chrisvoncsefalvay/vaers-outcomes huggingface dataset:
see ER note of 8/25/07 and office note of 9/18/07.  9/27/07 Case closed as complete w/medical records which accompanied report.  ER note of 8/25/07 reveals patient experienced headache, fever, vomiting & generally feeling unwell since received 2nd HPV vax on 8/21.  Developed left side ear ache & facial weakness 8/24 w/difficulty smiling & closing left eye.  Tx w/prednisone & antiviral meds.  D/C to home.  PCP office visit 9/19/07 reveals patient had continued mild left facial droop otherwise improved.  Warts had improved on antiviral & that med was continued. FINAL DX: Bell's palsy; viral syndrome.
Injection site swelling; Pyrexia; Injection site erythema; Injection site pain. Information has been received from a physician's assistant concerning a patient who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot #650453/0791P). Subsequently the patient developed a fever and injection site swelling, pain and redness. Unspecified medical attention was sought. Subsequently, the patient recovered. The reporter expressed a concern about the lot number. No product quality complaint was involved. The records of testing prior to release of this lot have been checked by Quality Assurance and found to be satisfactory. The lot complies with standards of the Center for Biologics Evaluation and Research and was released. In addition, a review of the Quality Control Quarantine/Rejection System revealed that there were no open Quarantines registered against this lot/fill. Additional information has been requested.
This child had a fever of 102 F, and vomiting within 24 hours.  Follow up call on 05/11/01, 3 days after immunization "all better".
After patient successfully answered the 2 pt identifiers, RN looked at the member's card that was issued today. The card was blank and there was no vaccination written on it. RN proceeded to tell the member "I am giving you Moderna vaccine today".  The member agreed and RN proceeded to administering the vaccine.  As RN was documenting vaccine administration, she found out that member received PFizer vaccine on 2/1/2021. RN notified (name removed) who was present about the error. (Name removed) contacted director, who called the Infectious Disease doctor. Per director, member assured of the safety of receiving a second dose from different manufacturer and that the vaccine she received will give her the same coverage from covid. Member stayed in the building and was observed for an hour. She did not verbalize any complaints nor did she have any unusual symptoms during the entire stay in the building. She was discharged accompanied by her husband in stable condition.  She was given an instruction to call advice if she develops any unusual symptoms.  All of their questions were answered and both member and husband verbalized understanding.
This spontaneous report as received from a 74 years old female patient concerning herself with allergic to sulfur. The patient had no pertinent medical history. The patient was vaccinated with one injection of PNEUMOVAX 23 (lot number, dose, route and injection site were not reported) on 23-JAN-2013. No other co-suspects were reported. Concomitant medications included unspecified thyroid medication, LIPITOR and PROTONIX. The patient called to report an adverse reaction with PNEUMOVAX 23. On 23-JAN-2013 the patient experienced injection site reaction became hot and tender and couldn't raise her arm for a day. Ice and unspecified topical antihistamine were given for adverse events. There was no laboratory diagnostics study performed. The outcome of adverse event was reported as recovering. The action taken and relatedness for PNEUMOVAX 23 was not reported. The patient had called her physician for medical attention. Additional information has been requested.
Seizure associated with fever 102 degrees by report approximately 1 min duration - records requested from ED. Will attach to form.
Haven?t been able to stabilize his BP since vaccination. It?s been at 160/85 even with medication. He has suffered 2 strokes so this is concerning. Today he woke up with his BP 176/87.
Fever, severe pain and ear infection. Saw MD next day who said that R eardrum had ruptured. Pt needed 7 days of antibiotics.
symptoms: dizziness, weakness, headache, low-grade fever, neck sore, nasal/throat congestion                                  onset: 18 hrs after flu shot            duration: 48 hrs                                 treatment: none except rest                      recovery: complete
recvd 1st dose of Engerix-B in JUN92; about 1 month later routine blood test revealed elevated gammaglobulins; pt was referred to a hematologist who saw the pt 29JUL92; gammagoblulins were still elevated;
red rash; a little swelling; diarrhea; slight fever; nausea; muscle feel sore; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash), SWELLING (a little swelling), DIARRHOEA (diarrhea), PYREXIA (slight fever) and NAUSEA (nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH ERYTHEMATOUS (red rash), SWELLING (a little swelling), DIARRHOEA (diarrhea), PYREXIA (slight fever), NAUSEA (nausea), MYALGIA (muscle feel sore) and FATIGUE (fatigued). At the time of the report, RASH ERYTHEMATOUS (red rash), SWELLING (a little swelling), DIARRHOEA (diarrhea), PYREXIA (slight fever), NAUSEA (nausea), MYALGIA (muscle feel sore) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   ? No treatment information was provided. ?   Reporter did not allow further contact
She is now being prescribed an anti-viral Valacyclovir; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer-sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VIRAL INFECTION (non-serious), outcome "unknown", described as "She is now being prescribed an anti-viral Valacyclovir".  Additional information: Swap from FC. She received both doses of COVID vaccine. She was now being prescribed an anti-viral valacyclovir and wondering if there are any documented interaction between medication and vaccine. Relayed PMI information and transferred. Faxed for AE. The caller did not provide any information other than 1st name.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse refers to a 17 year old female patient. The patient's medical history included anorexia. There were no known drug allergies. On 11-JUL-2014 the patient was vaccinated with the first dose of GARDASIL (lot#, expiration date, dose, frequency and route were unknown). Concomitant therapies included Fluoxetine. On 25-JUL-2014, two weeks after receiving the GARDASIL the patient developed blistery rash on her hands and feet. No treatment was given for the event. The outcome of blistery rash on her hands and feet was unknown. The patient has not been seen by a healthcare provider as of 01-AUG-2014. Additional information has been requested.
NNP called in to report adverse reaction to flu shot given near the bicep of the arm rather than the deltoid. Arm was red, hot, swollen and very painful. She started the patient on antibiotics.
Information has been received from a nurse concerning a 20 year old female with no pertinent medical history and no drug reactions/allergies who in 2007 was vaccinated with GARDASIL series. Concomitant therapy included SPRTINTEC, ZANTAC and GAVISCON. On 12-APR-2010 the patient had an abnormal PAP screening, positive for HPV. The patient sought medical attention. At the time of the report, the outcome was unknown. Additional information has been requested.
This is a spontaneous report from a non-contactable consumer communicated to a Pfizer colleague, reporting for the consumer himself. This male patient of an unspecified age received PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient had shoulder pain after receiving the vaccine for at least four weeks on an unspecified date with outcome of unknown. No follow-up attempts possible. No further information expected. No follow-up attempts are possible, information about lot number cannot be obtained.
Developed diffuse urticarial rash to body, lesions > 1 cm in diameter same day as injections.
1st dose 2 years ago, missed 2nd dose; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a 72-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received over 2 years ago on an unknown date).   On an unknown date, the patient 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 details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient stated that, just he/she needed a second shot, did not tell him/her to take a second shot.
Diagnosed with COVID; Diagnosed with COVID; This is a spontaneous report from a contactable other health professional. This reporter reported same events for three patients. This is second of three reports. A patient of unspecified age and gender received BNT162B2 (Pfizer BioNTech COVID vaccine), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The memory care patient received Pfizer-Biontech Covid vaccine, and then was diagnosed with Covid and had Covid symptoms on an unspecified date, the patient was scheduled to receive monoclonal antibody. Event took place after use of product. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to possibly short number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information,Linked Report(s) : US-PFIZER INC-2021004746 same reporter/product/event, different patient;US-PFIZER INC-2021004748 same reporter/product/event, different patient
hurt a lot more; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experienced achiness and hurt a lot more than dose two. HCP could not provide lot number and expiration date for dose one because it was given at another pharmacy. No start date or outcome for achiness provided. No additional information was provided. Consented to follow up. This case has been linked with case US2020113038, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020113038:for 2nd dose
Dizziness, fatigue, chills, body aches, muscle achces, nausea, vomiting, upset stomach, headache.  I'm also nursing and baby has been significantly more fussy-he is 9 weeks old.
Patient received a Shingrix vaccine on 09/21/2019 . Registered nurse administered Shingrix vaccines on 02/08/2023 and 04/10/2023 as the record showed that the Zoster vaccines were "overdue." The registered nursed thought the primary dose was supposed to be restarted since the initial immunization was not completed on schedule.
Information has been received from a physician concerning a female who in approximately 2007 (2 to 3 years ago) was vaccinated with the first dose of GARDASIL. The patient had not been given any other doses of GARDASIL vaccine. Subsequently the patient became sexually active and had abnormal cervical cells and possible HPV. At the time of the report, the patient's status was unknown. Follow-up information has been received from the physician. The physician reported that he could not recall the patient's name, although, reported that the patient was only 'partially dosed' and inquired if the patient needed to restart the vaccination series. No further information is available.
arm swelled from neck to fingers tips p/shot; pt ran low grade fever; mom called ER & was told not to come; pt given Motrin x several doses; arm swelled about 2" larger than other; alternated cool packs & warm water bath
10 days or  a little later, left arm pain developed in Triceps radiating to forearm and to left shoulder and eventually settle in left hand resulting in weakness, numbness and pain in fingers.
I tested positive for Influenza A 12/16/22. I had a fever, chills, fatigue, and body aches. I contacted my doctor, and they prescribed Tamiflu. My symptoms lasted for about 5 days.
Severe tinnitus. Right side only. 30% hearing loss high range 30 to 45 k
Presented to ER on 12/7/21. Patient was saturating at 61% on room air attending not non-rebreather mask then placed on a high-flow nasal cannula at 10 L saturating at 94 patient tested positive for COVID-19.Started on remdesivir, dexamethasone, ceftriaxone and doxy. Received tocilizumab on 12/9/21. Discharged with PO dexamethasone to finish steroid course. Walk test with patient requiring 0L NC at rest and 3L NC on exertion. Discharged on 12/15/21
Within hours was short of breath climbing stairs he climbed daily and it never happened before.  Doctor diagnosed that his heart was out of rhythm at next appointment.   He was treated with a few different drugs but it couldn't be controlled and  he never felt well again.  On 4/19/21 he was transported to Hospital by ambulance with AFib. The next morning he was found unresponsive and moved to ICU.  His oxygen level was low and carbon dioxide level was high.  For 2 weeks he suffered greatly.  Doctors tried to balance his high heart rate with his low blood pressure. He was intubated twice.  He died on May 2, 2021.  His cause of death was acute respiratory failure with hypercapnia and hypoxemia.  He had never had heart or lung problems before that.
Information was received 28-JUN-2017 via telephone call from a pharmacist. The pharmacist reported that a 47 year old female patient received a M-M-R II vaccine, 0.5 ml intramuscular (IM) on 31-MAR-2017 because she is a nursing student. (Lot # M017348, expiration date 06-APR-2018). It was noted that IM administration is an off label administration route. The patients medical history, current medical conditions, concomitant medications were not provided. The pharmacist reported that the patient did not report experiencing any issues and the prescribing physician was not contacted. Pharmacist reported that the second M-M-R II vaccine was administered subcutaneously on 27-JUN-2017. As of 28-JUN-2017 it was unknown if the patient would continue to receive the M-M-R II. The pharmacist had reported the typeface is too small to read the directions for determining the route of administration, very small print on box. Product Quality Complaint was filed. The outcome of MMR II vaccine administered IM instead of SQ was unknown. Additional information was requested.
Patient passed out 3 minutes after administration of gardasil 9; This spontaneous report was received from a physician via company representative refers to a 12 year old female patient. The patient's pertinent medical history, concomitant medications, and drug reactions/allergies were unknown. On approximately 27-MAY-2019 (reported as about 3 weeks ago), the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (unspecified lot number, expiry date and dosing details) for prevention of human papilloma virus infection (prophylaxis). On the same date, patient passed out 3 minutes after administration of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (loss of consciousness). The patient sought medical attention and was instructed to lay down for several minutes and was given water to drink. It was unknown that whether lab diagnostics/studies were performed. On 27-MAY-2019, the patient recovered with no further intervention. The reporter's causality assessment between the drug and the event was unknown.  Upon internal review, the event was considered to be medically significant.
This spontaneous report as received from a certified medical assistant refers to an adult patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not reported. On 20-NOV-2015, the patient was inadvertently administered a pediatric dose of RECOMBIVAX HB (strength 5mcg/0.5 ml, dose, route, lot # and expiration date were not reported). This was the first dose the patient was administered. At the time of the report, the patient had no known adverse effect. Additional information has been requested.
One day post vaccine patient developed fever 102 F.  Mom was on her way to taking child to ED when child had a seizure in the car
This spontaneous case, was initially received from a physician on 10-Oct-2017, concerning a female patient of an unspecified age. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2016, (last year) (as reported), the patient was administered with AFLURIA (TIV) (dose: 05. ml, batch number: 12649211A, expiry date, route of administration and anatomical location: not reported). On an unspecified date in 2016, after the vaccination, the patient developed a rash. Outcome of the event was not reported. The reporter assessed the events as non-serious. Non-significant case correction received with IRD 10-Oct-2017: Batch no. (12649211A) was captured in the case form and narrative was amended accordingly.
In the morning after her second covid vaccination she had fever, chills and fainted.  Slept most of the day and had a mild headache on Sunday.  She has fainted in the past but is not a normal occurrence for her.
Approximately 5 minutes post vaccine, patient reported feeling dizzy, warm and was sweating profusely.  Patient was given cold compress for back of neck and wrists.  Patient did not lose consciousness but did report dizziness and nausea.  Patient was able to hold conversation and reported feeling better after about 5 minutes.  Patient was monitored for an additional 15 minutes and reported feeling normal before she left.
Patient called 1 week after the injection and said her arm was red at the injection site with red bumps around the area. There were no issues with chest pain or breathing
FEEL WARM FROM MY HEAD TO MY NECK /WARMTH SENSATION ALL OVER/ LIGHT WARM SENSATION IN CHEST AREA; ANXIETY; ELEVATED BLOOD PRESSURE; FLUSHED FACE/GOT RED IN THE FACE; SHAKY LEGS; This spontaneous report received from a patient concerned a 79-year-old elderly female. The patient's weight was 180 kilograms, and height was 67 centimeters. The patient's past medical history included: constipation (the patient stated that Cholestyramine 4g gave her horrendous Constipation), and concurrent conditions included: hernias, Crohn's symptoms, and irritable bowel symptoms (IBS), and other pre-existing medical conditions included: The patient had no known allergies. The Patient added that her stomach started going bad when COVID hit, and that currently she was in remission from Crohn's/IBS and was currently undergoing GI diagnostic testing for her recent reappearance of GI (gastro intestinal) symptoms. The patient previously received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: unknown) 1 total, dose not reported, administered on 18-MAR-2021 for prophylactic vaccination (dose number in series 1), and reported no side effects at all. The patient received booster covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A and expiry: 11-APR-2022) 1 total, dose was not reported, administered at right arm on 15-DEC-2021 at 10:30 for prophylactic vaccination (dose number in series 2).  Concomitant medications included Cholestyramine Oral powder 4g (colestyramine) for Chron's symptoms (For stomach issues, not for Cholesterol). The patient skipped the medication as per her HCP (Health care provider) at the day of reporting. On 15-Dec-2021, the patient reported that she started getting warm, started in feet, went to neck too, all over, like getting IV dye, but not internal, more like in the skin- she got red in the face, flushed, became anxious after the 10-minute observation period was over and they had kept her there for another 45 minutes and then she got really anxious. The patient stated that there was 4 separate episodes of this, they started about 5'' after, occurring every 5-10''. The patient added that her blood pressure was elevated, no temperature was taken, and she had "shaking legs". The patient stated that vaccine facility suggested her to go to Emergency room but the episodes subsided, nothing else happened, so she went home. The patient was reporting that she was still having light warm sensation in chest area (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated blood pressure, flushed face/got red in the face, and shaky legs on 15-DEC-2021, was recovering from anxiety, and had not recovered from feel warm from my head to my neck /warmth sensation all over/ light warm sensation in chest area. This report was non-serious.
Mom called said child large hives swollen throat coughing and had wheezing, difficulty breathing. Gave BENEDRYL and 2 ALBUTEROL tx symptoms resolved.