chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Feeling flushed; Anxiety (include misc mental health); Elevated blood pressure; This is a spontaneous report from a non-contactable other hcp. A 52-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6205), via an unspecified route of administration on an unspecified date as first dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that during her 15 minutes waiting period after the injection, the patient began to experience feeling flushed, Vaccine related Anxiety (include misc mental health) elevated blood pressure. Patient received treatment included water, snacks and ice pack. Patient observed approx. 30 minutes. Patient improved in symptoms after rest, food, water and ice pack. Her BP was coming down. HR and RR normal. Patient felt better. She wanted to leave as staying there was making her more anxious. Recommended that she monitor her bp at home. If persisted to be elevated of 140/90 that she follow up with her PCP. On an unspecified date, the patient underwent lab tests and procedures which included BP: elevated of 140/90 and coming down, HR (Heart rate): normal, RR (respiratory rate): normal. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Foaming of mouth, difficulty breathing, syncope,  5 minutes, Eyes rolled back, possibly exaggerated vasovagal,
10/24  in evening- developed achiness in muscles, fever of 99.6, chills 10/25- morning achiness worsened, fever of 102,6, diarrhea 10/26- fever continued, diarrhea worsened (every 2 hours with cramping), achiness, anorexia, lethargy 10/27- diarrhea every 2 hours with cramping, anorexia, lethargy 10/28-lethargy, diarrhea with cramping, went to ER at Hospital, received  1 L of LR, ruled out C Dif, discharged with diet instructions, additional stool sample provided 10/29 -  diarrhea and cramping continued, stool sample QNS, MD prescribed antibiotic Z 10/30-  diarrhea and cramping continued 10/31- diarrhea and cramping lessened 11/1 - stools soft and no cramping 11/2 -stools returning to normal
This spontaneous report as received from a healthcare worker refers to a patient. The healthcare worker reported that the 52 year old patient who had negative titer for VARIVAX (Merck) actually received ZOSTAVAX (dose, route, lot number not reported) instead due to a human error. The provider wanted to give VARIVAX (Merck) to the 52 years old patient because the patient had no titer for varicella. No adverse event reported. Additional information has been requested.
booster dose > 12 hour post puncture; Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (booster dose > 12 hour post puncture) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 04-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (booster dose > 12 hour post puncture) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). On 04-Jan-2022, EXPIRED PRODUCT ADMINISTERED (booster dose > 12 hour post puncture) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Pharmacist reported about two patients who received Moderna COVID-19 booster dose administered after 12 hours of puncture. The doses were drawn up into syringes prior to administration.  No Concomitant medication were reported.  No Treatment information was reported.   This case was linked to MOD-2022-438999 (Patient Link).
on going high pitched cry from 11-12:00am on 03/14/2005 through 1:30 am 03/15/2005. 12 hours duration.
patient reports having unbearable pain, having difficulty raising his arm.  Had to undergo physical therapy.
Tested positive for covid after receiving the first shot; Tested positive for covid after receiving the first shot; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer-sponsored program. A 24-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and was not pregnant. The patient was tested positive for COVID after receiving the first shot on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Injection site pain; headache; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), on 03Feb2021 at 10:30 (at the age of 46-years-old) at 1st dose, single, administered in right arm, for COVID-19 immunization. Medical history was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient had not allergies to medications, food, or other products. Concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no medications were received within 2 weeks of vaccination. The patient experienced injection site pain and headache on 03Feb2021 at 13:30. The events were reported as non-serious. No treatment was received for the adverse events. The patient had recovered from the events in Feb2021.   Follow-up attempts are completed. No further information is expected.
Enflamed her fibromyalgia; Injection site pain; Aversion to light; Excruciating muscle pain from head to toe; Joints were really bad; Ended up in bed for three days; This spontaneous case was reported by a consumer and describes the occurrence of FIBROMYALGIA (Enflamed her fibromyalgia), PHOTOPHOBIA (Aversion to light), BEDRIDDEN (Ended up in bed for three days), MYALGIA (Excruciating muscle pain from head to toe) and ARTHRALGIA (Joints were really bad) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010AZIA and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PHOTOPHOBIA (Aversion to light), MYALGIA (Excruciating muscle pain from head to toe) and ARTHRALGIA (Joints were really bad). On an unknown date, the patient experienced FIBROMYALGIA (Enflamed her fibromyalgia), BEDRIDDEN (Ended up in bed for three days) and VACCINATION SITE PAIN (Injection site pain). The patient was treated with CELECOXIB (CELEBREX) at an unspecified dose and frequency. At the time of the report, FIBROMYALGIA (Enflamed her fibromyalgia) and ARTHRALGIA (Joints were really bad) was resolving, PHOTOPHOBIA (Aversion to light) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown and BEDRIDDEN (Ended up in bed for three days) and MYALGIA (Excruciating muscle pain from head to toe) had resolved.            No concomitant medications were provided.
After receiving the vaccine I was diagnosed with Pityriasis Rosea. I had the rash for 30 days then it went away. I also had arm pain through out the month, and it has been ongoing. I also had burning, hot, skin for about a week on my stomach and upper chest. I was prescribed a cream. I had a red swollen arm for a week.
Patient presented to the ED on 5/9/2021 and 5/11/2021 for right ureteral stone and acute pyelonephritis, and was subsequently hospitalized on 5/11/2021. These visits are within 6 weeks of receiving COVID vaccination.
PT STATED SHE HAD PINS AND NEEDLES IN HER ARM HX OFVASOGEL. ELEVATED LEGS, GIVEN GINGER ALE, AND CRACKERS.   OBSEREVD FOR 15 ADDITIONAL MINTUES FELT MUCH BETTER.
1 day p/receiving vax pt devel rash & reddness for legs & face; mom reported small white raised area on leg; mom took pt for ER visit;
Red, swollen, warm and tender mass, 8cm raised by 1cm on lateral right arm by 3rd day, post vax.
SWOLLEN, ERYTHEMA, LOW GRADE TEMPERATURE, FELT THROAT THICKENING BUT AIRWAY NOT OBSTRUCTED.
sore arm for about 24 hours then went away. Then patient's heart went into A-fib per patient
Headache and fatigue 5 hours post injection  Chills/Body aches/fatigue 6 hours post injection Body aches/fatigue 24 hours post injection Joint pain/fatigue 36 hours post injection
Swollen lymph nodes (bilaterally) with significant swelling on the left side.  This was a more severe reaction than the one I received after my first dose. Onset was immediate and swelling was worse.  I do still have some sensitivity with palpation in the area of my left neck where the swelling was the worst.
Did you/the patient previously receive a COVID-19 Vaccine?: Yes; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in right arm, in Jul2021 as dose 2, single (Batch/Lot number: unknown), in left arm and in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Did you/the patient previously receive a COVID-19 Vaccine?: Yes"; COVID-19 (medically significant), outcome "not recovered", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Rebound Covid infection. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient was received other medication in 2weeks. She had no known allergies. And no other medical history. The Paxlovid used as treatment for COVID 19 and it was started on 11Jun2022 and stopped on 15Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 1:42 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 1:42 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 70.10 for dose administered on 11 Jan 2021.  No concomitant medications were reported.  Batch number 041L20A underwent temperature excursion on 11 Jan 2021. This vial was moved to fridge on 08 Jan 2021 and beyond use date for the vial was reported as 07 Feb 2021. Product moved to clinic on 11 Jan 2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
tingling cool sensation in her lower legs from her knees down/tingling cool sensation in elbow and forearm; she has been tired; This is a spontaneous report from a contactable consumer or other non health care prfoesssional. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: EM9810 ), dose 2 via an unspecified route of administration on 15Feb2021 ( at the age of 50 years old) at 11:34 in the afternoon as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2(PFIZER-BIONTECH m-RNA COVID-19 VACCINE, Lot number EL9262, expiry date: not reported) via unspecified route on 25Jan2021 as dose 1, single for COVID-19 immunization and experienced tired which she noticed with the first one too.She also did after the first dose, and she already reported that.The patient experienced tingling cool sensation in her lower legs from her knees down/tingling cool sensation in elbow and forearm, she has been tired on 15Feb2021 . Her doctor did give her the okay for the second vaccine because she didn't have a major side effect to the first dose. She did not have an anaphylactic reaction. Her doctor did tell her to stay an hour instead of 30 minutes. She stayed for an hour. This time instead of the side effect coming on in 10 minutes like the first vaccine, it came on in 20 minutes. It was a tingling cool sensation in her lower legs from her knees down. Then a minute or so after the tingling and cool sensation started in her elbow and forearm. The forearm lasted maybe 20-30 seconds. The tingling in legs lasted a little longer. The doctor gave her hydroxyzine which is a medication for anxiety and it actually acts like a Benadryl. So it was kind of a two for one. She did take that 35minutes after getting the vaccine. It seemed to help a lot. She stayed an hour, and was fine. Four hours later, just to be safe, she took two over the counter Benadryl. She was basically fine. The next day, she didn't get flu like symptoms. She heard that is common, but she didn't have anything like that. For 2-3 days after she has been tired which she noticed with the first one too. When she checked out, the nurse told her people that day reported the same thing. Other reported that cooling tingling sensation some even reported numbness. The first time a different nurse told her the same thing. No further details provided. She was not taking any Benadryl or hydroxyzine. She is feeling 80% back to normal. The patient enquired She called the doctor, and the asked the nurse when she would technically be fully vaccinated and the nurse said 14 days, but Pfizer said 7 days, and so did someone else. Which was true.Caller was informed Medical Information's information comes from the product insert.The patient was recovered completely from tingling cool sensation in her lower legs from her knees down/tingling cool sensation in elbow and forearm on 15Feb2021. The patient was recovering from she has been tired. Follow-up attempts completed. No further information expected.
PT WAS ADMINISTERED INFLUENZA VACCINE, ABOUT 5 MINUTES LATER, PT SAID SHE WAS NAUSEATED AND VOMITED. PT SAID SHE FELT FINE AFTERWARDS. CALLED 911 JUST TO BE SAFE, PARAMEDICS ARRIVED IN 10 MINUTES CHECKED HER VITAL SIGNS AND SAID SHE WAS FINE AND GOOD TO GO HOME OR URGENT CARE. MOTHER CHOSE TO GO HOME. CALLED PATIENT'S MOM THE NEXT DAY AND WAS INFORMED THAT PATIENT WAS DOING FINE.
pt recv vax;in eve started off w/ itching & red blotches, pimples appeared & spread all over the rt side of the body;tx w/ dph & hives & itchiness abated shortly p/ tx;
Itching started at vaccination site about 20 mins after vaccination, then progressed to scratchy throat, face itching, tongue tingling.   This was the individual's second dose, she had no issues with the first dose.  She has history of allergy to IV contrast dye, but no previous issues with vaccines. Provided 50 mg Benadryl onsite and had no further issues, monitored for over one hour, symptoms improved, and drove herself home from vaccination event.
fussy, fever (measured @ 101 ax) for about 3 days; tx APAP;
On 7/22/2022, I had extreme fatigue, and the worse headache I have ever had in my life, and also COVID-19 brain for, if you will. On 7/22/2022, I took a COVID-19 home test and it was positive. On 7/23/2022, I had a PCR test, and it was positive. The fatigue got much worse, and I also started having digestive track issues, diarrhea and that went on for a couple of days. I contacted my doctor on 7/22/2022, and he told me to call if I started getting heart issues, otherwise he advised me to rest and hydrate. At some point after 2 weeks, I started having rapid heart rates and I called the doctor again. He told me to take baby Aspirin and go to the ER if it continued, but it did not continue. I recovered around day 10, I was over it. I had the extreme fatigue and brain fog till around the 14th day.
awakened at 0500 the following morning with a blinding migraine and nausea.  Prior to that there were no sequelae.  No redness or swelling at the injection site; mild generalized muscle aches.  Took ibuprofen 600 mg tid for 36 hours.  Additional -- difficulty concentrating, some word finding issues and fatigue.  Symptoms resolved after 52 hours.
Headache, Myalgia, Fever, Diarrhea, TIREDNESS, CHILLS Narrative:
Initial report was received from a consumer on 18 January 2013. Case is invalid (no patient identifiers). Three unidentified patients had received an intramuscular injection of FLUZONE (lot number, site and exact date of administration not reported) in October of 2012. Two months later, in December of 2012, the patients came down with flu symptoms and tested positive for the A strain using the BD Veritor test. Symptoms included cough, fever for 2.5 days, chest congestion, runny nose with copious mucus and widespread body aches. The symptoms lasted about a week. The patient had no illness at the time of vaccination. Outcome was recovered. Follow-up information was received from a healthcare professional on 01 April 2013. The patient was a 35-year-old female who received FLUZONE, lot number UH713AB on 21 September 2012. Adverse event onset date was reported as 18 January 2013. Outcome remained recovered. Documents held by sender: None.
On 6/18/99, the pt experienced anterior, posterior, occipital, and submandibular tender lymphadenopathy without other symptoms. The pt sought unspecified medical attention. Seven to ten days following onset, the pt's experiences resolved without antibiotic treatment.
Chills; Cough; Shortness of breath; Body aching; Loss of taste; Lots of nasal congestion and mucus; Lots of nasal congestion and mucus; This is a spontaneous report from a contactable consumer (parent). A 15-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot/batch no. was not reported) via unspecified route, as 1st dose, single dose on 14May2021 for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that on an unspecified date in May2021, a day later one of her children experienced chills, cough, shortness of breath, body aching, loss of taste, lots of nasal congestion and mucus, did not have a fever, then she presented the symptoms 4 days after receiving the vaccine and her other son presented it a week later. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24May2021. Therapeutic measures were taken as a result of events with antibiotics. The report was non-serious. Outcome of the events was unknown.  Information about Lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021650327 Same reporter/drug/event, different patient.;US-PFIZER INC-2021651029 Same reporter/drug/event, different patient.
10am, started getting dizzy when moving head quickly. By 4pm, was having a hard time understanding what people were saying, as well as feeling very dizzy and had chills. See a Doctor who gave her Prednisone to counteract the effects.  Advised her to not return to work the following day.  She went home and slept that whole evening as well as most of the following day.  Was feeling mostly back to herself by around 4ish the following day, Oct 11.
allergic reaction; Rash; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction) and RASH (Rash) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (allergy to penicillin), Sulfonamide allergy (Allergic to sulfa drugs) and Allergy to antibiotic (Cipro allergy).    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction) and RASH (Rash). At the time of the report, HYPERSENSITIVITY (allergic reaction) and RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information, if any, was not provided by the reporter.  Treatment information, if any, was not provided.   This case was linked to MOD-2021-256597 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow-up received and Reporter information updated and new event added.
Right after injection, just the normal sore arm. No other symptoms. 3 weeks later started getting stinging and pain along my side from the back around to the front. After about 3 days blisters started to develop. It was very painful. Lasted for about 4-5 weeks.