chrisvoncsefalvay/vaers-outcomes huggingface dataset:
poor response to pneumococcal vaccine; This literature marketed report was received form the authors of published article, stated as below, and refers to 51-year-old male patient. The patient's concurrent conditions included thymoma, hypertension, gastro-esophageal reflux, hyperlipidemia, Barret's esophagus and hypogammoglobulinemia (low IgM, IgG subtype deficiency (low IgG1 and IgG3) and absence of circulating B cells, associated with thymoma. The patient had history of blepharitis, childhood otitis media and one cellulitis (requiring intravenous antibiotics thirty years prior). It was reported that recently, the patient underwent resection of a 10 cm thymoma.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, frequency, route of administration and lot# with expiration date were not reported) for prophylaxis. The patient had poor response to the vaccine and on an unknown date, he was re-vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, frequency, route of administration and lot# with expiration date were not reported) for prophylaxis. The patient was also vaccinated with recombinant zoster vaccine (strength, dose, frequency, route of administration and lot# with expiration date were not reported).  The outcome of vaccination failure was unknown as follow-up pneumococcal titers were still pending.  The reporter considered vaccination failure to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown).   A copy of the published article has been requested.
Rash, itching to right side, headache. Evaluated by EMS-Cleared
Eye redness and puffy, migraines, fever cold chills, muscle pain and joint pain, it?s been five days and eye almost closed completely. Wanted to report the blood shot eyes and puffy ness around left eye
headachy; Tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a physician and describes the occurrence of HEADACHE (headachy) and FATIGUE (Tired) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced HEADACHE (headachy) and FATIGUE (Tired). On 31-Dec-2020, HEADACHE (headachy) and FATIGUE (Tired) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported No treatment medication were reported.
Pt recvd 3 doses of Engerix-B vax & titers were checked 6 months p/last dose; titer result was 5.2, indicating a low pos response;
Patient received 1st dose Moderna on 4/13/21 , received Pfizer on 5/4/21 for second dose.  I discovered Moderna was given at 1st dose when billing 3rd party for 2nd dose.  Patient thought he had gotten Pfizer for the first dose.  I informed patient about 10 minutes after his 2nd dose  - he didn't report any adverse events at this time.  We will follow up with patient.
Severe back and leg pain lasting at least 6 weeks; still continuing, but now about 60% better than it was.  Must use a walker due to pain  Saw neurologist's Nurse Practioner and am receiving Physical Therapy 2x weekly.  Scheduled to see doctor at pain clinic about injection in low back.
chills, fever, fatigue injection site pain swelling at injection site use of prescription pain reliever  prevent daily activity  myalgia diarrhea nausea
Patient got the  Pfizer bivalent booster on 10/14/2022 and then came to the clinic for another one on 11/4
Fever 104+ for 3 days Cold sorted covering both lips starting within 12 hours of shot Extreme fatigue * 4 days Extreme pain?? continues in ALL MY bones and joints
About 12 hours after administration of the vaccine into my left arm, I developed some L sided facial numbness. About 16 hours after administration of the vaccine, I developed paresthesia in my left hand radiating up my left arm. The symptoms worsened over the next 48 hours, which then resulted in an ER visit with a head CT. There was no facial paralysis and CT of the brain was normal. I followed up my ER visit with a visit to my primary care doctor 1 week after vaccination with the symptoms still present. I now have an appointment with a neurologist. The symptoms are still present and I have never had paresthesia or shooting pain to my ulnar or trigeminal nerves ever before in my life. Also, my menstrual cycle started very heavily about 48 hours after administration of the vaccine, which was the second time for July and  completely off track and unexpected. It lasted almost 1 week.
Information has been received from a healthcare worker concerning a 9 month old male patient who was vaccinated orally with the first and second dose of ROTATEQ on 14-SEP-2010 and 28-MAR-2011 respectively (lot# not specified). No adverse effects were reported. Follow up information has been received from a Certified Pediatric Nurse Practitioner, concerning a 9 month old male patient with "none" pertinent medical history, "none" drug allergies or reactions, who was vaccinated orally with the first and second dose of ROTATEQ on 14-SEP-2010 (lot# not specified) and 28-MAR-2011 (lot# 668967/1201Z, expiration date: August 2012) respectively. There were "none" concomitant therapies. The nurse reported that on 28-MAR-2011, the patient was given his 6 months vaccines at 9 months old. After given his ROTATEQ, was noticed he was 36 weeks old, when he should had gotten it at 24 weeks. No further information is available.
Beginning the morning after shots, and lasting for about 24 hours, she had fever of about 101, nausea (no vomiting) and headache.  She could not get out of bed.  She felt fine when she awoke the following day.
Felt like a fairly mild cold. Runny nose, sneezing but no fever. I had some coughing also. All symptoms lasted about 10 days.
some arm pain (unspecified) following the injection; shoulder and neck stiffness after going to sleep that night; This is a spontaneous report from a non-contactable nurse. A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, via an unspecified route of administration on 03Jan2021 (Sunday) at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The nurse reported some arm pain (unspecified) following the injection on 03Jan2021 and shoulder and neck stiffness after going to sleep that night. The nurse reported that her arm pain resolved the next day on 04Jan2020. The outcome of event "shoulder and neck stiffness after going to sleep that night" was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt had onset of seizures on 7/3/00, post vax. Better at the present time, taking phenobarbital.
Mom noted a red rash on legs 2 hrs post vax; No difficulty breathing; Was advised to take pt to pvt MD; Advised by pharmacist who advised mom to give DPH & APAP q 4 hrs; Talked w/mom 7AUG91 stated "light pink rash" & limping a little;
cough; Running a fever; Got a fever; Really bad headache; Headache lasted for couple of hours; She took the shower and she got really light headache; She is vomiting; Today she is throwing up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 11 year-old female patient received bnt162b2 (BNT162B2), administration date 18Dec2021 13:20 (Lot number: FL0007, Expiration Date: 12Jan2022) at the age of 11 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: FLOVENT.  The following information was reported: COUGH (non-serious), outcome "not recovered", described as "cough"; PYREXIA (non-serious), outcome "not recovered", described as "Running a fever; Got a fever"; VOMITING (non-serious) with onset 19Dec2021, outcome "not recovered", described as "She was vomiting; Today she was throwing up"; HEADACHE (non-serious), outcome "not recovered", described as "Really bad headache; Headache lasted for couple of hours; She took the shower and she got really light headache". Relevant laboratory tests and procedures were available in the appropriate section. Therapeutic measures were taken as a result of pyrexia. Reporter gave to patient, 200mg Advil last night for fever and it helped for fever.  Additional information included: Reporter stated, the patient was approximately 5 foot tall, and 90 pounds (reporter was not sure hence not captured in tab). Date of vaccination: Reporter stated, Dose 1 received on Saturday, 18Dec2021 at 1:20 pm on her left. The patient had no any vaccination 4 weeks prior to COVID 19 Vaccine. Reporter stated, she had asthma, so she was taking her asthma medications, she took Flovent and reporter don't had the box that had her information. Reporter stated, the fever she started, first she got really bad headache a really bad headache, and an hour after she had 'cough' and the headache lasted for couple of hours and then she got a fever and then today she was throwing up. Still experienced.  Follow-up attempts are completed. No further information is expected.
Fever; arm was swollen/ the  swelling is spreading around the arm; arm was hard underneath; Below injection site above elbow she developed a blister that itches; blister that itches; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was swollen/ the  swelling is spreading around the arm), INDURATION (arm was hard underneath), BLISTER (Below injection site above elbow she developed a blister that itches), PRURITUS (blister that itches) and PYREXIA (Fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Aug-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen/ the  swelling is spreading around the arm), INDURATION (arm was hard underneath), BLISTER (Below injection site above elbow she developed a blister that itches) and PRURITUS (blister that itches). On 22-Aug-2021, the patient experienced PYREXIA (Fever). On 23-Aug-2021, PYREXIA (Fever) had resolved. At the time of the report, PERIPHERAL SWELLING (arm was swollen/ the  swelling is spreading around the arm), INDURATION (arm was hard underneath), BLISTER (Below injection site above elbow she developed a blister that itches) and PRURITUS (blister that itches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Aug-2021, Body temperature: 100.4 (High) Fever-100.4F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment was not provided.  Pharmacist suggested patient a cold pack and Benadryl.
This is a spontaneous case, initially received from a pharmacist on 26-Jan-2018, concerning a 71-year-old, elderly, female patient. The patient's medical history and concomitant medications were not reported. On 26-Jan-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 196498, expiry date: 30-Jun-2018). On the same day (26-Jan-2018), after vaccination, the patient had bleeding at the injection site, so she applied pressure on it. However, lump was developed on the arm of the patient which was neither red nor warm but just a quarter size of knot. At the time of this report, the patient had not yet recovered from the events (injection site bleeding and vaccination site lump). The reporter assessed the events (injection site bleeding and injection site lump) as non-serious.
4 days after varicella vaccine vaccine pt's mother called and stated he had redness and swelling. Redness, swelling, she made an appt. for 9-30-10. We marked the area and brought back 10/10.
Pt presented to ED with c/o SOB/PNA, 2 day history of cough and body aches.  +d-dimer -CTA chest negative for PE.  Pt Covid19+.  PMHX of dementia/Alzheimer's dz.  Pt received IV Abx and IV/po steroids. Pt informed MD that he has been fully vaccinated with booster.
Client had a history of SVT episodes for about 10 years prior to smallpox vaccination.  She was taking Verapamil and the dose was lowered a couple years ago as episodes were not as frequent.  After the smallpox vaccination, client experienced 2 SVT episodes and the dose of Verapamil was increased again.
This spontaneous report as received from a nurse practitioner refers to a 20 year old female patient. On an unknown date the patient ws started vaccinated with  GARDASIL (dose, frequency and route not reported) twice within five years (received two (2) first doses). No adverse effects to patient. The nurse stated the patient would like to receive GARDASIL. The outcome of the event was unknown. The patient didn't seek medical attention. Additional information has been requested.
The night of the vaccines, the patient started to tell her mom that her arm hurt. Overnight, she had a small fever to touch, though mom didn't take it with a thermometer. The following morning 1/22/10, the arm was swollen, red and warm and the child was grabbing it saying it hurt. In the office, there was a warm, tender, erythematous area 10cmx8cm over the L deltoid with no fluctuance and unclear borders. It did not look like a hive and I put the patient on Keflex to cover for a cellulitis. 2 days later, 1/23/10 the erythema spread quickly per mom's report and in 4 hours extended down to the elbow. There were no further fevers. Mom called our service and was advised to go to the Emergency room. The child was admitted to hospital and placed on IV antibiotics overnight. She was discharged on Cleocin. And was seen on 1/25/10 in our office, fully improved with a pea-sized lymph node in the L axilla.
Her dad got the vaccine and now he is having heart trouble.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "Her dad got the vaccine and now he is having heart trouble.".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial reported received from a Health Care professional on 14 June 2012. A 59- years-old male patient with medical history of Knee Replacement and pulmonary emboli following Knee replacement, whose concomitant medications were not reported received a intramuscular dose of TYPHIM VI vaccine (Batch lot number: G0508-1, Route and site of administration: Not reported), Intramuscular 1st dose of ADACEL vaccine (Batch lot number: U4325AA, Route and site of administration: Not reported) and Hepatitis A vaccine (Batch lot number. Route and site of Administration not reported) on 08 June 2012. On 11 June 2012, the patient presented with complains of headache, feeling hot, having chills and labored breathing. The patient was treated with Forcing Fluids, TYLENOL or Ibuprofen and cool showers as corrective measures and the temperature was monitored. On 12 June 2012, the patient developed fever of 104 F, sore throat, red, raised, itchy rash. The outcome of headache, feeling hot, having chills, labored breathing, fever of 104 F, sore throat and red, raised, itchy rash was not reported. As of 14 June 2012, the patient had not recovered. Follow-up was received from a healthcare professional on 20 July 2012. Product screen two was amended from Td2cP to ADACEL, sanofi pasteur Ltd., (as reported and mentioned in narrative) sanofi pasteur Inc. lot number U4325AA, (corresponding sanofi pasteur Ltd. lot number C4105) dose one, intramuscular, (site not reported) on 08 June 2012. Based upon the new information provided, this case has been upgraded to serious. On 15 June 2012, the patient's symptoms were getting worse. The patient's wife contacted healthcare provider who encouraged patient to go to the emergency room (ER). The patient was evaluated in the emergency room and was admitted to an Intensive Care Unit (ICU) at another hospital with the diagnosis (Dx) of Borderline Steven Johnson Syndrome. According to the doctor (MD), Borderline Steven Johnson Syndrome was a result of the patient's treatment of SEPTRA DS, and not related to the vaccine. The patient was discharged from the hospital on 19 June 2012, with report that patient was much improved. The patient's outcome was reported as recovered on unspecified date. Documents held by sender: None.
pt stated the night after he got the vax he had flu like symptoms.  He was nauseas, dizzy, breathing heavy, fever.  pts left arm started hurting about 3 days later.  It was sore, red, and itchy.  Pt states he feels better today.
swelling in the respiratory system; Shortness of breath, feeling like she was breathing through a straw; Initial information received on 22-Feb-2022 regarding an unsolicited valid  serious case received from a consumer/non-healthcare professional.  This case involves an unknown age female patient who had swelling in the respiratory system and shortness of breath, feeling like she was breathing through a straw after receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DOXYCYCLINE (DOXYCYCLINE).  On an unknown date, the patient received a  dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE with unknown dosing lot number not reported via unknown route in unknown administration site.  On an unknown date the patient had swelling in the respiratory system (respiratory tract inflammation) and shortness of breath, feeling like she was breathing through a straw (dyspnoea) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The patient was hospitalized for this event.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events  Outcome: Recovered / Resolved on an unknown date for both the events; Sender's Comments: Sanofi company comment dated 24-Feb-2022: This case involves an unknown age female patient who had swelling in the respiratory system and shortness of breath, feeling like she was breathing through a straw after receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. Time to onset of the event is unknown. Information regarding condition at the time of vaccination, therapy details, latency, medical history, concomitant medications, autopsy findings would be needed to rule out any alternative etiologies. Based on the reported information, role of the individual vaccine cannot be assessed.
A report was received from a healthcare professional who is also the vaccinee's father on 11/22/2002 concerning a 10 year old male vaccinee who experienced an upper respiratory cough and fever 2 days after receiving Fluvirin on 11/19/2002.  On 11/21/2002 the vaccinee began to experience an upper respiratory cough and a mild fever.  The vaccinee had been exposed to other people with coughs and colds.  At the time of the report the vaccinee had not recovered. The reporter has assessed the relationship of the vaccine to the event as unrelated.  The reporter indicated that a possible reason was the vaccinee's exposure to other children experiencing similar symptoms and not due to Fluvirin.
Information was received on 19-APR-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. It is alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine on or about 10-JAN-2011 at a health clinic, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 06-JUL-2015, the patient was treated by her physician for a painful rash that was diagnosed as shingles that had spread into her eyes. While shingles is an incurable condition, the patient was prescribed acyclovir to manage her symptoms and outbreaks. As a direct and proximate result of these malfunctions, 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.
Wobbly legs; Fell once; Tenderness on left arm; Nausea; Little fever; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell once) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004MZ0A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced FALL (Fell once). At the time of the report, FALL (Fell once) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
HA, rash, red rash, swollen, hot to touch, sick to stomach, weak & tired
Patient was given pediatric Pfizer age 5-11 instead of Pfizer 12+. No adverse reactions or effects.
Vaccines given on 01/16/14 14 x 17 cm area warm erythema on left upper arm - Treatment BENADRYL and TYLENOL.
pt recv vax 13OCT98 & on 1DEC98 mom notified triage of T101, rash w/little bubbles over trunk, arms, legs;sx began yesterday;rx APAP, DPH;