chrisvoncsefalvay/vaers-outcomes huggingface dataset:
53 y/o Female, with Hx of Dm, HTN, had  Moderna booster 4/4/22. Came in ER c/o headcahe, low grade fever, and neuropathy exacerbation after she recived her booster vaccination.  Pt was treated with Zofran IM and Hydromorphone for pain, resulting in pain relief.
I had chills and headache for 12 hours; I had chills and headache for 12 hours; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), dose unknown via an unspecified route of administration on 27Aug2021 as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medication was none. Patient had chills and headache for 12 hours. It start developing after the 5 hours. The outcome of the event was recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Moderna  COVID 19 Vaccine.  Ringing in ears. Dizzieness
A patient was administered expired vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00659835) and transmitted to Sanofi on 28-Jun-2021.   This case involves a 73-year-old female patient who received  0.5 mL of expired dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (lot U6265AA and expiry date: 19-Apr-2021) via an intramuscular route in the left arm for prophylactic vaccination on 28-Jun-2021 (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   It was reported that "Caller would like to know if this dose is considered a valid dose or whether the dose needs to be repeated."  This was a case of actual medication error due to expired vaccine used (latency same day).  At time of reporting, no adverse events were reported.  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.
pt came in for primary series 1st dose and was given bivalent pfizer for 1st dose instead of monovalent
Awakened to go to the bathroom and almost fell due to extreme dizziness and headache. It lasted through 12/03/2014. Went back to clinic and advised to take Zyrtec, Ibuprofen and given meds for dizziness.
This spontaneous report as received from a physician refers to a female patient of unknown age. On 18-JUN-2013 the patient was vaccinated with first dose of GARDASIL lot # H021861 in the right deltoid for prophylaxis (lot # H021861, expiration date 09-OCT-2015). on 18-JUN-2013 ,four minutes after receiving the dose the patient experienced vasovagal episode and syncope. The patient recovered shortly, after sitting in the office for 20 minutes. Additional information has been requested.
Rec'd call from aunt 4:50 pm; aunt reports: "aches", "pain in stomach", "vomit x1" reported by aunt. Instructed for patient to call MD for concerns r/t symptoms. 6/4/14 5:04PM: Message left on machine for patient. 6/9/14 0920 MLOM for pt.
This spontaneous report as received from a Medical Assistant refers to a female patient of unknown age. The patient was vaccinated with her first dose of GARDASIL (route, dose and lot # were unknown) on 09-MAR-2011, her second dose of GARDASIL (route, dose and lot # were unknown) on 11-JUN-2011 and her third dose of GARDASIL (route, dose and lot # were unknown) on 23-OCT-2012. No adverse symptoms provided. Additional information has been requested.
Pt reported hives to vaccine. She says that she woke up with lip swelling,itchy welts on her back and legs in middle of night approx 12 hrs after receiving vaccine.  She felt more short of breath but says she was also having a lot of anxiety. She used inhaler, and  2 atarax pills with resolution of SOB and rash within 2 days. Sweats/chills continued for ~1wk. On 4/15, pt still had swelling and redness ""like a welt"" at site of injection. She did not have fever. She had shoulder pain and some tingling of area. Pt presented to ED for evaluation due to elevated WBC (12.67) and other symptoms.  ED did not believe it was cellulitis or any other emergent condition. Increased anxiety and SOB persisted >1mo but may not be due to vaccine as pt has numberous underlying health conditions. Allergy/adverse reaction was not reported until 7/6 while being seen via telephone visit for recent Positive FIT.
B/P 130/      HR 72     R16    O2 Sat 98%  Patient states he felt like passing out on the floor: He's diabetic
Hypertension, chest pain, dizziness, lightheadedness, left arm pain and numbness, left ear and jar pain, left sided neck pressure, headache, chills, fatigue, left calf cramping, weakness.
This spontaneous report was received from a Medical Assistant refers to multiple patients of unknown age and gender. On an unknown date the patients were vaccinated with improperly stored GARDASIL (dose, route, lot number and indication were not reported). No adverse effects reported. No product quality complaint involved. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a 66-year-old male with no pertinent medical history or allergies who on 01-APR-2008 was vaccinated subcutaneous with a dose of Zostavax (Oka/Merck) (lot # 659759/1873U).  There was no concomitant medication.  On 02-APR-2008, 1 day post vaccination, the patient developed left-sided Bell's palsy.  It was noted the patient began to have difficulty moving the left side of his lips about one hour and twenty minutes post vaccination.  The patient could not move the entire left side of his face within two hours of receiving Zostavax (Oka/Merck).  The patient sought medical attention and was examined by a nurse.  The patient had been referred for an evaluation by his physician.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  Left-sided Bell's palsy is considered an other medically important event (OME).  Additional information has been requested. 4/21/08-records received-4/2/08- Bell's palsy, symptoms began 1 1/2 hours after vaccination. C/O left hand weakness, eye drooping.
Moderna COVID -19 Vaccine EUA. I began to feel tired around 5 P.M. on April 28, 2021. I fell asleep at 7:30 P.M. until 9:00P.M. I felt dizzy and very sleepy. I went to bed. Then I woke up with a pounding headache and chills. This went on for the entire night. I was up almost every hour. The next day I felt fine until 4P.M. I started with the chills and dizziness again. I ended falling asleep after 6P.M.
Redness, swelling at injection site. Headache, fever. Prescribed cephalexin and prednisolone.  This is the second occurrence from  the flu shot. Same reaction last year.
I woke up with a 10/10 tension headache. My heart rate was in the 140s, my blood pressure was 165/103(no history of hypertension). My temp was 102.6 and I had severe nausea, vomiting, and diarrhea. The GI upset, fevers, and headaches lasted 4 solid days. I was alternating Motrin and Tylenol every 6 hours.
Shoulder area sore and stiff around injection site which never occurred with regular flu shot, similar to tetanus shot.
Pt recvd vax 2APR90 & 20APR90 pt devel a generalized rash, fever & malaise;
Second dose given on day 42; A spontaneous report was received from an unknown  years old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced second dose given on day 42 (inappropriate schedule of product administration).  The patients medical history was not provided. The relevant concomitant medications were also not provided.  On 21 Jan 2021, prior to the onset of the events, the patient received their first dose of two planned doses of mRNA (Lot number:unknown   ) through unknown route of administration for prophylaxis of COVID-19 infection.  On 04 Mar 2021, prior to the onset of the events, the patient received their second dose of two planned doses of mRNA (Lot number: unknown   ) through unknown route of administration for prophylaxis of COVID-19 infection.  On 04 Mar 2021, the  patient experienced that second dose was given on day 42. It was a medication error.  No laboratory data was provided. No treatment information was provided..  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the event was considered resolved.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.
CALL OFF WORK; JOINT PAIN; NAUSEA; HEADACHE; FATIGUE/ TIREDNESS; ARM ACHE; NEUROPATHY; DIARRHEA; BODYACHE AND LITTLE SHARP PAINS EVERYWHERE; SWOLLEN LYMPH NODES; BLURRY VISION; LETHARGIC; STOMACH CRAMPS; SWEATS; VOMITING; STOMACH DISCOMFORT; This spontaneous report received from a patient concerned a 48 year old female of unspecified ethnic origin. The patient's weight was 195 pounds and height was 70 inches. The patient's past medical history included Covid-19 (DEC-2020) and concurrent conditions included Hashimoto's disease, thyroid disease, blood pressure, leukocytosis, celiac disease, anemia, and auto immune disease. She had loss of smell, loss of taste since last 6 months. Patient was non alcohol user and non smoker. She was on a gluten free diet. The patient experienced drug allergy when treated with Dilaudid and Neomycin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A and expiry: 23-JUN-2021) dose was not reported, 1 total dose administered on 10-JUN-2021 at 15:15 to right arm for prophylactic vaccination. Concomitant medications included Synthroid (levothyroxine sodium), hydrochlorothiazide and Claritin D (Loratadine/pseudoephedrine sulfate). On 12-JUN-2021, the patient experienced neuropathy, diarrhea, body ache, little sharp pains everywhere, swollen lymph nodes, blurry vision, lethargy/ tiredness, stomach cramps, sweats, vomiting, arm ache, nausea and headache. On 13-JUN-2021, the patient experienced joint pain. On JUN-2021, the patient experienced stomach discomfort and fatigue. On 14-JUN-2021 patient reported that she had to call off work and she did not have fever. She had not seen her doctor yet but would call the doctor. Treatment medications (dates unspecified) included: Aspirin (acetylsalicylic acid), Tylenol (paracetamol) and Ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neuropathy on JUN-2021, was recovering from nausea, and vomiting, had not recovered from diarrhea, bodyache and little sharp pains everywhere, arm ache, headache, swollen lymph nodes, blurry vision, lethargic, stomach cramps, sweats, joint pain, stomach discomfort, and fatigue/ tiredness, and the outcome of call off work was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210629819-  JANSSEN COVID-19 VACCINE Ad26.COV2.S- Neuropathy. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
disoriented and dizzy; disoriented and dizzy; extremely tired and it bothered her eyes; extremely tired and it bothered her eyes; fuzzy/Caller stated she could still function but her thinking processes were weird/balance was bad and completely non functioning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) at the age of 76 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "malaria" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DISORIENTATION (non-serious), DIZZINESS (non-serious), outcome "unknown" and all described as "disoriented and dizzy"; FATIGUE (non-serious), OCULAR DISCOMFORT (non-serious), outcome "unknown" and all described as "extremely tired and it bothered her eyes"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "fuzzy/Caller stated she could still function but her thinking processes were weird/balance was bad and completely non functioning".  Additional information: Caller stated that she had the first dose of the pfizer covid 19 on 11Mar2021. Caller stated she had sort of a reaction. Caller stated she was disoriented and dizzy, extremely tired and it bothered her eyes. Caller stated the symptoms were mostly mental, describing it as fuzzy. Caller stated she could still function but her thinking processes were weird. Caller stated these symptoms started two hours after the vaccine and stated it is not a good feeling to have. Caller stated again that the dizziness was not that bad and she was able to function. Caller wanted to know if the dizziness and disorientation are natural side effects. Caller stated she was better now saying it took two weeks to get over. Caller stated that her RPh went through the ingredients of the Pfizer covid 19 vaccine and said to her no reason not to take the vaccine. Caller stated she was allergic to sulfa and does not take medications because she was highly allergic and stated she has an aneursym in her heart. Caller stated she had malaria and that is how she knows she is allergic to sulfa. Caller stated her HCP said her symptoms were not life threatening and it was up to her if she wanted to get the second shot. Caller wanted to know if the side effects were from the first and the second dose. Caller wanted to know were there any deaths from the vaccine stating her nurse said there were no deaths. Caller wanted to know if she should get the second dose. Caller stated people that took Moderna did not feel anything. Consumer reporting on herself regarding the COVID-19 vaccine. After her vaccine, she became completely disoriented and did not have this prior to the vaccine. Her balance was bad and she was completely nonfunctioning. She said she was better now.  No follow-up attempts are possible. No further information is expected.
I probably was infected on 01/01/2023, and I was in the hospital. I had all the classic symptoms of COVID-19. I've had COVID-19 four times now. I had breathing issues and headache, and generalized symptoms. I went to the hospital around 01/10/2023 until the beginning of February. I had COVID-19, RSV, and Pneumonia all at the same time. I was in the hospital for 2-3 weeks. They discharged me and had me on oxygen 24 hours a day. I'm still on oxygen, but less of a dosage. Around 8 to 10 hours daily.
Patient presents to the emergency department with a known history of positive COVID test on 05/27 with his wife being positive on 05/25.
Patient reported tongue tingling within the first few minutes following vaccination. Patient decided to leave pharmacy and over the next few days started to experience tongue/lip swelling along with white bumps on her lips and tongue. Patient tried to take bendaryl to help but ended up going to urgent care for treatment. Patient was prescribed steroids and stated that treatment with steroid helped with symptoms.
Pain around theinjection site; Slight headache; This is a spontaneous report from a non-contactable pharmacist, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 08Mar2021 at 09:45 (at the age of 36-year-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications taken within two weeks included ascorbic acid (vitamin C) (MANUFACTURER UNKNOWN), for an unknown indication from an unknown date and unknown if ongoing. On 08Mar2021 at 18:00, hours after taking the first dose of the COVID-19 vaccine the patient experienced, pain around the injection site. Also in the evening, developed a slight headache. The events 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 events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events pain around the injection site and slight headache was resolved on an unknown date in Mar2021. No follow-up attempts are possible. No further information is expected.
pt recv vax 1PM; 13 hr later 2AM pt awake w/itching; no rash; family hx of hives on the inside not the outside; unable to sleep; called MD who said take DPH; broke out in hives 2AM;
No adverse event on patient; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager regarding a 13-year-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 11-JAN-2023, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, 1 dose, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023, lot #1775827, expiration date: 27-JUN-2024, lot #U032681, expiration date: 26-OCT-2023, lot #1780876, expiration date: 09-NOV-2023, and lot #W009829, expiration date: 19-OCT-2024; however, it was not specified which one was received by the patient), (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (The temperature excursion occurred as a result of a reading from a Digital Data Logger) (Product storage error). There were no additional adverse events (AEs) reported in the patient.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Patient's concurrent conditions, concomitant medications, medical history and past drugs, drug allergies/reactions were not reported. On 17-JUN-2017, the patient was vaccinated with first dose of GARDASIL 9 lot # M035486 (expiry date: 05-JUN-2019) (dose and route not reported) for prophylaxis. On 13-JUL-2017, the patient received second dose of GARDASIL 9 lot # M035486 (expiry date: 05-JUN-2019) (dose and route not reported) for prophylaxis (inappropriate schedule of drug administration). No adverse events were reported. A product quality complaint (PQC) was not present.
Mild or moderate local reaction; suspected lot contamination. Pt was given 50mg of Benadryl and is being monitored by ER personnel.
no additional AE reported; she gave a dose of PEDVAXHIB to a baby at her 6 month check up instead of 12 months; This spontaneous report was received from a medical assistant and refers to a 6-month-old female patient. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not provided.  On 02-SEP-2020, the patient was vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # S023646, expiration date 31-MAR-2022, at a dose of 0.5 mL for prophylaxis (formulation, vaccine schedule, injection site and route of administration were not provided). Reporter stated that the vaccine was given to a baby at her 6 month check up instead of 12 months. No treatment was given. No additional adverse events were reported.
STYE IN EYE; NAUSEA; NEEDLES IN SKIN; ACHY; FEVER; CHILLS; DRY MOUTH; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Feb-2021 and was forwarded to Moderna on 15-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (NAUSEA), PARAESTHESIA (NEEDLES IN SKIN), PAIN (ACHY), PYREXIA (FEVER) and CHILLS (CHILLS) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced NAUSEA (NAUSEA), PARAESTHESIA (NEEDLES IN SKIN), PAIN (ACHY), PYREXIA (FEVER), CHILLS (CHILLS) and DRY MOUTH (DRY MOUTH). On 13-Feb-2021, the patient experienced HORDEOLUM (STYE IN EYE). On 14-Feb-2021, NAUSEA (NAUSEA), PARAESTHESIA (NEEDLES IN SKIN), PAIN (ACHY), PYREXIA (FEVER), CHILLS (CHILLS), DRY MOUTH (DRY MOUTH) and HORDEOLUM (STYE IN EYE) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient tested positive after their first dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of COVID-19 (Patient tested positive after their first dose) in an 83-year-old patient of an unknown 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient tested positive after their first dose). At the time of the report, COVID-19 (Patient tested positive after their first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: Positive.     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.   No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Feb-2021: Follow up information was received on 4 Feb 2021. Significant Follow up/ Patient info (Date of birth, age) added, reporter address and E-mail added, route of vaccine administration and anatomical location added. On 21-Apr-2021: No new information
pt recv vax 12MAY98  in rt arm & devel swelling on 12MAY98 PM no fever, no itching;rt deltoid very swollen & red-no sleeping well, eating ok;
The Lot # was 007M20A On the 7th February I noticed a small rash around the site of administration. It was hot to the touch and a little itchy. On the 8th February, it had grown progressively bigger. I could feel the heat of the rash through my sweat-shirt. It was still itchy. On the 8th, I took 10mg of loratadine to help with the itching/heat. I have been taking it every day (today is the 11th) since then. The rash has become even bigger still. The edges of the rash are somewhat darker than the rest of it. I have pictures of rash which can be made available upon request.