chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough case of COVID-19 after booster shot; Breakthrough case of COVID-19 after booster shot; booster; This is a spontaneous report received from a contactable reporter (Other HCP). A 23 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 30Sep2021 11:00 (Lot number: 301358A) at the age of 23 years as dose 3 (booster), single, administered in arm left, administration date 31Mar2021 16:00 (Lot number: ER8730) at the age of 22 years as dose 2, single and administered in arm left, administration date 10Mar2021 16:00 (Lot number: EN6208) at the age of 23 years as dose 1, single for covid-19 immunisation. There were no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported IMMUNISATION (medically significant) with onset 30Sep2021 11:00, outcome unknown; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Dec2021, outcome not recovered. The patient underwent the following laboratory tests and procedures sars-cov-2 test (08Dec2021) negative, Post vaccination: Nasal Swab; (11Dec2021) positive, notes: Post vaccination: Nasal Swab; (15Nov2021) negative, Post vaccination: Nasal Swab; (28Nov2021) negative, Post vaccination: Nasal Swab; (05Dec2021) negative, Post vaccination: Nasal Swab; (10Dec2021) positive, Post vaccination: Nasal Swab. The report of patient was a Breakthrough case of COVID-19 after booster shot. Therapeutic measures were taken as a result of vaccination failure, covid-19 including OTC cough and cold meds. The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure and immunization cannot be ruled out.
lost my voice; throat is on fire; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (lost my voice) and THROAT IRRITATION (throat is on fire) in a patient of an unknown age and gender 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced APHONIA (lost my voice) and THROAT IRRITATION (throat is on fire). At the time of the report, APHONIA (lost my voice) and THROAT IRRITATION (throat is on fire) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information was not provided.    Reporter did not allow further contact
Grade 1 Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 23Apr2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included colecalciferol (VIT D3), lysine (MANUFACTURER UNKNOWN), ascorbic acid; calcium carbonate; calcium pantothenate; calcium phosphate; chromium; cyanocobalamin; folic acid; magnesium carbonate; magnesium hydroxide; manganese gluconate; nicotinic acid; potassium bicarbonate; potassium carbonate; potassium phosphate dibasic;, pyridoxine hydrochloride; quercetin; riboflavin sodium phosphate; sodium bicarbonate; sodium phosphate; thiamine hydrochloride; thioctic acid; zinc ascorbate (EMERGEN C), cetirizine hydrochloride (ZYRTEC) and unspecified "MultiVit" ; all for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 01Apr2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 24Apr2021, the patient experienced grade 1 fatigue which lasted for 24 hours and was relieved by rest, started the day after the second dose was received. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event grade 1 fatigue was resolved on 25Apr2021 after a duration of 24 hours.   No follow-up attempts are needed. No further information is expected.
Pt was given varivax shot in right arm. Pt developed a headache and the injection site was red and swollen at the injection site. Also had mild stiffness of her neck.
Vision impairment; nausea; sweating; dizziness; equilibrium impaired.
10 HRS - PAIN IN SITE ARM  24 HRS -CONFUSED ,DIZZINESS, BODY ACHES, FATIGUE
juice ran out of it when she stuck needle; brown spot; hurts; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL EXPOSURE TO PRODUCT (juice ran out of it when she stuck needle), ERYTHEMA (brown spot) and PAIN (hurts) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL EXPOSURE TO PRODUCT (juice ran out of it when she stuck needle), ERYTHEMA (brown spot) and PAIN (hurts). At the time of the report, ACCIDENTAL EXPOSURE TO PRODUCT (juice ran out of it when she stuck needle), ERYTHEMA (brown spot) and PAIN (hurts) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Erythema multiforme rash. Started 10/12/2004. No treatment indicated.
This spontaneous report as received from a pharmacist refers to a 60 year old male patient with diabetes and hypertension. The patient had no known drug allergies. On 16-OCT-2013 the patient was vaccinated with ZOSTAVAX, (0.65 ml, subcutaneous, dose number and lot number not reported) for prevention of shingles. Concomitant therapies included atorvastatin, lisinopril (manufacturer unknown), ACTOS, glipizide, fenofibrate, LANTUS SOLOSTAR, vitamin d (unspecified), VICTOZA and metformin. On an unknown date the patient experienced a rash, redness closer to the elbow than to the upper, posterior injection site on the arm after receiving ZOSTAVAX. Varicella Zoster Virus Identification Program (VZVIP) packet accepted by pharmacist and VZVIP packet faxed to pharmacist and physician. The patient sought medical attention (saw the pharmacist on 19-OCT-2013) but received no treatment. The outcome of the events was unknown. Additional information has been requested.
Within 10 hrs.: sore arm, chills, abdominal pain (left and right). Within 24 hrs.: fever, muscle ache, and headache. Within 48-72 hrs.: pulsating headache, nausea, occasional heart pounding, dizziness when standing or moving, and feeling dehydrated even when drinking fluids. Within 96 hrs.: dizziness when standing or sitting, right abdominal pain, and heart pounding.
Had a red rash/hives around diaper area, neck, swollen red ears around two hours after DPT and Hib vaccine administration. Rash tapered on its own by 5 p.m. Patient slept through the night, woke up with rash on torso, armpits and back, and had swollen eye lids. Have Benadryl orally (4 ml) at 7:30 a.m. 7/24/14. Symptoms dissipated by 8:30 a.m.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: purple hands-Medium, Additional Details: Patient was very anxious prior to the moderna vaccine administration.  Once given, she started feeling dizzy and faint.  After about 10 minutes her hands were turning purple. She was asked if I can call 911 for help and she agreed. paramedics arrived within 5-10 min and took her in for care.
23 year old pt delivered by C section for toxemia on 3/3/2005 and prior to discharge received a rubella vaccine. Pt developed itchy rash on hands and arms symptoms were recurrent after treatment. Assessment urticaria likely from rubella vaccine. Pt treated with Benadryl and single dose of triamcinolone.
Herpes simplex; Stiff neck left/First sign of cold sore was concurrent with stiff left side of neck; This spontaneous case was reported by a consumer and describes the occurrence of HERPES SIMPLEX (Herpes simplex) and MUSCULOSKELETAL STIFFNESS (Stiff neck left/First sign of cold sore was concurrent with stiff left side of neck) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Hypothyroidism in 1983 and Essential hypertension in 2018. Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR) and AMLODIPINE for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, ZOLPIDEM TARTRATE (AMBIEN) for Insomnia, LIOTHYRONINE SODIUM (CYTOMEL) for an unknown indication.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HERPES SIMPLEX (Herpes simplex) and MUSCULOSKELETAL STIFFNESS (Stiff neck left/First sign of cold sore was concurrent with stiff left side of neck). On 02-Feb-2021, MUSCULOSKELETAL STIFFNESS (Stiff neck left/First sign of cold sore was concurrent with stiff left side of neck) had resolved. On 03-Feb-2021, HERPES SIMPLEX (Herpes simplex) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The reporter mentioned the first sign of cold sore was concurrent with stiff left side of neck.  Treatment information not provided by reporter.       Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up recived and reporter information updated, patient medical history and concomitant medications updated, vaccine information updated and event information updated.
My blood pressure has been uncontrollable since getting this vaccine.  I had been off water pills for almost 4 years prior.  Since the vaccine I have been put back on water pills that did not lower my blood pressure; therefore, for the first time in my life I was put on blood pressure medication which did not regulate my blood pressure either.
Fever, chills, headache, muscle soreness,swollen lymph node under right arm pit
I developed pain and tenderness in my forehead which progressed to blisters. It was diagnosed as Shingles by my doctor on 4/30/2021.
About 12 hours after injection, I had diarrhea (middle of the night) and also felt very tired.  This lasted for about 6 hours and then I felt fine.
Rebound of Covid-19 Awful taste while taking; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Rebound of Covid-19 Awful taste while taking) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE for an unknown indication.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-May-2022, the patient experienced COVID-19 (Rebound of Covid-19 Awful taste while taking). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 17-May-2022 to 22-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound of Covid-19 Awful taste while taking) had not resolved.            It was reported that the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.   It was reported that the patient previously received a COVID-19 Vaccine.  On 29-May-2022 at 16:30, the patient experienced rebound of Covid-19 Awful taste while taking.  The device date reported as 29-May-2022.  Company Comment: This spontaneous case concerns a 48-year-old, female patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19, described as rebound infection. The event occurred after receiving mRNA-1273 as third COVID-19 vaccine dose, which was administered on an unknown date. The patient initially received a complete course of NIRMATRELVIR/RITONAVIR (Paxlovid) but noted re-occurrence of symptoms 7 days post-treatment. Details on presenting symptoms, COVID-19 tests conducted and additional treatment administered, if any, were not provided in the case. The ongoing COVID-19 pandemic remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 48-year-old, female patient with no reported medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19, described as rebound infection. The event occurred after receiving mRNA-1273 as third COVID-19 vaccine dose, which was administered on an unknown date. The patient initially received a complete course of NIRMATRELVIR/RITONAVIR (Paxlovid) but noted re-occurrence of symptoms 7 days post-treatment. Details on presenting symptoms, COVID-19 tests conducted and additional treatment administered, if any, were not provided in the case. The ongoing COVID-19 pandemic remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Information has been received from a female consumer who on 30-JUL-2007 was vaccinated with a single dose of Zostavax (Oka/Merck).  On 31-JUL-2007 the patient developed redness at the injection site.  At the time of this report the patient had not recovered.  No further information was provided.  There was no product quality complaint involved.  Additional information is not expected.
PT COMPLAINED OF FEELING HOT 25 MINUTES AFTER INJECTION. PT HAD ALREADY LEFT FACILITY AND THEN RETURNED. SHE FELT HOT AND FACE FLUSHING. PT FEELING ANXIOUS, DOES HAVE HISTORY OF ANXIETY. VITALS OBTAINED EVERY 5 MINUTES, BENEDRYL GIVEN FOR SYMPTOMS. PATIENT BEGAN TO FEEL BETTER AFTER BENEDRYL AND COOLING DOWN IN COOL ROOM. PT REQUESTED TO LEAVE AFTER 15-20 MINUTES AFTER BENEDRYL, SHE WAS FEELING MUCH BETTER. LEFT WITH PARTNER
Pt called to state she was dizzy for 45 minutes since she received both Flu shot and ZOSTAVAX.
I had a miscarriage after getting vaccinated. I had two prior successful pregnancies, one of which was a full term twin delivery. Both babies were healthy and weighed over six pounds and the singleton baby was 7lbs 4oz and healthy as well. I was unaware of my pregnancy at the time of vaccination.
5hr: inject site red, swollen,painfull, fatigue 15 hr: hot, ache all over 36 hr: left arm pit painful & swollen 48 hr: severe stomach cramps for a moment 55 hr: nausea, more stomach cramps, feeling over heated 60 hr: feeling bloated & still stomach ache 72 hr: stomach cramps after eating, pain in arm pit not as bad but still swollen 96 hr: injection site and arm pit still little aches, still little nausea, little stomach aches, still fatigued  120 hr: generally feeling okay
Feeling of exhaustion, increasing over the next few days..   Need for enormous amount of sleep, including hours of napping during the day. Mental confusion and extreme lethargy.  Inability to read or pay attention to any activity requiring mental work Increasing muscle and joint aching, making sleep surprisingly difficult.   Back aches and stiffness particularly.  This seems to have decreased in the past 12 hours
Received my second shot on the late morning of yesterday (Thursday).  My arm was getting pretty sore by the time I went to bed (I could not sleep on my left side).  When I woke up, started feeling fuzzy and got the chills.  Took three 325 mg Acetaminophen in the morning.  Was running a low grade fever by lunch time (99.9 degrees) and was feeling like I had the flu.  Joints are sore, head still fuzzy, feel a little light headed when I move around too much.  Took three more 325 Acetaminophen after lunch.  No appetite, stomach feels queasy.  Tired but can't sleep.  Intend to take more acetaminophen this evening before bed.  Hopefully tomorrow my symptoms will start to go away.
pruritus  Narrative:  61 y/o female received COVID19 vaccine (Janssen) on 03/18/21 @0906. Has prior history to Shingrix vaccine on 02/2020 documented as causing diarrhea/facial numbness, but also had been exposed to Shingles prior to vaccination. Prior ADR was reviewed with RN and pharmD; was given the vaccine and observed for 30 minutes. @0930, was observed to be itching to back, legs, and left side of neck. @0935, diphenhydramine 50mg PO was given. @0944 itching continued and reports lips felt funny. @0947 patient reports feeling better and itching resolving, was observed until all symptoms resolved. Patient denied any shortness of breath. Patient stated symptoms of numbness/tingling in lips resolved. Patient left @1007. Instructed to seek emergency care if symptoms worsen or have any difficulty with breathing.
Patient called pharmacy approximately 1 hour after vaccination to report he could see and feel swelling in his face. Upon further questioning, the patient stated he was not having difficulty breathing, but was having slight "shortness of breath". Patient was advised by pharmacist that this could be sign of serious allergy/angioedema and recommended patient seek immediate attention at PCP, urgent care, or ER. Pharmacist also suggested that Benadryl may help to alleviate the symptoms of allergy, but due to the risk for severe allergy, it was best to be further evaluated in person as soon as possible. It is unknown at this time where the patient was seen for follow up care.
Cough; Headache; Muscle pain; Joint pain; Nausea; I had temperature of "101.18"; This is a spontaneous report from a contactable Consumer reported for self. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ2685 or E1685), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Patient had COVID very badly back at the end of March, in the beginning of April I was hospitalized for a couple of week. The patient's concomitant medications were not reported. The patient received the first shot of the COVID vaccine on 21Dec2020 and had a pretty extreme reaction to it within 12 hours, felt like being back in full blown COVID, had temperature of "101.18" (further not clarified), had a cough again raising headache, extreme muscle and joint pain, nausea, like everything was back. It lasted for about 2 days it started getting better within like 36 hours. Now being up, it's 3 weeks and so doctor and patient are in state of a quandary about what to do or whether or not should get the second vaccine. Outcome of event was recovering.   Information on lot/batch number has been requested.
Patient received an H1N1 because she was pregnant. When putting shot into patient's record, it was noted that patient had receive an H1N1 previously on 10/23/2009.
after second dose of Moderna vaccine was administered d-28 after first dose, patient was monitored for 15 minutes and left to her car with spouse. She returned approximately 20-30 minutes later with spouse to be evaluated as she reported she had developed left throat swelling, chills, and anxiety. O2 sat 99% and HR 115. Denied tongue and mouth involvement during evaluation. IM epinephrine 0.3ml administered and patient reported some improvement of s/s. PO Benadryl 50mg given per protocol and no issue swallowing. Transported to ED via wheelchair for follow up with MD. Accompanied by spouse. Dexamethasone 4mg IM x 1 given in ED and patient was discharged.
This is a spontaneous report from a contactable pharmacist. An 86-year-old female patient started to receive PREVNAR 13 (Lot # L43700, NDC number 0005-1971-05, Expiry Date Dec2016), intramuscular at 0.5 ml single in the right arm, on 09Sep2015 11:00 am. The patient medical history was not reported. Concomitant medication included FLUZONE (Lot # UI454AA, Expiry date 21Apr2016) intramuscular at 0.5 ml single in the left arm, on 09Sep2015. On 14Sep2015, the patient experienced an injection site reaction that was warm to the touch at the site, it was inflamed, a big circle of redness on the patient right arm underneath where the shot was administered, as medically significant. The outcome of the events was recovering.
Inflammation and swelling in area where vaccine was administered, approximately 2 inch diameter. Advised pt to take BENADRYL.
Pt was screaming uncontrollably for several hours. Treated with Tylenol and it helped slightly.
After the injection on Friday 03/12 at 1:50 PM at facility, I started to get a slight temperature, Along with chills as well. This continue throughout the weekend. I remained at home and did not have any energy to go out and be around people. The next day, I also got diarrhea and was very dehydrated.  Immediately, after I left the vaccine shot location, like within 5 minutes, I started to smell fish and my mouth tasted like salt for three days. I also had excruciating headaches that did not go away with advil. So I rested a  lot and had no real big appetite what so ever!.  Today, I am concerned that on my left side below my left clavicle, I feel a big bump what appears to be possibly a lymphatic swelling of node? I am concerned because I did not have this swelling before and do not know if it's a reaction to the vaccine.  Pls contact me via phone, this is urgent.  Thanks
Information has been received from a female pharmacist who in August 2007, was vaccinated intramuscularly in right deltoid with the first dose of GARDASIL. In October 2007 she received her second dose of 0.5mL dose intramuscularly of GARDASIL. There was no concomitant medication. Subsequently the patient experienced pain at the injection site for both injections, however she reported no problems after the vaccinations. The pharmacist stated that they loaded syringe "hurt" when it is administered, both doses hurt while being administered. Additional information has been requested.
Patient presented to me, RN (Mom) Friday 11/22/19 night 2130 with a 50 cent piece area on Left gluteal @ Tdap injection site, very red, swollen, hot to the touch. Area still red & not much size decrease, no heat, still red on 11/25/19AM. Size is the same.
After receiving the second dose of Pfizer vaccine my old Achilles? tendon repair became red, swollen and painful. I have been using conservative treatments  at home, everyday for 2 weeks.  ice, heat, over the counter anti-inflammatory meds. The adverse condition persists. To date, I have not sought medical attention from a orthopedic specialist but have an upcoming appointment scheduled. I do not know for sure if the covid vaccine has caused a flare-up of inflammation in an old Achilles? tendon injury but it does seem quite coincidental that having had no pain or problems with my old injury from 12 years ago, that two day after receiving the covid-19 vaccine, I have swollen inflammation in my tendon causing great difficulty in walking.