chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has  been received through the Merck pregnancy registry from a physician concerning a 25 year old female with a history of anxiety and depression who on 18-DEC-2006 was vaccinated with her first dose of GARDASIL (Lot # 654389/0961F). On 01-Mar-2007 the patient received her second dose of GARDASIL (Lot # 655849/0263U) and she subsequently became pregnant with LMP 11-Jun-2007. Concomitant therapy included LORAM. Subsequently the patient experienced shortness of breath, and chest pain secondary to anxiety. Additional information has been requested. 07/08/08 Follow up information received from the physician confirmed the second dose was given on 01-Mar-2007 and the patient's LMP was 11-Jun-2007. The primary reporter confirmed that the patient had the baby and was scheduled for a postpartum office visit. The reporter indicated that "she guesses" everything was normal with the delivery and the baby.
Patient had to go to ER and they told her she was having an immune reaction/response to flu vaccine and will be rechecked in 2 wks. Right eye was very red and painful.
This spontaneous report as received from a registered nurse refers to unspecified number of adult patients (gender and exact age were not provided). The patients' relevant medical history and concomitant medication were not provided. On an unknown date, the patients were vaccinated with 1ml dose of VAQTA (route, lot# and expiration date were not reported) using two combined pediatric doses of VAQTA. No adverse effects were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
After reconciling the clinic's inventory and lot number, it was noted that the patient received a diluted dose (diluted with 1.3 mls of Normal Saline)  of the adult vial (0.2mls injected, 10-20mcgs of diluted adult vaccine likely administered).  The patient did not suffer from any adverse reactions nor an increased immune response therefore not treatment was needed.
red bumps/hives all over her legs, hands, feet elbow and arms; red bumps/hives all over her legs, hands, feet elbow and arms; red bumps/hives all over her legs, hands, feet elbow and arms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (red bumps/hives all over her legs, hands, feet elbow and arms), MASS (red bumps/hives all over her legs, hands, feet elbow and arms) and ERYTHEMA (red bumps/hives all over her legs, hands, feet elbow and arms) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included PAROXETINE and ORAL CONTRACEPTIVE NOS for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced URTICARIA (red bumps/hives all over her legs, hands, feet elbow and arms), MASS (red bumps/hives all over her legs, hands, feet elbow and arms) and ERYTHEMA (red bumps/hives all over her legs, hands, feet elbow and arms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of UNK dosage form; PARACETAMOL (TYLENOL) at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE (BENADRYL ORIGINAL STRENGTH ITCH STOPPPING) at a dose of UNK dosage form. At the time of the report, URTICARIA (red bumps/hives all over her legs, hands, feet elbow and arms), MASS (red bumps/hives all over her legs, hands, feet elbow and arms) and ERYTHEMA (red bumps/hives all over her legs, hands, feet elbow and arms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other treatment medication included steroids
Phone call to School /Nurse 02/23/2022 regarding the incident and need for pt. to have Hep A  repeated. Was unable to leave phone message  with pt.  He  had been advised on day of immunizations at health  department  to return in 4 weeks for additional immunizations, will administer repeated dose of Hep A at that time.
Redness on arm for 4 days around area of shot 5? in length and 3? in width
Chills; fever-102 F; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (fever-102 F) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced CHILLS (Chills) and PYREXIA (fever-102 F). On 10-Apr-2021, CHILLS (Chills) had resolved. At the time of the report, PYREXIA (fever-102 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Body temperature: 102 (High) 102 F.         Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided
Metal taste in mouth 40 minutes after vaccine (4/7/2021).   7 hours after vaccine a  Headache (11:30pm), Next day, strong headache, very painful upper& lower gum (mouth) pain, Face throbbing, Fever up to 100.9, Chills, Body/bone aches.  Following  morning (4/9/2021), headache & fever gone but fuzzy brain, unable to focus, hard to read and comprehend emails quickly.  Confusion while putting dishes away in wrong places.  Fuzzy brain cleared up by the end of the day.
Asking if his wife can take Tylenol; High fever; This is a spontaneous report from a contactable consumer (patient's husband) from a Pfizer Sponsored Program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Mar2021 (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had high fever on an unspecified date. The patient's husband was asking if his wife can take paracetamol (TYLENOL). The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Caught Covid after first dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (Caught Covid after first dose) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced COVID-19 (Caught Covid after first dose). The patient was treated with STEROIDS at an unspecified dose and frequency; ZINC at an unspecified dose and frequency and VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency. At the time of the report, COVID-19 (Caught Covid after first dose) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient said doctor gave him a steriod, vitamin C, zinc, and cough medicine
vaccine administered to a patient using another diluent different that the one provided; vaccine administered to a patient using another diluent different that the one provided; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-month-old male patient who received Hib (Hiberix) (batch number EK5Y2, expiry date 25-MAY-2023) for prophylaxis.   On 11-APR-2023, the patient received Hiberix. On 11-APR-2023, an unknown time after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution (Verbatim: vaccine administered to a patient using another diluent different that the one provided) and incorrect dose administered (Verbatim: vaccine administered to a patient using another diluent different that the one provided). The outcome of the wrong solution used in drug reconstitution and incorrect dose administered were unknown.   Additional Information: GSK Receipt Date: 11-APR-2023 The pharmacist called to report a non-provided diluent may had been used to reconstitute and administer Hiberix.  The pharmacist reported an inconsistency between the powder vials and the diluent vials so suspects a vaccine was reconstituted and administered to a patient using another diluent different that the one provided but had not confirmed the situation. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email. The patient received Hiberix vaccine using another diluent different that the one provided, which led to wrong solution used in drug reconstitution and incorrect dose administered.
A physician reported that a 16 month old male received his second dose of Prevnar on 07 JUN 2001. On 28 FEB 2002, at 24 months of age, the child was seen in a emergency room with symptoms of an upper respiratory tract infection and fever. A blood culture was positive for Streptococcus pneumoniae. No serotype was identified. A WBC count was 20,000 cells per cubic millimeter. The child was treated with unspecified antibiotics and recovered. Streptococcal septimcemia is considered medically important. Per follow up: The child was treated with Rocephin (ceftriaxone) and Cefzil (cefpozil).
Patient received vaccination and immediately sat down to wait for the 15 minutes. He started to sweat and was feeling nauseous. We gave the patient ice water which he drank. He continued feeling nauseous and did vomit once. Once he vomited, he started to feel better but was sweating. He had no symptoms of dizziness or lightheadedness like he was going to faint.
This spontaneous report as received from a Nurse Practitioner via Company Representative refers to a 12 year old female patient. The patient's medical history included anxiety. On 23-AUG-2013 the patient was vaccinated with the first dose of GARDASIL (lot # J002641; expire on 10-DEC-2015) (dosage and route not reported). No concomitant therapy. The nurse practitioner reported to the representative that, "after the patient received their first dose in the series of GARDASIL, she experienced anxiety, depression, and nausea". The representative stated, "the patient did not discontinue the series of GARDASIL, and still planned on receiving the second dose in the future, on an unspecified date". The patient sought medical attention via office visit on 23-SEP-2013. At the time of reporting, the outcome was unknown. Additional information has been requested.
Severe itching on upper left arm vaccine site a week after receiving injection.; This is a spontaneous report from a contactable consumer reported that. A 79-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 05Feb2021 12:00 (Batch/Lot Number: EN5318) as DOSE 1 SINGLE for covid-19 immunization (Age at vaccination 79-years). The patient past Medical history included High cholesterol from an unknown date and unknown if ongoing, low platelets from an unknown date and unknown if ongoing and intrinsic factor deficiency from an unknown date and unknown if ongoing, Known allergies: Penicillin, Erythromycin and Sulfa from an unknown date and unknown if ongoing. Concomitant medication included metoprolol (METOPROLOL) taken for an unspecified indication, atorvastatin (ATORVASTATIN) taken for an unspecified indication, lactulose (LACTULOSE) taken for an unspecified indication and calcium (CALCIUM) taken for an unspecified indication, the patient previously took erythromycin and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 13Feb2021 the patient reported severe itching on upper left arm vaccine site a week after receiving injection and Looks like a rash has developed. No treatment was received. The event outcome was Not recovered.  Follow-up attempts are completed. No further information is expected.
Chest pain beginning the day after injection; persistent for about 48 hours and now recurring every few days for a few hours at a time.
Fever and chills for 48 hours. Injection very sore 3 days. Redness lasted a week.
After the second shot. Shingles really bad / Suspected vaccination failure; After the second shot. Shingles really bad; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows:  The patient reported the case for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication. The patient experienced really bad shingles and he/she still had them. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible, as no contact details were available.
Breakthrough COVID 19 vaccine not requiring hospitalization.  It should be noted that this patient received 3 doses of Pfizer COVID 19 vaccine
No pain or swelling at the injection site.  Rather since about the day after the injection, I have had an odd and rather mild tinnitus.  It is odd in that I don't experience it at one ear or the other, but more at the upper forehead (equally at both ears?).  At the same time, I feel during waking hours as if I am about to get a headache.  There is a feeling of pressure in my head at the upper forehead.   I have not taken any aspirin or ibuprofen for this discomfort.  (BTW, I am very healthy and never get headaches and I am "pro-vaccine" although this is the first vaccine I have taken related to pneumonia.) Although I have no drug allergies, I am sensitive to drugs in general.  I rarely drink alcohol and gave up all caffeinated beverages about two years ago.)  This on-going state of mild discomfort has made it more difficult to fall back to sleep after getting up at 2 or 3am to urinate.  And as a result of less sleep, I am not as well rested during the day.
After first Shot lot #040A21A  0n 3/17/2021 Patient stated that arm felt dead for 3 days. It was a heavy pain like he was knockdown in the arm by a fighter. Felt like He had covid19 for seven days. Could not eat any food with a smell. Ever since the second shot the patient smell his self smelling like sewer and the food he digests also taste like sewer.
Pt left the office after receiving the vaccines.  She & her mom returned approx 30 min later, because she c/o her heart racing - chest discomfort & felt like she also was clearing her throat frequently.  She was assessed .  Per physician was given Benadryl 25 mg-watched for 30 min.  D/C feeling better.  Injection site swollen & firm to touch.  (Ice pack applied).
HOSPITAL COURSE: This is a 61 y.o. female with PMHx of hypertension, chronic neck and back pain on chronic opiate agonist therapy (Subutex), anxiety/depression, migraines, autoimmune hepatitis and renal insufficiency, who is double vaccinated with Moderna but overdue for booster presented with fever, cough and shortness of breath starting 1/15.  Tested positive for Covid on admission 1/29.  O2 sats 95% on room air.  Chest x-ray showed bilateral patchy infiltrates.  CTA chest showed pulmonary emboli on the right, without evidence of cor pulmonale or right heart strain.  Started on Eliquis and admitted for further observation and management.   COVID-19 infection Multiple right sided pulmonary emboli Did not require supplemental O2. Sats remained stable on RA at rest and with exertion around the room. Started on dexamethasone on admission, continued this during her stay but no indication for ongoing steroid treatment on d/c. Started on Eliquis with loading and maintenance doses planned (10 mg twice daily for 7 days followed by a 5 mg twice daily). Pharmacy test claim was completed on day of d/c - pending at current time. Discussed with patient. Planning for the first month to be free with subsequent refills per her PCP (if cost-prohibitive then adjustments in anticoagulation therapy should be made through PCP). Procalcitonin 0.04, antibiotics not indicated. CRP 17.9 -- > 6.1. She felt well and felt ready to discharge to home. She was encouraged to continue using the IS. Discussed increased risk of bleeding on blood thinners.  Recommend ~6 months anticoagulation, presuming te PEs were provoked by her underlying COVID-19 infection.  F/u with PCP in 1-2 weeks and ongoing for anticoagulation monitoring and management.    Hypertension BPs controlled. Continued PTA lisinopril 10 mg daily and amlodipine 10 mg daily.    Mild acute renal sufficiency Creatinine 1.16 -- > 0.96.    Chronic pain syndrome with neck and back pain On chronic opiate agonist therapy Anxiety, depression Continued Subutex along with PTA Tizanidine, diazepam, hydroxyzine, pregabalin.
Patient received a Moderna vaccine on the same day as a Pfizer at an other facility. Was reported to our facility on 8/23/21 by the Immunization Registry. We have placed a note in patient's file instructing no one to give the 2nd dose of Moderna vaccine to patient. Patient has now received 2 doses of Pfizer vaccine (reported to us by Immunization Registry). No known adverse affects were seen by patient.
(R) arm at site of injection Hep A noticed after Band Aid removed round circle of raised bumps. Appx size of a quarter. Has become bigger since vaccination. Had slight fever x 1 day 10/26/12. No respiratory problem.
Received the first dose of the Moderna Covid-19 vaccine and contracted Covid afterwards; A spontaneous report was received from other healthcare professional concerning a patient of an unknown age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced covid after first dose of the moderna covid-19 vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On an unknown date, after the first dose of the Moderna Covid-19 vaccine and the patient had contracted covid afterwards. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of event received the first dose of the moderna covid-19 vaccine and contracted covid afterwards was not provided.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
The taste is about the same/ He can taste things occasionally; Loss of smell; Brain fog; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), 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: TASTE DISORDER (non-serious), outcome "unknown", described as "The taste is about the same/ He can taste things occasionally"; ANOSMIA (non-serious), outcome "unknown", described as "Loss of smell"; DISTURBANCE IN ATTENTION (non-serious), outcome "unknown", described as "Brain fog".  Additional Information: Received call from consumer regarding the Pfizer COVID vaccine. He was reading through most recent publication on effects of drug dated 29Mar2022. Question. From Day 1 (Withheld) was talking about brain fog. This article does not mention and the he is not sure if Pfizer site. He wants to know what became of the brain fog. The publication last page has Pfizer logo. Beneath it has Biontech. He did not wish to provide an address or email. He has had brain fog. If you want to get really technical about it, the medical dictionary described brain fog and a couple of other manuals describe it as confusion. Everyone, the CDC, (Withheld) and the whole bunch said brain fog and it actually means confusion. He carried 3 things over. Loss of smell, and from 24Mar2020 (he later stated his vaccine was 03Mar2021) when he had injection and 2nd one. He was a volunteer at clinic. He rolled the same guy in the clinic on 2 occasions. The first time they put him in a room, scrubbed him down and put clean clothes on him. The 2nd time they evacuated the office. He asked what was going on and why did they evacuate the office and they said, "can't you smell him?" He said no. The taste is about the same. He can taste things occasionally. The fist vaccine was no big deal and took 2nd one at drive through at health department site where EMT's gave it. He did not feel either shot. Two days later after getting the 2nd shot, he had every symptom except one, which was fever. He detailed it and wrote it down and documented how many days it lasted.Some lasted 2 days and some lasted a week. He was out of work 6 weeks with it. He said it was weird that of all things, he never got a fever. He had a digital thermometer and it is within a 10th of a degree of the ones at the clinic. He did not have his paper that he had written everything down on with him and did not wish to complete report. The clinic was requiring him to have his vaccine card with him to get in the door, so he kept his Vaccine card in the truck. 2nd dose was given on 24Mar2021 with Lot ER8733, expiration is unknown. He confirmed that both doses were the Pfizer COVID vaccine. He stated that (Withheld)was using Moderna, but they got some Pfizer from another county and he got the Pfizer ones.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
my body severe blister in my mouth . Lips face hand, face, Arm, and foot spreading.
I experienced severe Tinnitus in both ears and it is 24/7 and it is still occurring. I am taking a supplement that was recommended from a friend that suffers from it.
Chronic angioedema and uriticaria started 1.5 weeks after 2nd shot.
On 12/29/05 child was irritable, felt warm, had a poor appetite and had "red spots on her with no fluid on her head, diaper area and back. Ended up being worst on Sunday, 1/1/06 with big hard fluid filled red spots that popped open and scabbed over" per mother.  Mother states treated with baths and Tylenol and child recovered.  On 1/13/06 mother called to say that 2 brothers previousily immunized for varicella were also sent home from school with "chickenpox".