chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information regarding Prevnar was received from a healthcare professional regarding a 16 month old male patient who experienced pneumococcal bacteremia and empyema. At 16 months of age, the patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 0.5mL (IM). Concomitant medications were not reported. On an unspecified date in 2004, the patient experienced pneumococcal bacteremia and empyema. No additional information was available at the time of this report.
This spontaneous report as received from a other health professional (CMA) refers to a 12 months old male patient who was given VARIVAX (lot # reported as H018786; exp date: 15-OCT-2014), 0.5ml, once, subcutaneously in the left leg, on 27-DEC-2013 and accidentally given included PROQUAD (lot # reported as J000138, exp date: 04-JUL-2014), 0.5ml, once subcutaneously in the right leg on 27-DEC-2013. The patient's relevant medical history included acid reflux and congenital talipes equinovarus. The patient's relevant concomitant medications included amoxicillin, lansoprazole, ADVIL and TYLENOL. The patient had no relevant past drug history. He was given the VARIVAX for routine prevention of a 12 month old and given the included PROQUAD vaccination instead of the intended MMR vaccination, resulting in 2 doses of varicella. There were no adverse events observed. There was no relevant laboratory data. As of 27-DEC-2013, it was unknown if he would continue to take VARIVAX and included PROQUAD. The outcome of the dual varicella vaccination with VARIVAX and included PROQUAD was unknown. Additional information has been requested.
pt felt sick about 2hr p/vax 12DEC97;took advil;started to have diff breathing;taken to ER;recv med & 02 mask;pt has hx of asthma;
female felt lightheaded and faint. she was diaphoretic. denied pain. denied dif breathing. she was monitored and given water and released. Symptoms went away in 15mins. 13:42 125/72 p92 r 16; 13:54 131/69 p 90 r 20
develop a vesicle; It began to itch and he scratched it; Initial information received on 20-Oct-2017 regarding an unsolicited valid non-serious case received from other health professional via sales representative.  This case involves a male patient of unknown age who develop a vesicle (blister) and it began to itch and he scratched it (pruritus), while he received vaccine INFLUENZA USP TRIVAL A-B INTRADERMAL ADULT SUBVIRION VACCINE [FLUZONE INTRADERMAL].  Past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   On an unknown date, the patient received INFLUENZA USP TRIVAL A-B INTRADERMAL ADULT SUBVIRION VACCINE [lot number: unknown and expiration date: unknown] at a dose of 0.1 ml once via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) the patient developed a vesicle (blister) and it began to itch and he scratched it (pruritus) following the administration of suspect vaccine. The vesicle broke open and clear fluid came out.  He was wondering if the vaccine is going to work if the fluid came out.  He denies redness, induration, or itchiness since the vesicle popped open.  Lab data was not provided.  It was not reported if the patient received a corrective treatment.  The patient outcome was reported as resolved on an unknown date.  There will be no information available regarding batch number in this case.
No additional adverse effects reported.; patient received improperly stored dose of VARIVAX on 3/5/2020 which was administered via unspecified route.; This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were unknown. On 05-MAR-2020, the patient was vaccinated with improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck) (VARIVAX) therapy type : digital data logger, (lot # S025609 exp.date: 18-AUG-2021) which was reconstituted with properly stored sterile diluent via unspecified route for prophylaxis. No adverse event was reported. It was reported that the vaccine was stored at a temperature of 15 degree Fahrenheit to 46 degree Fahrenheit (-9 degree Celsius to 8 degree Celsius) -5.48 Celsius for a time frame of 7 hours. There was no previous temperature excursion.
Upper Arm Rashes; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 02Mar2021 12:15 PM (at the age of 48-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. Facility where vaccine was administered at Hospital. The patient did not receive any other vaccine in 4 weeks prior to the COVID vaccine. Patient did not receive any other medications in 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 07Feb2021 02:00 PM as dose 1, single for COVID-19 immunization. The patient experienced upper arm rashes on 07Mar2021 19:00. There was no treatment for the event. The clinical outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
headache/ a slight headache; knot in his stomach/ a little bit of an upset stomach; threw up/ Vomited; chills; tired; not hungry for anything; he was really sick/ he's still not feeling good/ sickness; This is a spontaneous report from a contactable consumer (wife) reported for her husband that a 63-years-old male patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, batch/lot number: FA6780, expiry date: 30Sep2021, code number: 59267100002), via an unknown route of administration in right arm on 18Jul2021 (at the age of 63-years-old) at 11:30 as single dose for COVID-19 immunisation at pharmacy. The patient's medical history and concomitant medications were none. History of all previous immunization with the Pfizer vaccine considered as suspect and additional vaccines administered on same day of the Pfizer Suspect were none. No additional vaccines administered on same date of the Pfizer Suspect. On 19Jul2021 at 00:30, the patient experienced headache/ a slight headache, knot in his stomach/ a little bit of an upset stomach, threw up/ Vomited, chills, tired, not hungry for anything, he was really sick/ he's still not feeling good/ sickness. The reporter explained that the patient received his first dose of the Pfizer COVID vaccine on Sunday 18Jul2021 then really late Sunday early Monday morning woke up with a bad reaction: headaches, knot in his stomach, threw up and had chills, he was really sick, he's still not feeling good. Caller confirms all symptoms started Sunday night at 11:30 AM, so technically on 19Jul2021 and all symptoms were still having have gotten a little better, they have improved. No adverse event required a visit to emergency Room and physician office. Prior vaccinations within 4 weeks, adverse event and relevant test were none. The outcome of the events threw up/vomiting and chills was recovered on 19Jul2021 at 21:00, while the outcome of the remaining events was recovering.  No follow up attempts are possible. No further information is expected.
Breakthrough Case of COVID, my symptoms are like allergies, cough, running nose and feeling slightly fatigue.
Pt developed induration of left arm->had to be hospitalized and treated with antibiotics and systemic steroids.
8/7/07 Varicella rash with multiple generalized, different staged vesicles on erythematous base. Onset rash 8/6/07 with fever.
No symptoms from first dose.   Immediately after second dose, injected arm felt numb/tingly. When seated at observation area, began to feel nauseous, dizzy, and began sweating. Rose to ask site staff for help, felt very uneven. Taken to back observation room and laid down on a cot. Blood pressure observed at 85/30, significantly lower than normal. Rested for approximately 15 minutes, then sat up. Nausea and blurry vision returned. No change in blood pressure. Blood was drawn, sugar and other indicators normal. Sat up again, feelings returned. Drank two water bottles and began to feel better, blood pressure returned to low end of normal after around 15 minutes. General weakness persisted throughout day, along with mild pain at injection site and in neck.
Day of vaccine, patient had some soreness at injection site. This was not particularly troubling. The next day, 12/1/18, she had chills, fever to 101.3, and headache. By 12/2, her fever had resolved, but she had swelling and erythema to a diameter of 4 inches, at the injection site. The swollen, erythematous area had pruritic and stinging sensations. This continued over next few days. She contacted, me, I initially advised Benadryl at night, and Zyrtec during day, to control sx, asked her to come in, which she did on 12/7/18. Exam confirmed the presence of erythema and swelling around the injection site, which by then had begun to resolve. She was instructed to continue the antihistamines until symptoms resolved.
Initial unsolicited report received from a healthcare professional on 14-Apr-2014. A female patient, whose medical history and concomitant medications were not reported had received a dose of Tetanus toxoid (batch number, expiry date, dose number, route and site of administration were not reported) on an unspecified date. On an unspecified date after vaccination, the patient became paralyzed for a 3-4 days and allergy. Upon internal review, the case is considered as serious due to important medical event (Paralysis). Laboratory investigations and corrective treatment were not reported. At the time of this report, the outcome for event paralyzed for 3-4 days was recovered and for allergy was unknown. Documents held by sender: none.
arm sore; "did not feel well"; inapproriate dosing schedule; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm, feeling unwell and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm, feeling unwell and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the pain in arm and feeling unwell to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported, but it could be 51 or 52 years. The patient received 1st dose of Shingrix a few months ago.  The patient reported arm soreness and did not feel well.  The patient may not come back for 2nd dose, which led to incomplete course of vaccination. The reporter consent to follow up.
No adverse events to date. Pt currently 14 day post vaccination. Total of up to 5 patients potentially received 5x  rec dose  (full 3.0 cc reconstituted vial) of yellow fever Vax.
Worsening of MG symptoms, to include diplopia (vertical plane) and ptosis.
fever-like convulsion; chills; This is a spontaneous report from a contactable other healthcare professional (HCP). A 43-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for Covid-19 immunisation. Medical history included polyarthritis. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for Covid-19 immunisation and experienced soreness in the arms. The patient experienced fever-like convulsion and chills on an unspecified date. The patient was advised to call the rheumatologist first before receiving the Covid 19 vaccine booster. She planned to sign-up for the Covid 19 booster shot (3rd dose) next month. The outcome of the events was unknown.   The lot number for the vaccine (BNT162B2) was not provided and will be requested during follow-up.
I wanted to report that I had the 2 doses of Pfizer?s vax in the spring 2021. As a caregiver of an immunocompromised family member, I decided to get the 2 Moderna shots, as well, which I did in July and August. For the 2nd dose, I also got the 1st dose of the Shingles vaccine. That night I had a fever of 102, which lasted about 24 hours. I also had a sore arm for about 2 days. That was it - seemed quite safe to have the Shingles and Moderna vaccines together - hard to say whether efficacy is affected. Thought you?d want to know as there isn?t much data on the safety of Covid vaccines with other vaccines.
soreness at the injection site; twinge pain near his neck area; 100.4(Degree)F fever; chilled/shivering; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration on 08Feb2021 (reported as "yesterday morning", at the age of 68-year-old male) at single dose for covid-19 immunisation. Medical history included ongoing arthritis, he also took 2 Tylenol for his conditions (arthritis) around 2:30 pm. The patient's concomitant medications were not reported. First the patient had no problem, but last night at 11:00 PM he woke up very chilled, shivering, these symptoms lasted for 30 minutes and the went away. Today he's feeling a light soreness at the injection site, it's not aching, he also had a quick slight twinge pain near his neck area, however his lymph nodes are not swollen. He has taken his temperature 3 times today, the last one was 100.4(degree)F; he also took 2 Tylenol for his conditions (arthritis) around 2:30pm. He would like to know if fever is one of the side effect how concerned should he be and what should he do. He would like to know if this is something temporary. He has some questions about the risk of receiving the vaccine. He took the first dosage yesterday morning (on 08Feb2021) and then when he came home, he noticed around 11pm, he woke up and noticed he could not get comfortable. He had chills and that lasted for 30 minutes.  Today, he noticed he has been taking his temperature. The last time he took it, it was 100.4 degrees. He has had slight soreness at injection site, not where some people he knows complained about pain all night long.  He just has slight soreness. He did not have any information to provide on the other people that had pain all night long. He did not have any redness or swelling.  He also read about lymph node swelling.  He has a twinge of swelling in his neck and is not sure that is what it is. His fever has not subsided.  He took Tylenol, which he later stated was an over the counter generic Acetaminophen, and he still has a fever. The outcome of the event Chills was recovered on 08Feb2021 23:30; of the other events was unknown.  Information on the lot/batch number has been requested.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.            Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-373949 (Patient Link).
Child received vaccine on 8/12/02 and come to clinic on 8/13/02 for physician provider. On exam, noted area of induration RLT. Pt not acting ill and was active. Mom instructed to administer Benadryl.
Unknown relation to vaccine but I received my Pfizer COVID booster shot on 10/3/21. I had a positive pregnancy test on 10/23/21. I had a miscarriage on 11/25/21 (8 weeks gestation).  D& C procedure completed on 12/14/21 at the hospital. Also, on 12/29/21 I was diagnosed with ulcerative proctitis after experiencing more frequent bowel movements and new bleeding/ clotting when defecating. Colonoscopy scheduled for 1/27/22 to explore if further colitis is now present.
Vaccine was administered at 10:12am on 3/5/20 with no initial problem.  Patient left vaccination room and went to sit in waiting area to meet her husband.  After ~10 minutes, the patient's husband alerted the pharmacy that the patient wasn't feeling well.  She complained of a tight feeling in her chest, a headache, and overall "funny feeling".  Pharmacist advised calling 911 and patient refused.  Patient was alert and responsive.  Pharmacist advised sitting in the waiting area until she felt better.  After a few more minutes, the patient's husband alerted the pharmacy that the patient needed help.  She was still alert and responsive, but was not feeling better.  Of note, the patient reported not taking her blood pressure medication (lisinopril) that morning.  The pharmacist called 911 and emergency responders arrived within a few minutes.  The patient was checked over by EMS and was determined to not need an ambulance.  She began feeling better and left the store without further incident.
I called mother of patient because she requested that a VAERS report be submitted. because her daughter was mistakenly given Rotateq prior to 6 weeks of age. Mother states pt. vomited after receiving Rotateq vaccine. Pt. displayed irritability and difficulty feeding x 3 days post vaccination. Mom noted bilateral sclera redness and measured temperatures in the 99 range for 2 days post vaccination. Mom notes that the patient's skin color has changed and  has a "brownish tone. " Pt. has been evaluated by a physician outside of our practice.
Purple rash to the right of the injection site left arm Started two days after shot. Has lasted five days
Left upper arm (site of vaccination) became edematous, erythematous, and pruritic.  Extended from left axillary to forearm, limited to left upper extremity.
I had a rash; my cheeks were just beet reddish blue looking; my face was swelled, it's kind of like a rash; low grade fever; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 20Mar2021 (Batch/Lot number was not reported) (at the age of 73 years old) as dose 1, single for COVID-19 immunisation. Medical history included diabetes, blood pressure high and arthritis. Concomitant medications included metformin, taken for diabetes, start and stop dates were not reported. The patient experienced rash, her cheeks were just beet reddish blue looking, her face was swelled, it was kind of like a rash and low grade fever on an unspecified date in 2021. The patient received no treatment for the events. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Adverse event is an  continuous  drop in Resting Heart Rate (RHR) from historical daily average of 62 bmp to now 46 bpm, and sleeping R.H.R. recorded at 42-40 bpm. (1) Primary Care Physician Office Visit on 8/13/21 recorded a finger pulse rate of 43 bpm .   PCP has referred me to a Cardiologist pending (2) Microlife Blood Pressure Monitor recording & stored readings:  3/24/21 = 60 bpm ; 5/9/21 = 63 bpm ; June no reading ; July 7/6 thru 7/15 reading averaged 51 - 54 bmp ; 7/19 = 45 bmp ; 7/20 thru 8/17 ranged 43, 44, 45 bmp (3) Fitbit 4 reading:  between 8/8/21 - 8/18-21 records R.H.R. of 46-47 bpm.  Sleeping RHR recorded between 42-40 bpm.
Patient was ok the day vaccine was administered - 9/12/19. The morning of 9/13/19 patient experienced nausea, sweating, malaise, fever (101.4), and fainted. She stayed in bed all day and reported events to pharmacist at 7:30 pm 9/13/19.  Patient was advised to seek medical attention.
Patient came to Pharmacy on 11/1/2012 said he has been feeling muscle pain after his shot and still has mucle pain now. No bruising. He called his Doctor. He plans to see his Doctor.
4 doses of vaccine administered more than 12 hours after puncture /vial first puncture for 4 patients was on 5/17/2021 and these 4 patients received vaccine on 5/18/2021 and 5/20/2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 doses of vaccine administered more than 12 hours after puncture /vial first puncture for 4 patients was on 5/17/2021 and these 4 patients received vaccine on 5/18/2021 and 5/20/2021) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 doses of vaccine administered more than 12 hours after puncture /vial first puncture for 4 patients was on 5/17/2021 and these 4 patients received vaccine on 5/18/2021 and 5/20/2021). On 20-May-2021, EXPIRED PRODUCT ADMINISTERED (4 doses of vaccine administered more than 12 hours after puncture /vial first puncture for 4 patients was on 5/17/2021 and these 4 patients received vaccine on 5/18/2021 and 5/20/2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   It was reported that 5 doses of COVID-19 vaccine were administered from 1 vial over a 3 day period. A vial of COVID-19 vaccine was first punctured on 17-May-2021. The vial was stored under refrigeration and subsequently used for 4 additional patients.  Two patients received doses of the vaccine on 18-May-2021 and 2 patients received doses on 20-May-2021. There were no adverse reactions. The patient's ages are 50, 67, 56 and 28 and the race of three patients is white, and one patient is black.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up received and reporter information and patient information updated.
This spontaneous report as received from a certified medical assistant refers to numerous unspecified patients. The medical assistant reported that numerous unspecified patients received doses of PNEUMOVAX23 (dose, route and lot # not reported) that went through an unsupported temperature excursion. No adverse effects were reported. It was unspecified if the patients sought medical attention. This is one of several reports received from the same source. Additional information is not expected.