chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax; painful, swollen, erythema for 72 hrs; swelling from inject site to approx 1" above elbow on Lt deltoid;
11OCT93 became irritable, had boyd aches, felt feverish, congested, coughing up bright green mucous; sl constipation; had lump on lt side of neck which became larger;
This spontaneous report was received from a physician via a company representative and refers to a 77 year old male patient. The patient's concurrent conditions included hypertension. The patient's medical history and concomitant therapies were not reported. On 09-FEB-2017 (reported as "last Thursday"), the patient was vaccinated with ZOSTAVAX 19400 "PFU" (dose, route, lot validation and expiration date were not reported) for prophylaxis. The physician reported that the patient presented in an unspecified emergency room on an unknown date in February 2017 (reported as "during the weekend") with facial paralysis. Therefore, the patient was prescribed acyclovir and an unspecified anti-inflammatory medication when discharged from the emergency room and was released without being admitted to the hospital. Additionally, on 13-FEB-2017, the patient went to the office, as a follow up from the emergency room visit. The physician recommended to the patient to seek a physical therapist for the facial paralysis. At the time of reporting, the patient was "recuperating". No product quality complain was reported. Upon internal review, the event facial paralysis was considered to be medically significant. Additional information has been requested.
Client was vaccinated with Pfizer vaccines on February 20 and March 20, 2021 at the health clinic.  Developed minor symptoms on 11/9 - runny nose, cough.  Tested with PCR on 11/11 and was positive for Covid.  Reported as a case of breakthrough Covid illness.
Vaccines given 7/28/03. 7/29/03 pt noted 101.3 fever, listless/lethargic x 30 minutes. with peripheral cyanosis. Paramedics gave O2 and transported to ED. Septic workup done: blood, urine, CSF. Admitted for obs. 7/30/03 pt afebrile, cultures negative growth to date. Discharged home for further followup. Back to baseline. The medical record received on 2/17/04 states pt vomited.
Mild headache; Can't raise left arm; Soreness on left arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Mild headache), LIMB DISCOMFORT (Can't raise left arm) and PAIN IN EXTREMITY (Soreness on left arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 045A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced HEADACHE (Mild headache), LIMB DISCOMFORT (Can't raise left arm) and PAIN IN EXTREMITY (Soreness on left arm). At the time of the report, HEADACHE (Mild headache), LIMB DISCOMFORT (Can't raise left arm) and PAIN IN EXTREMITY (Soreness on left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. Treatment included Heat over the area
I got really tired around 12:00 pm and slept a lot both Thursday and Friday. My entire body ached for both Thursday and Friday. On Thursday around 5 pm I noticed the start of a cold sore on the corner of the right side of my lip. I haven't had cold sores since I was a teenager and used to have oral herpes outbreaks a lot as a child. But for about 10 years I've had zero problems. By Sunday that little cold sore infected both upper and lower lips all over, and my chin. On Monday it got even worse and inflamed with the use of Abreva. My face was on fire and I had to go to my doctor.  My doctor then put me on Valacyclovir.
Local cellulitis at site of Varivax. Pt being treated for presumed infectious cellulitis.
Difficulty breathing, throat swelling (feels like it is) dizziness and weakness, nausea, feeling unwell, fever headache, tiredness and injection site pain
This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-SEP-2017, the patient was vaccinated with a dose  of RECOMBIVAX HB 2.5/0.5 (units not provided) (lot # N011851, expiration date: 19-DEC-2019; dose number and route of administration were unknown) and a dose of ROTATEQ (lot # N005080 with expiration date 03-OCT-2018, or lot # reported as N0118511 with expiration date 19-FEB-2019; orally, dose number was unknown), both for prophylaxis. The doses were improperly stored at 48.6 Fahrenheit (F) degrees for 2 hours. The temperature excursion was detected by a digital data logger. There were no previous temperature excursions and no adverse effects reported. This is one of several reports received from the same reporter. Lot number N0118511 is an invalid lot number for rotavirus vaccine, live, oral, pentavalent. Sender's Comments: US-009507513-1709USA004383.
Fever (up to 101.2 degrees) starting about 28 hours after injection and lasting about 24 hours. Swollen lymph nodes in armpit of injection arm starting 36-48 hours after injection.
Information was received from an investigator concerning a 15 month old female, who entered a study. On 11-APR-2012, consent was obtained and the subject was randomized to be vaccinated with DTaP-HepB-Hib-IPV, PREVNAR 13 and rotavirus vaccine live at 2, 4, and 6 months of age. On 11-APR-2011 (as reported by the site), 08-JUN-2012 and 27-AUG-2012, the subject was vaccinated IM with the first, second and third 0.5 ml dose, respectively, of DTap-HepB-Hib-IPV (injection site not reported). Other study vaccines include the first, second and third IM 0.5 ml dose, respectively, of PREVNAR 13 (injection site not reported) and first, second and third PO 2 ml dose, respectively, of rotavirus vaccine live. On 08-MAY-2013 the subject was vaccined with toddler dose in study series with the fourth 0.5ml IM dose of PREVNAR 13 (injection site not reported) and the first 0.5ml IM dose of PENTACEL (injection site not reported) to complete the childhood immunization series. There was no secondary suspect therapy. Previous therapy history included Hep B on 06-FEB-2012. On 08-MAY-2013, subject experienced febrile seizure (intensity severe) and was hospitalized. On 08-MAY-2013, subject was seen for well child check, was in good health and no fever. Subject was given 15 month vaccines at 12:15. At 16:50, subject's mother contacted the office and reported they had taken the subject to the ER due to the subject had a seizure. Per parent; after leaving the office, subject was acting normal-talking, laughing, eating, "etc". At about 15:30, subject had a seizure, described as a catatonic state, subject would not repond to parents and seemed a "little stiff" and had a rapid heartbeat. Subject was brought immediately to the local ER. Temperature taken in the ER was 103 (unit of measurement not reported). On 09-MAY-2013, subject was seen in office for re-check following ER visit: physical exam was normal along with labs that were checked (not further specified). On 08-MAY-2013, subject recovered from febrile seizure. There was no action taken with study vaccine therapy. The reporting investigator considered febrile seizure as not related to the first, second and third dose of DTaP-HepB-Hib-IPV, PREVNAR 13, rotavirus vaccine live but related to the fourth dose of PREVNAR 13 and the first dose of PENTACEL. Additional information has been requested.
Patient developed on 08/25/2021 w/ left deltoid pain after receiving the 1st dose of the COVID-19 immunization. Pain resolved about 8-9 weeks later. Patient developed right arm pain after the application of the 2nd dose of the COVID-19 immunization on 9/15/2021 on his right arm, which lasted about 8-9 weeks. After he received his 3rd shot of the COVID-19 "vaccine" on 05/05/2022 on his left arm, he developed again with stabbing pain. The pain on his left arm has been slowly increasing. At this moment the pain is of 2/10 intensity, but increases when he lays on it or when pressure is applied to 8/10 intensity. Pain decreases a few minutes after pressure is removed.
Chills, muscles aches, nausea, and headache suddenly set in at 9:30pm on the same day as second dose, ibuprofen helped and all these symptoms were gone by Saturday 03/27/2021 morning. Sore arm started earlier but was manageable pain and longer lasting.
Immmediately after recieving the vaccine the left arm, neck and jaw started aching. The next morning, a broken tooth on the upper left side of my jaw abcessed causing a lot of pain, that continued to get worse. I went to the emergency in Castlegar and was given a perscription for antibiotics. I have been maintianing by taking Advil, and strated the antibiotics.
Severe pain in the arm; soreness in the upper arm; soreness in the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe pain in the arm; soreness in the upper arm) and ARTHRALGIA (soreness in the shoulder) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (Severe pain in the arm; soreness in the upper arm) and ARTHRALGIA (soreness in the shoulder). At the time of the report, PAIN IN EXTREMITY (Severe pain in the arm; soreness in the upper arm) and ARTHRALGIA (soreness in the shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported no concomitant product use. No treatment was administered for the events.
Chills, fatigue, fever, cough, SOB, myalgia and headaches.
Trying to walk couldn't walk, trembling, severe attitude changed, couldn't hold spoon or cup, things got worse and worse, loss of mobility, hospitalized and diagnosed with Ataxia; Acute cerebellum. 8/26/08-records received for DOS 7/12/8/12/05-DC DX: Acute onset cerebellar ataxia, likely post viral and nystagmus, dysphagia. Presented to ED with C/O new onset trembling, difficulty walking, emesis and behavioral problems. Symptoms began 4 days prior with hands and arms shaking. Screaming, acting violent. Four days prior to onset of current symptoms had a viral upper respiratory infection with conjunctivitis.
pt recv vax 1140AM on 27AUG96 & devel hives on arm where shot was given then spread everywhere x/hands, feet & face;
pain all over her body, she has inflammation in back for 48 hours, still having pain in back
Pt had an appointment today for her second dose of the COVID-19 vaccine.  She received the dose at 0915 and began experiencing tingling/ swelling lips along with voice changes.  Zyrtec 10mg given at this time and adult medical response was called.  Pt states that she had a similar response to the first vaccine but that it occurred 45 min after receiving the vaccine.  At that time she did not have any medical intervention and did not take any medications at home.  A dose of 25mg PO benadryl was given at 10am.  No worsening symptoms occurred and pt stated her lips feel slightly improved.  Pt observed until 10:30am and discharged to home.  Vitals were stable throughout.  MD encouraged pt to take an additional 25mg of benadryl at home and if symptoms worsen to seek medical attention. Support provided.
Information has been received from a physician concerning a 15 year old female who was vaccinated with the second dose of GARDASIL. Concomitant medication included other unspecified vaccines. About 2 months ago, in approximately September 2008, the patient experienced fainted, hit the back of her head and got a lump. On an unspecified date in 2008, the patient recovered. Additional information has been requested.
He started having a runny nose, congestion, fatigue, loss of appetite, irritable, coughing and a low grade fever. They just told me to give him MOTRIN and TYLENOL. He hasn't been feeling good since the night of the vaccination.
arm is still like a lump,there bump,; it's reddish; arm is itching; This spontaneous case was reported by a consumer and describes the occurrence of MASS (arm is still like a lump,there bump,), ERYTHEMA (it's reddish) and PRURITUS (arm is itching) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, OLMESARTAN, COLECALCIFEROL (VITAMIN D3) and VITAMIN B12 NOS for an unknown indication.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced MASS (arm is still like a lump,there bump,), ERYTHEMA (it's reddish) and PRURITUS (arm is itching). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MASS (arm is still like a lump,there bump,), ERYTHEMA (it's reddish) and PRURITUS (arm is itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other concomitant drug used by patient was Multivitamin.
it's been more than 42 days since he received his first vaccination. Has not received 2nd dose.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (it's been more than 42 days since he received his first vaccination. Has not received 2nd dose.) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (it's been more than 42 days since he received his first vaccination. Has not received 2nd dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (it's been more than 42 days since he received his first vaccination. Has not received 2nd dose.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment history was reported.
Patient given incorrect vaccine, was given HPV  instead of prevnar at 12 mos of age
7 cm diameter red, raised, warm round/oblong rash centered 8.5 cm directly inferior to injection site.
No adverse effects reported.; an unspecified number of patients received improperly stored dose of RECOMBIVAX, GARDASIL 9, MMRII, or PROQUAD; The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify.  Follow-up information has been received from the practice manager on 18-SEP-2018.  This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided.       On 03-JUL-2018, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant Human albumin) (strength and route were unknown) (lot#  N024562 and expiration date 06-MAR-2019) for prophylaxis (Incorrect product storage). The sterile diluent (MERCK STERILE DILUENT) was properly stored. No adverse event was reported.  The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959:
Little fever; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 22-MAR-2023, the patient received the 2nd dose of Shingles vaccine. On 22-MAR-2023, less than a day after receiving Shingles vaccine, the patient experienced fever (Verbatim: Little fever). The outcome of the fever was not reported.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.     It was unknown if the company considered the fever to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 22-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the second one today and experienced little fever sore tomorrow, but so much better than Shingles. The patient sister had them years ago. no shots, had to be admitted to hospital for 2 weeks so painful we thought we would lose her. get the shots. The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information.
dose 1 on March 2020, never received 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 13th March 2020).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-APR-2022 Reporter's comment: The pharmacist reported that a patient never received the second dose of Shingrix. No vaccine detail were available. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Delayed skin itchiness at site of injection; Arm soreness; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 04May2021 at 10:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications was not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 13Apr2021 at 10:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. On 04May2021 at 14:00, the patient experienced delayed skin itchiness at site of injection and arm soreness. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On an unknown date, the patient underwent SARS-CoV-2 test (nasal swab) and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events delayed skin itchiness at site of injection and arm soreness was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Member had a 150 mm erythemic area with cellulitic response and fever 101, treated with antibiotics.
6/21/21 Patient was at home this past Saturday afternoon when she first noticed some change with her ability to drink from a bottle on the left side of her face.  Her husband then noticed her inability to close the left eye during her blinking.  She contacted the on-call provider who recommended presenting to the emergency department for initiation of corticosteroids and antiviral medication for suspected Bell's palsy.  She was placed on 40 milligrams of prednisone as well as 1000 milligram tablets of valacyclovir.  Since initiating those medications, she is noted slight progression in the paralysis of the muscles of the face on the left side.  The eye is now not able to be closed without assistance.  She is noticing some dryness and irritation of the left eye.  She has not had any left upper or lower extremity numbness or weakness.  With her noticing some slight worsening of symptoms here in the past 24 hours, I will up her corticosteroid dose to 60 milligrams for 3 days and then taper her on down with 40 milligrams for 3 days, 20 milligrams for 3 days followed by 10 milligrams for 5 days.  She will complete the valacyclovir as prescribed.  I discussed the importance of eye care to prevent corneal injury while she is unable to close her eyelids.  Recommended eye patch at night as well as aggressive hydration using drops or gels.  She does have an optometrist and could contact them for any further recommendations or supplies if she does not find appropriate products at her pharmacy.
Experiencing high blood sugars after receiving the shot; This case was reported by a consumer via interactive digital media and described the occurrence of blood sugar increased in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd June 2022, the patient received Shingrix. In June 2022, less than a week after receiving Shingrix, the patient experienced blood sugar increased. On an unknown date, the outcome of the blood sugar increased was not recovered/not resolved.   It was unknown if the reporter considered the blood sugar increased to be related to Shingrix.     Additional Information: GSK Receipt Date: 3-Jun-2022 Reporter's comments: This case was reported by the patient via interactive digital media. The patient received Shingrix on the day before the date of reporting. After vaccination, the patient experienced sudden high blood sugar levels post meals. The patient asked if this was known side effect or not. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Patient felt terrible pain in arm after shot on 9/22/17. After going home she had chills and could not get warm. Patient's son reported inability to understand patient on phone. Went to hospital on Friday evening 9/22 and was admitted to ICU. Temp 104 degrees F, BP 82/66. Diagnosed acute kidney failure. Released 9/25/17.
Chest discomfort, pain and pressure, heart palpitations, fever and chills, shortness of breath, aching joints, fatigue, dizziness, weakness, and headache and neck. Hydration and Tylenol and rest ~ was considering going to the ER. Symptoms persisted throughout the night. The next morning weakness and muscle aches continued but are gradually subsiding.
I was tested positive for breakthrough COVID today 05/23/2022. My symptom are moderate, I have a headache, chills, body ache, joint ache, sore throat and ears, fatigue, stuffing  & running nose and a cough. I have been feeling bad. My doctor called me in something but I haven't went to pick it up as of yet.