chrisvoncsefalvay/vaers-outcomes huggingface dataset:
INJECTION SITE PAIN; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a 77 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: upadacitinib (oral, batch number: 1138391 expiry: UNKNOWN, form of admin was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On 11-MAR-2021, the subject experienced injection site pain. On 11-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain, headache, and tiredness on 11-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210425531.
no adverse reaction, vaccine ordered, and vaccine given have same generic name Bexsero, education given to employee and immunization schedule reviewed.
Fever, chills, headache, bodyaches, periodic zingers of pain in my knees, exhaustion. Basically resolved after 19 hours. Ongoing fatigue for another 10-12 days.
Area surrounding injection site became larger, redder, and more swollen from day 1 to day 3 following DT shot. (5 X 6 inch area)
About 10 hours after getting the shot, I had a 100.2 deg temp, the chills, and violent vomiting. About 3 hours later, another bout of violent vomiting. The next morning, vomiting returned about 8am after drinking some juice. My wife had the same shot at the same time, our diet was the same, and she had no adverse effects.
Bursitis; Couldn't lift her arm to comb; Arm is still sore but can lift it.; Achiness in the body like flu; This spontaneous case was reported by a consumer and describes the occurrence of BURSITIS (Bursitis), DYSKINESIA (Couldn't lift her arm to comb), PAIN IN EXTREMITY (Arm is still sore but can lift it.) and MYALGIA (Achiness in the body like flu) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced BURSITIS (Bursitis), DYSKINESIA (Couldn't lift her arm to comb), PAIN IN EXTREMITY (Arm is still sore but can lift it.) and MYALGIA (Achiness in the body like flu). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 01-Apr-2021, MYALGIA (Achiness in the body like flu) had resolved. On 03-Apr-2021, DYSKINESIA (Couldn't lift her arm to comb) had resolved. On 04-Apr-2021, BURSITIS (Bursitis) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm is still sore but can lift it.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-116697.
Physician states that a 25 year old patient was given Vaxelis by accident; This non-serious spontaneous safety report, with Case Number: 2023SA184651 (Inquiry Number: 01655266), was received by partner, on 15Jun2023 and forwarded to agency on 16Jun2023 from a physician.  Due to the nature of the event, the causal relationship between Vaxelis and the reported event "Physician states that a 25 year old patient was given Vaxelis by accident" was assessed as not applicable.  Further information is expected.
Local rxn approx 72 hrs p/immun; c/o swelling, pain & hot to the touch;
Fever 104 degrees, chills, rigors left arm pit went to ER on 11/24/05 treated with antibiotics discharged on septra, ibupofen, zyrtec fot itching
Confusion; problem with memory; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusion) and MEMORY IMPAIRMENT (problem with memory) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (Confusion) and MEMORY IMPAIRMENT (problem with memory). At the time of the report, CONFUSIONAL STATE (Confusion) and MEMORY IMPAIRMENT (problem with memory) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication information was reported. No treatment medication information was reported.
Discomfort; couldn't walk; Plantar fasciitis; sore arm / foot pain; This case was reported by a consumer via call center representative and described the occurrence of pain in extremity in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 13th September 2019, immediately after receiving Shingrix, the patient experienced pain in extremity. On 15th September 2019, the patient experienced discomfort, unable to walk and plantar fasciitis. On an unknown date, the outcome of the pain in extremity, discomfort and unable to walk were recovered/resolved and the outcome of the plantar fasciitis was unknown.   It was unknown if the reporter considered the pain in extremity, discomfort, unable to walk and plantar fasciitis to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. The patient's arm was sore right after the injection.  Two days later, on 15th September 2019, the patient woke up with discomfort in the instep of his right foot. By the end of the day his foot was so painful that he couldn't walk on it.  The patient started off it for a couple days and the pain resolved.  The patient stated it felt like plantar fasciitis, which he has never had before. The reporter did not consent to follow up.
This spontaneous report was received from a 65 year old female patient via physician refers to herself. Patient's medical history included reactions to past unspecified flu vaccines, including getting the flu after vaccination. Patient's drug reaction or allergies included Swelling and weight gain from LYRICA. On 20-FEB-2014 the patient was vaccinated with ZOSTAVAX. Concomitant therapies included hydrochlorothiazide (manufacturer unknown) and pantoprazole sodium. On 21-FEB-2014, the patient developed swelling, redness, and tenderness around the injection site in an approximately 3 inch x 2 inch area. The patient also stated that the area was uncomfortable, however due to her level of tolerance she had not felt a need to seek out medical attention or treatment. The outcome of events was reported as not recovered/not resolved. Causality of the events was not provided. Additional information has been requested.
L arm red, swollen and hot from left shoulder to left elbow the entire circumference and back to left scapular.  Temp 98.2 sent to PCP.
cardiac arrest; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 12Feb2021 (Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient scheduled for the second dose 05Mar2021, however missed her second dose since she had a cardiac arrest on 04Mar2021. The outcome was unknown.  Information on Lot/batch number has been requested.
Temperature of 103.3, hypotensive requiring vasopressors. Family did not want to continue, patient was switched to comfort care and admitted to hospital. Patient rapidly improved after 24 hours and continued to improve. Hypotension resolved. Patient was discharged to home.
Patient fainted about 5-10 minutes post vaccination. EMT was summoned and patient was taken to near by hospital.
fever; joint pain; cold like symptoms; she had some pain her in arm; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 09Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her 1st dose on 09Feb2021 and after she had some pain her in arm, but then it went away. The following night on 10Feb2021 however, she developed a fever, joint pain around the area where the shot was given and cold like symptoms. She wants to know if the 2nd dose will be like this too, or is she allergic to it. Outcome of the event pain her in arm was recovered in Feb2021, while unknown for the other events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
At time of administration 4 vaccines given in left arm first, after administration of PCv15 in right arm client said, "oww" This nurse continued with administration and finished 3 IM shots. At this time the clients head drooped. This nurse reached out and supported the client and he lost consciousness, first his head fell forward and then he went rigid and jerked backed. His eyes rolled back. Within 5-10 seconds the client regained consciousness and responded to questions. He was diaphoretic and pale. He laid down on a mat and took the final SQ shot. A cool washcloth, juice and crackers were given. After a period of observation the client left with his friend who had provided transportation.
Starting the following day I felt ill. I got chills about 30 hours after the shot. I felt very tired and sick for the next three day. After that things got a little better but I still felt very run down and tired. I went to my doctor and he ran some blood work. I saw the doctor in June of 2021 but couldn't get the blood work done till July of 2021. The blood work came back with a platelet level fo 126. I have never tested low before. My prior count on a blood plannel 9 month prior to this test was at 170, with in the normal range. I am feeling much better now. I have been focusing on good food and walking and my platelet level came back at 146 in Sept 2021. I am not feeling as tired all the time, like I did.
This spontaneous report was received from a pharmacist refers to a 77-year-old male patient. The patient did not have any pertinent medical history, drug reactions or allergies. There were no concomitant medications. On 06-SEP-2017, the patient was vaccinated with PNEUMOVAX 23 injection, (lot # M041394 with expiration date on 23-MAY-2018; dose and route of administration were not provided) for prophylaxis (indication was reported as "vaccination"). On an unknown date in September 2017 (reported as "a couple days later"), the patient experienced swelling from his shoulder to elbow. No treatment was given for the event and no laboratory diagnostic studies were performed. Product quality complaint was not involved in this case. The outcome of the event was reported as recovered on an unknown date in September 2017 (reported as "a few days ago"). The reporter did not assess the relatedness between the event and PNEUMOVAX 23.
fever 103; chills; muscle soreness; Joint pain; This is a spontaneous report from a contactable other health care professional (patient). A 42-year-old male patient received second dose BNT162B2 (Solution for injection) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. Historical vaccine included first dose BNT162B2 (Covid 19; Batch/Lot number: EJ1685 on Interdermal Rightt deltoid, Expiry date: 28Jun2021) on 19Dec2020 at 14:30 for Covid-19 immunization and had Fever 100.2, Chills, Headache, Swollen lymph neck, Muscle and joint ache, Tiredness, Injection site pain. Family history included ongoing High Blood pressure, History of antibodies without confirmed covid 19 +(positive) on Mar2020. Patient previously took Erythromycin and had allergy. On an unspecified date, 6-12 hours post 2nd injection, patient had Fever 103, Chills, muscle soreness/Joint pain. Outcome of events Fever and Chills were recovered on an unspecified date, while with other events was unknown.  Information on the lot/batch number has been requested.
Patient received the vaccine, the next morning when he woke up he felt very dizzy and disoriented. He experienced extreme muscle weakness which caused him to fall to the floor. Due to his muscle weakness he was unable to pull himself up and was helpless until his handyman arrived 4 hours later.
Incision site cellulitis; pain; vomiting Information has been received from a registered nurse concerning a patient in their 60's who in approximately October 2005 was vaccinated intramuscularly with a 0.5ml of pneumococcal 23v polysaccharide vaccine. Concomitant vaccination at the same time included influenza virus vaccine (unspecified) (both vaccines were administered at separate sites and via separate syringes). Subsequently the patient developed a site reaction of cellulitis, vomiting and described their body as "hurting". Unspecified medical attention was sought. The patient was treated and subsequently recovered. Additional information has been requested.
Swollen,hard red hot area below injection site. Headache, nausea, fever, fatigue
pt recv vax 25OCT95 & that evening pt exp soreness @ the pneumococcal vax inj site & a swollen arm;tx w/warm compresses & recovered w/in 24 to 36hr;
This is a former 26 weeks by dates infant currently in RA and on Theophylline with a level of (11.3).  He had no apnea/bradycardia for 48 hours.  On 6-14-03 at 1545 he received his 2 month immunizations.  On 6-15-03 at 0550 he began to have bradycardia and desaturations.  A NC was restarted at 1 liter/minute at 21%.  His apnea/bradycardia improved throughout the day.  A theopylline level was obtained and found to be 6.4.  The theophylline was discontinued.  On 6-16-03 the NC flow was decreased to 1/2 lpm 21-25%.  The infant continued to have occassional desaturations, but no apnea/bradycardia.  On 6-18-03 he failed a trial on RA and three apnea/bradycardic episodes.  On 6-20-03 the NC was increased to 1 lpm and the infant continued to have desaturations X 12 which were thought to be feeding related.  The the infant was later discharged home on a NC and monitor. 60-day follow up on 01/22/04: "It is unknown if the pt recovered from the adverse events."
Narrative:  Patient received first dose of Pfizer COVID19 vaccine 5/3/21 and presented to ED 5/9/21 with rash. Reported itching and painful rash starting ~24 hours after receiving vaccine. Per nursing notes, red and swollen bumps observed on patient's bilateral legs, face, and right arm. Given prednisone, famotidine and diphenhydramine in ED. Diagnosed with allergic reaction and cellulitis by ED MD. Discharged from ED with doxycycline and prednisone outpatient prescriptions.
7 days after receiving PREVNAR; Patient had red rash on arm; no streaks. Asked if fever - pt stated not known. Advised pt to take TYLENOL; use ice pack. Consult physician if worse.
Since April 8 - he has had severe headache.  Was taking Tylenol for this, but did not work.  Then started taking Advil and that helped.  As time went on he did get off Advil but still had headache.  States as he talks to me today he has headache.  Really bad when he bends over or coughs.  Goes all the way to the back of his head.  Now, when he coughs he has severe pain in forehead and it goes back to above the ears and if he coughs hard it goes "All the way back."  Sometimes, all he has to do is bend over to get up from a chair and has pain. It is more of a pain then a headache.  He never had any headaches before this.  Now he gets them every day since the second shot.
Patient mother reports patient right thigh was very swollen, red and tender to touch. No fever. Seen in office next day after given Tylenol and ice. No signs of infection. Spoke with mom day after and significant improvement.
My daughter got her second HPV shot on February 18, 2019. Since then my daughter has been suffering from constant stomach pain. This stomach pain has caused her to have many panic attacks. We have been in and out of the emergency room five times, pediatrician twice, gastrointestinal doctor, therapist, psychiatrist, and just had a week stay in the hospital. Every test possible has been completed and nothing has been found to be the cause. She has been put on many prescriptions during this time. She is now on five prescriptions. She has been unable to participate in her normal activities. She's missed swimming championships, band concert, and even her own birthday party. Before this she was a perfectly normal very active girl. I've mentioned this to every doctor and they see it as coincidence. She was hospitalized for a week with many tests done. I truly believe this shot is the cause.
Initial report received from a healthcare professional on 17 October 2008.  A 39-year-old female patient had received a left deltoid intramuscular injection of FLUZONE SV 2008-2009 (lot number U2745AA) on 15 October 2008 at 11:30 AM and that evening, she experienced fever (temperature unknown), chills, aches and vomiting.  The patient had a history of cough for one week prior to the vaccination.  She was hospitalized on 16 October 2008.  At the time of the report, outcome was 'not recovered' and the patient remained hospitalized.  No additional details were provided.  Documents held by sender: None.
This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 67-year-old female patient who received SHINGRIX (batch number 539A2, expiry date 20th March 2019) for prophylaxis. Co-suspect products included SHINGRIX (batch number ZY3X4, expiry date 20th April 2019) for prophylaxis. On 8th March 2018, the patient received the 1st dose of SHINGRIX. On 15th May 2018, the patient received the 2nd dose of SHINGRIX. On 8th March 2018, less than a month after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced convulsion (serious criteria GSK medically significant). On 14th April 2019, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles (serious criteria other: ER visit). The patient was treated with Valacyclovir. On 8th March 2018, the outcome of the convulsion was recovered/resolved. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the vaccination failure, shingles and convulsion to be related to SHINGRIX. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX. Additional details were provided as follows: The patient experienced convulsions after receivng 1st dose of SHINGRIX vaccine. The patient experienced shingles after 2nd dose of SHINGRIX. The patient received valacyclovir and shingles resolved. The shingles also reappeared again. The patient went to hospital and was put on valacyclovir again.
Lack of drug effect; Lack of drug effect; This is a solicited report based on the information received by Pfizer  (MFR Control No. # 21K-163-4050966-00). A non-contactable female consumer (patient) reported a 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular on 01Jun2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 intramuscular on 07Jul2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) at CITRATE FREE for Moderate to severe chronic plaque psoriasis.  The patient's medical history and concomitant medications was not reported.The patient experienced lack of drug effect on an unspecified date with outcome of unknown.  The action taken in response to the event(s) for adalimumab was unknown.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the temporal relation the events of drug ineffective and COVID-19 are related to the suspect product of BNT162B2
Name:  Date of Birth: MRN:    Primary Care Physician at Discharge: MD Hematologist/Oncologist:  MD Admission Date: 1/27/2023 Discharge Date: 01/30/2023   PRESENTING PROBLEM: Febrile neutropenia (HCC)  COVID   HOSPITAL COURSE: Patient is a 9 y.o. female with B-cell ALL in remission on maintenance therapy and history of PRES with seizures who was admitted on 1/27/2023 for febrile neutropenia.   She was febrile to 99F at home with cough and congestion. She presented to the ED where she was found to have a Tmax of 39.2. Fastbreak protocol was initiated. She was started on Cefepime q8h and both peripheral and central cultures were drawn. Cultures remained no growth during admission. Respiratory film array was positive for COVID-19 infection. Labs were significant for WBC of 650 and ANC of 140. She was admitted to the pediatric hematology/oncology service for further management. She was continued on cefepime and her home epilepsy medications.  Patient remained afebrile without the use of antipyretics while admitted. Per discussions with ID without a formal consult, a three day course of Remdesivir was started. A full five day course was unnecessary as she was not hypoxic throughout admission.   While inpatient, her home chemo regimen of 6-mercaptopurine and methotrexate was held due to low ANC levels. She was given GCSF x3. ANC on 1/30 was 200, and she was given her last dose of GCSF before discharge with plans to repeat CBC on 2/2.    Patient was discharged home on 1/30 with plans to follow-up in the outpatient clinic on 2/17 or sooner if needed. She was instructed to call with any new fever.   NUDT15 enzyme test was sent out to clinic Lab while patient was admitted. This will require follow-up as an outpatient.
Patient admitted for scheduled admission for Tikosyn initiation for persistent A fib rvr. Hospital admission within 6 weeks of receiving the COVID vaccine.
Injection site became red, hot, swollen and tender to touch, 24-48 hours, post vax. To PMD on 10/27/00 with temperature of 99.2F-100F and placed on antibiotics for 10 days and use hot and moist packs alternating with ice packs. Returned to MD on 10/30/00 with marble-sized knot below injection site and complaint of "shingle-like nerve" pain.
Got vaccine on 9/29/10 on right arm deltoid. and on 9/30/10 got red mark, swollen and painful then 10/1/10 got 2 more red swollen marks on right arm. Was told to do warm compresses and ibuprofen.
Ulnar Nerve pain going down left arm to fingers aggravated with dorsiflexion of left wrist. Two erythematous  circles one inch diameter four inches away from injection site.
Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tinnitus-Medium, Additional Details: Aches along the edge of his ulna bone on his left arm. Patient also describes tingling in the heel of his left had. Tinnitus worse in left ear than right.
Pt given Tdap 6-4-12 & mom called 6-7-12 with c/o upper (L) arm very red & swelling & now redness spreading downward. Pt came in to have arm looked at by Dr..