chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
WITHIN A WEEK AFTER ADMINISTRATION OF DOSE #3, TINNITUS BEGAN IN BOTH EARS. TINNITUS HAD BEEN EXPERIENCED DURING FEVER STAGE OF LYME DISEASE (JULY 11-15) BUT HAD DIMINISHED COMPLETELY BY TIME OF COVID BOOSTER ON 12-06-2021. WITHIN 3 DAYS, THE TINNITUS HAD RETURNED AND IS NOW CONSTANT INSTEAD OF INTERMITTENT (AS HAD BEEN EXPERIENCED PREVIOUSLY DURING LYME DISEASE). IN OTHER WORDS, IT'S BECOME NEXT LEVEL.
Information has been received from a registered nurse concerning a 17 year old female patient who on 06-JUN-2008 and 16-SEP-2008 were vaccinated with the first and second doses of GARDASIL respectively. On 27-APR-2011 the patient was in office "today" for an unrelated, unspecified reason but would like to receive the third dose of GARDASIL. In March 2011 the patient had a PAP smear that was positive for "high risk HPV, Group 1 and Group 2". At the time of report the patient's status was unknown. Additional information has been requested.
Parent states that pt was crying inconsolably for 4-5 hours on evening of vax and irritable for 1-2 days.
Systemic: vasovagal episode-Mild, Systemic: Seizure-Mild, Additional Details: Mother called stating after vaccine was given, pt experienced a seizure. Contacted Hospital, the ER department stated it was worked up as a vasovagal episode after a vaccine. After vaccination, I did not notice any injection site reactions.
Follow-up information received on 12/May/2006.  New information received does not change the nature, seriousness or listedness of case.  No further information is expected.  A corrective version was created on 13/Jul/2006 (with a LRD of 12/May/2006) in order to document a narrative for this case.  Initial version received on 18/Apr/2006 from a health care professional.  An 18-year-old male patient had received an intramuscular, left arm injection on Menactra, lot number U197BAA on 17/Apr/2006.  The following day, the patient had experienced muscles aches and a fever of 100.6 degrees Fahrenheit.  It had been initially reported that the patient had experienced stiffness in his neck and legs but, when the reporter was subsequently contacted, it was indicated that the patient had not experienced stiffness.  He was examined by a physician and had no neurological symptoms.  The reporter indicated that "blood test so far were normal", but the reporter did not know what tests had been ordered.  The patient was treated with Ibuprofen.  At the time of this report, the patient was doing "okay", but the reporter was uncertain whether the patient had made a full recovery.  Follow-up information received on 12/May/2006 from a health care professional.  The blood work that the patient had received was a complete blood count. There was no illness at time of vaccination.  At the time of this report, the patient had recovered from the events.
Within 2 hours of vaccine receipt, patient noted vaccination site pain, warmth and redness. Denies axillary lymphadenopathy, fever or chills, joint pain, and upper extremity numbness and tingling. Within 24 hours of vaccine receipt, reports feeling achy and tired, with increased immunization site reaction ? redness, warmth, pain, and swelling, which involved an oblong area of approximately 6? by 4?. No self-treatment.  On 21 Sep, patient reported significant improvement of site reaction over past 24 hours. Denied dyspnea, chest pain, nasal discharge, N/V, hives/rashes, shoulder pain, and lightheadedness. No other vaccines were received that day. EXAM on 21 Sep: LUE: vaccination site placement in anterior mid-deltoid (almost in biceps). Oblong area, approximately 4? x 2? ? red, warm, tender, with minimal swelling. No induration. Full ROM of UE.
Information regarding Prevenar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 5 month old male patient who experienced pneumococcal meningitis and drug ineffective. The patient received the second dose at 4 months of age, on an unspecified date in 2005. Relevant medical history was not provided. Indication for Prevnar was immunisation. Product was administered on an unspecified date in 2005. Dose regimen was 1 dose 1 time per day intramuscular. Concomitant medications were not reported. The patient developed pneumococcal meningitis, drug ineffective in Nov 2005. The reporter considered the event to be life threatening and required hospitalization. Recovery status is unknown. Blood culture results confirmed pneumococcal meningitis, serotype pending, was done in Nov 2005. No additional information was available at the time of this report.
Hospitalized (1.23.22 - 1.29.22);  COVID-19 positive (1.18.22); Fully vaccinated  Admission Date: 1/23/2022  Discharge Date: 01/29/2022 DETAILS OF HOSPITAL STAY: Acute hypoxemic respiratory failure due to COVID-19  [U07.1, J96.01] COVID-19 [U07.1] Pneumonia due to COVID-19 virus [U07.1, J12.82] Acute respiratory failure due to COVID-19 [U07.1, J96.00]   HOSPITAL COURSE: Patient is a 10 y.o. male with PMHx complex partial epilepsy, GDD, Dysphagia, Spastic CP, G-tube dependence who was admitted for admitted for acute hypoxic respiratory failure secondary to COVID Pneumonia.  Patient presented to ED on 1/23 following a 3-day history of worsening cough. Patient had been unwell since 1/15 when he developed terrible nasal congestion. He was seen by his PCP on 1/18 who diagnosed him with acute bacterial rhinosinusitis and started him on a 10-day course of Omnicef and Culturelle. He also tested positive for COVID-19 at that time. 2-3days prior to admission, he then developed a productive cough for which his PCP started him on Albuterol. Patient did not seem to improve with albuterol. Additionally, mom also noted that he had low SpO2 on home pulse ox and so he was brought in to the ED for further evaluation. In the ED, patient was hypothermic and hypoxic (SpO2 87%). He was placed in a heating blanket and started on 4L NC. Labs notable for CRP 15, ESR 19, Procal 0.08. CBC, UA wnl. CXR notable for perihilar opacities. He received 2x NS boluses and 1x albuterol and was then admitted to the inpatient service.  While admitted to the floor, the patient was started on Decadron for his COVID pna, with Pepcid for GI prophylaxis. He had an AWARE called overnight due to increased WOB for which he was started on HFNC and then transferred to the PICU. While in the PICU, his respiratory support was escalated to NIPPV. He also had Albuterol, HTS and Chest physiotherapy added to his pulmonary regimen. He completed his Omnicef course on 1/26. He was eventually weaned off NIPPV to CPAP on 1/27, and then weaned to NC later that day. Patient was then transferred back to the floors on room air. For the rest of his admission, patient remained clinically stable and was on room air. His pulmonary medication regimen was simplified to Albuterol 2.5mg with chest percussion q6h. Shared decision making was made between family and treatment team who agreed that the patient can be discharged home with albuterol and manual CPT q6-8hrs for the next 2-3days. Patient discharged home in stable condition.
6 hours after I had significant abdominal pain, nausea, and diarrhea. It?s now been 49 hours since vaccination and I still have mild stomach upset.
No adverse event.  Client had MMR vaccine on 6/7/23. Given another live, varicella vaccine on 6/14/23.
Patient admitted for dyspnea on exertion. Recent admission at hospital for open surgery for aortic valve replacement followed by COVID-19 infection which kept him in the hospital for about a month. Seen by pulmonary.  They ordered CTA chest with PE protocol. Results as above no evidence of PE. Noted to have moderate sized right sided pleural effusion with right basilar atelectasis and some loculation. Discussed with pulmonary service.  They do not believe pleural effusion is causing dyspnea.  It could be combination of debility & prolong hospital stay.
Pt received DTAP/IPV combo and MMRV combo vaccines at well child visit on 8/23/16. FOC reported via email that pt had headache, nausea, and decreased appetite since his vaccines the day prior. Pt seen in office for ongoing symptoms 8/31/16. Normal exam.
patient was given peds dose of hep B,  patient returned same day to receive another Peds dose of the Hep B per CDC guidlines
This spontaneous report as received from a pharmacist refers to a 74 year old female patient who was a retired nurse with no drug reactions/allergies. A retired physician mentioned to pharmacist that his wife (the patient) in the past had herpes simplex on the bottom of an unspecified foot that would heal up and go away then come back and this would occur several times. The wife at an unspecified time started taking lysine and the herpes simplex didn't come back until after wife received ZOSTAVAX. the patient was given ZOSTAVAX (lot# reported as J012659, exp date as 10-JAN-2015, 0.65ml, subcutaneous in the left arm) per unspecified physician's recommendation on the afternoon of 04-APR-2014 and on the night of 04-APR-2014 patient experienced on the bottom of the left foot blisters and pustules. The treatment of ACYCLOVIR started the evening of 04-APR-2014 after the events occurred. Patient sought medical attention that patient's husband called the pharmacy this morning 07-APR-2014. Patient present status was reported as "blisters are drying up". The outcome of event was unknown. Additional information has been requested.
Information has been received from a nurse concerning her 63 year old mother with allergies to penicillin and codeine, who on 04-JAN-2008 was vaccinated with ZOSTAVAX. Concomitant therapy included vitamins (unspecified). On an unspecified date, the patient developed a 1 and 1/2 inch by 1 inch induration and the site was pretty red. The patient sought medical attention by calling her daughter who is a nurse. No diagnostic or laboratory studies were performed. Current patient status was not reported. A product quality complaint was not reported. Additional information has been requested.
Patient stated that she had pain upon administration ( 9-14-2022)  and the pain has continued to date of reporting to the pharmacy 09-28-2022.  She said she googled it and that the shot was administered incorrectly.  She has pain down to her fingers.
Right arm rec'd shot got hard, red, and itchy 5 days after pt. rec'd shot for PREVNAR 13. Redness and discomfort (L) arm flu shot for 2 days.
L. UPPER DEVELOPED RED STREAK INFERIOR TO FLU SHOT SITE, PAINFUL, WARM, RED. CAME TO PCP ON 10/18/2010 IT WAS GETTING BETTER. WAS GIVEN BACTRIM DS 1 BID X10D. ALSO ZYRTEC 10MG. 1 QD X7D.
Information has been received from a physician concerning his 12 month old son who 15-MAY-2007 was vaccinated with PROQUAD. A few days later, on approximately 18-JUN-2007, the patient developed vesicles around the injection site. Subsequently, the patient recovered from vesicles around the injection site. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
4/25/15 Developed rash on legs and back areas itching. 4/25 and 4/26 myalgia 4/27/15 seen in office, rash on legs and back continue. Myalgia improved. Swell noted at injection site. Plan: CLARITIN/ZYRTEC 10 mg daily follow up as needed.
Patient reported arm to be swollen and warm. She contacted the pharmacy and her primary care doctor. She was advised to use a cold compress and analgesic. A follow up call  was made to the patient a few days later, she reported that her arm was fine.
7/21/04- anthrax vaccine #4 7/22/04- SPV 8/1/04- woke up and noticed rash "all over" her chest area- rash bright red and extremely pruritic- also c/o headaches, "fever," bodyaches, diarrhea, and upset stomach 8/2/04- rashes worsened- seen by a healthcare practitioner- given Atarax 8/3/04- seen by her Case Manager- rashes "improving" but still pruritic- rashes present on upper chest, upper bilat arms, upper back, and neck- lesions non tender- coalesced multiple erythematous inflammatory round/oblong nodules present with scattered discrete papules and pustules 8/16- rashes now completely dissipated
Chest pain, palpitations, tachycardia extreme fatigue, exercise and heat intolerance, anxiety.
pt screamed all noc p/shot given;refused feeds;no fever was fine on next day
pt recvd vax & on 12FEB93 pt devl haemophilus b septic arthritis;
Mother returned to Health Dept at 1625 requesting someone to assess her daughter and that something was wrong. Upon immediate assessment: Client pale, cool to touch, lethargic then within a minute awakened to touch and voice. Pupils 3mm equal and reactive and speech clear and non slurred. Client c/o nauseated, HA and lightheaded. Had not eaten since approx noon today. Thready radial HR 60, manual B/P 96/60 HR 72. Juice x 2 given, cool AC to improve sweaty clammy skin. Time period approx 20 min then s/sx subsided. Followed up with client's mother 11/10/10. Mother states "she felt a little nauseated through evening but otherwise she is feeling fine". Mother states "injection site a little red, but no other problems".
Dizziness, lightheaded, hot. After using an ice pack and sitting for 15 minutes, it went away.
Vaccine on 2/4/2021. No reactions until the morning of 2/6. Woke up with chills at 7:00 a.m. at 9:00 took temperature of 101.4 F. Took 2 tylenol. At11:a.m. temp was100.4. temp ebb and lowed all day. Took 2 tylenol whenever temp was over 100.5, probably 3 times every 4 hours. On Sunday 2/ at 10:00 temp was back up to 101.8. Took 2 tylenol  at 12 noon temp was100.1
expired vaccines inadvertently administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number T93SR, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-SEP-2022 Reporter's Comments: The medical assistant reported there were 2 boxes of Fluarix that left over from last year which was expired on June 2022. The three vaccines from it was inadvertently administered to 3 patients. The vaccine administration facility was the same as Primary Reporter No other details were available.  The reporter did not consent to follow up. The case was linked with US2022138666 and US2022AMR139387 reported same reporter. Additional Supportive Information: The patient received an expired dose of Fluarix, which led to expired vaccine used.; Sender's Comments:  US-GSK-US2022138666:Same reporter US-GSK-US2022AMR139387:Same reporter
Severe migraine, chills, body aches, low grade fever, low to no energy for about 24hrs and then for about 3-5days low energy/ fatigue.
Patient was admitted to the hospital with COVID-19 also had respiratory failure he was treated for it. Patient was treated with steroids and oxygen. Once patient was stable he was discharged.
Vaccine recipient received vaccine on 12/18/2020 at 7:30 am and at 9:00 am reported their bottom lip had swelling and around the chin had tingling that lasted 1.5 hours.   At the occupational health follow-up visit on 12/28/20, the vaccine recipient reported that the injection site has been soar with occasional numbness and weakness that has not changed in intensity.    Pfizer-BioNTech COVID-19 Vaccine
Hives and itchiness in the scull,freaking out on hives; Hives and itchiness  on the insides of their thighs,spread to their legs and arms and hands; Wheezing randomly; A lump in the upper chest area; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives and itchiness in the scull,freaking out on hives), PRURITUS (Hives and itchiness  on the insides of their thighs,spread to their legs and arms and hands), WHEEZING (Wheezing randomly) and MASS (A lump in the upper chest area) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0691T21A, 026A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, the patient experienced URTICARIA (Hives and itchiness in the scull,freaking out on hives), PRURITUS (Hives and itchiness  on the insides of their thighs,spread to their legs and arms and hands), WHEEZING (Wheezing randomly) and MASS (A lump in the upper chest area). At the time of the report, URTICARIA (Hives and itchiness in the scull,freaking out on hives), PRURITUS (Hives and itchiness  on the insides of their thighs,spread to their legs and arms and hands), WHEEZING (Wheezing randomly) and MASS (A lump in the upper chest area) had not resolved.            No concomitant medications were reported   No treatment information was provided  Patient state he did not have Covid-19 nor a heart condition diagnosed before
After the 1st dose, two days later I had an infected tooth.  After 2nd dose of Moderna vaccine, I woke up the 2nd day with my neck lymph glands completely swollen, my jaw hurt really bad, and every tooth in my mouth hurt, and I had another infected tooth on the other side of my mouth.  I had to take an antibiotic for both tooth infections.  Teeth were not infected prior.  By the end of day 2, my lymph nodes were back to normal using Advil for swelling.
screaming for more than 3hr, high fever, body was stiffening, had diff swallowing;
Developed welts/hives on side and back 2 days after MMR vaccine, advised BENADRYL, quh pm, cool compresses to area, and avoid heat to rash.
Death (found down in home ) having died the night before, and he received his COVID vaccine <24 hours before his death.
Six days after I received my 4th vaccine dose I broke out with shingles. You went to see my doctor, she prescribed me valacyclovir HCL 1GR tablets and Calmoseptine ointment.
Initial information was received from a health care professional on 18 August 2008.  A 17 year old female with allergies to augmentin, penicillin, strawberries, cashews, and pitted fruits received a first dose injection of MENACTRA (U2422AA) intramuscularly in the left deltoid on 14 August 2008.  On 14 August 2008 she complained of "pins and needles" in the hands, fingers, and feet.  A few hours after vaccination she developed cramping in her knees and elbows.  She had a temperature of 101.9 the evening after vaccination.  The following day she complained of a headache.  She was seen by a doctor and her temperature was 98.9.  The patient's recovery status was unknown at the time of the report.  10/31/08 Reviewed PCP office records & vaccination records. Records reveal patient felt dull ping sensation in hands, feet, fingers, toes, cramping feeling in knees & elbows starting evening of vaccination 8/14/08.  Developed HA & fever 8/15/when seen in office & arms/feet/hands were feeling normal.  Was encouraged to rest & increase fluids, monitor condition. No further medical records available.
Developed intermittent fevers to 100.5 lasting 4 days with persistent diffuse body ache.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (had pain for 24 hours on his arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (had pain for 24 hours on his arm). At the time of the report, PAIN IN EXTREMITY (had pain for 24 hours on his arm) outcome was unknown.            No concomitant product information was reported.  No treatment product information was reported.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-045043 (Patient Link).
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: Says tongue felt tingly? Took benadryl they had from home. RPh monitored regularly and patient otherwise acting completely fine. Advised she could wait in store until she felt better. After about 45 minutes patient went home.
Information has been received from a licensed practical nurse concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The nurse reported that on an unknown date, the patient received one dose of VARIVAX (either lot # M037642, expiration date September 2018; lot #N000681, expiration date 06-JAN-2019 [reported as 31-JAN-2019]; lot #M042858, expiration date October 2018; lot #N012486, expiration date April 2019; or lot #M045205, expiration date 11-NOV-2018) following temperature excursions of between -9°C and +8°C for 5 hours and 9-25°C (14.85°C) for 1.5 hours (route of administration not provided). No adverse effects were reported. Temperature/time frame: 14.85°C for 1.5 hours Previous temperature excursion: Yes, -9°C to +8°C for 5 hours Data logger involved: Yes This is one of six cases from the same reporter concerning the same adverse event. It is unknown which lot number each patient received. 03-AUG-2017: Lot number N012486 with expiration date 24-APR-2019 (reported as April 2019) has been verified to be a valid lot number for VARIVAX. Additional information has been requested.; Sender's Comments: US-009507513-1708USA000472: US-009507513-1708USA000473: US-009507513-1708USA000474: US-009507513-1707USA004998: US-009507513-1708USA000475:
I think it was Bivaent, not sure. It was my SECOND booster of Pfizer Covid 19. No immediate problems. By Nov. 22, I started having a spasm under my right eye (on cheek bone area or the "bag" of the undereye area) that is pretty consistent. Feeling of odd numbness in same twitching area. I thought it would resolve. It just comes and goes all day long. Twitching. Drives me nuts and doesn't appear to be resolving. Also, notice EYE sensitivity in right eye. Photosensitivity. Have to avert that eye when looking at a screen directly. Hurts the eye.