chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The day she got the injection, she woke up that night with fever of 101.6 with chills and myalgias after getting a Tdap vaccine at her physical at the clinic yesterday.  She had labs drawn that day and her CBC with diff. looked fine.  Fever didn't resolve and on 6/30/17 she called us with fevers going up to 102F.  She came in for appt with Dr. who deemed it an adverse reaction to vaccine.  Here was plan from Dr. visit: This is likely a reaction to the TDaP vaccine as there is no indication of other underlying pathology. The symptoms appear to already be improving as the myalgias have dissipated and the fever has resolved. Continue to monitor symptoms. For fever and discomfort, take 400-600 mg of ibuprofen every 6 hours for fever and muscle aches. Do not exceed 2000 mg in a day.
Pt received ZOSTAVAX SQ 5/29/12. Pt presented 6/4/12 with red spots on stomach, back & legs. Spots presented about 3 day post injection. Still very itches, red, spots. Pt states she had a rash that disappeared for several days before injection was requested/given.
Expired Shingrix 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 Herpes zoster (Shingrix) (batch number 9ZJ25, expiry date 23rd January 2023) for prophylaxis.   On 14th February 2023, the patient received the 2nd dose of Shingrix. On 14th February 2023, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 14-Feb-2023: Reporter comment: The patient inadvertently received an expired dose of Shingrix vaccination. This was the patient's second dose of the series.  This was a webform submission by healthcare professional for follow up. The healthcare professional phone and email address was in healthcare professional details. Additional supportive information:  The patient was administered an expired dose of Shingrix, which led to expired vaccine used.
Information has been received from a health professional concerning a 9 year old male who on 07/15/1996 was vaccinated with a dose of varicella virus vaccine live.  On 02/07/2005 the patient developed a case of generalized chickenpox with fever.  It was reported that the patient has not recovered and still has symptoms.  Unspecified medical attention was sought.  No product quality complaint was involved.  Additional information has been requested.
Patient received Pneumovax on 08/16/2005, returned to urgent care clinic on 08/17/2005 and was admitted to med-surg floor for cellulitis. Information from 60 day follow-up report states: Info was reported to you by another pharmacist at this facility. Discharge summary states edema. msv
Felt ill, fever of 102 degrees, weakness and body aches, red and swollen.
Pt seen at office on 5-3-07, R arm with lg red, warm circle at Varicella inj site. Itchy. RX Zorivax 200/5 2tsp PO QID x 5 days. Had received varicella booster 5-2-07
Patient came to pharmacy reporting injection site reactions (redness, swelling and severe muscular pain) to FLUZONE HD. Patient is a doctor and reporting in good faith.
The following morning after the SHINGRIX vaccine, I awoke with an oral cold sore and feeling as if I had the flu. These symptoms, along with an extremely painful injection site, continue to worsen throughout the evening into the next day. I developed a fever of 100.9 (PO). I felt as if I had a very bad flu with horrible muscle aches, chills, malaise, pounding headache, and fatigue. This lingered for 2 days but then I recovered fully. The cold sore, which appeared within 12 hours after administration of vaccine, took about 10 days to heal. This all was most concerning since I have CVID but yet lack any natural immunity to chickenpox. It was determined my MD that this was necessary as it was a non-live vaccine, and that I've had Shingles twice before the age of 45 years. Interestingly, two other women that I know, one in her 60s, and the other in her 70s, both who had the first SHINGRIX vaccine developed similar, yet more severe reactions. The one developed severe and multiple mouth sores in and outside of her mouth along with the flu like symptoms. The second developed mouth sores along with a very high fever and flu like symptoms which lingered for one week. In more cases, the mouth sores appeared, like myself, the following morning after administration. I have encouraged both of these women to report their adverse reactions to VAERS. I, and these other women, are most hesitant to receive the 2nd vaccine in 2 months after our reactions to the first.
Bilateral arm swelling: 1. Occlusive thrombus is present within the right cephalic vein extending from the upper arm to the elbow. 2. Nonocclusive thrombus is present within the left basilic vein in the mid and distal arm.  also developed acute appendicitis 04/06/2021 and underwent lap appendectomy.
Within one hour swelling and itching at injection site and pain. Difficulty sleeping due to muscle soreness at injection site and generalized whole body aches, nausea, diarrhea. Woke up feeling  a little better,  but arm still extremely sore. Went to work, felt really sick around 2 pm. Came home and had fever, chills, body aches, extreme fatigue, emesis, headache.  Next morning, add ear congestion and nasal congestion.  By noon, improved still had headache and arm pain. 3 days later still have headache.
Information has been received on 11-DEC-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 24-OCT-2014, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 31-OCT-2014, the patient was treated by a physician at a health & urgent care for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
Left arm swelling and round red rash- continued to expand over the next 24 hours and became hot to the touch, raised.  It was firm and tender.  Lasted 7 days and resolved.  2/7 had recurrence with redness and swelling, hot to the touch and firm and tender.  Bruised.  persisted and became flattened and bruised.  Erythema and bruising resolved 2/21.  Now has discoloration and mild deep tenderness
This case was reported by a pharmacist via call center representative and described the occurrence of paresthesia skin in a adult male patient who received Flu Seasonal TIV Dresden. In 2011, the patient received Influenza vaccine unspecified 2011-12 season. On an unknown date, an unknown time after receiving Influenza vaccine unspecified 2011-12 season, the patient experienced paresthesia skin. On an unknown date, the outcome of the paresthesia skin was unknown. It was unknown if the reporter considered the paresthesia skin to be related to Influenza vaccine unspecified 2011-12 season. Additional details were provided as follows: The age at vaccination was not reported. This case was previously not reported to anyone. The pharmacist reported that the patient experienced feeling of thorns coming out of skin when the patient received unknown manufacturer flu vaccine five years ago from the date of reporting. No further information was available on the event per pharmacist. The reporter declined to provide patient demographics and to answer all question for safety report.
red, swollen sore thigh over rt vastus lateralis;2" in diameter, very tender & hot;
Slight fever; Headache; Body aches; Fatigue; Received bnt162b2 first dose on 27Feb2021 10:30 and second dose on 13Mar2021 10:30; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration, administered in left arm on 13Mar2021 at 10:30 (at the age of 54-year-old) as dose 2, single for covid-19 immunization at Health Clinic. Medical history included Type II Diabetes from an unknown date and unknown if ongoing. Patient had no known allergies. Prior to vaccination, patient was not diagnosed with COVID. Concomitant medications (in two weeks) included Ibuprofen 800mg via an unspecified route for an unknown indication and unknown if ongoing. Historical vaccine included first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration, administered in left arm on 27Feb2021 at 10:30 (at the age of 54-year-old) as dose 1, single for covid-19 immunization. Patient did not receive any other vaccine in four weeks. It was reported that on 13Mar2021 at 15:30 patient experienced Headache, Body aches, Fatigue and Slight fever. Since the vaccination, the patient has not been tested for COVID-19. Patient did not receive any treatment for the events. Outcome of the event Inappropriate schedule of vaccine administered was unknown and rest all were recovering.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness about 2 inches in diameter at injection site (R) arm from varicella vaccination. Pt c/o pain & itching at inj site. Monitor injection site & report any changes.
Patient's (R) arm had a red, swollen & warm area about 2 inches in diameter approximately 2-3 inches below vaccination site. No fever, or other complaint.
Temp to 105.9 one day post vaccine. Temp to 103.6 two days post vaccine. Temp to 100.2 four days post vaccine. Low grade fever five days post. No fever 6 days post.
First dose 12/28/2020.  On 01/05/21 patients states arm was throbbing at injection site, and that same night and next day her joints started hurting. On 01/06 she states her hands were swollen the size of sausages.  She consulted a MD who is rulling out RA.  Lab work ordered and a specialist consulted who thinks it is covid vaccine related. Patient also states numbness in both hands.  Patient received 2nd dose on 01/25/21 with a remarkable reaction of fever of 102 for 3 days, sore throat, headache, dizziness, loss of appetite, loss of taste and loss of hearing in right ear.  After further consultation, patient tested negative for COVID.  Patient states she continues to wake up with sore hands and slight swelling.
pt woke up 2AM 23AUG96 w/fever 102, sweating, startled, screaming-inconsolable lasted off & on for 6hr;APAP given by mom;
This is a spontaneous report from a contactable physician. This report was received via a sales representative. A 16-year-old patient of an unspecified ethnicity and gender received the 1st dose TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced body aches, headaches, chills, fever, nausea, and vomiting on an unspecified date lasted 2 days, with outcome of recovered. The patient went to the emergency room.
fatigue; headache; chills; vertigo; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), HEADACHE (headache), CHILLS (chills) and VERTIGO (vertigo) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 28-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 FATIGUE (fatigue), HEADACHE (headache), CHILLS (chills) and VERTIGO (vertigo). At the time of the report, FATIGUE (fatigue), HEADACHE (headache), CHILLS (chills) and VERTIGO (vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication given no treatment provided
1 week and 2 days post vaccination I woke up with a tender reactive axillary lymph node in the left extremity. Around this same time erythema and a mild pruritus was noticed at vaccination site. Area was warm to the touch. No treatment was started.
2/5/2021-Reaction started left arm around injection site- redness, swelling and itching 8 days after injection given. Redness spread down left arm each day until it reached near the elbow on 2/11/2021. Saw physician on Friday 2/12/2021. Redness approx.4 or 5 inches wide, still swollen, itching. Was prescribed Keflex 500mg 3 times per day for 10 day in case of bacterial infection. Told to call physician on 2/15/2021 to give update on my condition.
Arm remains sore and tender in the muscle of the injection site and in the upper arm.. arm was sore after the shot and remained sore following
Information has been received from a physician concerning a 65 year old female patient with diabetes and no known drug allergies who on 17-AUG-2011 was vaccinated IM with the first dose of PNEUMOVAX 23 (lot number: 668009/1174Z, expiration date: 10-MAR-2012), 0.5 ml. Secondary suspect therapy included metformin hydrochloride (+) sitagliptin phosphate (MSD) 500/50 mg tablet, twice daily for approximately two months. Concomitant therapy included amlodipine, glimepiride, hydrochlorothiazide (manufacturer unknown), isosorbide, levothyroxine Na, lisinopril (manufacturer unspecified), ezetimibe (MSD) and PLAVIX. On approximately 24-AUG-2011, the following week after receiving her first dose of PNEUMOVAX 23, the patient experienced generalized joint and muscle pain, joint swelling in both hands, and elevation CPK levels. She also complained of chills and fever. No treatment was given for the treatment of the adverse events. The patient sought medical attention by an office visit. On approximately 29-AUG-2011, metformin hydrochloride (+) sitagliptin phosphate (MSD) therapy was discontinued by the physician in case the adverse event was associated with metformin hydrochloride (+) sitagliptin phosphate (MSD). At the time of the report, the patient had not recovered. The patient's generalized joint and muscle pain, joint swelling in both hands, elevation CPK level, chills and fever were considered to be disabling by the physician. Additional information has been requested.
Started with general malaise then severe headache, and slight dizziness .  These subsided for about 12 hours.  Returned later in the evening with severe dizziness that wouldn?t go away, severe headache, difficulty walking.   Spoke to On call ?night nurse?  via my doctors service ( office closed entire weekend for holiday) she told me to ride it out.   For 48 hours these symptoms continued.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 29-DEC-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance and the intended purpose of long-term prevention of shingles and zoster-related injuries. The vaccine did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster. On or about 11-SEP-2017, the patient was treated by a physician assistant for herpes zoster, or shingles. On 30-SEP-2017, the patient was diagnosed with post herpetic neuralgia and other zoster-related injuries, and he was prescribed medication for management of his painful symptoms. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Myalgia, NauseaVomiting, malaise Narrative:  Other Relevant History:
44M with no significant PMH who presented with acute ICH 2/2 sagittal sinus thrombosis complicated by seizures requiring intubation for airway protection, and aspiration pneumonia. Patient successfully extubated on 12/6. Subsequent head CT head scans have shown stability. Patient started on heparin drip then transition to lovenox on 12/7. Started on 3% NS therapy due to cerebral edema and that has since improved too as well. Keppra 500 mg BID initiated for seizures. CT chest/abdomen/pelvis negative for malignancy, but consolidation present suspicious for pneumonia, Zosyn started on 12/7. Vanco added on 12/8. Would recommend a 7 day course for pneumonia. Hypercoag workup revealing as well, other than patient is heterozygous for prothrombin mutation. He will need anticoagulation for 3 months with repeat CTV at that time, econsult to neurology needed upon discharge to manage seizure medication (keppra 500 mg BID). Currently he is on lovenox cause his swallowing recently has been an issue, once his swallowing is more reliable he can be switched to pradaxa. He was started on decadron on 12/8 for headaches. That can be tapered off over the next 1-2 weeks. The etiology of his cerebral venous sinus thrombosis remains unclear but perhaps related to his vaccine which he received 5 days before his onset of headaches.
excessive fatigue and weakness, shivering and chills, severe headache, swelling and tenderness where shot was given, lasted 36 hours
Her other arm started hurting as if she had gotten the shot in the other arm; spasms; she started having itchy hands/arms/face; headache; The is a spontaneous report received from contactable consumer. This 43-year-old female consumer (patient) reported that she had first dose BNT162B2 (Pfizer BIONTECH COVID19 vaccine) via unknown route of administration on 25Mar2021 at single for COVID-19 immunization. The patient medical history included of muscle spasms and nerve issues. She did not have an immediate allergic reaction. After she took the vaccine, it seemed to have set off these symptoms that she had before. She mentions that by evening time it started to spread. Her other arm started hurting as if she had gotten the shot in the other arm. She reached a peak a week later for the spasms and she started having itchy hands/arms/face in 2021. She had a headache after leaving the site that persisted for 1.5 weeks in 2021. She spoke to her doctor/doctor's office and they said to take Claritin and muscle relaxants before her next shot. She read online (CDC) that people should not pre-medicate before the vaccine. It's been 2.5 weeks now; her second appointment is scheduled on Friday. The outcome of the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
After receiving the third series of Anthrax Vax. Became insulin dependent, shortly after.  2/23/09 Office note received for 1/23/08 for Diabetes Mellitus f/u and medication consult. Rx-Novolof pen.
The patient received two doses of  Dtap on the same day. The patient didnot  have any adverse  event, treatment  or  outcome.
Patient reports on Monday 4/17/2017 that she was unable to pick up either of her arms on Sunday 4/16/2017.  She reports she is having neck stiffness. Has raised injection site reactions..
Information has been received from an office manager concerning a female who was vaccinated IM with a 0.5 ml dose of GARDASIL (dose # unknown).  Within minutes the patient fainted.  The patient was transported to Emergency room where she was treated and released.  She had recovered.  This is one of two cases from the same source (WAES# 0804USA02539).  Additional information has been requested.
Patient became unresponsive and rigid for 10-15 seconds a few minutes after his Covid vaccine was given.  Mild shaking was noted by the RN.  Patient became alert and oriented immediately following this episode and was seen by the Pediatric team which included a Pediatrician, and pediatric nurses.  No interventions were needed as vitals were stable and was continually observed by the Pediatric team.  His mother will be following up with patient's primary care doctor.
arm hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 14th June 2022, the patient received the 1st dose of Shingles vaccine. In June 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient received the first dose Shingles vaccine on Tuesday before the reporting time and only side effects was arm hurts so bad. The patient wished to get shot in his/her left arm.  Wednesday night arm started to feel better. Additional Supportive Information: The follow-up would not possible as no contact details were available.
PATIENT HAD SWELLING OF THE ARM, HOT TO THE TOUCH, CANNOT SLEEP OR REST ON ARM. FEELS AS THOUGH IT WAS GIVEN IN TOO HIGH OF A LOCATION