chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient presented to pharmacy for 2nd booster shot. 0.5ml was administered instead of 0.25ml. At this time patient is not experiencing any side effects
2-3 minutes after receiving the vaccine. the patient turned pale, start sweating and complaining of feeling  little bit nauseous. a bottle of water was given and he start drinking. at the same time EMT's were called. patient was conscious  and alert at all time.
3-2-11 red blotches on (L) arm down to elbow. Warm to touch & tender. Monitor - TYL, Ibuprofen, & BENADRYL.
pt recvd vax & had high pitched scream 1 cry for 1 1/2-2 hrs;
This spontaneous report as received from a consumer refers to her unknown age daughter who is the patient and also has a twin sister. Information regarding concurrent conditions and medical history was not provided. Approximately 1 year and 2 months ago, on an unknown date in June 2013 the patient was vaccinated with the first dose of GARDASIL (lot#, dose and route were not provided). No concomitant medications were reported. And at the time of the report the patient would like to receive the second dose. No adverse symptoms reported. There was no product quality complaint. This case is linked to SR# 1-12068244292 (Marrs# 1408USA002263), which has adverse information for the other twin. Additional information has been requested.
Extremely dizzy, almost fell, after reaching up. This has never happened before; Extremely dizzy, almost fell, after reaching up. This has never happened before; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9263), via an unspecified route of administration, administered in left arm on 28Jan2021 18:30 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included glucose tolerance impaired. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination.Patient did not have allergies to medications, food, or other products and no known allergies. The patient's concomitant medications were not reported. On 29Jan2021 08:45, the patient experienced Extremely dizzy, almost fell, after reaching up. This has never happened before. Treatment was not received for the adverse event. Outcome of the event was recovered on an unspecified date.  Follow-Up (15-Apr-2021): Follow-up attempts are completed. No further information is expected.
experiencing a hissing water running ringing in her head; she can not sleep at night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 86 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 (Batch/Lot number: unknown) at the age of 86 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Anatomical Site of injection: Arm (Left), Batch/Lot number: Unable to locate read the details , Not legible), administration date: 20Mar2021, when the patient was 86 years old, for COVID-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset Apr2021, outcome "unknown", described as "experiencing a hissing water running ringing in her head"; INSOMNIA (non-serious) with onset Apr2021, outcome "unknown", described as "she can not sleep at night".  Additional information: States she has a caller on the line calling about the Pfizer COVID Vaccine and asked what will she do because after having the 2nd dose in April, patient is hearing ringing in her head and cannot sleep at night and wanted to know what to do. Comments/narrative: After receiving 2nd Dose of Pfizer vaccine ringing head started occurring. Have not been able to sleep at night since 2nd Dose, continual buzzing in head throughout the day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Upon second medical examination of the case during internal review, a significant correction was performed on 5 February 2016 to correct the product code of DPT from 'DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE' to 'DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED)'. Upon second medical examination of the case during internal review, a significant correction was performed on 2 February 2016 to correct the product code of DPT from 'DIPHTHERIA/TETANUS/WHOLE CELL PERTUSSIS ADSORBED VACCINE' to 'DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE'. SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. Initial report received from a consumer on 29 September 2014 via a social media page. That report is from social media and contact information in based upon the location of our trading partner. A female consumer reported that in 1975, at two months of age, she received DTP (DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED)) (manufacturer and lot number not reported) and an unspecified amount of time later experienced spinal meningitis and encephalitis ("I had just gotten my DPT shot"). According to the reporter, family history included a third cousin who experienced a similar "allergic reaction", and the reporter attributed the events to a "recessive gene". Symptoms included a fever of 106 degrees, and per the reporter "they took the fluid off my brain with a needle, and I still have the white freckle from the scar on my scalp". Outcome was not reported. Documents held by sender: None. Addendum on 2 February 2016: Upon second medical examination of the case during internal review, a significant correction was performed to correct the product code of DPT from 'DIPHTHERIA/TETANUS/WHOLE CELL PERTUSSIS ADSORBED VACCINE' to 'DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE'. Addendum on 5 February 2016: Upon second medical examination of the case during internal review, a significant correction was performed on 5 February 2016 to correct the product code of DPT from 'DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE' to 'DIPHTHERIA, TETANUS AND PERTUSSIS VACCINE (ADSORBED)'. Sender's Comments: This is a poorly documented, consumer-reported case of meningitis in a 2-month-old following DTP vaccination. Infants are at higher risk for meningitis, as are patients with certain underlying diseases. In addition, the event occurred in 1975 prior to the availability of a vaccine for Hib, a common cause of meningitis in infants. Additional information regarding the patient's past medical history, laboratory and pathology findings, and vaccination details would be helpful in fully assessing the case.
On date that patient received vaccine arm was sore for about an hour, felt fine the following day, Friday and continued to feel fine until the following evening, Saturday evening. Patient began to feel nauseous, fatigued, vomiting, couldn't keep anything down, headache. This continued thru Sunday, ate a small amount of dinner but vomited. Called PCP on following Monday 4/5/2021. Symptoms improving but still nauseated and can't eat anything. Headache persists.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. The vial was placed in the refrigerator on 18-October-2021. No adverse events were reported. No temperature excursion was reported.
Chest tightness, closing throat, coagulation in the throat of phlegm, difficulty breathing
Injection on Tues. 10/12/10. On Fri. 10/15/10 site began to swell with swollen lymph nodes (L) neck and axilla.
Patient said that he felt dizzy when he was in class after receiving the vaccine. Teacher(s) noted him to be pale. Brought to auditorium where he was assessed, monitored, & given orange juice over 20-30 min period. Returned to class @ 1002 hr w/teacher aide. + CTA both, cr<2sec; 2+ pulses both, RRR without murmur noted initially pale appearing, but coloring returned.
Agitation, sleep disorder, mood: anxiety, anxious, angry, irritable, Balance: dizziness, vertigo, Blood pressure high, pain muscle and joints. Cramps legs arm left side. Cramp head. Feeling these symptoms on daily basis.
Patient inadvertently received vaccine after published expiration date. Moderna Company analyzed lot 007B21A and advised vaccine maintained activity necessary to protect against covid 19 at time of administration.  Also patient did not call in to complain of adverse event.  This is administrative error without  adverse event.
The afternoon after pt received vaccines caregiver called because experienced severe nausea and chills. Patient was taken to hospital later that night and held for observation. Pt had a fever of 102.6.
Pt missed her menstrual cycle this month. She has been menstruating regularly since age 11 and 5 months without ever missing a period.
Muscle spasm after injection. Rash over Right Deltoid area within 6 hours of injection despite 25 mg of BENADRYL being taken 1.5 hours prior to injection. Point tenderness over injection site lasting longer than 21 days.
Soreness at injection site; Slight headache; Joint pain; Draggy feeling; The patient received a third/booster dose of BNT162b2.; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD0809) via an unspecified route of administration in the left arm on 11Nov2021 at 11:00 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, diabetes and heart disease. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified prescription medication within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0140) via an unspecified route of administration in the left arm on 22Dec2020 at 14:30 (at the age of 77-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 11Jan2020 at 10:45 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. On 11Nov2021 at 15:00, the patient experienced soreness at injection site, slight headache, joint pain and draggy feeling. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events soreness at injection site, slight headache, joint pain and draggy feeling was not resolved at the time of this report.
This spontaneous report was received from a 69 year old female patient regarding herself. The patient had no pertinent medical history and drug reactions or allergies. There were no concomitant medications. In approximately 2015 (reported as a year ago), the patient was vaccinated with ZOSTAVAX subcutaneous (dose, lot number and expiry date were not reported). In approximately June 2016 (reported as 8 weeks ago), the patient developed shingles. She stated that she did not have what was considered the normal rash and blistering that was associated with shingles, instead she had a flat rash. On the 3rd day after the pain and rash began, she sought medical attention and went to the emergency room (ER) where she underwent chest x-ray examination and white blood cell count however results of tests were not provided. She reported that the ER physician thought she was experiencing "some type of muscular problems" as she was unable to move without experiencing pain. She explained to the physician that she had a rash that went from her upper back, down and around her torso to the center of her stomach. The patient stated that ER physician confirmed that she had shingles, but no treatment was provided. She visited her primary physician the next day, who prescribed her with two month supply of LYRICA (dosage details were not reported) which helped relieve minimal pain, but she was still unable to comfortably wear clothing and was only able to do light house work. She was doing better but still experiencing a lot of discomfort. The outcome of the event was reported as recovering. The causal relationship between the event and the suspect therapy was not reported. Additional information has been requested.
chills, muscle pain, nausea, h/a, arm pain;t99.3 given APAP;
Patient vaccinated x2 (Moderna: 12/10/21, 01/20/22)   Patient tested COVID+ during hospital admission on 5/13/22
2 weeks after the first dose, broke out in hives for a few days. After second dose, got hives within 24 hours.
HCP stated that her TB positive test may be related to her recent COVID-19; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer. (Reference ID: NUS2021US085589_NC). A 59-year-old female patient received BNT162B2 (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that HCP stated that her TB (tuberculosis) positive test may be related to her recent COVID-19 on an unspecified date. The outcome of event was unknown.  Information about lot/batch number has been requested.
This is a spontaneous case, initially received from other non-health professional on 14-Nov-2018, concerning a female patient of unspecified age. On an unspecified date, the FLUCELVAX QIVc underwent first temperature excursion with maximum temperature (Tmax) 8.2 degree centigrade for 4 minutes. On 22-Oct-2018, vaccine underwent second temperature excursion with Tmax 9.8 degree centigrade for 23 minutes (explicitly coded as incorrect product storage). On an unspecified date, two temperature excursions were identified after and audit. On 01-Nov-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid, batch number: 252672 and expiry date: 30-Jun-2019) which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience and adverse events after administration. This case is linked to 201805262 (same reporter).
Fever disoriented sweating heavier abnormal menses tooth infection loss of smell respiratory illness acute onset of asthma difficulty breathing and new diagnosis of congestive heart failure fluid in lungs enlarged heart
Patient started to develop maculopapular rash and itching starting ~15 minutes after the vaccine administration. The patient did not report shortness of breath or other respiratory symptoms. The patient was given IV diphenhydramine 50 mg, famotidine 20 mg IV, and methylprednisolone 125 mg IV. The patient's symptoms resolved and was sent home with a Medrol dose pack and antihistamine.
This case was reported by a healthcare professional and described the occurrence of injection site soreness in a 50-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). The subject's medical history included arthritis. Concurrent medications included Multivitamins and Magnesium. On 18 April 2014, the subject received booster dose of BOOSTRIX (route unknown, right arm, batch number not provided). On 19 April 2014, 1 day after vaccination with BOOSTRIX, the subject experienced injection site soreness, muscle stiffness and muscle pain in her right arm which came and went and stiff neck. Sometimes, she also had muscle pain in her left arm. On 25 April 2014, injection site soreness was resolved. At the time of reporting, muscle stiffness and pain and stiff neck were improved.
Area injection site red & induration 50 mm by 60 mm, red to touch.
Pt. arrived for appt at 11:20. Seen for rash that began on 10-15-08, spread to trunk and draper area, arms, legs, hands and feet. resembles measles rash. No other s/s of infection.
Vaccinated with Moderna on 2/6/21 and 3/6/21.  Symptom onset 7/6 with cough, loss of smell, headache and fatigue.  Tested positive for Covid-19 on 7/10/21.
My period has been lasting all the way up to now since the first shot on May 28, when I was in my period for 1 week or so.  At this point, my period has been almost 4 weeks long and will continue going on as I can see since the bleeding amount has drastically increased and become heavy 2 days after the 2nd shot administered on June 21. I went to my medical care provider on May 25, and reported this problem. And the provider ordered lab test, i.e. CBC and Prothrombin Time, for the the results have not come out yet. (continued in the section below). The provider also referred me to the department of Obstetrics and Gynecology, for which I am waiting for their call. The following information is provided here in an hope to bring to your attention, which reveals that many women has experienced/been experiencing the similar problem as I do subsequent to be vaccinated: Tweet from Dr. regarding the abnormal period subsequent to got vaccinated. And many women replied to her tweet telling their own experience in this regard.
Ischemic stroke on Saturday morning following vaccine Thursday.  Symptoms were muscle weakness and inability to speak
PT REPORTED CELLULITIS THAT HAD TO BE TREATED WITH ROCEPHIN @ URGENT CARE
pt was given vaccine on 3/7/22  from vial that was first punctured on 3/4/22.  Pt did not show any signs of adverse effects after waiting the 15 minutes after injection.  Manufacturer contacted, waiting on info regarding revaccination of patient
From initial information received on 03Sep04 from a health care professional regarding an adverse event occurring, it was reported that an 18 year old male pt received a Menomune A/C/Y/W-135 vaccination, lot number UE158AA, administered SC in the right arm on 19Aug04. Two days later, the pt experienced intense muscle pain, fever of 100 F, severe headache and neck stiffness. Reportedly the symptoms lasted for 48 hours and subsequently. From additional information received on 11Oct04 from a health care professional, the pt's full name was provided. Per the reporter the information has been reviewed and no additional information is available at this time. No further information is anticipated. This case is considered closed.
Patient was given vaccine dose that was expired(3/18/2022) by 3 days past viability.
Initial information received on 31-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 7 months old patient (gender not reported), who was vaccinated with a dose of PENTACEL (batch number: C5462AA and expiry date: 26-Jul-2019) via intramuscular route in the right thigh and also received a dose of ACTHIB (batch number: UI894AAA and expiry date: 28-Sep-2019) in the left thigh (route not reported) (dose and dose in series were not reported for both the vaccines) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunisation on an unknown date. It was a case of actual medication error due to extra dose administered. It was also reported that the patient received both ACTHIB and PENTACEL on the same day, their intended action was administration of the third PENTACEL dose by the doctor. No side effects 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 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. Documents held by sender: none.
the patient was inadvertently administered an incomplete second dose of VAQTA; The nurse reported that no adverse effects were reported; This spontaneous report as received from a nurse, refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications, drug reactions or allergies.   On an unknown date, the patient was vaccinated with an incomplete(underdose) second dose of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (route of administration, lot number and expiration date were not reported). No adverse effects were reported.  At the moment of this report the outcome and the causal relationship between hepatitis a vaccine, inactivated (VAQTA) and underdose was unknown.
4:38 pm - Generalized "achiness" - "not feeling good" - laid on table, cool towel to face, sipping Sprite, BP 93/55, HR 81. 4:46 pm - "not feeling better - like I'm gong to pass out" B/P 106/57, HR 86, laying down sipping Sprite. 4:48 pm - CPNP examining pt - "has not eaten since AM" "Get food, monitor, to ER for distress". 4:49 pm - pt brought to car per wheelchair, myself, mom - assisted with walking, looks a littler perkier - no distress.
Hives at injection site and on face; itchiness at injection site and on face. Cool clothes on face and Benadryl. Hives subsided from face 1.5 hours later; not injection site. Hives subsided from injection site on Monday 10/18. Injection site still itchy, red and less sore.
Pt complained in ER of difficulty breathing, swollen throat, extreme weakness, dizziness and itching. Given 2 dose of Benadryl and monitored. Discharged to home with Benadryl.
4-5hr p/vax 7-730PM pt seen for heartburn, SOB, swollen neck gland;rx DPH;EKG discharged;told that had an adverse rxn to vax;
My graves disease was well controlled for the months prior to my 3rd PFizer booster. I received the 3rd booster on Oct 1 and by Oct 8, my TSH had plummeted to 0 . I think that the vaccine caused a Graves disease flareup.