chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have had 3 outbreaks of fever blisters on my lips since the 2nd dose of the vaccine and I hadn't had one in years.; I have had 3 outbreaks of fever blisters on my lips since the 2nd dose of the vaccine and I hadn't had one in years.; This is a spontaneous report from a contactable consumer (patient himself).   A 43-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP7534, expiration date: not reported, dose 2 via an unspecified route of administration, administered in Arm Right on 07Apr2021 (at the age of 43 years) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: not reported, expiration date: not reported, dose 1 via an unspecified route of administration, administered in Arm left on 17Mar2021 (at the age of 43 years) as dose 1, single for covid-19 immunization. On an unspecified date, the patient had 3 outbreaks of fever blisters on my lips since the 2nd dose of the vaccine and i hadn't had one in years. Clinical outcome of the events was reported as recovering.  No follow-up attempts are possible. No further information is expected.
rash that was burning/diagnosed as Shingles; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 23Feb2021 at 08:15 AM (at the age of 74 years old) (Lot Number: EN6200, unknown expiration) as a single dose for COVID-19 immunisation.  Medical history included high blood pressure and diabetes. The patient has unspecified concomitant medication. The patient also received first dose of BNT162B2 on 30Jan2021 at 09:15 AM (lot number: EL9264, unknown expiration) in right arm for COVID-19 immunisation. On 24Feb2021 at 08:00 AM, the patient experienced rash that was burning which was diagnosed as shingles. The patient had blood work and x-ray done with unknown results and was given prescriptions. The event resulted in doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit. The patient did not receive other vaccine in four weeks.  The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient had not yet recovered from the event.  No follow-up attempts are possible. No further information is expected.
2 hours later chills, fever, weakness, nausea, great body aches in all joints lasting for 2 days. My reaction to flu vaccines and shingles vaccines is so severe that it makes me think twice about having them. I am glad that I am now protected against shingles but I will probably not have the flu shot anymore. I know you eliminated thiomersal from the medium but I wonder if it is another component in the delivery medium. I can eat eggs, so it is not that.
pt recvd flu vax-was 1 of 15 who recvd vax & devel influenza & was hospitalized;
Narrative:  90yo male patient died inpatient hospice on 10/22/21. Death was caused by: acute hypoxic respiratory failure r/t presumed lung primary malignancy with pneumonia and pleural effusion. Pt had received covid vaccines on 2/2/21 & 3/3/21. Death is not related to covid vaccines.
JOINT PAIN, FEVER, SWELLING AT INJECTION SITE WITH NUMBNESS OF RIGHT ARM (ARM OF INJECTION)
COVID; Loose skin; Scarring; COVID; Chills; Feverish; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program (MARKETING PROGRAM NAME NOT AVAILIBLE). The reporter is the patient. Other Case identifier(s): 22K-163-4302126-00 (Agency).  A 23 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Mar2021 (Batch/Lot number: unknown) at the age of 22 years as dose 2, single and intramuscular, administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for hidradenitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 02Jul2021, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Feverish"; SKIN LAXITY (non-serious), outcome "unknown", described as "Loose skin"; SCAR (non-serious), outcome "unknown", described as "Scarring". The action taken for adalimumab was unknown.  The reporter's causality for the event of Chills, Loose skin, Scarring, Covid and Feverish with Adalimumab (Humira) was not provided.  The reporter's causality for the event Chills and feverish with Pfizer Biontech Covid-19 vaccine was reported as possible and for the event skin laxity, scarring and Covid-19 was not reported.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events Cannot be excluded "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."
patient complained of lethargy, diarrhea, headache ,coughing the same night as the vaccine administration
The patient started to feel an incessant itching from her head to her knees, with a more intense sensation at the injection site and her back, although she has no rash or redness.  She tried everything from moisturizers to Benadryl with no relief and decided to go see her PCP who put her on Prednisone daily until the itching stops.
Child received seasonal flu shot during a school flu clinic on 10/28/10. She experienced a syncopal attack. While waiting in the holding area to observe for reactions, she fell to the floor. Child does not remember falling but awakened right after she fell. She was dazed, hands were cool & clammy, lips pale & face diaphoretic. Monitored for 1/2 hr. VS stable. Returned to class.
Fever 101.5 Lightheaded Headache Muscle pain/weakness Loss of appetite/energy
PATIENT PRESENTED WITH RIGHT ARM SWELLING AND REDNESS X 2 DAYS. DX WITH REACTION TO ANTHRAX VACCINE. PATIENT TREATED WITH DICLOXACILLIN AND IBUFROFEN. ANCEF 2 GM IV, TORADOL 30 MG IV.
patient admitted for stroke 10/20-11/2/2021. received Pfizer vaccine 10/28/2021. discharged to SAR 11/2/2021. date of death = 11/20/2021.
felt mild chest tightness and shortness of breath for 2 days post vaccine (1st dose) that self resolved
75 yo male with a hx of diffuse idiopathyic skeletal hyperostosis, hand pain, hyperlipidemia, htn, mitral valve insufficiency, and vitamin d deficiency complained of numbness to finger post Pfizer COVID-19 vaccine. Dr.  from UCnotified and instructed to release patient if numbness resolved. The numbness did resolve and the patient was released home with family at 1730 2/17/2021. At 1810 that day, a follow-up call was made to make sure the patient was still ok. He reported he was. UC/ ER precautions given.
Beyond normal "brain fog", struggling to choose words, stuttering and stammering where none existed previously, neurological degradation.
lost her appetite; Slight fever; tiredness; headaches; Nausea; Weakness; This is a spontaneous report from a contactable consumer(patient). A 73-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EI9269), first dose via an unspecified route of administration, administered in left arm on 17Feb2021 as SINGLE DOSE for covid-19 immunization. Patient was 73 years old at the time of vaccination. The patient's medical history and concomitant medications were not reported. On 17feb2021, Wednesday the patient went to work after getting the vaccine and about 2 or 3 in the afternoon, she started having headaches, and nausea that came on slowly. She also experienced tiredness and weakness. She had a slight fever also, but she took Tylenol and that went away. Next day on 18Feb2021 the patient lost her appetite. She was still experiencing tiredness, weakness and headaches as well as the loss of appetite and nausea. She was wondering if she should expect the same side effects from the second dose, as she was scheduled for it on 10Mar2021, and she was scared she might get the same side effects, because she still had not been able to go back to work yet. Her nausea had improved a very little, but when she moves around it persists again, but when she rests is slows down. She confirmed that she had no other vaccines on the same day as her COVID vaccine. The patient underwent lab tests and procedures which included blood test: unknown: she has not received the results yet. She had not taken any medication at all, because all the medicines she was taking, she did not take them because she was worried they would interfere with the vaccine. Stated that when she gets the flu, which is very seldom, it is months before she gets better and states that the symptoms she was experiencing now, were the same thing she experiences when she has the flu. Therapeutic measures were taken as a result of slight fever. The outcome of fever was reported as unknown and other events was recovering.
24 hours after the 2nd dose my temperature rose 4 degrees, full body aches and sweating for 24 hours. Followed by dizziness and headache. Within two days my body began having seizures accompanied with ongoing flushing/cold sensations in the occipital region/top of spine, with a feeling of fainting and dizziness, nausea, without loss of consciousness. Sudden jerking movements of the arms, legs and the head/neck range from 2-5 minutes in duration and continue in clusters for 8-20 hours per day. This seizure activity has not subsided since February 17th, and is ongoing to date. MRI confirms no new structural abnormalities in the brain. CBC and metabolic panels are all within normal range. EKG normal. I am not epileptic. No history of drug use. No alcohol use.
The Menveo vaccine that this patient received may not have been mixed properly. During inventory at the end of the month there was only 1 vial of diluent left in the box suggesting that an improper diluent might have been used to administer the vaccine, rendering the vaccine invalid. We are unsure what patient may have received the improper solution, so we notified all patient seen in August, and suggested revaccination. Our state registry was updated to reflect the subpotent dose.
-huge lacrosse sized lymphnode in left armpit woke up in the morning repeatedly because it was tender.
This case was reported by a nurse via call center representative and described the occurrence of chills in a adult female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills, tiredness, fever and headache. On an unknown date, the outcome of the chills, tiredness, fever and headache were recovering/resolving. The reporter considered the chills, tiredness, fever and headache to be almost certainly related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. This case was not previously reported to any one. The healthcare provider provided information as reported by patient after receiving vaccine.
Appointment had to be postponed; A spontaneous report was received from a consumer concerning a female patient of unknown age, who received Moderna's COVID-19 vaccine(mRNA-1273) and appointment had to be postponed (product dose omission).  The patient's medical history was not provided. No relevant Concomitant medications were reported.  On 28 Jan 2021, prior to the onset of event, the patient received her first of the two planned vaccine doses of mRNA-1273(Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient was scheduled to receive the second dose, but a death in the family occurred and the appointment had to be postponed.   No treatment information was provided.  Action taken with the mRNA-1273 in response to the event was not reported.  The outcome of the event, appointment had to be postponed, was considered recovered; Reporter's Comments: This report refers to a case of Product dose omission, for mRNA-1273, lot #: unknown,  with no associated AEs.
Flulaval had temperature excursion, then administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 13th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's comment: Medical assistant reported that Flulaval had a temperature excursion during shipping from GlaxoSmithKline. The vaccines were put in the fridge at arrival. However a patient was administered a dose on the 13th October 2022. The reporter declined to provide additional information. The reporter did not consent to follow-up. Additional Supportive Information: The patient received dose of Flulaval which had a temperature excursion during shipping from GlaxoSmithKline, which led to Incorrect storage of drug.
Within 12 hours of vaccine patient complained of being short of breath and asked his wife to call 911, he then stopped breathing and she did CPR until rescue squad arrived. Pt was unable to be revived and died.
pt says she became very  weak, had 102 fever and sore right arm.   She says the fever has come down but she had no energy at all, she was unable to do anything and this has lasted for hours.  She has never had a vax that has disabled her for hours like this.  She says she feels like she is starting to get better at this point.
Weakness, Excessive urination ,Dizziness, developed chills and fever also UTI .
Patient cried when given shot; spiked a fever later in the evening. Gave Motrin. Patient started to slowly spiral down, lost words, babble, difficult to get to sleep/nap. Was given DTaP #4 in January 2001. Really started to see a difference after this.  As per annual follow up report. pt still diagnosed as having autism, language and sensory issues.   Nurse follow up on 06/30/04 states: "Complete."
Pt stated that she had become light headed and dizzy just after getting her shot. Pt stated that she also started to feel like her vision was starting to narrow. Staff stated that she had passed out for a couple of seconds and had become alert after laying her down.
12/29/09 evening, bruise, 12/30/09 2:30 PM, lump present at site, 12/31/09 7:30 AM, lump increased to nickel size with redness, 90mm redness present. No pain at present time. (Measured transverse to arm).
arm is numb from the middle finger up, he has some feeling around his elbow; double pumped; pain in his wrist which sends an electric shock up his arm; lump/small knot; can barely lay in bed; left arm and shoulder is sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump/small knot), ASTHENIA (can barely lay in bed), PAIN IN EXTREMITY (left arm and shoulder is sore), HYPOAESTHESIA (arm is numb from the middle finger up, he has some feeling around his elbow) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (double pumped) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy. Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for Allergy.   On 20-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced VACCINATION SITE MASS (lump/small knot), ASTHENIA (can barely lay in bed) and PAIN IN EXTREMITY (left arm and shoulder is sore). On an unknown date, the patient experienced HYPOAESTHESIA (arm is numb from the middle finger up, he has some feeling around his elbow), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (double pumped) and ARTHRALGIA (pain in his wrist which sends an electric shock up his arm). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (lump/small knot), ASTHENIA (can barely lay in bed), PAIN IN EXTREMITY (left arm and shoulder is sore), HYPOAESTHESIA (arm is numb from the middle finger up, he has some feeling around his elbow) and ARTHRALGIA (pain in his wrist which sends an electric shock up his arm) outcome was unknown and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (double pumped) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: inconclusive (Inconclusive) Inconclusive. On an unknown date, X-ray: inconclusive (Inconclusive) Inconclusive.         This case was linked to MOD-2021-093925 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Significant Follow up appended included Lab test X-ray and MRI added. New Events Numbness in hand, Wrong technique in drug usage process and Wrist pain were added.
Received injection 3-23-12 at 9:18 am. Pt reports that evening her throat was swollen, had px in throat and chest - heart racing and palpitations. Developed a rash on her cheeks. Symptoms resolved that evening. Pt called 3-28-12 to report these sy. Has had no sy since.
slight nausea; Clear liquids leaked out during the vaccination; Clear liquids leaked out during the vaccination; sore arm; This spontaneous case was reported by a physician and describes the occurrence of DEVICE CONNECTION ISSUE (Clear liquids leaked out during the vaccination), UNDERDOSE (Clear liquids leaked out during the vaccination), PAIN IN EXTREMITY (sore arm) and NAUSEA (slight nausea) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Gastritis, Obsessive-compulsive disorder, Low back pain and High cholesterol. Concomitant products included OMEPRAZOLE for Gastritis, ATORVASTATIN for High cholesterol, CITALOPRAM for Obsessive-compulsive disorder.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced DEVICE CONNECTION ISSUE (Clear liquids leaked out during the vaccination), UNDERDOSE (Clear liquids leaked out during the vaccination) and PAIN IN EXTREMITY (sore arm). On 11-Mar-2021, the patient experienced NAUSEA (slight nausea). On 10-Mar-2021, DEVICE CONNECTION ISSUE (Clear liquids leaked out during the vaccination) and UNDERDOSE (Clear liquids leaked out during the vaccination) had resolved. On 11-Mar-2021, NAUSEA (slight nausea) had resolved. On 13-Mar-2021, PAIN IN EXTREMITY (sore arm) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up information received on 04 May 2021 contained patient's medical history and concomitant medications, new events added and event outcome updated.
arm was pretty sore; large red, circular; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced pain in arm and erythema. On an unknown date, the outcome of the pain in arm and erythema were unknown.   It was unknown if the reporter considered the pain in arm and erythema to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received the 2nd dose of Shingrix on Monday. Monday night, the patient's arm was pretty sore, as he/she expected. Tuesday morning, 1 day after vaccination, the patient had a large red, circular (not further specified). The follow-up would not be possible as no contact details were available.
This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age and ethnicity received PREVNAR 13, intramuscular at 0.5 ml single in the deltoid on 21Jun2016 at 6:000PM. Medical history included ongoing diabetes. The patient was taking regular medications, but the details of those medications were unknown. At the time the vaccine was administered, the patient stated that she had never had the PREVNAR 13 vaccine in the past, but apparently she had in fact received PREVNAR 13 on 30Sep2015. Reporter also stated the patient developed a rash on her arm at the injection site and flu like symptoms on an unspecified date with outcome of unknown. The patient was hospitalized for was given vaccine twice and flu like symptoms on 19Jul2016.
Fatigued, sleep disturbance, "lesion" to R thigh inject site and R groin area, very irritable, decreased appetite, cold sweats.
Area of cellulitis at inj site. Started approximately 24h after vaccine. Area 3x4cm. Started on Bactrim DS 1 po q 12 hours for 10 days.
Patient has never had a seizer in his life. On June 14th he started having 30-40 per day for 3-days. He was in the full grand mal seizer for at least 1.5 hours prior to hospitalization.