chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ lot # L039298, expiration date 27-JUN-2017 (dose was not reported), oral. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 55 degrees Fahrenheit for 187 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Inappropriate schedule of vaccine administered; Hives on chest and shoulders; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 09Sep2021 08:00 (Lot number: Fc3183) at the age of 33 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Allergies: cephalexin, reaction(s): "Allergies: Cephalexin", notes: Allergies: Cephalexin. Vaccination history included: Bnt162b2 (1st dose, lot number=Ew0164,, Administrator route=Intramuscular,, Administration time=08:00 AM,, vaccine location=Right arm), administration date: 24Aug2021, when the patient was 33 years old, for Covid-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 28Sep2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; URTICARIA (non-serious) with onset 28Sep2021, outcome "recovered" (2021), described as "Hives on chest and shoulders". Therapeutic measures were not taken as a result of inappropriate schedule of product administration, urticaria.  Additional information: The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. The patient has not received 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 has not been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
Infant received immunizations. Five hours later, was not breathing. Had been asleep on grandmother's chest. Autopsy revealed SIDS death. Date of death: 1/20/05.
Initial misuse report received from a healthcare professional on 13 September 2013. MENACTRA vaccine was inadvertently used to reconstitute MMR powder component and was given SC to a patient. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Delayed skin reaction approximately on Day 8.  Reddened, mild-moderate "splotch" about 3 inches x 1 inch on upper arm surrounding site of injection.  Very mild itchiness, skin was warm to touch;  redness worsened in the evening.    No arm soreness.   The redness is ongoing but not worse  (Day 9) at the time of this report.
Hyperventilation Anxiety  High panic (it was a slow increase; the panic started slowly and then increased as days went by) Became depressed  Started crying randomly Full body rage; became enraged at random times
12/28/2021:  Event occurred after 2nd vaccine.  85-year-old male with past medical history of HTN, thyroid dysfunction and hyperlipidemia who comes for evaluation of dyspnea. He has a 9-day history of shortness of breath. Denies any other covid symptoms.
Chief Complaint Patient presents with ? Covid-19 Screening     cough, congestion low grade temps for the past week,.   Patient presents today for viral symptoms. She received both COVID vaccines - January 22 and February 12. She notes fatigue and body aches after each vaccine. On 2/15, she started with nasal congestion and dry cough. Temp 99-100 F which continues. No n/v/d. Denies loss of taste/smell. She is taking tylenol prn.
lethargy, vomiting dark coffee ground emesis with small clots appearing, low grade temps
Patient did not have any reaction at the injection site, however, she did have hive like rash down her left arm and on her upper left neck (the side of the injection).
Positive Covid test 11/28/2022, cold and flu like symptoms, chest congestion. Started Paxolvid treatment 11/29/2022
TREMOR IN BOTH LEGS FOR THE PAST HALF AN HOUR; This spontaneous report received from a patient concerned a 35 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 05-AUG-2021) dose was not reported, administered on 01-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-JUL-2021, the subject experienced tremor in both legs for the past half an hour. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tremor in both legs for the past half an hour. This report was non-serious.
irritability (anger/aggressive feelings); irritability (anger/aggressive feelings); irritability (anger/aggressive feelings); chills/shaking; chills/shaking; body aches; congestion; severe fatigue; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender started to receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Patient received the first dose of vaccine on an unknown date for covid-19 immunization. The patient medical history and concomitant medications were not reported. After receiving 2nd Covid vaccination, patient was experiencing irritability (anger/aggressive feelings), chills/shaking, body aches, congestion, severe fatigue. The outcome of events was unknown.  Pfizer is a marketing authorization holder of [BNT162B2] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [BNT162B2] has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
PT REC'D 2 MONTH SHOTS.  REC'D PEDIARIX TO RIGHT THIGH AND AREA IMMEDIATELY BECAME VERY RED WITH RED CIRCLE APPROXIMATELY 5 INCHES IN CIRCUM.  MOM WAS ADVISED TO APPLY COOL COMPRESSES TO AREA AND MEDICATE WITH TYLENOL EVERY 4 HOURS AS NEEDED FOR PAIN.   MA CALLED MOM LATER THAT EVENING TO CHECK ON PT AROUND 7:18PM AT WHICH TIME MOM REPORTED SITE REACTION HAD IMPROVED.  NO FURTHER CALLS REC'D REGARDING THIS AS OF TIME OF THIS REPORT.
Extreme swelling and pain in right arm starting a few hours after the injecting and lasting for 72 h. Numbness in left hamstring starting 6 hours after the injection. This still occurs today 4 months later. Tingling on left side of body, muscle spasms in feet, vibrations in head when sleeping that prevents sleeping. This occurred a few days after the injection and has continues today, 4 months later. This is mostly on the left side. Electric shocks that occur randomly everywhere.
Patient experienced dizziness and migraine 30 minutes after receiving the vaccine. Patient had dizziness, nausea migraine and light sensitivity 1 day after receiving the vaccine as well. Sent home from work
Inappropriate schedule of vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on12th September 2018).   On 14-JUL-2023, the patient received the 2nd dose of Shingrix. On 14-JUL-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate schedule of vaccine). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date:10-NOV-2023 The reporter was consumer. The reporter reported that patient was confused about whether she needs another shingles shot due to a reminder sent to her on her phone that she needs another shingles shot. The patient had no further information to provide about this event. The patient reports she probably received both vaccines in her right arm, but she was not sure. The patient received 2nd dose later than recommended which led to lengthening of vaccination schedule. The reporter consented to follow up.
slept a lot; real bad chills; shakes; aches, soreness in the area; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Lot number: ER8732, Expiration Date: 31Jul2021) at the age of 61 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN AND PHENYLEPHRINE. Vaccination history included: Bnt162b2 (First dose; lot# EN6199; Expiration date: 30Jun2021. , ), administration date: 03Mar2021, when the patient was 61 years old, for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 24Mar2021, outcome "not recovered", described as "real bad chills"; TREMOR (non-serious) with onset 24Mar2021, outcome "recovering", described as "shakes"; PAIN (non-serious) with onset 24Mar2021, outcome "unknown", described as "aches, soreness in the area"; HYPERSOMNIA (non-serious) with onset 25Mar2021, outcome "unknown", described as "slept a lot". Therapeutic measures were taken as a result of chills, tremor, pain. Additional information:  The patient got her second dose on Wednesday, 24Mar2021, and experienced real bad chills, aches, soreness in the area and stated that she has taken ibuprofen (ADVIL) and ALEVE as treatment for the events, but the chills was not going away. It was also reported that the patient slept a lot yesterday, 25Mar2021 and all she could eat was cereal. Patient stated that she wanted to make sure there was something she can take to relieve the symptoms. Patient would like to know how long the symptoms will last. 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 and since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products.  No follow-up attempts are possible. No further information is expected.
Severe swelling, redness, heat, and pain on set first day lasting 4 day,s headache,  nausea, fever 102 first day 101 2nd day 100 3rd day 99 4th day and then returned to normal day 5. Nausea and headache still present. Fatigue constant since shot.
Heart palpitations; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 04Mar2021 at 10:30(at the age of 68-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and diverticulitis from unknown dates and unknown if ongoing. Concomitant medications included atenolol (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN), celecoxib (CELEBREX) and lorazepam (ATIVAN); all from unknown date for an unspecified indication. The patient had no known allergies to medications, food or other products. 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 four weeks prior to the vaccination. On 05Mar2021 at 12:00 the patient experienced Heart palpitations. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event Heart palpitations was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pateint  got flu; Initial information was received on 26-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional (patient).  This case involves a 75 years old patient who experienced who experienced flu (influenza), while patient received INFLUENZA VACCINE, [Flu shot].   Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry not reported] via an unknown route at an unknown administration site for prophylactic vaccination.   On an unknown date, the patient developed a non-serious flu (influenza) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the lot number for this case.
Anaphylaxis with labored breathing, coughing/vomiting with Epi Pen administered and immediate trip to the Emergency Room. Pt was treated with IV fluids, steroids and benadryl. He was released 4 hours later.  The next day he returned to Urgent Care for ongoing symptoms of stomach pain, coughing that led to vomiting, flushed face and runny eyes. He was treated with an oral steroid and more benadryl to be given every 6 hours.  Pt was also seen at his father's family care practice for further follow up.  Pt has been experiencing ongoing stomach pains, diarrhea, headaches and regression with bed wetting.  This was pt's first vaccine. He was unvaccinated until this.
Tested positive for Covid 19; Tested positive for Covid 19; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on Thursday (05Aug2021), the reporter learned that the person who had sat closest to him and had the Pfizer Covid Vaccine had tested positive for Covid 19 on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
The following day I was very tired and a headache. Then this morning at 3am, I woke up with chills but my head was on fire. My stomach is cramping. I have diarrhea.  I can hardly move, I?m so exhausted.
Watery eyes and nasal congestion to start.  Three days later progressed to dizziness, fatigue, cough, laryngitis and sneezing.
NO ADVERSE REACTIONS. PATIENT RECEIVED DOSE 2 WEEKS PRIOR TO 12TH BIRTHDAY. ON SIGNED CONSENT FORM THE PARENT STATED HER BIRTHDAY WAS EARLER AND MANUALLY WROTE AN AGE OF 12. PER THIS INFORMATION SHE WOULD HAVE BEEN ELIGABLE AND RECEIVED VACCINE AS SUCH. IT HAS COME TO OUR ATTENTION THAT PARENT WROTE WRONG INFO WHICH SHOW SHE ACTUALLY RECEIVED DOSE 2 WEEKS PRIOR TO APPROVED ELIGABLILITY.
We just had an otherwise healthy family friend drop dead "suddenly" a few weeks ago; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A 48-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death), outcome "fatal", described as "We just had an otherwise healthy family friend drop dead "suddenly" a few weeks ago". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: drop dead "suddenly"
I had a red circle around vaccination site that then traveled down my upper arm.  It has finally cleared up after two weeks.
I certainly got very sick the evening after my 1st dose and stayed sick with flu-like symptoms for about 24 hours after the 1st dose. I did not get quite as sick after the 2nd dose. However, in the months that followed, I developed what I believed to have been shingles in the left side of my neck/face. I was treated with anti-virals and the blisters (on the roof of my mouth, left side) did diminish, but they are still present months later. Since the blisters have persisted, we have tried swabbing them to detect the shingles virus, but it's too late to find any lingering zosters virus on the blisters. I wish I had been tested for shingles right away when the symptoms presented in late July. I still have the irritating blisters on the upper roof of my mouth and they are unchanging. No one can tell me what it is. I have also had some minor facial ticks (left and right side) and have been experiencing high blood pressure, when I have never had high blood pressure in the past.
Swelling and redness at injection site and down arm. MD requested pt. be sent to ED. Was treated like a topical allergic reaction in ED with orders to continue and monitor. No further complications. Status improved.
Patient called saying the day after vaccine was given patient developed a rash with blister in the crease of elbow that grew and has not gotten any better. Patient was instructed to see physician for medical evaluation and treatment
approx 6x6cm red, raised lesion warm, non tender, non pruritic w/more generalized papulopustular finer eruption on torso, face, lower & upper extremities, also non pruritic;
CHILLS; FEELING UNWELL; MYALGIA; This spontaneous report received from a health care professional concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included botanical remedies, and nutraceuticals, and other pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, The batch number was not reported and Expiry: Unknown) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced chills. On 10-MAR-2021, the subject experienced feeling unwell. On 10-MAR-2021, the subject experienced myalgia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, feeling unwell, and myalgia. This report was non-serious.
neck pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain) and HEADACHE (Headache) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, EZETIMIBE (ZETIA), CARVEDILOL, HYDROCHLOROTHIAZIDE, FLUOXETINE HYDROCHLORIDE (PROZAC), TRAZODONE, PRAMIPEXOLE, PREGABALIN (LYRICA), IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE SOLUTION) and OLODATEROL HYDROCHLORIDE, TIOTROPIUM BROMIDE MONOHYDRATE (STIOLTO RESPIMAT) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (neck pain) and HEADACHE (Headache). The patient was treated with LOSARTAN POTASSIUM at a dose of UNK dosage form. At the time of the report, NECK PAIN (neck pain) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Rec'd HepA #1, Tdap & Typhoid on 4-10-12. Broke out with red, raised hive described as a "cherry tomato" - progressively got larger - also has 4 smaller lesions. Initial break-out 1 week later and smaller lesions 11 days following vaccines. Mild itching.
High red spot in the site of the injection; Arm hard as a rock; Arm hurts at touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (High red spot in the site of the injection), VACCINATION SITE INDURATION (Arm hard as a rock) and PAIN IN EXTREMITY (Arm hurts at touch) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (High red spot in the site of the injection), VACCINATION SITE INDURATION (Arm hard as a rock) and PAIN IN EXTREMITY (Arm hurts at touch). At the time of the report, VACCINATION SITE ERYTHEMA (High red spot in the site of the injection), VACCINATION SITE INDURATION (Arm hard as a rock) and PAIN IN EXTREMITY (Arm hurts at touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Treatment was not reported.       Reporter did not allow further contact
Site: Bruising at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Medium, Systemic: low injection site- extremity numbness-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
reports cramping (R) calf several times between 11/29-11/30.  On 12/1/09 noted discomfort (R) neck and shoulder.  On 12/2/09 upon rising noted numbness and tingling (R) side of face x 1/2 hour.  As of 3pm this date (12/3/09) there have been no other symptoms noted by employee.
Lost of hearing; This is a spontaneous report received from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at left arm on 09Apr2021 04:00 PM at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient was not pregnant. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced Lost of hearing (reported on 08Apr2021, pending clarification).  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the event was not recovered.   Information about Batch/Lot number has been requested.
Within 5 minutes after leaving the hospital, my lips and left cheek started tingling. When I got home, my left cheek was beet red. That went away in a couple of hours, but left jaw up to my ear still feels strange with intermittent tingling in left cheek and lips. Called dr.
Information has been received from a nurse refers to a pediatric patient of unknown age. On 22-JAN-2015 the patient received an expired dose of PNEUMOVAX23, lot # J005068, expiry date: 18-JAN-2015 (dose and route not reported). The vaccine had been expired 4 days when it was given. No adverse effects reported.  Additional information as been requested.