chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Prominent chills; body aches; headache; arm soreness the day after; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 18 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10May2021 12:00 (Batch/Lot number: unknown) at the age of 18 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot unknown reason: Unable to locate or read the details, Administration date: 19Apr2021, Administration time: 14:15 , Dose number: 1, Vaccine location: Left leg), administration date: 19Apr2021, when the patient was 18 years old, for Covid-19 Immunization, reaction(s): "Dose Number=1,vaccine location=Left leg".  The following information was reported: CHILLS (non-serious) with onset 11May2021 02:00, outcome "not recovered", described as "Prominent chills"; PAIN (non-serious) with onset 11May2021 02:00, outcome "not recovered", described as "body aches"; HEADACHE (non-serious) with onset 11May2021 02:00, outcome "not recovered", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 11May2021 02:00, outcome "not recovered", described as "arm soreness the day after". Therapeutic measures were not taken as a result of chills, pain, headache, pain in extremity.  Additional information: The patient had no known allergies. Th patient had not received other vaccine in four weeks. Th patient had not received other medications in two weeks.  The patient had no COVID tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A non-serious spontaneous report of body aches has been received from a consumer, patient's wife, concerning a 38-year-old male subsequent to H1N1, Intranasal. The patient's medical history and concomitant medications were not reported. The patient received H1N1, Intranasal on 23-Oct-2009. On 22-Oct-2009, the night before receiving H1N1, Intranasal, the patient had body aches. After vaccine administration, on 24-Oct-2009, the patient "could barely move." The reporter was not sure if her husband experienced adverse reaction to the H1N1, Intranasal or if he was infected with the circulating novel H1N1 strain. The outcome of the event was unknown. On 09-Sep-2010 this is a corrected report to the previous report: MedDRA coding of the event was changed from myalgia to pain.
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 32-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 4 (booster)., single (Lot number: GJ5342) at the age of 32 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Lot number: EN6207), on 07Apr2021 as dose 2, single (Lot number: EW0151) and on 22Oct2021 as dose 3 (booster), single (Lot number: 301358) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15Dec2022) Positive; (21Dec2022) Negative; (22Dec2022) Negative; (24Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient took paxlovid for COVID 19 Treatment from 15Dec2022 to 20Dec2022. Rebound after completing Paxlovid prescription. Tested positive initially on 15Dec2022 and started prescription. Completed prescription 20Dec2022. Tested negative 21Dec2022-22Dec2022. Tested positive with sore throat 24Dec2022.  No follow-up attempts are possible. No further information is expected.
INJECTION SITE PAIN; This spontaneous report received from a patient 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: Unknown) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 29-APR-2021, the subject experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injection site pain was not reported. This report was non-serious.
bursitis; shoulder pain; This case was reported by a other health professional and described the occurrence of bursitis in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 5CB4K, expiry date 23rd August 2023) for prophylaxis.   On 19th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced bursitis and shoulder pain. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the bursitis and shoulder pain were not recovered/not resolved.   It was unknown if the reporter considered the bursitis and shoulder pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received dose in the left arm.  She reported that several unspecified days later, she experienced shoulder pain that was not resolved.  She followed up with her orthopedic specialist who took X-Rays and MRI and diagnosed Bursitis.  The patient alleviated the pain with Advil, but symptoms still present at time of report.  The reporter consented to follow up. For 2nd dose tolerance refer case US2020AMR249346. Note: She noted that she received correspondence from GSK from Consumer Health and had case number 01438803 but Hub could not find this physician or patient or reference number in any data base.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR249346:Same reporter
PATIENT CALLED AND SAID THAT LAST  EVENING SHE STARTED GETTING CHILLS, THINKS HAD FEVER BUT DIDI NOT TAKE TEMP, SLEEPING ALOT AND HURTS/ACHEY ALL OVER. ADVISED TO INCREASE FLUID TAKE OTC ANALGESIC AND CALL PCP
Pulmonary embolism; This is a spontaneous report from a contactable Physician via the company representative. This Physician reported two case for two male patients (one is 25 years old, another one is 27 year old), this report is for the patient who was hospitalized due to the event.   An adult male patient (unknown 25 year old or 27 year old) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation on unknown date. Relevant history and concomitant drugs were unknown. The patient experienced pulmonary embolism after the vaccination, and hospitalized due to the event. Outcome of the event was unknown.      Information about lot/batch number has been requested.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. Based on the information currently available, a causal association between the reported event pulmonary embolism and BNT162B2 cannot be fully excluded. Case will be reassessed when additional information is available.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate. ,Linked Report(s) : US-PFIZER INC-2021711416 Same reporter/ drug/ event for different patients
Arm pain since second injection in right arm, progressively gets worse, pain now in elbow and shoulder and back / shoulder blade area.
Side effects from second shingles shot / discomfort of the shot; This case was reported by a consumer and described the occurrence of injection site discomfort in a 91-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Voltaren with an associated reaction of arthritis (Voltaren Arthritis Pain 1% Gel used it on shoulder, About a year ago,(batch number:-LA9R,expiry date :- 31st January 2023 )).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site discomfort. On an unknown date, the outcome of the injection site discomfort was unknown.   It was unknown if the reporter considered the injection site discomfort to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. Patient received the Shingles vaccine and experienced injection site discomfort. Reporter wondered if putting some Voltaren on arm would be beneficial. Reporter also stated that she used it for bad shoulder and definitely helped her. Patient hoped to use it for the discomfort of the shot. The reporter consented to follow up
administered Infanrix by mistake instead of TDAP. They were supposed to receive Boostrix.; This case was reported by a nurse via sales rep and described the occurrence of adult use of a child product in a adult patient who received DTPa (Infanrix) for prophylaxis.   On an unknown date, the patient received Infanrix at an unknown dose. On an unknown date, unknown after receiving Infanrix, the patient experienced adult use of a child product. On an unknown date, the outcome of the adult use of a child product was unknown.  Additional case details were reported as follows: The age at vaccination was not reported. The patient was administered Infanrix by mistake instead of TDAP, which led to adult use of a child product. The patient was supposed to receive Boostrix. The patient identifiers were not available at the time of reporting. This is 1 of the 9 linked cases reported by the same reporter. The reporter consented to follow up.
12 year old patient was administered 1st dose of modern vaccine/12 year old received moderna vaccine/1st dose administered/Mistakenly administered moderna covid vaccine/error; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old patient was administered 1st dose of modern vaccine/12 year old received moderna vaccine/1st dose administered/Mistakenly administered moderna covid vaccine/error) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old patient was administered 1st dose of modern vaccine/12 year old received moderna vaccine/1st dose administered/Mistakenly administered moderna covid vaccine/error). On 29-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old patient was administered 1st dose of modern vaccine/12 year old received moderna vaccine/1st dose administered/Mistakenly administered moderna covid vaccine/error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow-up received contains additional Non-significant follow-up appended additional reporter details were added.
Arm throbbed badly for over an hour.  Felt "weird" like somewhat dizzy, somewhat nauseous, achy. Cancelled errands and went home and to bed. Drank fluids. Called advice nurse. Didn't drive rest of the day. At 5:00 PM (now) getting better.
Patient in clinic 05/24/2021 with father for immunizations. Approximately 3 minutes after MCV and MENB administered patient stated, "I don't feel good." Patient began to slump in the chair and close eyes but was still easily arousable. Patient was lowered to floor and placed on oxygen via nasal cannula. Cold towels and a fan was placed on patient. EMS was called. After EMS assessment it was determined that patient had a vagal response. Patient's father opted to take patient home and not have her transported to hospital. Patient left ambulatory with father at her side in personal vehicle.
No additional adverse effect reported; underwent a temperature excursion that took place on 8/13/2021 were administered; This spontaneous report has been received from a reporter specified as other, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided.  On 13-AUG-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, vaccine scheme, dose number, route of administration and anatomical site of vaccination were not reported; lot number T030746 has been verified to be valid, expiration date reported and established as 16-MAR-2023) as prophylaxis.   The vaccine was exposed to a temperature excursion of below 36 degrees Fahrenheit (32.9 F) during a time frame of 90 hours (product storage error). There was no previous temperature excursion. No additional adverse event (no adverse event) was reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2109USA003185:
Started to get cold sores on lip two and a half weeks later; Period was lighter; Yeast infection two weeks; This is a spontaneous report from a contactable consumer (patient).   A 41-year-old non pregnant female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, batch/ lot number: FA 6780), via an unspecified route of administration, administered in left arm on 10Sep2021 01:00 (at the age of 41 years) as dose 1, single for COVID-19 immunization. The patients medical history included seasonal allergies and doxycycline allergies. There were no concomitant medications. The patient did not take other vaccine in four weeks. The patient did not take other medications in two weeks. The patient did not have COVID prior vaccination. The patient did not get COVID tested post vaccination. Patient was not pregnant at the time of vaccination. On 24Sep2021 03:00 (two and a half weeks later) the patient started to get cold sores on lip. On an unspecified date in Sep2021 patient stated period was lighter. On an unspecified date in 2021 (two weeks) the patient experienced yeast infection. She was not prone to these and had not changed her diet. Acyclovir was taken as a therapeutic measure as a result of the events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 22-AUG-2017 the patient was vaccinated with PNEUMOVAX 23, intramuscular for prophylaxis, lot # N013521, expiration date 23-JAN-2019.  On 22-AUG-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to PNEUMOVAX 23.
I felt like it burned inside my arm, going up my neck and reaching my head, tired, headache and dizzy, but the most important thing is that the left side is asleep as if it had anesthesia. Today, the arm is still the same. with pain and goes down into the bottom of my armpit and continues towards my chest.
2 mo infant received HIBtiter/DTP/OPV on 3JAN91 on 6JAN91 had temp to 105; hospitalized - positive blood & spinal fluid cultures for H. Influenzae. Child doing well.
got shingles vaccine 5 yrs ago and never got a second shot; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 5 years ago from the date of reporting).   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. Till the time of reporting, the patient never get  2nd dose of Shingrix, which led to incomplete course of vaccination.
The patient states she has raised and "blood red" skin from right upper shoulder down to elbow area.  It is hot to the touch.  The left arm is sore but has no swelling or redness (Adacel only).  The patient states she got the same reaction last year, but included more swelling.  Last year she received the flu vaccine from the doctor's office.  She noted this prior to receiving the shot but thought perhaps it was the doctor's office that was the issue as she received it before, multiple times, from another pharmacy, with no issues.  The patient has been taking Benadryl for the swelling.   It has now been 5 days from the injections.
shipment was delayed, breaking cold chain regulations, No AE; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 44 years old female patient who received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and reported that shipment was delayed, breaking cold chain regulations (product storage error).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 23-Sep-2019, the patient received a dose of suspect 0.5 ml INFLUENZA QUADRIVAL A-B VACCINE lot UJ223AA and expiry date: 30-Jun-2020 via unknown route in the left deltoid.  It was a case of actual medication error due to incorrect product storage.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
15cm round raised warm area of induration without discharge at site of injection 1 week after administration.
Case number PHEH2013US026137 is an initial spontaneous report from a nurse received on 18 DEC 2013. This report refers to a 12-year-old female patient. She was an inpatient psychiatric ward resident. No concomitant medications was reported., She was erroneously vaccinated with FLURIVIN 2013/2014 (batch number: 1309101, expiry date: Apr 2014) at a dose of 0.1 ml intradermally instead of PPD for tuberculin skin test on 17 DEC 2013. On the same day immediately after vaccination, she experienced intense itching and stinging at the injection site. On 18 DEC 2013 the injection site was painful upon palpation, tender upon touch and slightly swollen and red. The outcome of the events was reported as condition unchanged. The seriousness and causality were not reported.
Per Client received COVID 19 Vaccine in left arm on 02/9/2021 at 4:00 PM and by 2/11/2021 at 2:00 PM started having symptoms: Right arm painful, sore and left sided trapezius musle sore, achy and tender to touch. Per Client taking over the counter Aleve by mouth, applying ice and heat to site. per Client symptoms are still present in areas listed above and Client has already placed a telephone call to PCP for further follow up.
frequent urination; diarrhea; chills; nausea; vomiting; loss of appetite; intermittent chest pain; This is a spontaneous report from a Pfizer sponsored Program. A contactable Consumer reported A 81-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included sarcoidosis from an unknown date and unknown if ongoing. Took their 1st Pfizer vaccine dose on 23Jan2021 for covid immunisation. The patient's concomitant medications were not reported. on 20Feb2021 Caller states, starting on the 20Feb2021, her husband started having frequent urination, chills, diarrhea, nausea, vomiting, loss of appetite and intermittent chest pain. Outcome of the events was unknown No follow up attempts are possible. No further information is expected.
About 5 minutes after being administered the flu shot, patient complained of dizziness. Patient was seated at the time and went unresponsive for a few moments. He did not seem to be breathing and a pulse could not be felt since he became so stiff. Before EMS arrived, the patient became responsive and complained of wanting something to drink. EMS arrived and patient claimed that he was okay. He denied any further treatment from EMS and ended up walking out of the pharmacy on his own with his mother and father. No EPIPEN was administered.
None at this time. The adverse event was gving her nasal instead of injectable. There have been no adverse reports from the doctor or client.
On Thurs, June 3, I developed a strong pain behind my left knee. It was intense and sharp, while also feeling like a deep bruise in my vein.  At first I thought it might be related to something I did in my workout at the gym the night before but when I thought about the workout I couldn't see anything that would cause this type of pain.  On Friday, July 4 the pain intensified even more, to the point that I could barely walk and I was in tears due to the pain.  When I got home after work,  I had dinner and then drove myself to the hospital ER.  By this time, I suspected a blood clot.  The ER doctor examined me, ordered X-rays of my knee, bloodwork and an ultrasound.  The ultrasound revealed a DVT blood clot in my left gastrocnemius.
Congestion, headache on one side, difficulty breathing through that side of nose, aches, cold symptoms.
This spontaneous report as received from a physician refers to a 5 month old patient. On 21-AUG-2017, the patient was vaccinated with PEDVAXHIB (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 21-AUG-2017, the patient experienced incorrect product storage. Sender's Comments: US-009507513-1708USA013219.
After the shot, that night it hurt to lay down. The next couple of days, I couldn't extend my arm 90 degrees moving out away from my body. This lasted for the two days. Also had a headache and lymph nodes swelling.