chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ate breakfast at the same time as taking her first dose of Vivotif; Spontaneous report received on 09MAR2020.  A female consumer reported that she "ate breakfast at the same time as taking her first dose of Vivotif" (PT: Product administration error). She was receiving Vivotif for immunisation. She stated that she ate breakfast and had her first dose of Vivotif at the same time. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer ate breakfast at the same time as taking her first dose of Vivotif (Product administration error). Vivotif should be taken at least one hour before a meal. Considering the nature of the event, the causality of product administration error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer ate breakfast at the same time as taking her first dose of Vivotif (Product administration error). Vivotif should be taken at least one hour before a meal. Considering the nature of the event, the causality of product administration error is assessed as not applicable to Vivotif.
Optic Neuritis (Papillitis) OD Loss of central vision - 20/100
Herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of currently 71 year old. No information was provided regarding medical history, concurrent conditions, concomitant medications, drug reactions or allergies. On or about 27-DEC-2011, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration and anatomical location were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced Herpes zoster and she was treated by a physician for the event. The outcome of the event herpes zoster was not reported. The reporter considered the event of herpes zoster to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Information has been received from a certified medical assistant referring to an unspecified number of unspecified patients. Since 01-JUN-2015 the patients were vaccinated with an unspecified number of improperly stored GARDASIL (lot # K005881, expiration date 14-JAN-2016) (dose and route unspecified) by an unspecified physician. No adverse reactions were reported. This is one of several reports received from the same source. Additional information has been requested.
PATIENT RECEIVED AN EXTRA DOSE OF H1N1 VACCINE. HAD DOSES ON 11/19/2009 AND 12/19/2009. NO ADVERSE REACTION NOTED.
I had some pretty bad flu like symptoms/Began to have flu like symptoms, pretty severe flu like symptoms; pain; This is a spontaneous report from a contactable nurse (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) solution for injection, via an unspecified route of administration on 08Jan2021 (first dose, lot/batch number: EL1284, expiry date: Apr2021) at a single dose, then via an unspecified route of administration on 29Jan2021 (second dose, lot/batch number: EL1284 , expiry date: Apr2021) at a single dose for Covid-19 immunization. Medical history included was reported as none. There were no concomitant medications. Patient received his first vaccine on the 8th of this month and the second dose the 29th of this month. On both occasions for 3 days after the vaccine, he had some pretty bad flu like symptoms. He began to have flu like symptoms, pretty severe flu like symptoms and pain on 09Jan2021. He stated taking some Ibuprofen 400mg, every 8 hours as needed for pain. Outcome of the event flu like symptoms was not recovered while pain was unknown at the time of the report.  No follow-up activities are needed. No further information is expected. Information regarding the lot/batch number has been obtained.
Patient received his first Pfizer booster back on 5/21/22.  Since then he's had sores on this upper arm (deltoid) that keep coming and going but have never cleared up.
Inadvertent administration of vaccines due to electronic health record not showing  full list of already administered vaccines at the time of patient check-in.
Information has been received from a physician concerning a 14 year old male who on 31-OCT-1996 and 16-FEB-2000 was vaccinated with his first and second dose of MMR II (route and site were not reported), respectively. On 10-NOV-2009 the patient experienced mumps. The patient's body temperature was 103F. On 28-DEC-2009, mumps immunoglobulin M antibody was <1:10, mumps immunoglobulin G antibody was 6.58, serum amylase was 895 and the patient was diagnosed with parotitis. At the time of the report, the outcome was unknown. Follow up information has been received from the physician. It was reported that on 18-NOV-2009 (previously reported as 10-NOV-2009) the patient developed mumps. The patient was afebrile. On 17-NOV-2009,  mumps immunoglobulin M antibody was negative, mumps immunoglobulin G antibody was 4.41, serum amylase was 88. On 19-NOV-2009, mumps immunoglobulin M antibody was <1:10, mumps immunoglobulin G antibody was 9.27, serum amylase was 39 and the patient was diagnosed with parotitis (previously reported as 28-DEC-2009). Additional information has been requested.
I had my vaccination 09/22/2022. On 10/02/2022 I tested COVID-19 negative. I started to have mild symptoms to include lethargic and feeling not well. I tested COVID-19 positive on 10/05/2022. I isolated and used throat lozenges. My throat was so sore and neck was frozen in place.
Mild Fever for about 12 hours,  100.4 , redness and huge lump at injection site, moderate arm pain from swelling, body aches, fatigue, increased hunger, chills, feeling hot and cold simultaneously, nausea
The day after the patient received her COVID vaccine her face turned red, she had a burning feeling to her face and ears and she felt like her throat was tight.  She took 50 mg of diphenhydramine at home around 4 a.m. and later in the day presented to the emergency department.  The ED doctor noted the patient's face and right ear were mildly red.  Her oropharynx was clear, neck supple and no rash or urticaria were noted.   She was given diphenhydramine 25 mg IV and methylprednisolone 125 mg IV.  After being observed in the ED for a while the patient's face was no longer red and she reported no trouble with swallowing so she was discharged home.
Fever 104 F; Muscle aches-whole body; Chills; Nausea; Chest tightness; Dizziness; This is a spontaneous report from a contactable consumer. This 58-year-old male consumer (Patient) reported. A 58-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6204), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 16:45 (at the age of 58-years-old) as a single dose for covid-19 immunization. Medical history included type 2 diabetes mellitus, hypertension, haemochromatosis. Concomitant medication(s) medications in two weeks included insulin glargine (TOUJEO); losartan potassium; gabapentin; metformin; fenofibric acid. The patient did not have any allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Mar2021 15:00, the patient experienced fever 104 F, muscle aches-whole body, chills, nausea, chest tightness, dizziness. The patient did not receive any treatment. Outcome of the event was recovering, at the time of this report. No follow-up attempts are possible. No further information is expected.
pt felt ill 9JUN97 devel gen rash 10JUN97 erythematous, macular-papular was seen by MD 10JUN;also c/o stiff joints & fatigue;pt out of work from 9JUN97 to 17JUN97;dx as viremia secondary to MMR:
Swollen, hot, pink at injection site painful 5/10 on 0-10/10 pain scale - tx: cool compress, TYLENOL po.
Patient came in on 15 Sept. 03 to have a PPD placed and an 4th dose of Anthrax vaccine to be given.  Patient received PPD placement to left arm and Anthrax to the right arm.  Later that same day, he experienced redness and swelling to right arm where Anthrax vaccine was administered.  He came in today (17 Sept. 03) and saw MD prescribed a sterroid cream and sent patient on his way.
TOOK THREE UNREFRIGERATED DOSES; DID NOT TAKE DOSES ACCORDING TO SCHEDULE; This spontaneous case (PVX2019-1137) was received from pharmacist on 07-May-2019. It describes a 19-year-old male consumer who "took 3 unrefrigerated doses" and "did not take doses according to schedule", while being on oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took three unrefrigerated doses. Also, she did not take doses according to the schedule. The doses were taken on Tuesday, Thursday, and Monday. He did not take the fourth dose as he was recommended to speak with physician. He stated that he would be leaving for an endemic area in about a week.  Action taken with Vivotif was not applicable.  The clinical outcome of the events was unknown.  Company's Comment: The causality of the event "took three unrefrigerated doses" and "did not take doses according to schedule" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took three unrefrigerated doses" and "did not take doses according to schedule" was considered as not applicable.
About 24-26 hours after injection I began experiencing a fullness, congestion, pressure, and warmness in my deep ear area bilateral.  This was accompanied by a shift in my hearing that can best be described as droning sounds and low tones being pronounced.  It did seem that some tones were harding to hear but this was difficult to determine.  In some ways it sounded like being underwater.  The feeling was moderate in severity and did come on over seconds to minutes equally in both ears.  The symptoms progressed slightly over several hours.  By 10pm that evening I was hearing ringing in my ears.  I had contacted several physician friends that advised me to start a course of prednisone.   The physical symptoms slowly resolved over 3 days.  A slight ringing in ears was still persistent on 2/14, five days following the Phizer Covid Vaccine booster.
Lack of taste; Had no energy; Completely wiped out; Fever of 100.2 F; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lack of taste), ASTHENIA (Had no energy), FATIGUE (Completely wiped out), PYREXIA (Fever of 100.2 F) and MYALGIA (Muscle aches) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013AZ1A and 038AZ1A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced AGEUSIA (Lack of taste), ASTHENIA (Had no energy), FATIGUE (Completely wiped out), PYREXIA (Fever of 100.2 F) and MYALGIA (Muscle aches). At the time of the report, AGEUSIA (Lack of taste), ASTHENIA (Had no energy), FATIGUE (Completely wiped out), PYREXIA (Fever of 100.2 F) and MYALGIA (Muscle aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, Body temperature: 100.5 (High) Patient experienced fever 100.5.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant product use was provided by the reporter. No treatment medication was provided.  The patient was fine in a few days and was pending for his third dose.  This case concerns a 86-year-old male patient with no details on previous relevant medical history, who experienced the unexpected non serious event/AESI of Ageusia and other non serious events after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred approximately 1 day after the first dose of Spikevax and resolved after a few days. The rechallenge is negative, since the event did not recurr after the second dose. The benefit-risk relationship of Spikevax vaccine is not affected by this report; Sender's Comments: This case concerns a 86-year-old male patient with no details on previous relevant medical history, who experienced the unexpected non serious event/AESI of Ageusia and other non serious events after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred approximately 1 day after the first dose of Spikevax and resolved after a few days. The rechallenge is negative, since the event did not recurr after the second dose. The benefit-risk relationship of Spikevax vaccine is not affected by this report
Extreme weakness in legs. Could barely stand or get up from a chair. Once the fever broke, these symptoms went away.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL injection, lot # K007828, expiration date: 02-MAR-2017 (exact dose, dose number and route of administration were not provided). Administered doses of vaccines experienced the temperature excursion of 33.2 degrees Celsius for 11 hours and 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt had urticaria from waist down 2 days post hep A, DTaP, IPV, and MMR. No local reaction.
20-30 minutes after the vaccine extremely sore arm on the same day. I started having chills and goosebumps and riggers. Fever but didn't take temperature. Woke up in the middle of the night my body hurt very badly. Next morning started vomiting and had diarrhea and so tired and could barely move and needed help going to the bathroom and had a really bad headache. My lymph nodes was swollen. There was pain on the side and hurt to touch on the right. it was sore for a long time. Saw the doctor in Mar 2021.Yearly physical exam in Feb 2021 and nothing showed up. 30 Oct and with booster as well, fever, nausea and no vomiting .
Patient was seen in our office around 3:00 PM 4-24-07 for earache. He received 2 vaccines Tdap & Menactra. Patient's mother called our office 4-25-07 and stated he passed out last night (4-24-07) at 11:00 PM. He felt dizzy, was off balance and was thinking slow.  Mother had difficulty waking him up. She took him to Emergency Dept and was told by ER doctor that above symptoms was most likely due to his ear problem-his ear canal was red.
Information has been received from a registered nurse referring to a 5 year old patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 04-AUG-2014 the patient was vaccinated with a second dose of VARIVAX (Merck) (lot # J009728 with expiration date 07-AUG-2015; dose and router were not reported). On 27-AUG-2014, the patient was received the second dose of M-M-R II (lot# J013315 with expiration date 18-OCT-2015; dose and router were not reported) (inappropriate schedule of drug administration). No adverse effect was reported. Additional information has been requested.
It was reported that a year old female received IPOL on 7/31/02. The pt developed pain and swelling at the injection site within 24 hrs of administration. It was not reported whether the pt recovered from the event.
periods for four months now; They were very painful and heavy cycles; They were very painful and heavy cycles; Overdose; inappropriate schedule of vaccine administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 22Mar2021 (Lot number: EN6206) as dose 1, single and administration date 22Mar2021 (Lot number: ER8734) as dose 2, single for covid-19 immunisation. Relevant medical history included: "hypothyroidism" (unspecified if ongoing); "Hashimoto's  Disease" (unspecified if ongoing); ""breakthrough" bleeding as they had been so light", start date: 2018 (unspecified if ongoing), notes: By 2019-2020 my periods could be classified as, "breakthrough" bleeding as they had been so light. The patient took concomitant medications. The following information was reported: OVERDOSE (non-serious) with onset 22Mar2021, outcome "unknown", described as "Overdose"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 22Mar2021, outcome "unknown", described as "inappropriate schedule of vaccine administered"; MENSTRUAL DISORDER (non-serious) with onset 20Jun2021, outcome "unknown", described as "periods for four months now"; HEAVY MENSTRUAL BLEEDING (non-serious), DYSMENORRHOEA (non-serious) all with onset 20Jun2021, outcome "unknown" and all described as "They were very painful and heavy cycles". Therapeutic measures were not taken as a result of menstrual disorder, heavy menstrual bleeding, dysmenorrhoea.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications (not specified) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient had no known allergy. It was reported that since 2018 Patient had routinely had light periods with few symptoms or pain. Her cycles were slowing down in both flow, and it was normal to skip one month occasionally. By 2019-2020 her periods could be classified as "breakthrough" bleeding as they had been so light. After her vaccination in Mar, she went three months with no period. That was not too alarming, given her age. (So, no periods Mar, Apr, or May.) Since then, she has had periods for four months now. (Jun, Jul, Aug, and Sep.) They were very painful and heavy cycles.   No follow-up attempts are possible. No further information is expected.
I am reporting the fact that pt was given his second dose of Pfizer vaccine a week early.  The second dose was to be administered on 08/18/2021, but instead got his second dose on 08/11/2021.  Pt notified.
Intense dizziness and vertigo. First two days- nearly constant and accompanied by nausea and headache.  Dizziness lasting for more than 1 week. Vertigo still present after 7 days if laying in certain positions. Taking meclizine as needed for dizziness and motion sickness.
chills and shivering, fever, nausea, light-headed -  off and on for 8 hours.   About 1/2  hour with symptoms severe enough that patient could not walk and had to lay down on the floor to keep from falling.
Initially I experienced a very itchy non specific rash, which did not respond to antihistamine.  The rash subsequently spread over my entire body, becoming red, inflamed and unbearably itchy - totally disrupting my sleep routine.  Eventually, when blisters also started appearing, I was seen by a Dermatologist.  A skin biopsy and full blood count were taken and a diagnosis of Bullosa Pemphigoid was confirmed 30.11.2021
This spontaneous report as received from a licensed vocational nurse refers to multiple unspecified patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot#L018501 exp date 22-JUN-2017, L026599 exp date 22-JUN-2017 and lot #L045117 exp date 06-OCT-2018) (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Narrative:  Hospitalization: COVID positive and asymptomatic on admission, admitted for weakness and falls
severe allergies; Initial information was received on 25-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media (under reference number: US-SA-SAC20211130000189).  This case involves an adult patient of unknown gender who experienced severe allergies (allergy to vaccine) after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed serious severe allergies (allergy to vaccine) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as life-threatening.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the event.  At the time of reporting, the outcome was unknown for the event (allergy to vaccine).  The reporter assessed the causal relationship for the event (allergy to vaccine) with the INFLUENZA VACCINE as not reported.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns adult patient of unknown gender who experienced allergy to vaccine (unknown latency) after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Patient did not report an adverse events at the time of her pharmacy visit today. Report filed because Flublok was the second flu vaccine patient received in a span of 29 days. First one was Fluzone Quadrivalent on 9/23/2022 at same location.
This medically confirmed report (initial receipt 26-Oct-2012) concerns a 90-year-old female patient with a medical history of hypertension and hyperlipidemia. On 22-Oct-2012 the patient received AFLURIA (batch no: P50408) intramuscularly in her right arm at a dose of 0.5ml. On the same day the patient developed pain and swelling in her right arm. On 26-Oct-2012 the pain and swelling continued. The patient consulted a pharmacist and was planning to see a physician. The outcome for the events was not yet recovered.
SWELLING AROUND INJECTION SITE AND AROUND EYES, DEVELOPED RESPIRATORY WHEEZING
Racing heartbeat, extreme sweating ( I've had to shower twice since 9pm), chest pains, shortness of breath, muscle tension and spasms
Employee states she had flu like symptoms, aching, fever, chills, redness at (L) deltoid site, swollen lymph nodes. Limited range of motion in (L) arm for 48 hours.
5 days of neck pain, fever, muscle spasm, muscle pain, neck pain. Pt seen at office on 9/3/10 - pt sent to ER after I called CDC.
Patient lost consciousness 10-15 minutes after receiving vaccine. Patient reported not feeling well, then waking up on the floor. Patient fell from a seated position to a prone position on the floor. 911 was called. Patient regained consciousness, complained of not feeling good/having nausea. Patient was vomiting into a trash can. Unsure if patient hit his head, but patient did feel warm and sweaty. Paramedics arrived and patient walked with them to the ambulance.  Assumed patient went with them to hospital, outcome unknown.
At 8:40 am participant complained of dizziness.  VS at 08:50 am; BP= 166/113, O2 Sats= 97% RA, HR= 78, RR= 18.  Patient stated she did not have breakfast and perhaps she was hypoglycemic, thus she consumed a bottle of orange juice.  VS at 08:56 am; BP= 195/106, O2 Sats= 98% RA, HR= 76.  At 09:14 am, participates stated she is feeling better.  VS at 09:20; BP=176/99, O2 Sats= 100% RA, HR= 79.  At 09:42 am participant stated she continues to feel better; BP= 186/94, HR= 82.  At 0945 am participant left the site.