chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid 19; Covid 19; Breathlessness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN9581), as dose 2, single (Lot number: EN6203) and as dose 3 (booster), single (Lot number: 30155BA) for covid-19 immunisation. The patient's relevant medical history included: "Herpes" (unspecified if ongoing); "I occasionally take anti-inflammatory" (unspecified if ongoing). Concomitant medication(s) included: VALTREX taken for herpes zoster; CELEBREX taken for inflammation. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid 19"; DYSPNOEA (medically significant), outcome "unknown", described as "Breathlessness". The patient underwent the following laboratory tests and procedures: Blood test: I had blood work done to check my liver function, notes: because of taking Celebrex. I have not yet the result back but I am assuming in acceptable parameters because my Doctor hasn't called me yet. Therapeutic measures were taken as a result of suspected covid-19, dyspnoea.  Additional information :This is the second time patient have had COVID, she is fully vaccinated with the Pfizer vaccine and Booster one time with the Pfizer Booster COVID-19 Vaccine and she still had this breakthrough infection. she experienced breathlessness with COVID infection. Patient has no other medical condition, she only takes anti-viral Valtrex for a herpes that she had many years ago and she occasionally takes anti-inflammatory Celebrex.
I received my Covid-19 vaccine on 09/22/2022. On 12/09/2022 I woke up with rhinorrhea and cough. I took a home test for Covid-19 and it was positive. I called my doctor and was prescribed medication. Symptoms lasted for about 12 hours after taking medication.
Died since taking your COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Died since taking your COVID vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Additional information: Reporter also reported that he/she has countless sick friends thanks to it. Stated that the clock was ticking, the truth will prevail.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300020087 as same reporter/drug/event, different patient.;; Reported Cause(s) of Death: Died since taking your COVID vaccine
Information has been received from a licensed practical nurse concerning an 84 year old male who in November 2000, was vaccinated with a first dose of Pneumovax 23.  On 18-DEC-2006, the patient was vaccinated with a second dose of Pneumovax 23 (lot #655291/0985F).  On 18-DEC-2006 the patient experienced fever and redness and swelling from shoulder to elbow.  The patient sought medical attention and was treated with cold compresses and TYLENOL.  On 20-DEC-2006, the patient recovered.  Additional information is not expected.
no additional adverse event reported; Varivax was administered by the intramuscular route instead of the subcutaneous route; This spontaneous report was received from an office manager and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported. On 02-JUN-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # S030223, expiration date 26-SEP-2021, at a dose of 0.5 milliliter, intramuscularly instead of subcutaneous route for prophylaxis (strength and anatomical location were not provided).
Severe migraine 9 days after vaccine. Lower back pain, tight muscles, aches.
Patient experiences soreness when arm is hanging. No loss of strength. Able to bend arm. Unable to lift or rotate arm. Difficulty dressing self. At night, unable to find comfortable position to sleep.
02/25/22 presents to ED for "headache and double vision". PMHx of "HTN, Diabetes".
Patient stated that she was feeling nauseous about 15 minutes after administration. Patient stated that she ate some food and took som acetaminophen and was feeling better as of 2:42 PM.
Suffered fatigue after second dose of COVID vaccine; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient suffered fatigue after second dose of COVID vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The next day after injection joint pains everywhere followed by a head ache intensifying around 7:30pm.  Red irritated throat.  Still having these issues.  Has seen his PCP several times since the second vaccination.
second dose administered 18 days after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered 18 days after the first dose) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered 18 days after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose administered 18 days after the first dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provide No concomitant medications were reported.
My left arm developed a large hot red rash with a raised welt in the middle of the the injection site. My arm is extremely sore and I feel very tired. I have the same symptoms I had the first  3 days after the injection. I am wondering if I should get the 2nd shot??
Pt is immunocompromised and was supposed to receive a 0.5 ml of Moderna booster (lot# 012H21B) but instead he was given a booster of 0.25 ml.
No symptoms, PCP heard a heart murmur, ECHO showed severely reduced systolic function, started medications Coreg and Entresto, diagnosis mild unspecified cardiomyopathy, heart failure, elevated BP w/out diagnosis of hypertension.  The above took place between 11/02/2021 and 01/05/2022.
Narrative:  Pt was a 71 YO male with a PMH of lymphadenopathy, carotid artery stenosis, head & neck cancer, stoke, DM, HLD, HTN, and obesity who received the COVID-19 vaccine. Facility was notified of patient's death by agency. No evidence that patient's death was caused by the COVID-19 vaccine.
Intense and Debilitating joint/muscle pain from head to toe.; Intense and Debilitating joint/muscle pain from head to toe.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Apr2021 at 10:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included naproxen (MANUFACTURER UNKNOWN) and ethinylestradiol, norethisterone (NORTREL); both for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Apr2021 at 10:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation and received cefprozil (CEFZIL) for unknown indication on unknown date and experienced drug allergy.  On 26Apr2021 at 03:30, the patient experienced intense and debilitating joint/muscle pain from head to toe. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown, if the patient received any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events intense and debilitating joint/muscle pain from head to toe was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Pt presented to ED 4/10/21 with a possible allergic reaction to her Covid vaccine. She received it today about 30 minutes afterwards while she was driving home for like her throat was closing. Last for short period of time and seems to resolve. EMS reports stable vital signs in route. She is feels extremely uncomfortable when it occurs. She feels short of breath with it. She will like there is a tightness in her throat and into her chest. She is never had a problem with any vaccines before. Discharged from ED with prescription for prednisone 40 mg daily x 5 days and famotidine 20 mg BID x 7 days.
I received my second Moderna booster for COVID-19 on 6/6/2022. On about 7/8/2022 or 7/9/2022, I began to have a mild cough and runny nose. I then developed a headache and had trouble clearing my throat on about 7/11/2022 or 7/12/2022. It felt more like a sinus issue than anything. I didn't suspect that I had COVID-19, but at my granddaughter's behest, I took a home test on the night of 7/11/2022 and got a positive result. On 7/12/2022, I went to an urgent care clinic. I underwent another rapid test there and got another positive result. My vital signs were checked, and my BP was 193/92, which was unusual for me, as my BP is usually in the normal range. Aside from the high blood pressure, though, my vital signs were normal. I was visiting some relatives at this time, and my sister called her doctor, who prescribed me PAXLOVID, prednisone, and Z-PAK. The doctor also instructed me to take plenty of vitamin C, MUCINEX, and OTC PEPCID. I followed the doctor's orders. The symptoms never worsened, and if my granddaughter hadn't suggested that I take a home test for COVID-19, I wouldn't have, because I didn't suspect that I had it. By and large, my symptoms remained mild, though I did have to blow my nose a lot. I took two more home tests on 7/16/2022 and 7/17/2022, and the results were negative. At the time of this writing, I continue to have a productive cough. I also sometimes have difficulty clearing my throat.
the dose was given due to timing error with no reported adverse event; once the extra doses were already given with no adverse event; Initial information was received on 07-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA351280(CLUSTER).  This case involves a 16 years old male patient to whom dose was given due to timing error and once the extra doses were already given with no adverse event after receiving diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included polio vaccine inact 3v (vero) (ipol), hepatitis b vaccine, measles vaccine, mumps vaccine, rubella vaccine (mmr) for immunisation; and hpv vaccine (hpv vaccine) for immunisation.  On 19-Mar-2023, the patient received an unknown (Dose 1) of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult lot number (Suspension for injection) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for Immunisation.  On an unknown date in September 2023, the patient also received 0.5 mL dose 2 of same vaccine.  On 01-Nov-2023, received (extra dose, dose 3), 0.5 ml (Frequency: twice), of the same vaccine (lot U7745AA, expiry date: 20-May-2025, strength: standard) via intramuscular route in the right deltoid for Immunization.  On 01-Nov-2023, patient was given due to timing error and once the extra doses were already given with no adverse event (inappropriate schedule of product administration) and (extra dose administered) (Latency: same day) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Mild erythema multiforme onset 24 hrs post immunizations. Persisted 1 week.
5/17/21  - severe endless headache  5/22/21 - doctor visit - Toradol shot 5/28/21 - doctor visit - Toradol pills 6/1/21 - doctor visit - Imitrex 6/7/21 -  doctor visit - Fioricet 6/15/21 - spinning headache with severe dizziness 6/16/21 - emergency room visit - bloodwork, CT scan 6-18-21 - neurologist visit - referral for MRI
Lightheaded.  Queasy.  Arm pain.  Fever: 100.4. Fatigue.
Arm pain, chills, low-grade fever, body aches, intermittent stomach pain.
Severe joint pain; Muscle pain; Red, swollen left arm; Red, swollen left arm; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on an unknown date in Apr2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC) and esomeprazole sodium (NEXIUM); both taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 31Mar2021 at 13:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021, after the second shot, the patient experienced severe joint and muscle pain for more than 4 days and red, swollen left arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe joint and muscle pain and red, swollen left arm was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Several small raised bumps at the site where vaccine was given in the left deltoid. Denies any itching.
pt recv vax; approx 45 min later pt c/o redness, swelling & itching @ inject site.  Pt tx w/ meds. All complaints subsided.
Swelling, itchy rash, lump -- pt basically waited for it to resolve itself (about 4 days).
Pt. presented with ongoing pain in shoulders, back, and legs. Pt was afebrile, pain was more profound in right deltoid area. Pt was treated with prednisone.
NowI have COVID; NowI have COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 27Mar2021 at 14:30 as dose 1, single (Lot number: ER8733), in left arm and on 19Apr2021 at 14:30 as dose 2, single (Lot number: EN6203) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism", start date: 2017 (unspecified if ongoing); "pre-NASH" (unspecified if ongoing); "known allergies: possibly excipients in tablets" (unspecified if ongoing); "known allergies: latex" (unspecified if ongoing); "Vitamin D score was 11/ it was low" (unspecified if ongoing); "Bad tinnitus" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Sudafed, reaction(s): "known allergies:Sudafed"; Nickel, reaction(s): "known allergies: nickel". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "NowI have COVID".  Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid. Clinical course: mRNA shots ruined patient's life permanently. Now she had COVID and not realized Pfizer made Paxlovid, she took one dose.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300297843 Same patient, different drug and event;US-PFIZER INC-2021787750 Same patient, different vaccine dose and event;US-PFIZER INC-202101578013 Same patient, different vaccine dose and event;
I started having excessive itching on 11/24/21. This progressed to hives all over my body on 11/26/21, which have come and gone daily since. I also experience very itchy palms and dermatographia as well, all of which I?ve never experienced before in my life.  I was taking Benadryl almost nightly to stop the itching for sleep. I finally saw a NP in a walk-in clinic  on 12/13/21 because my PCP had no openings and she agreed this was likely a delayed, exaggerated immune response to the Moderna booster and prescribed me a Medrol dose pack. I didn't experience any symptoms on days 3-5 of treatment, but then they returned, though they do seem less severe now, as I haven?t experienced any dermatographia since the steroids. I then was instructed by my PCP to take a Claritin and Pepcid daily while I await to be seen by an allergist on 01/04/2022. My symptoms have mostly been at bay since starting those on 12/20/21, with only having itchy palms once.
Vaccine at 2pm developed runny nose, sneezing, trouble breathing, vomiting, red eyes and headache, symptoms resolved in 24 hours. PCP called. Mother had identical reaction.
After recovery I experienced long Covid symptoms/ Paxlovid treatment start date: 07Oct2023; After recovery I experienced long Covid symptoms/ Paxlovid treatment start date: 07Oct2023; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received bnt162b2 (BNT162B2), on 16Mar2021 at 11:00 as dose 1, single (Lot number: EN6208), in right arm, on 06Apr2021 at 12:15 as dose 2, single (Lot number: ER8734), in left arm and on 24Feb2022 at 15:15 as dose 3 (booster), single (Lot number: FM0698) at the age of 49 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Pcn Penicillins" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Pneumococcal 20-val conj vaccine, reaction(s): "allergies"; Vancomycin, reaction(s): "allergies"; Cortisone base, reaction(s): "allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "After recovery I experienced long Covid symptoms/ Paxlovid treatment start date: 07Oct2023". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not received other medication in 2 weeks. Patient received COVID 19 treatment with Paxlovid Treatment start date was 07Oct2023 and Treatment stop date was 12Oct2023. It was reported that patient caught Covid 08Jan2022 after starting the vaccination process. After recovery patient experienced long Covid symptoms. Continuous joint pain, pain at injection sights, intense pain in the heart area. Patient was sent to the emergency room and was given treatment and released. Patient was also cleared from and complications. Chest X-ray and bloodwork and oxygen. The symptoms lasted about a year. Patient was rechecked regularly by his primary physician. After taking Paxlovid this past week patient started to have intense stomach pain and joint pain along with his long Covid symptoms coming back including chest pains, headaches that will not go away and loss of energy.
The evening of the vaccination I spiked a temperature of 101, I had aches, pain, chills. I did not seek medical care because I knew it was attributable to the vaccination, so I treated it with Advil and rest. These symptoms resolved, except for fatigue, by Monday I went back to work. On 02/18/2021 I spiked a temperature again and I started to feel unwell. I also developed GI symptoms, diarrhea, sometimes episodes of 10 times a day. The GI symptoms took about 2 or 3 months to subside and I did see a physician for that. I was diagnosed on 03/01/2021 with IBS. On the 02/19/2021, I had a telehealth with my dr., he had me take a COVID test, the results were negative. I'm a PT by trade, and I self diagnosed myself occipital neuritis. I was waking up with headaches on the back of my head, it was pressure on the back of my head, like pressure hitting my nerves and that went away within about 2 or 3 weeks time. I feel like I'm left with IBS and occasionally the occipital neuritis will flare up.
Patient began to neurological symptoms 3/12/2018 which gradually progressed and was diagnosed with Guillan Barre Syndrome. She was admitted to hospital 3/23/2019 and plasmapheresis initiated.