chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse effects reported; one patient was administered improperly stored PEDVAXHIB; This spontaneous report was received from a registered nurse and refers to a 9-week-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 07-JUL-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # S023646, expiration date: 31-MAR-2022 (exact dose, injection site and route of administration were not provided) for prophylaxis. The administered dose experienced a temperature excursion of above 47 degrees Fahrenheit: 57.39 degrees Fahrenheit for 6 hours. The digital data logger was involved in regards the temperature excursion details. No previous temperature excursion had occurred. No additional adverse effects were reported.
urinary tract infection; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: not provided), via an unspecified route of administration on 14Feb2021 as a dose 2, single for COVID-19 immunization. The patient had received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: not provided), via an unspecified route of administration on 26Jan2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. On 14Feb2021, the patient experienced symptoms of a urinary tract infection the night. The outcome of the event was unknown.  Information about lot/batch number is requested.  Follow-up attempts are completed. No further information is expected.
developed ITP; This spontaneous report was received from a consumer referring to a 5 years old female patient. The patient's concurrent condition, medical history and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported).  In approximately 2004, the patient experienced an adverse reaction to measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown), which was immune thrombocytopenic purpura (ITP). The outcome of the event was not reported.  Upon internal review, ITP was determined to be medically significant.
Flu vaccine given on 09-22-2009 at 2 p.m., hives and swelling on hands started at 9 pm on 9-22-09 until 7 p.m. on 09-23-09. Benadryl was taken orally three times. No trouble after last dose.
Patient complained of feverish, myalgias, generalized headache once a day. Physical exam: unremarkable, no rash. Treatment with rest and Tylenol PRN.
no adverse event, we were contacted by local health department, Pt received a Johnson and Johnson. and asked us to submitt a vaers report
Information has been received from the Pregnancy Registry for GARDASIL from a 23 year old female with a latex allergy and no pertinent medical history who on 22-FEB-2007 was vaccinated with a dose of GARDASIL (lot # unknown) injection. Concomitant therapy included "CHANPIX" [therapy unspecified]. On 22-FEB-2007 the patient received GARDASIL when she was 5 weeks pregnant. The date of the last menstrual period was approximately 01-JAN-2007. Medical attention was sought. On an unspecified date a pregnancy test was performed to confirm the results. The patient is currently 6 months pregnant. The estimated date of delivery is 08-OCT-2007. No further information is provided. Follow-up information was received from the patient. The patient called and advised that she will be in 90-95% range to have a high birth weight baby. (9lbs +). Patient advised that she may require a c-section. Follow-up information was received from the LPN and reported that the baby had a full-term live birth (female) weighing 7 pounds 3 ounces. The LPN had no further information. Follow-up was also received from the patient who reported her baby is now 7 months old and has a right hip "click". The baby was evaluated by a specialist (not specified) who told her the baby was normal. No further information was provided about the baby. Additional information has been requested.
Right upper arm swelling, pain and erythema started w/in 6 hrs of vaccine, persisted 1-2 wks, improving course.
Incident Details: Per Drs. email sent out on 9/1/22- 'the monovalent mRNA COVID-19 vaccines are not authorized as booster doses for individuals 12 years of age and older. Any patients that are currently scheduled to receive a booster should wait until we have the bivalent booster on hand'. The patient was seen in office on 9/2/22 and received a booster dose of the monovalent mRNA COVID-19 vaccine (Pfizer) by staff in error as patients are now only supposed to receive the bivalent booster per Drs. email. Patient was due for booster at the time they received it, however the bivalent booster was not yet stocked. Possible Cause: Possible cause of the incident is that an email was sent out regarding the discontinuation of monovalent Covid boosters until Private receives the bivalent booster doses. This was overlooked by management and staff, as previous changes to clinic processes is usually discussed in a meeting. Also 'monovalent' and 'bivalent' are new terms that have not previously been used when discussing booster vaccines.  Corrective Action: Corrective action included notifying staff and providers of the recent change regarding COVID vaccines and were notified to stop giving COVID booster doses until the Clinic receives the bivalent vaccines. Staff and providers were notified via email, skype, and verbally. Incident reported to VAERS. Recommendation: I would recommend holding a meeting to notify Leads/Supervisors/Managers of any changes regarding COVID vaccine administration, rather than sending out an email that may not be read by all staff. If an email is needed to be sent, I recommend making it clear that a process is being changed.
Numbness in the Left Arm up to the Left side of the Face; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in the Left Arm up to the Left side of the Face) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced HYPOAESTHESIA (Numbness in the Left Arm up to the Left side of the Face). At the time of the report, HYPOAESTHESIA (Numbness in the Left Arm up to the Left side of the Face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Began developing joint pain and skin plaques shortly after Covid immunization. Was diagnosed with psoriasis & psoriatic arthritis shortly after.
Patient came to the pharmacy today. He said he had an adverse reaction to his COVID vaccine or flu shot during the middle of the night, following his immunization. He was vaccinated around 11:23 AM. He experienced swelling of his throat around 2:00 AM that night. He had difficulty swallowing and breathing for about 10 minutes. He said he was on a CPAP machine and was able to increase his air flow for the duration of the swelling. He got through it on his own and decided not to go to the emergency room.
Day 1 - fatigue, drowsiness Day 2- fatigue, mild muscle aches, temperature elevated to 99.1, bloating/gas Day 3 - fatigue, lymphadenopathy (right side jaw, neck, clavicle, breast/chest), bloating/gas Day 4 - fatigue, lymphadenopathy (right side jaw, neck, clavicle, breast/chest) Day 5 - fatigue, lymphadenopathy (right side jaw, neck, clavicle, breast/chest), nausea, decreased appetite, decreased ability to focus, headache, elevated blood pressure, anxiety Day 6-  fatigue, lymphadenopathy (right side jaw, neck, clavicle, breast/chest), nausea, decreased appetite, constant tinnitus left > right, anxiety Day 7 through present - lymphadenopathy improving; continued, unrelenting tinnitus left > right, headaches
Headache next AM that worsened on 12/25/20 Fatigue-same
Patient received pneumonia & flu shot on 9/9/11. On 9/10/11, she did not feel well, was weak, arm was hot to the touch, swollen red, & sore. Took CLARITIN, feeling better on 9/11/11. Arm still red.
INJECTION SITE SORENESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on left arm on 11-MAR-2021 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. On 12-MAR-2021, the subject experienced injection site soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site soreness on MAR-2021. This report was non-serious. This case, from the Others is linked to 20200903207.
Pt received 2 booster doses of Bexero and Menquadfi instead of just one booster dose of each. First series were administered elsewhere. Second and third doses were received at clinic.
5cm x 6.7cm area of localized erythema, swelling, warmth & induration;no lymphadenopathy; pain & swelling 17NOV;mild erythema still present 17NOV98;
Child received 15 month shots about 11:00AM, Pt became fussy and seemed in pain when mom changed Diaper. Around 10PM patient developed fever and was shaking. Temp 102.9. Mother call triage Nurse was advised to take child nearest ER, OK per mom. Seen at ER was advised Ibuprofen: Monitor temp, warm compresses to upper legs. Dx: Febrile seizure.
Severe persistent arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe persistent arm pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2021 at 2:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Severe persistent arm pain). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Severe persistent arm pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Tinnitus. A white noise and slightly muffled effect. Hearing acuity doesn?t seem affected. (No hearing test administered)
1.5 days after vaccination patient began to have itching, redness, and welts on both arms, especially at wrist area.
This case was reported by a consumer and described the occurrence of injection site soreness in a 34-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included allergic to COMPAZINE and allergy to REGLAN. Previous and/or concurrent vaccination included hepatitis A vaccine inactivated; manufacturer unspecified; unknown; unknown given in November 2009. There were no concurrent medications. On 15 January 2010 the subject received 2nd dose of HAVRIX (1 ml, intramuscular, unknown). On 15 January 2010, less than one day after vaccination with HAVRIX, the subject experienced injection site soreness and inappropriate schedule of vaccine administered. The subject reported that she possibly received hepatitis A vaccine in November 2009. The subject was immunized on 15 January 2010 which was before the label recommended next dose. The subject also experienced soreness at injection site. The subject denied contact for follow-up. At the time of reporting the outcome of the soreness at injection site was unspecified.
Last Saturday the 14th, it started as seasonal allergies I have each spring- itchy eyes, coughing, running nose, hoarseness. The next day 101 fever and checked my oxygen saturation it was 93-95 percent and continued to have the symptoms. I took an at home COVID test and it was positive. I went to my PCP yesterday the 16th. I've developed achiness, some dizziness, diarrhea.  I was pretty sick Sat/sun by Monday the symptoms were diminishing. I was prescribed prednisone and Paxlovid and continue to improve.
Initial report received on 17/Aug/2006 from a physician.  A 20-year-old female patient, with mild asymptomatic tonsillitis at the time of vaccination, had received an intramuscular, left arm injection of Adacel, lot number C2454AA, and an intramuscular, right arm injection of Menatra, lot number U2057AA, ON 14/Aug/2006.  Within 24 hours, she experienced weakness in her legs, pain under her right axilla, general malaise, arthralgia, fatigue, low grade fever, chills and aches.  The signs and symptoms were "flu-like".  Per the report, the event required no medical intervention. Recovery status was not reported. Follow-up information received on 14/Aug/2006. It was reported that the patient had a mild viral infection prior to injection, but was asymptomatic. No further description of the event of leg weakness was provided and the reporter stated that it was "difficult to give the etiology" no diagnosis was reported. The event did required examination by a physician. The patient did not require any neurological testing and no diagnostics were completed. No treatement was prescribed, the subject developed a mild, dry cough which resolved in five days. The patient recovered from all reported events.
pt looked pale 10 minutes after vaccine went out to check on him he was getting faint and lips looked purple, was NOT having breathing problems and BP was normal at 104/54, called 911 patient was very clammy and sweaty, stayed with patient until paramedics arrived, patient was feeling much better a little before paramedics arrived, but they decided to take him to hospital
Headache; chills; sweating; nausea; tonsil stones; muscle aches; This is a spontaneous report from a contactable other healthcare professional (reported for herself). A 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular (left arm) on 12Jan2021 (12:15 PM) at single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 (lot number: EK9231) intramuscular (left arm) on 23Dec2020 (03:00 PM) for Covid-19 immunization. The patient's medical history included migraines and anemia; no known allergies. Concomitant medications included spironolactone, frovatriptan succinate, ethinylestradiol, norgestimate (TRI-SPRINTEC), and ferrous sulfate. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced headache, chills, sweating, nausea, tonsil stones, and muscle aches on 13Jan2021 (07:00 AM). There was no treatment received for the adverse event. The outcome of events was recovering. The patient has not been tested for COVID-19 since the vaccination.
blood sugar level 204; fever; nausea; chills; headache; heart rate over 100; A spontaneous report was received from a consumer concerning a 74-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fever, nausea, chills, headache, heart rate over 100, blood sugar 204.  The patient's medical history was not provided. Concomitant medications reported were Chloratholidone, Omeprozole, Aspirin, Clonidine, Alprazolam, vitamin D3-400, Fish oil 400, Multivitamin, Magnesium, Colace, Proair HFR inhaler, Metformin, Carvedilol, Lovastatin, Pravastatin, Doxazosin, Potassium chloride unknown indication.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 024M20A) via unknown route for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) fever, nausea, chills, headache, heart rate over 100, blood sugar 204.Treatment medication include acetaminophen .  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), fever, nausea, chills, headache, heart rate over 100, blood sugar 204 was unknown.
I tested positive for COVID-19 on 05/19/2022 and was asymptomatic. I was prescribed PAXLOVID on 05/19/2022 by my primary care physician.
She then got home and decided to read a book but instead fell asleep for 4 hours; This spontaneous case was reported by a patient and describes the occurrence of SOMNOLENCE (She then got home and decided to read a book but instead fell asleep for 4 hours) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SOMNOLENCE (She then got home and decided to read a book but instead fell asleep for 4 hours). On 24-Feb-2021, SOMNOLENCE (She then got home and decided to read a book but instead fell asleep for 4 hours) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported.  On 24-Mar-2021, patient took Moderna monovalent dose 2; lot number 007B21A. On 03-Nov-2021, patient took Moderna monovalent dose 3; lot number 071F21A. On 06-Apr-2022, patient took Moderna monovalent dose 4; lot number 048L21A. On 31-Oct-2022, patient took Moderna bivalent dose 5; lot number 059F22A.  With the first Moderna shot she went to run errands afterwards. She then got home and decided to read a book but instead fell asleep for 4 hours. That was very unlike her. No additional symptoms or side effects. No medications or treatments.   Patient was asking about which symptoms she can expect with the new vaccine and what makes this vaccine different than previous Moderna vaccines.
soreness in left arm (site of injection) vertigo on 1/1/2021 at 5:30pm (dizziness that prevented standing, nausea, extreme fatigue). Pt has never experienced vertigo before. On 1/2/21 some mild dizziness remains though the pt can resume normal activity in the home.
tested Covid-19 Positive 4 days after her first dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported. A female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient Concomitant medications were not reported. The patient already had the first dose of the Pfizer Covid-19 vaccine and was tested Covid-19 Positive 4 days after her first dose and now she still feels sick. Caller wants to know if when she's fully recovered on the 30Apr2021 which is her second dose due date, is it still safe to get her second dose. The relevant lab tests included test : COVID-19 test, result: positive on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Hours after vaccine administration pt developed severe neck pain. This lasted for 14 days before history was connected. Spinal tap was negative. Immediate relief a/6 tap.
Employee reports to being lightheaded immediately after getting immunized. 2/21/07 states feeling nausea and having pain to the eyes. Reports having nasal drainage, stated her legs started to itch while talking to her at 1055. Employee is itching whole body and reports feeling congestion in nose and eyes. Per Dr sent employee for follow up. VS at 1045 130/73 with pulse 64 BPM, Temp 96.4, VS at 1115 132/72 with pulse 55 BPM.
?I recd the first moderna vaccine 2-13-2021 at 11 AM.  Headache, right side only, started same day at 7:30 PM, sore shoulder at vaccine site about 10:30 PM same day.  Both were gone the next morning.  I recd the second dose of the moderna vaccine 3-13-2021 at 11 AM.  By 2 PM I had a ranging head ache, again right side only.  I drove four hours to the vaccination site, hospital.  I was driving home when this started.  I stopped to purchase Tylenol about 3 pm which it turns out had no effect.  I was driving west into a setting sun, as the headache got worse, my eyes became more and more sensitive to the sun, I stopped a second time to purchase a second pair of sunglasses that I could wear over the first pair, that didn?t help, I ended up stopping at a rest area until the sun set.  I got to my house at about 6 PM, by then I could no longer wear my prescription glasses, besides the headache I was now very dizzy.  At about 9 PM the pain started, between my shoulder blades first, never at the injection site.  From that time on, including today, the pain has constantly moved around my body, the worst pain is associated with areas that arthritis affects me, hips, knees, hands, ankles.  I have had a mild fever, ranging from 100.9 Saturday night to 100.3 now at11 AM 3-15-2021.  Yesterday, 3-14, my head was swearing, my feet were ice cold.  I had an electric blanket from my waist down and an ice pack on head.  If I have ever felt worse in my life I don?t remember when that would have been.  The pain has moderated today, I expect the worst is now over.    If as the health specialists are suggesting a booster will be required this fall I will undoubtedly have incredibly significant reservations with this vaccine.
Woke up following day with a horrible migraine.  Dizzy. Got the chills about 22 hours post vaccine. Sore arm.
I received the second does of the COVID vaccine on 9/28/2021 and a week later I started having intermittent chest pains. The pain was squeezing in nature and also radiated to the right chest too. I noticed my primary doctors office of this. The pains lasted on/off for a month or so.
Information has been received from a certified medical assistant concerning a 9 yr old white male who on 06Jan98 was vaccinated in the right thigh (route unk) with a second dose of varicella virus vaccine live (lot 0158B). Subsequently the pt experienced red bumps. The report indicated that the pt has a younger brother (DOB 28Jul04) who contracted them from two other brothers and varicella was given because of age. Additional information has been requested.
This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 27-DEC-2021, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S038177, expiration date 26-NOV-2021 (exact dose, frequency, route of administration, anatomical location and vaccination scheme were not reported) (expired vaccine used) for prophylaxis. No additional adverse events were reported.
Vaccine expired 2/12/2022, but administered to patient on 2/17/2022.
On the 31st of December  I woke up with a 4 inch  long red patch on the front of my left arm. This lasted 4 or 5 days . Went away after 4 days . Once I received the second does it appeared again and now it just comes and goes