chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had their Pfizer COVID-19 vaccination (first and second doses); didn't feel well; positive COVID-19; aches; doesn't feel good; temperature at 102 and 101; like they had the flu; Had their Pfizer COVID-19 vaccination (first and second doses); didn't feel well; positive COVID-19; aches; doesn't feel good; temperature at 102 and 101; like they had the flu; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for two patients. This is the second of two reports.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, the first dose in Feb2021, and the second dose in Mar2021, both at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient and his wife had their Pfizer COVID-19 vaccination in Feb2021 and Mar2021. About a week and a half ago (Apr2021), they didn't feel well for 2 weeks. So, they went and had a COVID-19 test and they both have positive COVID-19 in Apr2021. It affected both of them. It's been 2 weeks since the patient was tested. 2 weeks ago (Apr2021), the patient was tested positive. The patient's wife wanted to report it and she wanted to know how many there has been other instances and what are some of the symptoms. The patient just doesn't have nausea (but his wife does) but feel aches (not clarified further). All over, the patient doesn't feel good, he had a temperature at 102 and 101 for a couple of days in Apr2021. So, like they had the flu or something you know very discouraging. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021466214 Same reporter, drug, and events; different patient
noticed an increase in heart burn; Period changes; headaches; tiredness; nausea; joint pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Mar2021 (Lot number: EW0172) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Known allergies: adhesives" (unspecified if ongoing); "Known allergies: latex" (unspecified if ongoing), notes: Known allergies: latex; "Known allergies: Nutmeg" (unspecified if ongoing), notes: Known allergies: Nutmeg; "Known allergies: Ginger, cinnamon, turmeric, all spice" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "IMMUNE difficulties" (unspecified if ongoing); "Constipation" (unspecified if ongoing); "malabsorption" (unspecified if ongoing); "Digestive issues" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Hypoglycemia" (unspecified if ongoing). Concomitant medication(s) included: TRAZODONE; STOOL SOFTENER; MULTI VITAMIN & MINERAL. Past drug history included: Hycosan, reaction(s): "Known allergies: Hyposam", notes: Known allergies: Hyposam; Ciprofloxacin, reaction(s): "Known allergies: Ciprofloxacin", notes: Known allergies: Ciprofloxacin. The following information was reported: DYSPEPSIA (non-serious) with onset Mar2021, outcome "unknown", described as "noticed an increase in heart burn"; MENSTRUAL DISORDER (non-serious) with onset Mar2021, outcome "unknown", described as "Period changes"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headaches"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "tiredness"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "joint pain".  Additional information: The patient had headaches, tiredness, nausea, joint pain and have also noticed an increase in heart burn since her first shot in March, and period changes as well. The patient was diagnosed with Covid 19 prior to the vaccination and not tested for COVID-19 since vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected
Patient is 11 years old and received a Fluzone Quad High Dose vaccine. According to CDC: Fluzone High-Dose Quadrivalent vaccine is approved only for people 65 years and older. Fluzone High-Dose Quadrivalent is not approved for people younger than 65 years or for people of any age with a history of severe allergic reaction to any influenza vaccine or to vaccine components other than eggs. Information about vaccine ingredients is located in the manufacturer?s package insert.
Insomnia night after vaccination  Feeling ?drugged? day after vaccination  Sore arm
Raised rash w/in 2 days, suggested BENADRYL, Urgent Care after 3 days Prednisone-continuing muscle pain.
Constant brain confusion; Fast heart at night; Uneasiness; Anxious; Jittery; Immediate dizzy; Nausea; Constant headache; Brain tingling; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient 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 29Mar2021 at 10:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation and 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 12Apr2021 at 03:45 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. Concomitant medications included colecalciferol (VITAMIN D3), zinc (MANUFACTURER UNKNOWN) and estrogens conjugated, medroxyprogesterone acetate (PREMPRO), all taken for unspecified indications from unknown dates. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 29Mar2021 at 10:45, the patient experienced immediate dizziness, nausea, headache and brain tingling. On 30Mar2021, a day later, the patient experienced constant brain confusion, fast heart at night, uneasiness, felt anxious, jittery, had continued dizziness and constant headache. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if any therapeutic measures were taken as result of the events. The clinical outcome of the events dizziness, nausea, headache, brain tingling, constant brain confusion, fast heart at night, uneasiness, anxious and jittery were not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
seeing spots/seeing blue lines and weird shapes/seeing some funny shapes and colors like in the sky; blurred vision; This is a spontaneous report from a contactable consumer (patient father). A 33-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EW0169), dose 1 via an unspecified route of administration in right arm on 27Apr2021 (at the age of 33-years-old) as dose 1, single for COVID-19 immunisation.  Medical history included Down's syndrome. It was reported also that patient handicapped. Concomitant medication included lisinopril (LISINOPRIL) taken for blood pressure, start and stop date were not reported. It was reported that reporter wife and son both got both doses of the Pfizer BioNTech Covid 19 vaccine. Both have been having issues with eyes, seeing spots. The patient was seeing blue lines and weird shapes, but had a hard time communicating that due to a handicap, but showed physical signs of seeing things.  Went to eye doctor today, and they gave him new glasses.  Eye doctor said he can't get into specifics, but he knew of people that were experiencing blurred visions, fuzzy visions, and "eyes not working properly" .  Said it was temporary, but no time frame given. His wife and son got the Pfizer shot, both on the same day, second one back to back. They had their card stamped and left. The reporter stated also that his son was handicap with down syndrome and he went to a day program that was a group home. He was going there every day back in 2019 and they shut it down due to regulations. They said everyone had to wear a mask and face shield if they open up and everybody was getting full vaccinations, so they the needed the shot. They both have the exact same day, exact same pretty much one after other, Pfizer COVID shot and they like a week later started to have some reactions to it and they had the second shot. The patient had second dose of bnt162b2 (Lot Number: EW0176), via an unspecified route of administration on 18May2021.  The outcome of event was unknown.
Before the injection was administered the syringe was examined and needle tightened. After injecting the patient with the vaccine in the left deltoid, the syringe popped apart as soon as I attempted to administer the vaccine. Vaccine contents ran down patient's arm and sprayed on this nurse. Needle removed from patient's left arm with no noted injury.  Patient's arm was cleansed with alcohol pads as well as nurse cleaned self off with alcohol and washed hands well. Patient did receive the Moderna vaccine on this date in Right Deltoid with out issue.
Patient experienced a hot flash, racing heart and felt as though her throat was closing.  Benadryl 25 MG PO was given and RRT was called.  HR was 118, BP 146/80 pulse ox 100%
Service member received a Tdap vaccine. Woke up in middle of night vomiting, has pain at injection site, stiff neck, headache and is running a fever. Still vomiting about every 30 minutes: Taking TYLENOL and ALEVE for pain. Unable to move arm. Going to be seen by PCP.
12 days p/the vax devel blurring vision itching & watering eyes;
Excruciating pain in arm near injection site, moving to shoulder, down under the arm, and down to the hand. Loss of motion in arm, high fever, hives, nausea.
pt recv vax;05apr94 devel a rash that was felt to be a light case of the measles;rash dx as recurrent urticaria on 08apr94;MD felt no problem w/ the particular lot;however was also felt that pt's rxn not related to vax;
Information has been received from a nurse concerning a 15 year old female patient with pertinent medical history reported as none and amoxicillin allergy developed hives who on 03-JUL-2008 was vaccinated with a first dose of GARDASIL (lot # not reported) intramuscularly. On 30-DEC-2008 she received second dose of GARDASIL (lot # 661703/0651X) intramuscularly. There was no concomitant medication. After second dose of vaccine the patient developed rash to her arms and chest. The patient did not seek medical attention for the rash and no treatment was reported. On an unspecified date the patient recovered. On 15-JUL-2009 the patient went to the office for her third dose of GARDASIL but the physician decided not administer any further doses. There were no laboratories diagnostics studies performed. Follow up information has been received from nurse concerning the female patient who received second dose of GARDASIL intramuscularly into left deltoid. On an unknown date after the second dose the patient complained of rash to her arms and chest. On an unknown date, the patient recovered. Additional information is not expected.
Pt presented 10/10/12 with 3cm bruise at inj. site and 6cm diamond shaped raised, warm, red area radiating down from inj. site. Spoke to her family Dr - said to have her apply BENADRYL topically and see him. Pt saw Dr 10/11/12 - Dr not overly concerned - "temporary local reaction - will go away with time".
Case number PHEH2014US000713, is a spontaneous initial report received from a pharmacist on 06 Jan 2014, with a follow up received on 21 Feb 2014. This case refers to a 17-year-old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUCELVAX (batch number: 010031A and expiry date: Jun 2014) at a dose of 0.5 ml intramuscularly into the left deltoid on 05 Jan 2014 at 13:20 PM. No adverse event was reported following this maladministration. Follow up received from a pharmacist on 21 Feb 2014: Updated date and site of vaccination with FLUCELVAX. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 21 Feb 2014: The labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
I WAS SUPPOSED TO GET MY PERIOD THE DAY I GOT THE SHOT AND IT NEVER CAME. I AM VERY REGULAR AND ALWAYS START MY PERIOD ON TIME SO THIS IS VERY ABNORMAL. THE VACCINE IS THE ONLY CHANGE THAT HAS HAPPENED IN MY LIFE FROM MY LAST PERIOD. I AM NOW 4 WEEKS LATE AND I HAVE TAKEN 3 PREGNANCY TESTS NOW TO CONFIRM THAT I AM IN FACT NOT PREGNANT AND ALL HAVE BEEN NEGATIVE. THIS IS A SIDE EFFECT THAT SHOULD HAVE BEEN STUDIED AND DISCLOSED DURING CLINICAL TRIALS BUT UNFORTUNATELY WOMENS HEALTH IS ALWAYS A LAST PRIORITY IN HEALTH CARE.
1st day I had headache, fatigue just for one day. 09Sep2021, I was not feeling well, headache, earache and rash on the side of my face , eyelid on the left the side. went to urgent care. diagnosed with shingles - see healthcare and ophthalmologist. The rash got better but went back to the ophthalmologist to make sure. You can see some remanence of the rash. Its not active. Got antiviral meds given.
Side effects; This case was reported by a other health professional via call center representative and described the occurrence of adverse reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. A healthcare professional reported about a possible adverse event for Shingrix via online chat. The adverse event was not specified, only described as side effects. The reporter denied consent to follow-up.
Right upper arm muscle soreness has been  increasing severeness and become very painful about 4 hours after the injection. Feeling chill and fever 100.1F by the evening at 9 p.m. (10/17/2019)
ACUTE ST ELEVATION MI, LATERAL WALL ACUTE CORONARY SYNDROME, UNSPECIFIED
Developed fever 101.8 with chills; red, raised rash on arm and legs within 24 hrs of vaccine. Symptoms resolved over 4 days.
Fully vaccinated.   COVID infection breakthrough with inpatient hospital stay on a general medical unit.
This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Influenza  vaccine Quadrivalent. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death and GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent. Additional details were reported as follows: The age at vaccination was not reported. It was reported that, 8 patients died from flu of which 7 patients had flu shot and all eight patient's were on THERAFLU. This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. No further details provided about the product.
Case number PHEH2014US025096, is an initial spontaneous report received from a nurse on 09 Dec 1014. This report refers to a 57 year old male patient. Medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 21 Oct 2014. Nurse reported that patient received FLUVIRIN that was at degree F 12 times over a period of 34 days. The temperature excursions began around 16 Oct 14. 12 separate temperature excursions lasting 30 minutes each in which the temperature was 46-49 degree F each of those excursions. No adverse event was reported following this maladministration. No further information was provided.
No adverse effects reported; improperly stored doses of VARIVAX was administered to the patient; This spontaneous report has been received from an office manager (medical assistant) regarding to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medication, drug allergies or reaction were not reported.    On 02-MAY-2019, the patient was vaccinated with an improperly store dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # R027993 and expiration date 01-OCT-2020)  (dose and anatomical location of vaccination was not reported) mixed with a properly stored sterile diluent (DILUENT MRK)for prophylaxis. The administered dose of the vaccine experienced a temperature excursion to 9°C to 25 °C (20.5 °C) for a time frame of 22 hours and 30 minutes. From -9°C to 8°C for 1 hour 15 minutes and -14 °C to -10°C for 1 hour 30 minutes. There was no previous temperature excursion. The call was because of a "data logger". There were no adverse effects reported.  This is one of several report from the same reporter.; Sender's Comments:  US-009507513-1905USA010083: US-009507513-1905USA010084: US-009507513-1905USA006081: US-009507513-1905USA010080: US-009507513-1905USA010081: US-009507513-1905USA010092: US-009507513-1905USA010082:
DIED; BLOOD CLOT; This spontaneous report received from a consumer via a company representative concerned a 44 year old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown and expiry: unknown) dose, start therapy date were not reported, dose number in series was 1, 01 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  The reporter stated that, on 03-AUG-2021, the patient experienced blood clot and next day on 04-AUG-2021, she died from unknown cause of death (dose number in series was 1). It was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 04-AUG-2021 from unknown cause of death, and the outcome of blood clot was not reported.  This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20211254542 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Death, Blood clot. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
pt recv vax 29APR97 & 24NOV97 pt broke out in a rash;pt seen by MD who dx chickenpox;It was reported that @ the time of dx pt had approx 50 lesions & that the rash started on thighs & moved to chest, stomach & legs;
soreness of the left injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness of the left injection arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL and AMLODIPINE for Blood pressure management, CALCIUM for Calcium supplementation, ASPIRIN [ACETYLSALICYLIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness of the left injection arm). On 18-Mar-2021, VACCINATION SITE PAIN (soreness of the left injection arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details were not reported. In concomitant medications iron pills was also reported.   This case was linked to MOD-2021-078137 (E2B Linked Report). This case was linked to MOD-2021-078137 (Patient Link).; Sender's Comments:  MOD-2021-078137:
Patient came in on the 21st which is 3 days after receiving the immunization. She had developed a rash about 2 inches by 3 inches around the injection site. The patient said her doctor told her to get some oral Benadryl and to go by the pharmacy to show the pharmacist. The patient did not come in until the 21st because she said she didn't have a ride into town. She said the rash had peaked in size on the 20th but it still felt warm and it was very itchy. She said her doctor did not prescribe any medications for it but if it did not look any better by sometime next week she would be provided an antibiotic.
Swollen and redness at the site of reaction which was spreading. Patient was not feeling dizzy. She had no hives. Patient was observed for about 45minutes and she left the facility, No medication was administered.
Adverse Reaction - Redness and warmth noted at injection site. As reported in chart.
Aching joints; Bone [muscle] ache; Feeling very bad; High fever of 103 F; Muscle ache; This spontaneous case, initially received on 12-Oct-2018 from other health professional (nurse), concerns a 38-year-old, adult male patient.  The patient had no historical condition and concomitant medication.  On 11-Oct-2018, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 02644611A and expiry date: 18-Jun-2019) for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.  On the same day, about 8 hours after vaccination, the patient developed high fever of 103 F, aching joints, bone pain and muscle ache. Overnight, the patient felt very bad. The patient felt much better the next morning, when he woke up.  On 12-Oct-2018, the patient had recovered from the events.  The reporter assessed the case as non-serious.; Reporter's Comments: A 38-year-old, male patient developed high fever, aching joints, bone and muscle ache, about 8 hours after the administration of suspect vaccine Afluria Quadrivalent. The patient also felt abnormal overnight, on the same day after vaccination. The company assessed the causality of the events as related due to plausible temporal relationship between the events and suspect vaccine.