chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 11-Feb-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (office staff). This case involves a patient of unknown demographics who was accidentally administered with product which expired on 12-Jan-2019, while he/she received vaccine TENIVAC. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 11-Feb-2019, the patient received a once dose of 0.5 ml suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot number: U5541AA and expiry date: 12-Jan-2019) (dose in series, route and site of administration was not reported). It was a case of actual medication error due to expired vaccine used. No adverse event was reported. 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.
Elevated heart rate between 43-144 for intermittent times of day after exercise. This is accompanied by heart palpitations and chest pains. Noticeable discomfort in chest. No shortness of breath. Elevated heart rates may last for 1 min to up to 20min off and on for the afternoon/evening and following days. At first they would subside after a 1-2 days after exercise, now they are more frequent and only with very minor exercise or none at all. I am used to exercising a lot - doing martial arts, but now I cannot go outside and walk my dog without elevated heart rate in the 100's and drops down to 40's.
Patient's words: "Fever for 60 hrs beginning 9 hrs after vaccination. Fever ranging from 101.6-102.4.  After 60 hours a series of spikes and breaks in rapid succession causing complete soaking in sweat then freezing cold sensation, shaking and chills.  Horrible head and neck pain beginning about 3 hrs after onset of fever.  Inability to put thoughts together, swelling/numbness in face, nausea, inability to walk and speak due to pain.   Intense back and head pain that felt like I had been beaten with a hammer.   Pressure in front and back of chest."
ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE HYPOXEMIA
HIGH BLOOD PRESSURE; CHILLS; FEVER; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 18-MAR-2021, the patient experienced high blood pressure. On 18-MAR-2021, the patient experienced chills. On 18-MAR-2021, the patient experienced fever. Laboratory data included: Blood pressure (NR: not provided) 189/101, and Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high blood pressure, fever and chills was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210358958-COVID-19 VACCINE AD26.COV2.S-High blood pressure. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient had simple febrile seizure 8 days after receiving vaccines. Patient also had likely viral upper respiratory infection that started 3-4 days prior to febrile seizure.
Patient had a metallic taste in her mouth.  Her entire left arm felt itchy.  She was also dizzy.  Gave patient one Cetirizine 10mg tablet. Patient refused benadryl and said that she was allergic.
red; hurts; very sick; terrible diarrhea; feeling nauseous; arm still hurts; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of erythema in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced erythema (Verbatim: red), pain (Verbatim: hurts), sickness (Verbatim: very sick), diarrhea (Verbatim: terrible diarrhea), nausea (Verbatim: feeling nauseous) and pain in arm (Verbatim: arm still hurts).  The outcome of the erythema, pain, sickness, diarrhea and nausea were resolving and the outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the erythema, pain, sickness, diarrhea, nausea and pain in arm to be related to RSV vaccine.     It was unknown if the company considered the erythema, pain, sickness, diarrhea, nausea and pain in arm to be related to RSV vaccine.   Additional Information: GSK receipt date: 13-Sept-2023 The case was received from the patient via interactive digital media. The patient got RSV shot Wednesday and had red and hurts. The patient was very sick on Thursday with terrible diarrhea and feeling nauseous. On Friday the patient felt better but arm still hurts.
A non-serious spontaneous report of inadvertent administration of expired H1N1 was received from a registered nurse/health professional concerning a 34-month-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Patient fainted. She did not hit her head and recovered quickly. We offered to call 911 but Dad said daughter was fine.  Patient received water and a lollipop. Dad and daughter waited for about 15 to 20 minutes, and Dad said she was doing well before they left.
PT VACCINATED USING PFIZER ON 3/1/21 (LOT EL3248) + 3/30/21 (LOT EN6204). S/O 8/29/21, TESTED + 8/31/21
This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (He get sick every 2 months from the vaccine.) in an adult male patient who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.    Co-suspect product included non-company product DIAMORPHINE (HEROIN) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and DIAMORPHINE (HEROIN) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ILLNESS (He get sick every 2 months from the vaccine.). At the time of the report, ILLNESS (He get sick every 2 months from the vaccine.) had not resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered ILLNESS (He get sick every 2 months from the vaccine.) to be related.    Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
So far there have only been two short times associated with pain.  In the day time of December 9th and the evening of December 12th. Both instances were brought on by activity. December 9th included sudden onset severe chest pain that caused him to grab his chest and immediately stop dancing and was crying out Ow!. The severe pain took several minutes to go away.  It continued to get better but 30 mins later he still had some discomfort. On the evening of December 12 he complained of chest and back pain during an activity.  The chest pain went away when the activity stopped however the back pain stayed.  The chest pain immediately returned when the activity resumed even though it was greatly subdued. The severity was clearly less on the 12th as it did not stop his activity, but he was less energetic while playing after the pain started.
I need to get all my immunizations again since having that transplant; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported that a patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization.  Medical history included stem cell transplant. The patient's concomitant medications were not reported.  The patient needed to get her/his all immunizations again since having that transplant on an unspecified date.  Outcome of event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Swelling 4" diameter around injection site, painful, indurated, erythematous.
Patient started having abdominal pain sudden 30lb weight loss.  Dx with metastatic ovarian cancer.  Sudden Onset of cancer!
Apparent allergic reaction with face swelling.  No recent changes to diet, exposure, or medicines.   I plan to see a doctor prior to getting second shot on 4/12.
10 minutes after vaccination, patient stated "I feel my body is rejecting the vaccine." Symptoms included watering of eyes, paresthesia of fingers, mild angioedema involving tongue. Denied symptoms of shortness of breath, swelling of throat, or chest pain. VSS. Patient was observed for an hour. Symptoms resolved. Called the evening of event. No new symptoms.
The shot was given at 11 am, at 12:45, the employee started feeling warm (hot flushes), sick to stomach,and lightheaded. No shortness of breath, no rashes and vital signs stable. Patient sent home to rest.
Information has been received from a female consumer who on an unspecified date was vaccinated with a dose of ZOSTAVAX. Subsequently the patient "got all kinds of side effects." No further information was provided. No further information is available.
After receiving the flu shot required by my employer, administered at an employee clinic site, I began experiencing pain in my left shoulder and arm, with radiating pain to my hand and fingers. There has been a constant ache located in my left deltoid and mid arm. I experience shooting pain down my arm, aching pain under my arm, and sometimes numbness and tingling throughout my arm and fingers. There is pain behind my shoulder. It hurts to use my left arm and when I do, it increases the pain.
One day post vax, pt experienced mild swelling and tenderness in his testicles. There were no other symptoms. He sought unspecified medical attention. Pt was treated with ibuprofen and symptoms resolved. No further information is available.
mom reports vomiting 2 hrs eve of vax; vomited next day t99, screaming 2nd noc, calmed by car ride; c/o lethargic 9MAR94;
lymph node inflammation; swollen lymph nodes on injection side; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 09Feb2021 10:00 (Lot number: EC3246) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "overweight" (ongoing), notes: a little overweight. There were no concomitant medications. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 16Feb2021, outcome "recovering", described as "swollen lymph nodes on injection side"; LYMPHADENITIS (non-serious) with onset 16Feb2021 12:00, outcome "recovering", described as "lymph node inflammation".  Additional information: The patient received vaccine at Hospital. The patient did not have any other vaccinations within four weeks prior to the first administration date of the suspect vaccine or on administration date of the suspect vaccine. states on 09Feb2021, he received his first dose of pfizer covid vaccine and developed swollen lymph nodes on injection side  one week after vaccine and is still ongoing. He is supposed to have his 2nd dose on 02Mar2021 however it was rescheduled to 07Mar2021. The event lymph nodes inflamed started at Around 12:00. It was mentioned that the patient is a radiology technician who was administered his first dose of Pfizer-BioNTech COVID-19 Vaccine 09Feb2021. He was then scheduled for second dose on 02Mar2021, but second dose was temporarily discontinued due to his wife having been diagnosed with COVID and he himself being quarantined while taking care of her. He was then advised to get the second dose of the vaccine on 07Mar2021 after his quarantine period was complete; but due to his lymph nodes inflamed onset on 16Feb2021. He called to ask for dosing recommendations relative to these events. The lymph node inflammation was slightly decreased, improved. He assumed the Lot is EC3246, but the handwriting was not very clear, but believed it to be EC3246.  No follow-up attempts are possible. No further information is expected.
injection site reactions; Hands will turn bright red/Ankles and calves get red marks; It feels like they (hands) are on fire/symptoms seems to be getting worse; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (injection site reactions), ERYTHEMA (Hands will turn bright red/Ankles and calves get red marks) and BURNING SENSATION (It feels like they (hands) are on fire/symptoms seems to be getting worse) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced ERYTHEMA (Hands will turn bright red/Ankles and calves get red marks) and BURNING SENSATION (It feels like they (hands) are on fire/symptoms seems to be getting worse). On an unknown date, the patient experienced VACCINATION SITE REACTION (injection site reactions). At the time of the report, VACCINATION SITE REACTION (injection site reactions), ERYTHEMA (Hands will turn bright red/Ankles and calves get red marks) and BURNING SENSATION (It feels like they (hands) are on fire/symptoms seems to be getting worse) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE REACTION (injection site reactions), ERYTHEMA (Hands will turn bright red/Ankles and calves get red marks) and BURNING SENSATION (It feels like they (hands) are on fire/symptoms seems to be getting worse) to be related.    No concomitant medications were reported.  Treatment information was not provided. Patient was healthy except for the COVID time and did not take any medications and believes the reactions were related to the vaccine. The symptoms lasted for 3 to 4 days.   This case was linked to MOD-2021-404647 (Patient Link).
Covid arm; This spontaneous case was reported by an other caregiver and describes the occurrence of PAIN IN EXTREMITY (Covid arm) in a 66-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Covid arm). At the time of the report, PAIN IN EXTREMITY (Covid arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported. No treatment medications were reported.    This case was linked to MOD-2021-066393 (Patient Link).
redness at the injection site that is in line with "COVID arm". In the injection arm, swelling of the lymph nodes and the direct injection site with persistant pain. Slight swelling and tenderness started day of injection and continued to progress.
I got both doses went ahead and gave the second; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.     Additional Information: GSK Receipt Date: 28-SEP-2022 Reporter's Comments: The patient got a Shingrix shot and then thought he/she should get the second dose in two weeks.  The patient made an appointment at the same for the second dose and got it. The patient told I should had waited at least a month. The reporter understand that patient got second dose within 2 weeks of first dose. In the clinical trials, the 2nd dose was spaced out from the first by either 2 or 6 months. The reporter recommends that to speak with his/her healthcare provider to see how to proceed since second dose was early. The patient was kind of upset because the he/she got both doses went ahead and gave the second dose too early.  The patient had to pay per dose. Additional supportive information: The patient received the Shingrix dose earlier than the recommended interval, which led to shortening of vaccination schedule.
developed a large blister at the vaccine site day 2 it appears to be forming a keloid some itchiness
TINGLING IN LEFT ARM AND FINGERS TINGLE; HAD ME IN BED WITH FLU LIKE SYMPTOMS FOR ABOUT 36 HOURS; VACCINE DID KICK MY BUTT; SHARP PAIN RADIATES DOWN ARM; PAIN IN THE MUSCLE LEADING FROM MY ELBOW TO MY FINGERS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 06-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced tingling in left arm and fingers tingle. On MAY-2021, the subject experienced had me in bed with flu like symptoms for about 36 hours. On MAY-2021, the subject experienced vaccine did kick my backside. On MAY-2021, the subject experienced sharp pain radiates down arm. On MAY-2021, the subject experienced pain in the muscle leading from my elbow to my fingers. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tingling in left arm and fingers tingle, pain in the muscle leading from my elbow to my fingers, sharp pain radiates down arm, vaccine did kick my backside, and had me in bed with flu like symptoms for about 36 hours. This report was non-serious.
Felt "not right", minor 'thickness of my tongue', tightness of airway   (all minor in severity)
patient started to decline 1/10/2021, patient seen at facility by medical professional - patient deceased 1/13/2021
Jabbing pain around the Appendix area and the lower back on the  right hand side.  Lasted about 4 hours. Could not could not sleep on right side of Body as pain got Worse. Did have nausea all day ,vomited once and had low grade fever. Horrible Muscle Ache and felt like every bone in my body ache.  I new about other symptoms but the jabbing pain was not expected.
Initial report was received on 13 November 2012 from a healthcare professional. This case was originally part of a cluster of approximately 17 patients (six elderly patients, two adolescent patients and approximately nine unidentified patients) who test PCR positive for influenza A/H3N2. The two adolescent patients were captured in case number 2012-05659 and the ten unidentified patients (previously reported as nine patients) were captured in case numbers 2012-05660, 2012-06067, 2012-06068, 2012-06069, 2012-06070, 2012-06071, 2012-06072, 2012-06073. In addition this case was previously part of the six elderly patient's case 2012-05658. The other elderly patient cases have been captured in case number 2012-10692, 2012-10693, 2012-10694 and 2012-10695. An 89 year-old female patient had received on 11 October 2011 a dose of FLUZONE, lot number UH454AC (route and site of administration not reported). The patient participated in an influenza surveillance program. The patient's approximate treatment date and "collection date" was 24 January 2012. According to the reporter, the type of influenza was flu A and the subtype of influenza was H3N2. Treatments were not reported. No further information was available at the time of the report. The patient's outcome was recovered (date not reported). Documents held by sender: None.
sore arm for a day; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm for a day) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (sore arm for a day). At the time of the report, MYALGIA (sore arm for a day) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication included.  No treatment was provided by the reporter.       Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Non significant follow up appended-NNI
shingles and other zoster-related conditions.; shingles and other zoster-related conditions.; Information has been received from a lawyer regarding a case in litigation, concerning a patient (pt) of unknown age and gender. Information regarding the pt's concurrent conditions, medical history and concomitant medications was not provided.     On or about 12-AUG-2012, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions.         On an unknown date, subsequently to  zoster vaccine live(ZOSTAVAX) administration, the pt experienced shingles and other zoster-related conditions treated by the family doctor. As a direct and proximate result of pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continued suffering  ongoing injuries, including but not limited to: mental, physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continued to suffer such losses, and damages in the future.  By the time of this report, the pt had not recovered from shingles. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).