chrisvoncsefalvay/vaers-outcomes huggingface dataset:
slight pain; felt warm; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient, reported for self).  A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 06Mar2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced slight pain and felt warm. Patient asked if she could take any medication for fever and pain killer. The events slight pain and felt warm were non-serious. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained
The vaccine was entered into the computer as a COVID 19 vaccine and the patient's mother filled out the VAERS for the COVID vaccine. When the pharmacist went to administer the vaccine, she asked the mother to come back with the child and she said that he did not want her back there with him. Patients name, date of birth, and vaccine were verified with the patient, the vaccine was administered, the patient left, then the mother came back saying her son was given the COVID vaccine when he was meant to receive a Tdap vaccine.  No adverse event was reported.
right lower lobe pneumonia; COPD with hypoxia; COPD with hypoxia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On or about 27-JUL-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Subsequently, the patient suffered shortness of breath, chronic cough with yellowish to brown sputum. The patient was hospitalized and diagnosed with right lower lobe pneumonia and chronic obstructive pulmonary disease (COPD) with hypoxia. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient symptoms have resulted in physical limitations not present prior to using this product. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events were determined to be disabling by the reporter. Upon internal review, the events of hypoxia and right lower lobe pneumonia were considered to be medically significant.
Shot received at 3:20. By 3:45, injection site flushed red and was hot to the touch. Showed the staff at the clinic and they did not seem alarmed. But in talking to nurse after the fact, this may be an allergic and adverse reaction.  No other symptoms present for that date.  Rash receded later that day. Was hot and sore for 2 days. Now has a much smaller rash. Pictures available if necessary.
Started with headache a few hours after shot, by 1-2am I couldn't move the right side of my neck, open the right side of my jaw or even touch my right arm.    The symptoms lasted the entire second day, by around 3pm the second day I felt like I had the flu and my headache turned into a migraine.   By the 3rd day my jaw was  sore, but was able to open, but I still couldn't move the right side of my neck and I still had the migraine.  I ended up taking some Tylenol and my the evening my headache was gone and my arm didn't throb anymore, just a dull ache.   This is the 11th day and my neck is still sore.
got an outbreak on her nose / herpes simplex; This case was reported by a consumer via call center representative and described the occurrence of herpes simplex in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th November 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In November 2021, several days after receiving Shingrix and an unknown time after starting Valacyclovir, the patient experienced herpes simplex. The patient was treated with valaciclovir (Valacyclovir). On an unknown date, the outcome of the herpes simplex was not recovered/not resolved.   It was unknown if the reporter considered the herpes simplex to be related to Shingrix.  Additional details provided were as follows: The patient received a dose of Shingrix in right arm and patient stated that she was prone to to herpes simplex outbreaks and got an outbreak on her nose a few days after receiving the first dose of shingrix. She took valacyclovir to treat the outbreak which has not yet resolved. Spoke per Doctor and patient was referred to health care professional (HCP) for follow up. The reporter did not consented to follow-up. The case was linked with case US2021AMR237385, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR237385:Same Patient
Two red areas nickel size just below flu injection site, have been sore to touch, or lay on to sleep, no fever, did just find out stem cell donor has egg allergy.
cough, nauseated, cold chills, pain at injection site, headache, body aches,
This spontaneous report was received from a nurse and refers to a 19 year old female patient with asthma, hyperthyroidism and Hashimoto's thyroiditis. There was no drug reactions and allergies reported. On unknown dates, the patient was vaccinated with the first, second, third doses of GARDASIL (lot#, expiration date, dose, site of administration were not reported) and subsequently, had no adverse effects reported regarding these vaccinations. On 08-JUL-2015, the patient was inadvertently vaccinated with the fourth dose of GARDASIL (lot# L012190, expiration date 13-APR-2017, dose, site of administration were not reported) administered intramuscularly. Concomitant therapies included VOLTAREN and CLARITIN. On 09-JUL-2015, the patient called the unspecified physician's office and reported that she experienced fever, headache and shivering. There were no lab diagnostics studies performed and no treatment was given. The outcome of the events was unknown. The patient sought medical attention. The relatedness between the fever, headache, shivering and GARDASIL was not reported. Additional information has been requested.
I have petechiae all over my right thigh and some on my right arm as well as bruising very easily. Not sure if it?s related to the vaccine but it is concerning me as I?ve never had petechiae on my body in my whole life.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 28 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Clinically isolated syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course Patient received treatment with Paxlovid from 09Jun2022.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
This spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In 2012, the patient was inoculated with ZOSTAVAX (dose, route, and lot # were not provided) at a pharmacy for routine adult health maintenance and for the long-term prevention. It was mentioned that the vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. Later in 2014, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. 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 would continue to suffer significant medical expenses, and pain and suffering, and other damages. At the time of the report, the outcome of the aforementioned adverse events was unknown. The relatedness assessment between the aforementioned adverse events and ZOSTAVAX was related.
COVID-19; COVID-19; Vaccine brand other: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6205), in left arm, on 28Mar2021 as dose 2, single (Lot number: ER8732), in left arm, on 06Aug2021 as dose 3 (booster), single (Lot number: EQ0217), in left arm and in May2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 23Dec2021 as dose 4 (booster), single (Lot number: 041J21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Rheumatoid arthritis" (unspecified if ongoing); "Skin cancer" (unspecified if ongoing); "Known allergies:Penicillin" (unspecified if ongoing); "Known allergies:NSAIDs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "known allergies: Aspirin". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Dec2021, outcome "unknown", described as "Vaccine brand other: Moderna"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jan2023) Positive, notes: Paxlovid-rebound (converted back to positive test). Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Patient said their are was sore.  They did not feel well. They thgouht it was an allergic reaction to the injection.  They felt so ill they went home from work.
Patient was administered the second dose of Moderna COVID-19 vaccine at 21 days after first dose. CDC guideline is 28 days after first doese. No adverse effects have been reported.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (lot # reported as L016428, expiry date 30-JUL-2017; dose and route of administration were not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Pt develop fever and chills that evening, the next day developed blisters in her mouth and vagina,  Blook in bowel movements.
Around November 19, 2022, I started experiencing flu like symptoms. I took a rapid COVID-19 test. The result was positive. I was lethargic for about a week. I also had a fever and was sweating. That lasted for about 4 or 5 days. I had a cough and congestion. The symptoms lasted about ten days. I continued to test positive for COVID-19 for two weeks. The doctor prescribed methylprednisolone 4 mg dose pack.
This spontaneous report as received from a physician via company representative refers to a patient of unknown age. The patient's pertinent medical history was not reported. Approximately in 2009 (reported as 5 years ago) patient was vaccinated with first dose of GARDASIL. Approximately in 2014 (reported as recently) the patient was vaccinated with second dose of GARDASIL. No adverse effect reported. The outcome of second dose of GARDASIL was administered to a patient who had received the first dose of GARDASIL 5 years ago and no adverse effects was unknown. Additional information has been requested.
pt recvd vax & was adm to hosp w/purpura; hx reveals bleeding gums starting 4NOV, easy bruising & diarrhea w/blood noted 5NOV; spots noted on tongue 7NOV & nodule; final dx thrombocytopenic purpura; also exp swelling of proximal phalanx
Arm pain immediately following administration, followed later with itching/redness/warmth of vaccination site, over 12 hours, progressed to entire lateral arm with cellulitis.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. No information about medical history, concurrent conditions and concomitant medications were reported. The reporter stated that on 12-AUG-2014 the patient was inadvertently administered with PNEUMOVAX23 (dose strength not reported) lot# J009827, expiration date 10-AUG-2014, route intramuscular which had expired on 10-AUG-2014 and this was supported. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information is not expected as the reporter refused additional contact.
Passed out twice, for a few seconds each time, during trip to bathroom in attempt to vomit. Nausea, low grade fever, cold sweats following.   Did not vomit.  Arm soreness at site, other muscle soreness, headache, fatigue continued for six hours. Symptoms lessened and continued for 24 hours at lesser extent.
Chills; Bad fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and PYREXIA (Bad fever) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included PREDNISONE and SULFAMETHOXAZOLE for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced CHILLS (Chills) and PYREXIA (Bad fever). At the time of the report, CHILLS (Chills) and PYREXIA (Bad fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.  The patient's stated that his second vaccine appointment is on 18May2021.
Information has been received from a physician concerning a 65 year old male with no drug allergies who on 06-Oct-2008, was vaccinated with PNEUMOVAX (lot # not provided), injection. Concomitant therapy included influenza virus vaccine. Two days after receiving vaccine, on 08-OCT-2008, the patient experienced fever of 103 degrees. A dip urinalysis was positive for nitrites and protein, negative for leukocytes and blood. The patient also had a blood test, which indicated that he had an elevated white count of 23000. In follow-up it was reported the patient was prescribed CIPRO 500 mg BID. Blood work revealed a white blood cell count (WBC) of 26, 2000 with shift. Urine culture was negative and blood cultures x2 were negative. Another white blood count test result was 26200 with shift. The patient also had a urine culture tests which all indicated negative. The patient was treated with "CYRO" 500 mg bid. On 10-OCT-2008, the patient's fever resolved and the patient fully recovered. Additional information is not expected.
slight itching after 3 days then 8 days later huge red circle about 5 inchs  slight pain itching lasting for 3 days took one benedryl
Pain in arm, 2nd day Aches and pains throughout body, 9 pm - 6 am Fever and chills, less on 3rd day, but bruise appeared on opposite side of right arm from injection. 4th day fever of 100 F till noon. Six inch wide red mark appeared around arm, height centered at injection sight - faded two days later.
patient experienced transient ischemic attack; patient is still suffering from speech aphasia; memory recall issues; Initial information received on 11-Oct-2023 regarding an unsolicited valid serious case received from a consumer/non-healthcare professional.  This case involves a 90-year-old male patient who experienced transient ischemic attack, patient is still suffering from speech aphasia and memory recall issues after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccine included ABRYSVO vaccine.   On 26-Sep-2023 at 16:15 hours, the patient received a 0.7 ml total dose of suspect influenza quadrival A-B high dose HV vaccine (strength, form, lot number, expiry date: unknown) via unknown route in upper arm for immunization.  On 26-Sep-2023 at 18:00 hours, the patient had an event of patient experienced transient ischemic attack (transient ischaemic attack) (latency: 1 hour 45 min) following the administration of influenza quadrival A-B high dose HV vaccine.   On an unknown date the patient had events of patient is still suffering from speech aphasia (aphasia) and memory recall issues (memory impairment) (unknown latency) following the administration of influenza quadrival A-B high dose HV vaccine.  It was reported, that on 26September2023 at 16:15, the patient received a FLUZONE HIGH DOSE shot, and afterwards received ABRYSVO vaccine on the same arm. At 18:00, he states patient experienced transient ischemic attack and they immediately called an ambulance. He was rushed to the ER where he spent an entire night. When asked about the patient's condition now, he says that patient is still suffering from speech aphasia and memory recall issues,  It was unknown if any lab data/test results available.  Action taken with quadrivalent influenza vaccine (Fluzone High-Dose Quadrivalent) was not applicable.  It was not reported if the patient received a corrective treatment for the events.  Outcome: unknown for all the events.  Seriousness criteria: event of  patient experienced transient ischemic attack was assessed as medically significant. The patient was hospitalized for this event.; Sender's Comments: Sanofi company comment dated 16-Oct-2023: This case involves a 90-year-old male patient who experienced transient ischemic attack, after receiving influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent].The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history,lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Fever, Chills, Night Sweats, Muscle aches, Fatigue, Swelling at vaccination site Lasted 48 hours
FELT ALITTLE NAUSEOUS; TIRED; SHORT HURT; SLIGHT HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) once total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced felt a little nauseous, tired, short hurt, and slight headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt a little nauseous, tired, short hurt, and slight headache. This report was non-serious.
After aprox 6 hours of receiving vaccine body was covered in hives. Back, neck, back of legs, stomach, arms and front of legs.  Hives lasted for two days and Claritin or Benadryl eased symptoms but never took hives away fully.
Nasal Congestion, runny nose, drainage into throat (slight congestion starting 10/8; worsened thru at least 10/11). Headache; sinus pressure / mild sinus pain: 10/10 starting approx. 12:30 p.m. Sneezing and Cough: Mainly started noticing 10/11 10 a.m. Suspected sinus infection starting afternoon of 10/10. Went to Urgent Clinic 7:45 p.m. on 10/10. Diagnosed with sinus infection and given amoxicillin prescription.
Patient developed severe reaction at injection site - red, hot and raised area for 5 inches around point of needle insertion. Hard solid mass and still visible 11.10.18.
17 year old female became syncopal 10 minutes after injection. Recovered with fluids and food.
patient with seizure disorder, within 10 minutes patient had a seizure with typical presentation for this patient.
Patient claims to feel dizzy, hot and shaking after receiving shot. Ambulance crew took patient to truck to cool down and drink cold water. First set of vitals where taken and then 2nd and final.  Patient claims she no longer felt dizzy, hot or shaking. Told patient if she does not feel better to seek medical attention.
Patient fainted shortly after receiving dose on 4/10.  Patient did respond shortly afterwards and was given juice and a ice pack.  Continued to monitor for some 30 plus minutes prior to releasing.  Called patient  around 5PM same day, patient sounded great and was doing well.  Note: Patient has a history of fainting upon vaccine admin. but did not indicate to provider prior to administering vaccine.  Patent called at moms request on 4/12 at 9:54 am and indicated she noted upon waking 2 hives in crevasse of arm which spread to all over body.  Advised patient to call MD office for guidance and speak to live person.  Spoke to doctor's office whom indicated they would address hives condition and then advise provider this provider.