chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Guillain-Barre Syndrome and later developed acute renal failure; started as pain in feet and legs. Admitted to the hospital on 12/26/00. Received IVIG  and IV contrast which may be related to acute renal failure. Per F/U 5/1/01: BP 220/100. During her stay in the hospital, she gradually became weak and worse. Attempts to insert an IV line were made, but it was unsuccessful anf for this reason, we had asked MD to see her to insert a Port-A-Cath which was performed on 12/27/00. The pt was then given 8mg of Globulin, immunogloblin, 17 grams daily for 5 days over 16 hours. However, this was discontinued on 12/30/00 after 4 dosages, after she developed an elevated BUN and creatininie who had a history of was felt to be secondary to the immunoglobulin. Because of this, we had asked MD to see her who then started her on short-term dialysis. Slowly and gradually the rhythm failure improved. She remained stable and was then transferred to the skilled nursing facility on 1/16/01. Impression: Guillain-Barre syndrome, improving; Acute renal failure, transient secondary to the immunoglobulin therapy; hypertension.
On 3/16/03, (day 5), vaccinee complained of a "slight headache and sore Rt.axillary node".  On 3/21/03, (day 10), vaccinee was admitted to Hospital, with fever (103.4F), HA, backache and stiff neck.  She was treated with IV Zithromax X 3days.  Liver function tests were elevated slightly therefore INH prophylaxis discontinued. Blood cultures were pending (later returned negative) when she was transferred to the regional medical center, for further evaluation.  All medications were discontinued.  LP was performed - mild elevated glucose and protein were only findings.  Sample of CSF and 1 red top tube of serum were sent to CDC as requested. CT and MRI were negative.  She received neurological supportive care while hospitalized.  Vaccinee was discharged on 3/26/03 with diagnosis of "Adverse reaction to Smallpox Vaccine, Headache".  On 3/28/03, vaccinee was re-admitted to with Headache and vomiting according to her mother.  Mother did not know is she had fever at the time of this admission.  Have been unable to obtain the records of this admission but she was hospitalized for either 1 or 2 days.  She did return to work on 4/1/03.  The vaccinee was unable to be interviewed after last hospitalization due to another unrelated but elective hospitalization within 2 weeks of returning to work.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for 1 day, in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies Latex" (unspecified if ongoing), notes: known allergies Latex. 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". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient reported red bumps on his torso (chest, stomach and back) 8 days after receiving smallpox vaccine. He reported no constitutional symptoms. His vaccine site showed a dime-sized white pustule, surrounded by erythema, less than 3 inches. Photos were viewed showing pustular-type lesions on an erythematous base. The on-call physician spoke with the patient and viewed the photos and determined this was mostly likely Non-viral Pustulosis after smallpox vaccination. At follow up with the patient 3 days later (day 11 post-vaccine), he reported the bumps had diminished in size and color and were not itchy or bothersome.
Headache sensitivity to light and noise nausea, started 2/16/2022 doesn?t respond to over the counter medication. Did not respond to toradol Im or fioricet
This spontaneous report as received from a pharmacist refers to a 77 year old patient of unknown gender. There was no information about concurrent condition, medical history or concomitant medication. On 05-MAR-2016, the patient was vaccinated with expired dose of PNEUMOVAX 23 (lot # K007826 and expiry date 03-FEB-2016) (dosing details unspecified). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Numbness in the arm.  One day there was absolutely no feeling in my left arm for over an hour.  The numbness is less now, only from the wrist down .  New issue is a bundle of nerves in the center of my palm.
This spontaneous report was received from a pharmacist refers to a female patient of approximately 65 years. No relevant medical history of the patient was reported. On 01-OCT-2014, the patient received FLUZONE HIGH DOSE injection (Lot number reported as U5017AA, expiry date: 03-APR-2014) (strength, dose and route of administration were not reported) in her left deltoid. On an unknown date in October 2014, reported as a few days later, the patient was vaccinated with PNEUMOVAX 23 (lot number, expiration date, strength, dose and route of administration were not reported) in the right arm at a pharmacy. It was also reported that the patient was not sure if she received PNEUMOVAX 23 or PCV13 at the pharmacy. No concomitant medications were reported. The patient asked the reporter if she would be having an injection site reaction to the unspecified PCV 10 days after she received it. On an unknown date in October 2014 the patient experienced adverse symptoms in her right deltoid area, but the patient had not described her adverse symptoms to the reporting pharmacist at the time of the report. The reporter did not know if the patient had notified her health care provider or if she received any treatment for the adverse symptoms. There was no product quality complaint reported. The outcome of adverse symptoms in right deltoid area was unknown. The causality was not reported. Additional information has been requested.
First shot two years ago; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago of reporting 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 age at vaccination was not applicable for this report. The patient was it too late to receive 2nnd dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination.
I checked my blood pressure it was 135/97, and 135/85 in the morning; Head ache at the same time in the evening; dose 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Dec2021 13:15 (Lot number: FJ1620) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Yes" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Yes, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0151, Location of injection: Arm Left, Vaccine Administration Time: 01:15 PM), administration date: 08Apr2021, when the patient was 58 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0176, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM), administration date: 06May2021, when the patient was 58 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 05Dec2021 13:15, outcome "unknown", described as "dose 3"; HEADACHE (non-serious) with onset 06Dec2021, outcome "unknown", described as "Head ache at the same time in the evening"; BLOOD PRESSURE INCREASED (non-serious) with onset 06Dec2021 15:00, outcome "unknown", described as "I checked my blood pressure it was 135/97, and 135/85 in the morning". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of headache, blood pressure increased.  Additional Information:Seriousness was no,Seriousness criteria-Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating,Congenital anomaly/birth defect was no,Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that Other medications were received by the patient received within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19.Since the vaccination, patient had not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Excessive screaming (when awake) alternating w/lethargy for 2 days following vax.
DIZZINESS; SORENESS AT INJECTION SITE; HEADACHE; This spontaneous report received from a patient concerned a 60 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient has no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: 21-JUN-2021) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced dizziness. On 03-APR-2021, the subject experienced soreness at injection site. On 03-APR-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, and had not recovered from soreness at injection site, and dizziness. This report was non-serious.
4am started to get chills. 6am extreme nausea and dizziness along with the chills.  Extreme fatigue began shortly after.   Nausea and dizziness subsided around 12.  Aches, chills and fatigue lasted until about 8am the next day.
Complained of cold chills, shivering, neck pain and pounding head.  At injection site of flu shot swollen bump that was hot and painful.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received FLUARIX quadrivalent. In 2015, the patient received FLUARIX quadrivalent. On an unknown date, less than a month after receiving FLUARIX quadrivalent, the patient experienced injection site pain was unknown. The reporter considered the injection site pain to be related to FLUARIX quadrivalent. Additional details were received as follows: This case was previously reported to a manufacturer. The reporter was Director of Pharmacy and was asked to contact GlaxoSmithKline by employee health department to saw if there were any reports of extreme arm pain. The reporter stated that, their hospital changed FLUARIX trivalent to FLUARIX quadrivalent this year. The reporter stated that, last 2 weeks ago from reporting date, the patient had received FLUARIX quadrivalent and experienced severe arm pain (injection site pain). The reporter did not have the further information about patient and vaccine. The reporter did not know when the arm pain began or resolved. This case has been linked with case US2015149594 reported by the same reporter.
Pt has a raised rash approximately 2" x 4" at the administration site. Pt saw MD and was placed on cephalexin 250mg PO qid.
Pain causing arm immobility. Called pharmacy for advice. Treatment - ibuprofen 24 hrs.
Patient received 1/2 dose of Live Seasonal Flu (LAIV) and Live H1N1 on the same day-10/16/09. According to CDC recommendations he was revaccinated on 10-27-09 with Inactivated Influenza and Live H1N1. No adverse effects.
Approximately 24 hrs after receipt of vaccine arm became swollen & red & hot at site of intradermal flu injection.
pt rcvd vax; pt admitted to ER 8pm on 21jun94; t 104.6; pt had seizure at home;
Information has been received from a nurse practitioner (N.P.) concerning a 4-year-old male with no allergies or medical history, who on an unspecified date was vaccinated with a dose of Varivax. There was no concomitant medication. Subsequently, on an unspecified date, within 3 months of vaccination, the patient developed Type I Diabetes. Unspecified medical attention was sought and the patient was hospitalized. The patient required insulin treatment. It was reported that as of 27-APR-2007 the patient had not recovered. The nurse practitioner reported that there was no family history of diabetes. No product quality complaint was involved. The reporter considered the patient's experience to be an other important medical event. Additional information has been requested.
Was notified by nurse at  clinic that  Patient started having right eye dripping, swelling and burning starting on Monday 3/1/21. Patient went to see her Family Dr. with complaint of right side drooping starting today 3/3/2021. She was sent to the ED at Hospital for evaluation.
With in the 24 hours bilateral hands were inflammed joints.  The inflammation was serve.  Lasting more than two weeks.  Medication using Motrin and resting joints by taping .
Proquad (MMR and varicella combination vaccine) ordered, only Varicella given.
Three to four days after receiving my second shot I lost my sense of taste. It has now been a month & a half now & the only thing that is different is anything spicy like pepper or other spices are intensified greatly.  Most foods or drinks leave something like  a film on my tongue.
Patient presented to the ED 2/6/2021 with increasing SOB and found to have abnormal labs as an outpatient.  Patient was found to be COVID positive on 2/6/2021 as well.  Patient was discharged on 2/9/2021 for acute decompensations diastolic HF.  At 2/19/2021 visit with Nephrology, patient found to have hypervolemic hyponatremia, not responding to oral diuretics and decision was made to manage as an inpatient.  Patient found to have cardiomegaly, mild pulmonary vascular congestions with small bilateral pleural effusions, EF 59%, severely elevated pulmonary artery systolic pressure, and had a AKI.  Patient did not improve with diuretic therapy.  Hospice and comfort care measures were pursued and patient expired on 3/1/2021.
Got really quiet and weak and eyes rolling back but responsive and follows commands. O2 saturation was 99%, HR=78/min, BP=110/60.RR=20. BP before vaccination was 108/62. Child was placed in supine position. By 5:30 PM, she was laughing at picture on her phone and talking loudly. At that point she was discharged home.
no known cardiovascular disease. He has been feeling less well recently .  About 1 month ago, he received the 2nd dose of the Moderna COVID-19 vaccine, and he developed an erythematous, non-raised rash involving the upper and lower extremities. This has subsided, but still persists on his thighs. He presented to the emergency department on 7/3 with worsening dyspnea. and diagnosed with  pulmonary emboli.  After a week in the hospital deteriorating with the following the patient expired.  Pulmonary embolism  Active Problems:   Cardiogenic shock    NSTEMI (non-ST elevated myocardial infarction)    Cardiomyopathy    Acute liver failure without hepatic coma   Rheumatoid arthritis    Renal failure   Aortic stenosis   Lactic acidosis   Cardiac arrest    Cerebral anoxia
Patient experienced swelling and redness on entire upper arm that was warm to the touch. Also experienced joint pain and aches and a bump at site of injection. Treated with BENADRYL and redness and started to recede.
Headaches, Myalgias/Arthralgias, Fatigue (chronic), Pruritus, angioedema (not noted until Nov 2003), feeling like he is cold/cold intolerance
Swollen, red, and hot from site of vaccines down to elbow. Also had fever.
Vasal Vagal response. Vitals 72/24 initial and 102/58 at D/C.  Placed pt in Trendelenburg No SOB, some dizziness and diaphoretic.  After B/P more stable sat pt up pt was able to walk after 15 minutes without any difficulty. Dr.  and Dr. assessed patient and ok to go home.
Cellulitis, superficial injury face/scalp infected, Subcutaneous lipoma. Medical records include hearing loss & acne. Follow-up: Pt states recurrent Lipoma on back of scalp; swelling and pain.
Throbbing, ache, decreased range of motion, decreased strength, constant discomfort, sleep interruption due to pain.
Very swollen injection site; red at injection site; hot and sore at injection site; Rash on upper body; vaccination site itching; Upper body itching; Sick to stomach; bad headache; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration, in the left arm on 29Mar2021 at 14:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy and depression. Allergies to medications, food or other products included peanut, peanut by products, thimerosal, penicillin and amoxicillin allergy. Concomitant medications received within 2 weeks of vaccination included lamotrigine (LAMICTAL), venlafaxine hydrochloride (EFFEXOR), calcium (MANUFRATURER UNKNOWN) and vitamin D (MANUFRATURER UNKNOWN) all were from unknown date and for unspecified indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not get any other vaccine within 4 weeks of COVID-19 vaccine. On 29Mar2021, at 20:00 the patient experienced very swollen, red, hot and soreness at injection site. Rash on upper body that has started on last night and hasn't get better. The patient also reported itches on upper body and around injection site, and stomach discomfort and bad headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment received for the adverse events was reported as no. The clinical outcome of the events very swollen, red, hot and sore at injection site, rash and itches on upper body, itches around injection site, stomach discomfort and headache were not recovered.  Information about lot/batch number cannot be obtained. No further information is expected.
Patient developed redness/swelling in LEFT ARM.  She visited the beach over the weekend and stated that she had take Aleve to help ease swelling and also applied sunscreen frequently in the area.  The redness seemed to be spreading when she came by the pharmacy on 7/22/2019, Monday.  I suggested for her to see her physician and get checked out.   I followed up with her today, Tuesday (7/23/2019).  She went to go see her physician and was prescribed a Medrol Dose Pak.  She stated that according to her doctor,  it was a little difficult to determine which vaccine actually caused the bad reaction.
Instant and extreme pain at site, pain up shoulder and into the neck, bleeding, large bruise, pain for a week at injection site
pt recvd vax & w/in 24hrs exp rt upper chest muscle soreness which lasted 4 days & then subsided;sx following dose 1 were not considered significant enough to discontinue the vax series;pt recvd 2nd dose 12OCT94;
Patient states that about 6 days after his 2nd Moderna vaccine his right hand and wrist became painful and swollen. On day 10 post vaccine he went to the ER for evaluation of the pain and swelling, and was told he had tendinitis.   States that the vaccine was in the same extremity as the pain and swelling- the right arm.  Saw Dr. and per the patient, the pain and swelling are due to lymph involvement related to the vaccine.  Per the patient, this lasted more than one month before it resolved.
Information has been received from a physician concerning a male patient. The patient may have had a case of chicken pox in 2002 although he received Varivax on 15-JUN-1008. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested
Information has been received from a physician concerning a female patient who on 20-SEP-2007 was vaccinated IM with a dose of Gardasil.  On 21-SEP-2007 the patient developed a localized red rash at injection site.  No other symptoms were noted.  An office visit was required.  The patient's outcome was not reported.  Additional information has been requested.
Sore arm, headache, fatigue for 28 hours and self resolved. However I have had what can only be described as ?brain fog? since getting the vaccine.  I am normally very on top of my game and have just noticed minor but very atypical changes in my thought processes.
Patient was being observed for 15 minutes after his shot. He reported that during that fifteen minutes, he blacked out for a few seconds. I took his BP and it was 126/75 and his pulse was 73. He drank a bottle of water and 15 minutes later, felt fine. I instructed him to follow up with his physician because he stated that this has happened before (not after a vaccine though).  Patient said he did just finish a tennis match and may be dehydrated.
Swollen arm, lymph nodes, neck, sinuses, and chest on left side; redness and pain in arm; difficulty breathing and heaviness in left side of chest; chills; loss of appetite; fever (her normal is 96.5 and she had 101 degrees); lethargy; aching all over
Ear ache; Head ache; Numbness; Tingling on right side face; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 26Mar2021 at 12:00 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included levothyroxine sodium (SYNTHROID), taken for an unknown indication from an unknown date. The patient previously took codeine and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Mar2021 at 16:00, the patient experienced ear ache, headache, numbness and tingling on right side her face. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events ear ache, headache, numbness and tingling on right side her face was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.