on 27 October 2010. The subject was not hospitalized. At the time of final contact on 27 October 2010, the subject's cough had been ongoing for 23 days (also reported as 20 days) and was still persisting. It is unclear if PCR testing was conducted. However, it was reported that this case was epidemiologically linked to a laboratory confirmed case. The subject had not recovered. Investigator causality assessment is not required as per protocol. Documents held by sender: None
Hospitalized 10/19/2021; COVID-19 positive 10/19/2021; fully vaccinated  HISTORY OF PRESENT ILLNESS: PT is a 62 y.o. female who presents today with not feeling well with shortness of breath and feeling sick. Her husband had covid and he is recovering now. Has chest pain with cough. No abdominal pain. She has had diarrhea. Her symptoms started on last Wednesday. No leg swelling. She recently had left foot fracture. CT angio was negative for PE. She has type 2 DM as well.  ASSESSMENT / PLAN: # Acute hypoxic respiratory failure: # Covid 19 pneumonia:     - Decadron and remdesevir as symptoms are ongoing for 5 days     - fully vaccinated     - not a candidate for MAB due to hypoxia     - continuous pulse ox 10/22/2012 note: CHIEF COMPLAINT: Hypoxia ASSESSMENT / PLAN: Acute hypoxic respiratory failure Covid 19 pneumonia - Symptom onset 10/14; COVID positive 10/19 - Decadron started 10/19 - On remdesivir through 10/24 - Fully vaccinated with Pfizer March and April 2021 - not a candidate for MAB due to hypoxia - Today desatting on 95% high flow. Requiring NRB. If continues to decline will need to reach out to ICU for possible intubation - Continuous pulse ox - CTA 10/19 no definitive PE, diffuse ground glass opacities  -CRP 80.3->28.1 -ddimer 460->680 -Will trial IV lasix
Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 25-JAN-2022 16:12:14; Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 25-JAN-2022 16:12:14; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 25-JAN-2022 16:12:14) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 25-JAN-2022 16:12:14) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     It was unknown if patient had any acute illnesses at the time of vaccination and up to one month before. It was unknown if the patient had chronic or long-standing health conditions.     On 25-Jan-2022 at 4:12 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 25-Jan-2022 at 4:12 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 25-JAN-2022 16:12:14). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 25-JAN-2022 16:12:14). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 25-JAN-2022 16:12:14) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 degree Celsius thaw state on or about 24-Dec-2021 and administered on 25-JAN-2022 16:12:14) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.     It was unknown if any prescriptions, over-the-counter-medications, dietary supplements, or herbal remedies were being taken by the patient at the time of vaccination and/or at the time of the adverse event.  It was unknown if other vaccines were given on the same day as Moderna COVID-19 Vaccine to the patient.  It was unknown if patient received other vaccines within one month prior to any dose of Moderna COVID-19 Vaccine.  On 25-JAN-2022 16:12:14, the patient received a booster dose (Lot: 066H21A and expiry date 04-APR-2022) of Moderna vaccine.  Reported that patient received Vaccine past its 30-day expiry date, vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021.  No treatment drug information was reported.   This case was linked to MOD-2022-542869 (Patient Link).
Had symptomatic positive COVID test; Had symptomatic positive COVID test; This is a spontaneous report from a contactable consumer. An unspecified age and gender patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) via an unspecified route of administration on an unspecified date at dose number unknown, single for COVID-19 immunization. The medical history and concomitant medications were not reported. On an unspecified date the patients COVID test was positive. Prior vaccination within 4 weeks reported as none. It was reported that the patient was on vacation with 6 vaccinated adults all 3 was Pfizer vaccinated individuals and had symptomatic positive COVID test. Outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Swelling redness in area of PENTACEL injection fever 100.5 received PENTACEL at 2 mins and did well. Had reaction to PEDVAXHIB (local) 4 mths.
rash developed 15 days after receiving the vaccination.  Feels warm to the touch.   approx size 3 by 4 inches.
arm soreness, body aches, fatigue Narrative:  employee states: after 1st dose 12/30/20 had injection site soreness beginning a few hours later, some dizziness, fatigue, irritability, and body aches, the next day fatigue, body aches, and headache. sx resolved within 24 hours 2nd dose: injection site soreness in a few hours. within 7 hours experienced body aches,, fatigue, and feeling cold. temperature swings hot/cold and other sx continued throughout the night. better in the morning but still hot/cold and other sx continued throughout the night. better in the morning but still hot/cold swings and fatigue and body aches intensified and by that evening neck pain and soreness. Morning of 1/29 still some sx persist but body aches havesubsided. still some redness at injection site
Marble size lymph node left axilla, small amt of erythema, painful to touch. Keflex 500 mg BID x 10 days. Warm compress, FU PRN.
Father of pt. called Health Dept. 9-18-14 reported his son was urinating blood and he was taking him to the ER. On 9-19-14 father reports son was seen in ER: was told he was dehydrated. He had an IV with IV antibiotics and was released. Per father txd for UTI is not taking any medications at home.
Nausea, lump in throat, hypertension, chest pain. Slowly subsided until Benadryl was taken then about 1 hour after it was all better except the nausea which lasted intermittently for  a whole day
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not provided. On 13-SEP-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, frequency, route of administration and indication were not reported, lot # L024993 with expiration date: 17-OCT-2017). Concomitant medications were not reported. No adverse effects were reported. The administered dose was stored in 25.7 Celsius degrees for 57 hours. There was no previous temperature excursion. Additional information has been requested.
CHILLS; SPIKING FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetic. 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 10-APR-2021 10:15 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced chills. On APR-2021, the subject experienced spiking fever. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and spiking fever was not reported. This report was non-serious.
Pfizer lot #FJ6369 with temp excursion. Reported to Pfizer company and okd for use. Instructed by their staff to report each dose given in this system.
Pt vaccinated w/DTP/OPV on 17DEC90 5PM 18DEC90 became unresponsive (hypotonic) w/eyes rolling back. BT was 102 recovered after 10 minutes. Fever, oculogyric crisis, stupor.
Hyperemia, swelling and warmth at site of DTaP and MMR (left arm). 5" diameter later side. No fever or pain, swelling noted today after left arm used to take blood pressure reading. DTaP and MMR given 6/10/02. Redness noted 1st day at morning. Blood pressure taken 10:36 AM.
RINGING IN EAR; 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) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-MAR-2021, the subject experienced ringing in ear. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ringing in ear. This report was non-serious.
Infant received vaccines, cried for approx. a minute. Closed eyes, became slightly cyanotic around mouth, opened eyes with fixed stare. Infant placed in trendelenburg position and stimulated. Began crying in about 30 seconds, color returned to pink.
Loss of hearing and tinnitus.  Called ENT for appointment to have "wax" removed.  Ultimately diagnosed by Dr. as sensorineural hearing loss and tinnitus.  Referred to Hospital and Dr.  Treated with steroid pills, followed with steroid shots in right ear drum.  Treatment failed to restore hearing, stop tinnitus. Hearing aids prescribed and purchased.
Rash and itchy all over; Rash and itchy all over; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Feb2021 as DOSE NUMBER UNKNWON, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she got her shot back in February. She stated that she had a rash and itchy all over. She stated she was fixing to go to her to doctor. She has a rash on her face. The outcome was unknown for the event.  No follow-up attempts are completed; information about lot/batch number cannot
arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was swollen) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was provided by the reporter.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 27-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen). On 27-Jan-2021, PERIPHERAL SWELLING (arm was swollen) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
(First dose of Moderna Covid 19 vaccine was 1/2/2021 and lot #025L20A)  Approx. 3 weeks following the second dose of the Covid 19 vaccine I noticed a sudden hearing loss in my left ear. I first tried to use wax softeners/bulb syringe flushes for a few days to see if hearing loss was due to wax. When there was no resolution, I contacted my primary care provider and obtained an appt for 3/16/2021. At that time, provider saw "negative pressure" w/L eardrum and fluid bubbles behind L eardrum and placed me on Zyrtec, Flonase and Mucinex for 6 weeks to see if hearing resolved. When it did not, I was referred to ENT. A hearing screen was performed on 4/27/2021 prior to scheduled ENT appointment which showed "Mild-Severe Sensorineural Sloping" and an urgent appointment was made with ENT the following morning. On 4/28/2021 the ENT felt the hearing loss was most likely permanent as too much time had passed since initial loss was noted. She put me on an oral course of Prednisone as a "salvage attempt". The doses were 60mg for 3 days, 40mgs for 3 days, 20mgs for 3 days and 10mgs for 3 days. A follow up hearing screen on 5/17/2021 showed "no signficant change in hearing status." Further treatment has been deemed unlikely to improve hearing and I have been advised to consider a hearing aid. (Of note, following first Covid vaccine I only had significant soreness at injection site (L arm for that injection). Following the 2nd Covid vaccine, I had a Tmax of 100.5 with significant injection site pain/soreness in R arm, generalized muscle aches and significant fatigue. Tmax and height of symptoms were 31hrs following injection. At 43.5 hrs past injection, temp was 98.2 and fatigue/muscle aches were improved with just mild headache developing at that time.By 56hrs following vaccine, felt 100% back to normal.) I kept a journal following the second dose of symptoms because I am a nurse and I wanted to keep an accurate record of my experience since I had heard such a wide range of responses reported which is how I have such accurate times following that dose.
Morning of Sunday February 7th experienced tachycardia, chest pounding/palpitations, light headedness/dizzy, nausea and shakiness. SBP 150's. HR in 130's. Symptoms would plateau then worsen, on and off for approximately 30 minutes. 2nd episode occurred at work Thursday February 11th with same symptoms lasting 10 minutes. Seen by provider February 11th (3 hours after episode) with noted HR in 100s at rest and SBP 140's and started on metoprolol 25 mg once a day.  Symptoms briefly returned 2-3times in span of 2 weeks after starting metoprolol with lessening of symptoms and duration.  Attempted to wean off metoprolol went to 12.5 mg once a day 4/1/21 to 4/7/21. First day off metoprolol HR returned to 130s at rest while driving , resulting in going back on metoprolol (12.5 mg) until scheduled Holter Monitor beginning of May.  Have been off medication since the holter monitor. Since being off the metoprolol have not experienced any episodes however noticeable palpitations intermittently at home/work with brief episodes dizziness/light headed.
sore throat; congestion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 14 year-old male patient received bnt162b2 (BNT162B2) (Lot number: Unknown) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 15May2021, outcome "not recovered", described as "sore throat"; NASAL CONGESTION (non-serious) with onset 15May2021, outcome "not recovered", described as "congestion". The events "sore throat" and "congestion" were evaluated at the physician office visit and emergency room visit.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any list of any other medications the patient received within 2 weeks of vaccination were reported. Patient administered their most recent covid-19 vaccine at Doctor's office/urgent care.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a physician and refers to an unknown number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDISAL 9 (lot # M005714, expiration date: 03-OCT-2017; dose and route were not provided). The vaccine underwent a temperature excursion of 29.7 degrees Fahrenheit for 21 hours. There was no previous temperature excursion. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.