chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Racing heart began approx 30 minutes after shot. About 3.5 hours later became shaky and started to sweat profusely with mild confusion. Was checked out by fire department with a pulseox and blood pressure. First blood pressure reading was 188/122 at which point they encouraged going to the er. I refused. They then decided to continue to monitor my blood pressure every 5 minutes. It slowly was coming down. When it reached 149/105 they allowed me to go home with advice to continue to monitor my blood pressure. If it began to increase they suggested going to the er or calling 911.  I continued to monitor my blood pressure at home every hour. It was slowly coming down, however the first normal (120/80) reading did not appear until 12:30 pm on 3/19/21.  On 3/18/21 at approximately 4:30pm a low grade fever of 100.5 developed with slight chills. At 8pm 3/18/21 I went to sleep after taking two tylenol and slept for 16.5 hours.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202100969793 (Pfizer). A 80 year-old male patient received bnt162b2 (BNT162B2), administration date 22Jul2021 (Lot number: EW0198) at the age of 80 years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VISION BLURRED (non-serious) with onset 24Jul2021, outcome "recovered" (24Jul2021), described as "Blurry vision right eye". Additional information: Caller was a male consumer who states that he had his first dose of the Pfizer COVID 19 vaccine on 22Jul2021 and then two days later on 24Jul2021 he experienced some blurry vision (he had blurred vison in his right eye for most of the day and then it went away). This had since subsided. He stated he had no other side effects, not even a sore arm. He relayed that his daughter and her husband also had the Pfizer COVID-19 vaccine and they only had mild symptoms. He would like to know if this had been reported and if it could happen again when he had his second dose on 12Aug2021. No follow-up attempts are possible. No further information is expected.
pt c/o onset of red rash 3-4 days p/vax;also knot under rt arm @ same time;rash red & itching over chest rt leg;no bleeding oozing, cracking;no n/v, no elevated temp;
head full; upper lip tingly; Received third dose after a booster/ vaccine in the incorrect order; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (head full), PARAESTHESIA ORAL (upper lip tingly) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received third dose after a booster/ vaccine in the incorrect order) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 039F21A, 027L20A and 031L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: FLU (Many years ago she had a reaction). Past adverse reactions to the above products included Vaccination adverse reaction with FLU. Concurrent medical conditions included Sjogren's and Immunocompromised. Concomitant products included LEVOTHYROXINE, SODIUM BICARBONATE, POTASSIUM CHLORIDE, PROBIOTICS NOS and ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS) for an unknown indication.   On 10-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) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2022, the patient experienced HEAD DISCOMFORT (head full) and PARAESTHESIA ORAL (upper lip tingly). 01-Feb-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received third dose after a booster/ vaccine in the incorrect order). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 01-Feb-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received third dose after a booster/ vaccine in the incorrect order) had resolved. At the time of the report, HEAD DISCOMFORT (head full) and PARAESTHESIA ORAL (upper lip tingly) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, Blood pressure measurement: fine (normal) Pressure fine. In February 2022, Heart rate: fine (normal) heart beat fine.         Concomitant medications include AREDS2 vitamin daily.  It was reported that patient took the vaccine in the incorrect order and received third dose after a booster. Patient did test and had fine lungs.  Treatment medication include steroid.   This case was linked to MOD-2022-472950 (Patient Link).
SICKER THAN A DOG; ARM SWELLED UP/3 INCH KNOT ON ARM; RED ARM; COULDN'T MOVE ARM; SORE ARM; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient previously received tetanus shot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced sicker than a dog. On 01-APR-2021, the subject experienced arm swelled up/3 inch knot on arm. On 01-APR-2021, the subject experienced red arm. On 01-APR-2021, the subject experienced couldn't move arm. On 01-APR-2021, the subject experienced sore arm. On 01-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sicker than a dog, arm swelled up/3 inch knot on arm, red arm, sore arm, couldn't move arm, and fever. This report was non-serious.
Insomnia, trouble sleeping for 7 days; This spontaneous case was reported by an other health care professional and describes the occurrence of INSOMNIA (Insomnia, trouble sleeping for 7 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 INSOMNIA (Insomnia, trouble sleeping for 7 days). At the time of the report, INSOMNIA (Insomnia, trouble sleeping for 7 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.
Was administered a dose of VARIVAX on 06/14/2008, which was too early to the patient; No adverse effects; 1 patient was administered a dose of improperly stored VARIVAX on 07/09/2019; "This dose of VARIVAX was also the patient's 4th dose of VARIVAX; The patient was then "administered a dose ofMMR II on 06/30/2008 and there has not enough time between the first dose of VARIVAX and the dose of M-M-R II; This spontaneous report was received from a physician concerning to patient of unknown gender who was 12 months of age at the first vaccination. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.   On 14-JUN-2008, the patient was administered a dose of varicella virus vaccine live (oka/merck)(VARIVAX) for prophylaxis (strength, dose, frequency, route of administration, lot # and expiration date were not reported), the physician considered it was too early for the patient to received the vaccine (product administered to patient of inappropriate age).  On 30-JUN-2008, the patient was administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis (strength, dose, frequency, route of administration, lot # and expiration date were not reported), and there was not enough time between the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) and the dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (inappropriate schedule of product administration). The patient received another dose of varicella virus vaccine live (oka/merck)(VARIVAX) on 30-JUN-2008, then a booster dose of the same vaccine on 23-JUN-2011.   On 09-JUL-2019, the patient was vaccinated with a dose of improperly stored of varicella virus vaccine live (oka/merck)(VARIVAX) lot. No. R022116 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck), expiration date reported  and establish as 02-AUG-2020, it was also reported that this was the 4th varicella virus vaccine live (oka/merck)(VARIVAX) administered (extra dose administered).  The administered 4th dose of varicella virus vaccine live (oka/merck)(VARIVAX) experienced a temperature of 6 to 14 Fahrenheit for 15 minutes. There was a digital data logger involved, but there was no previous temperature excursion.   No adverse effect was reported.
Patient had reaction to the influenza vaccination received on 9/16/10 and said that she was told as a result of the flu shot she contracted GUILLAIN BARRE Syndrome.
Feel my heart is really fast; Feel the heart coming really very fast; Feel very bad; Make me not comfortable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose, No events reported), for Covid-19 immunization. The following information was reported: PALPITATIONS (non-serious), outcome "unknown", described as "Feel my heart is really fast; Feel the heart coming really very fast"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Feel very bad"; DISCOMFORT (non-serious), outcome "unknown", described as "Make me not comfortable".  Additional information: I have a problem. I want to know, the third shot, I need to get it or not because after the second shot, I feel my heart is really fast and like for a 'time no feeling' (not clear), after the second shot for about 25 minutes. Then, I feel very bad then after that, then when I went down on the street I was try to fetch the, to catch 'purse' or something like that, I feel the heart coming really very fast. So, that is why now, I have a question, I need to do the third shot or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chest pain, SOB, palpitations, fatigue and dizziness. Cardiologist told her she had myocarditis.
I have COVID; I have COVID; This is a spontaneous report from a contactable consumer (the patient) from a Pfizer Program.  A 85-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) and  dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) both as single dose for covid-19 immunisation  .  The patient medical history was not reported. Concomitant medications included tofacitinib citrate (XELJANZ XR - 11mg tablet) taken for an unspecified indication, start and stop date were not reported.  The patient stated I have covid  on 22Aug2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive   on 22Aug2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
15 cm x 14 cm area of erythema, warmth and generalized swelling of (R) lateral arm, superficial abrasion over mid arm from scratching.
Around 10 or 11 pm, arm pain, chills, fatigue, headache, nausea, swollen lymph nodes, lightheadedness, fainted in tub. Next day, fatigue all day, couldn't talk, or eat.  Went back to bed again. The following day hot flashes, weakness. went to ER. Felt like blood pressure was dropping, tingling in legs, difficulty lifting her head.
Had shot and next day began horrific heart palpitations. Have continued need for 4 supplements daily to keep heart from racing.  Have never had issue with my heart in my life until i rcvd this one dose.
This spontaneous report was received from a 66 year old female patient enrolled in a Market Research program, referring to herself. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (formulation, dose, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced bad reaction. The outcome of bad reaction was unknown. The relatedness between the event and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not reported. Additional information is not expected as there was no consent for follow up.
Red, swollen, and itchy at injection site Treated with 50mg Benadryl
Tiredness, Fatigue; Experienced 101 Fever; This is a spontaneous report from a contactable nurse. This report was received via a sales representative. A 16-year-old female patient received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history was not reported. Concomitant medications included meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA) for immunization, montelukast sodium (SINGULAIR) and Birth Control Pill. The patient experienced 101 Fever, Tiredness, Fatigue for 2 days after dose on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
4 doses of expired Bexsero were inadvertently administered; This case was reported by a nurse via sales rep and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA14BA, expiry date March 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th April 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 26th April 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: During a school vaccination clinic, a dose of expired Bexsero was inadvertently administered to the patient which led to expired vaccine used. This was one of 4 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR094019:same reporter US-GLAXOSMITHKLINE-US2021AMR094020:same reporter US-GLAXOSMITHKLINE-US2021AMR094018:same reporter
pt recvd vax;mom observed a rash next am p/ vax;erythematous rash on dorsum of hands & feet,diffusely scattered across lower extremities & abd & around neckline;apparent distress;will give DPH if appear to itch;
4 month old patient received the acthib component of the pentacel vaccine reconstituted with sterile water instead of the dtap-ipv component with no adverse event; 4 month old patient received the acthib component of the pentacel vaccine reconstituted with sterile water instead of the dtap-ipv component with no adverse event; 4 month old patient received the acthib component of the pentacel vaccine reconstituted with sterile water instead of the dtap-ipv component with no adverse event; Initial information received on 29-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old female patient who received the ACTHIB component of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] reconstituted with sterile water instead of the DTaP-IPV component with no adverse event.    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13); and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Immunisation.  On 09-Sep-2022, the patient received a second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE at dose of 0.5 ml once (lot UJ648AAA,exp date: 25-Feb-2023) via intramuscular route in the left thigh for Immunisation.  On 09-Sep-2022 the patient received the ACTHIB component of the PENTACEL vaccine reconstituted with sterile water instead of the DTaP-IPV with no reported adverse event(product preparation error) (single component of a two-component product administered).   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Trend of elevation of total and direct bilirubin levels. Pt is a 4.5 mo female infant born with Gastroschisis requiring first day of life bowel reaction surgery with colostomy. Patient had reversal of ostromy on 9/1/09. This patient has had an elevation of bilirubin levels, likely secondary to TPN cholestasis since initial evaluation. She is enrolled FDA IND #13843 study to evaluation Rotateq vaccine in infants with short Bowel Syndrome. According to her pediatric surgeons, she is not in need of a transplant of liver/sm. bowel. Bilirubin can be elevated from red blood cell hemolysis or sepsis, of which this patient has also had during this course. However, her bilirubin levels remain elevated, which can be considered normal in some SBS infants. She has received 2 doses of study vaccine: dose #1 on 7/31/09 and dose #2 on 9/25/09.
Patient that received a dose of Moderna vaccine that expired 11/1; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient that received a dose of Moderna vaccine that expired 11/1) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 03-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient that received a dose of Moderna vaccine that expired 11/1). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient that received a dose of Moderna vaccine that expired 11/1) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had no adverse event.   On 16-Oct-2021 vial was initially stored in the refrigerator.  No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Nov-2021: Additional information includes updated reporter contact information,Added date of administration of vaccine. On 04-Nov-2021: Additional information includes Added batch/lot number,narrative was updated.
OBSTRUCTIVE SLEEP APNEA 4/5/2023 ACUTE UTI
SWEATING; POSSIBLE COVID 19; This spontaneous report received from a patient concerned a 20 year old male. 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, batch number: 1802068, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced sweating, and possible COVID 19. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of the sweating and possible COVID 19 was not reported. This report was non-serious.
Member was to receive Moderna Vaccine. She was given Pfizer instead. The administering nurse stated she asked the member if she was to receive a Pfizer vaccine. The patient replied, ?Yes.? After getting the Pfizer vaccine the patient pulled out an external card and stated it was supposed to be a Moderna vaccine (as a second dose), not a Pfizer.  1st Dose: Moderna Lot #: Unknown  2nd Dose: Pfizer Lot#: EW0176 No further treatment required. Monitored for an additional 30 minutes in the observation area.
Did not have a period for 2.5 months post second vaccination.  When she finally had a period on the 3rd month, post vaccination, it was significantly lighter in amount and number of days menstruating.  She is not scheduled to have her next period for another 10 days, so it in unclear if this has resolved itsself.
he felt the same as when she had COVID (scratchy throat and cough); he felt the same as when she had COVID (scratchy throat and cough); This is a spontaneous report from a contactable nurse. This nurse is reporting similar events for two patients. This is the second of two reports.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation.  The patient medical history included COVID. Concomitant medications were not reported.  It was reported that the patient got the vaccine (COVID 19 Vaccine) same day and was saying that she felt the same as when she had COVID (scratchy throat and cough) on Sunday (20Dec2020).. The outcome of the event was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020514115 same reporter, same drug, same event, different patient.
Information was received on 03-MAY-2017 from a licensed practical nurse regarding a patient (age and gender not reported). Medical history, concurrent conditions and concomitant medications were not reported. On 03-MAY-2017 the patient was inadvertently administered an expired dose of VARIVAX (lot # K018959, expiration 15-OCT-2016) (dose not specified). No adverse effect was reported. Action taken is not applicable and the outcome and causal relationship were not reported. No further information was provided. Additional information has been requested.
Headache, Myalgia, Fever,  chills, fatigue Narrative:  1/12 - onset of headache. 1/15 onset of chills and low grade fever (feels hot an cold), and fatigue 1/16 headache went away late afternoon. All symptoms resolved.
EVENT: Administration of FLUARIX QUAD vaccine. SYMPTONS: Limited range of motion of left arm; perpetual sharp-stabbing pain in left arm. TREATMENT: Physical exam 01/23/2017; physical therapy ordered 01/23/2017.