chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was given an expired pentacel with no reported adverse event; 101 year patient received vaccine with no reported adverse event; Initial information received on 20-Oct-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 101-year-old female patient received vaccine with no reported adverse event and patient was given an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (VERO)] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal conjugate vaccine for Prophylactic vaccination; measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination; hepatitis A vaccine for prophylactic vaccination; and varicella zoster vaccine (Varicella Vaccine) for Prophylactic vaccination.  On 25-Sep-2023, the patient received a dose 1 of 0.5 ml dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (strength: unknown) (lot: UJ737AAA, expiry date: 18-Sep-2023) via intramuscular route in the right thigh for Immunization and patient was given an expired pentacel with no reported adverse event (expired product administered) and 101 year patient received vaccine with no reported adverse event (product administered to patient of inappropriate age) (latency: same day)  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 the 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.
Narrative:  79yo male patient with a h/o melanoma on keytruda, s/p 4x stroke (last 2020) with expressive aphasia, colon cancer s/p partial colectomy, DMII, HTN, HLD, carotid artery stenosis, GERD, and OSA who presented to ER on 11/20/21 with 6 weeks of weakness since starting keytruda. Pt has been having progrssive side effects, including generalized itching, nausea vomiting, aches, and finally generalized weakness. Pt presented to ER on 11/20/2021 after a fall at home. Pt was admitted. Pt received his first covid while inpatient on 11/23/2021. On 11/22/21 chest xray suspicious for pneumonia. Of note covid test negative on admission (11/20/21). Pt was given and completed abx course for aspiration pna. On 12/1/21 pt was discharged to short term rehab. On 12/21/21 pt sent from rehab to ER for evaluation. Pt tested positive for covid infection. Pt had planned to discharge home from rehab to home hospice given cancer diagnosis on 12/22/21. Pt transferred to inpatient hospice. Pt died on 12/23/2021 during inpatient hospice admission. Pt did receive a covid vaccine on 11/23/2021 & tested positive for covid on 12/21/21. Pt also had terminal cancer diagnosis with plans for hospice care. Difficult to determine actual cause of patient's death. Possibly covid vaccine contributed to this patient's death.
So, Wednesday I felt a little tired and then the next day on Thursday I had a little headache and I had cramps in my stomach. Then on Saturday it hurt even worse and felt like my stomach was being knotted up. Then Sunday the pain was even worse still and I got a headache. I had to constantly go to the bathroom, and I started officially having diarrhea on Saturday. On Sunday I went to the hospital at 5:30PM when my temperature was 103. I was at the hospital for about four hours, and they gave me Tylenol, Motrin, Sodium Chloride, Diacylamine and Zithromax. Then yesterday, Monday 7/26/2021, I was feeling a little better. I was still weak yesterday and in pain, but the pain died down a little bit. I was also able to eat a couple of things. Today, 7/27/2021, the pain is bearable but still there.
Ventricular tachycardia; This is a spontaneous report from a contactable physician and consumer. A 73-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Lot Number: UNKNOWN) via intramuscular in left arm on 10Mar2021 (at the age of 73-years-old) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient did not receive other vaccine in four weeks prior to vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included carvedilol (COREG), apixaban (ELIQUIS), enalapril(MANUFACTURER UNKNOWN), furosemide (LASIX), dofetilide (TIKOSYN), allopurinol (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unspecified date for Covid-19 immunization. On 13Mar2021, the patient experienced ventricular tachycardia. Seriousness criteria was considered as emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for 1 day and died on same day (13Mar2021). The patient was not tested for covid post vaccination. The patient received treatment for the event. An autopsy was not performed, and the reported cause of death was ventricular tachycardia.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a causal association between the reported event ventricular tachycardia and BNT162B2 cannot be fully excluded. Case will be reassessed when additional information is available including medical history data. 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. ; Reported Cause(s) of Death: Ventricular tachycardia
extreme pain to the Right hip and leg; extreme pain to the Right hip and leg; muscle pain; This is a spontaneous report form a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 11Feb2021 as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 for covid-19 immunisation. The patient who received the second dose of the Pfizer Covid vaccine on 11Feb2021 and 2 weeks after began to extreme pain to the Right hip and leg. "she was able to walk, but it was extremely painful, it took 5 months for her to be able to put full weight on her foot." Reporter asking has anyone else reported muscle pain as a side effect of the Pfizer Covid vaccine? What was a few people or a lot that reported this side effect? The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient received Adult Hep A Vaccination and Inactivate Polio Vaccination on 10/24/06 and developed a raised rash to her lower back the morning of 10/25/06. The rash was described as a circular border which progressed to spots with a red center with 5-10 spots appearing at a time. Patient stated the rash itched intensely and spread to her upper back, trunck, stomach and neck within 24 hours. Patient did not complain to dyspnea, throat itching and had previously received vaccinations without problems. Patient reported no history of allergies. Patient was examined by MD on 10/26/06 who diagnosed "allergic reaction to ?", treated with Zrytec and Adevax, and advised to return to MD in 5 days if rash did not resolve. On Oct. 29, patient reported episodes of vomiting, nausea and diarrhea and was seen at the Emergency Dept of Yampa Valley Medical Center in Steamboat, CO. She was rehydrated, treated with antinausea medication and released. No diagnosis was made. On November 1, 2006, patient reports rash is receding and itching has stopped, and is recovering from the earlier symptoms.
tested positive for Covid; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable consumer (wife) reported for a male patient reported that, A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration on 23Mar2021 at a SINGLE DOSE for covid-19 immunization. Patient had a medical history of cough and his ears were plugged and he was dizzy. The patient's concomitant medications were not reported. On 25Mar2021 patient visited urgent care and was performed COVID-19 virus test resulted as positive. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
pt states that she had nausea , diarrhea, headache, fatigue, sinus congestion, body aches, no fever.  Pulse ox reads 95.  She went to an urgent care since she wasnt feeling well and they did PCR Covid test which came back positive.  She has only had aspirin for pain at this time.
Maculo-papular rash on area, tender and itching after varicella vaccine. CLARITIN advice and sent to PCP.
Heart beat of 200 bpm; Heart attack; Flu like symptoms; frequent urination; Dry heaves; Heart fluttering; Atrial Fibrillation; fever; Little flutter; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Heart beat of 200 bpm), MYOCARDIAL INFARCTION (Heart attack) and ATRIAL FIBRILLATION (Atrial Fibrillation) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cardiac catheterisation (Found blockages which resulted in 2 stents.) on 17-Mar-2021.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PALPITATIONS (Little flutter). On an unknown date, the patient experienced HEART RATE INCREASED (Heart beat of 200 bpm) (seriousness criterion hospitalization), MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and medically significant), INFLUENZA LIKE ILLNESS (Flu like symptoms), POLLAKIURIA (frequent urination), RETCHING (Dry heaves), CARDIAC FLUTTER (Heart fluttering), ATRIAL FIBRILLATION (Atrial Fibrillation) (seriousness criterion medically significant) and PYREXIA (fever). The patient was hospitalized on 16-Mar-2021 due to HEART RATE INCREASED. At the time of the report, HEART RATE INCREASED (Heart beat of 200 bpm), MYOCARDIAL INFARCTION (Heart attack), PALPITATIONS (Little flutter), INFLUENZA LIKE ILLNESS (Flu like symptoms), POLLAKIURIA (frequent urination), RETCHING (Dry heaves), CARDIAC FLUTTER (Heart fluttering), ATRIAL FIBRILLATION (Atrial Fibrillation) and PYREXIA (fever) outcome was unknown.            Patient went to the hospital in an ambulance.  Treatment information was not provided.   On 26 Mar 2021, the patient had to wear holter monitor for 1 month for observation of atrial fibrillation.   This case was linked to US-MODERNATX, INC.-MOD-2021-056770, US-MODERNATX, INC.-MOD-2021-056770 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities US-MODERNATX, INC.-MOD-2021-056770:1st Dose Case US-MODERNATX, INC.-MOD-2021-056770:2nd dose case
On 12/16/2020, approximately two hours after administration of Pfizer BioNTech Covid-19 vaccine, patient developed SOB and chest pain.  Patient reported to ED where she was given fluids, diphenhydramine, ipratropium/albuterol nebulizer treatment, magnesium,  famotidine, and epinephrine.  Of note, patient has anaphylactic reaction to corticosteroids.  On 12/17/2020, around 3:00 pm the patient reports to the ED at a different facility (one closer to her home) with difficulty breathing and sensation of her airway closing.  Patient again was given epinephrine, fluids, ipratropium/albuterol nebulizer, diphenhydramine, famotidine, and was also given a dose of lorazepam. The patient now has stated that she had an anaphylactic reaction to a prior flu vaccine, however this was not listed as an allergy prior to administration of the Pfizer BioNTech Covid-19 Vaccine.
3 Days after shot given the patient experienced flu like symptoms, general overall malaise, bronchospasms, then deep muscle pain down arm
My subject elder child was not 100%. Was feeling feverish.  He fell sick with hoarse throat and frequent coughing. Later he also complained pain where vaccine was administered in the arm.
Severe pain ln neck, back, up the back of the head and behind the ears. Some rash around the waist. Chills for several hours one night. Pain lasted about 9 days. Yesterday and today, 15 and 16 February, no energy.
Within 10 mins. Tongue was tingling lips were swelling and tingling left arm fingers were tingling , headache
Throbbing headache for two days after the injection, one of the worst headaches I have every had. Widespread muscle aches, weakness and fatigue and not localized to the injection site, began the morning after the injection and has not subsided.
Feels Dizzy after booster shot; Off Balance; Does not feel normal; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feels Dizzy after booster shot), BALANCE DISORDER (Off Balance) and FEELING ABNORMAL (Does not feel normal) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 069F21A, 013M20A and 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced DIZZINESS (Feels Dizzy after booster shot), BALANCE DISORDER (Off Balance) and FEELING ABNORMAL (Does not feel normal). At the time of the report, DIZZINESS (Feels Dizzy after booster shot), BALANCE DISORDER (Off Balance) and FEELING ABNORMAL (Does not feel normal) outcome was unknown.            No Concomitant medications were provided by the reporter. No Treatment information was reported. The patient felt  dizzy, and off balance. The patient got up to go to the bathroom and did not feel normal so he went back to bed.
This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# 8729), at the age of 52, via an unspecified route of administration, in the left arm, on Apr 21, 2021, single dose, for COVID-19 immunisation. Medical history not reported. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medicines within two weeks prior to the vaccination. On May 1, 2021, patient had tinnitus in both ears. No therapeutic measures taken as a result of the event. Since the vaccination, patient has not tested for COVID-19. The outcome of tinnitus in both ears: not recovered (at the time of report). No follow-up attempts possible. No further information expected.
Patient was  given an expired injection. Daptacel injection given expired on 02/7/20 but was given on 02/18/20.
Pt received first Pfizer COVID vaccine dose at approximately 0800 on 5/27/2021.  Injection administered in left deltoid.  Pt states that she took two Tylenol before going to bed the night of 5/27/2021.  Felt fine prior to going to bed except for injection site pain.  She was awakened by chest pain, muscles pain, joint pain and swelling and malaise at 0200 on 05/28/2021.  She states she did not have a fever and felt cold but no chills.  States the chest pain lasted about 30 minutes.  Unable and afraid to go back to sleep after this episode.  Joint and muscle pain resolved after about 2 days.
FLU SYMPTOMS; SKIN HURT; FATIGUE; MUSCLE ACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072) dose was not reported, administered on 09-MAR-2021 18:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced fatigue. On 10-MAR-2021, the subject experienced muscle aches. On an unspecified date, the subject experienced flu symptoms, and skin hurt. The patient recovered from fatigue, and muscle aches, and the outcome of flu symptoms and skin hurt was not reported. This report was non-serious.
nerve pain; After being vaccinated, had shingles, had the new one,Suspected vaccination Failure; Shingles an back and side, still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. In February 2022, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and post herpetic neuralgia were not recovered/not resolved.   The reporter considered the vaccination failure, shingles and post herpetic neuralgia to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 21-FEB-2023 Reporter's Comments: This case was reported via interactive digital media. The patient got the shingles after getting vaccinated. The patient said she had shingles February of 2022 on her back and side, event after being vaccinated. The patient said she had new one and still got shingles. The patient still had nerve pain. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not possible, as no contact details were available.
This spontaneous report was received from a healthcare professional referring to a 61 year old female patient. The patient's concurrent conditions and medical history included hypothyroidism, Basedow's disease, gastrooesophageal reflux disease, spinal osteoarthritis and allergy to penicillin. On 19-APR-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 0.5 ml, intramuscular, lot#: L035882, expiration date on 19-APR-2017 (dose number and anatomical location were not provided). Concomitant therapies included methimazole (manufacturer unknown), PEPCID AC and clobetasol propionate. On 19-APR-2016, about one minute after the dose was administered, patient experienced difficulty breathing, flushed, visibly sweating and her tongue started swelling. Additionally, the patient stated she felt like she was going to pass out. The patient was transported via ambulance to an emergency room at a medical center, but it was unknown whether she was admitted. DEPO-MEDROL, EPIPEN and BENADRYL were administered in the ambulance. The outcome of dyspnea, swollen tongue, hyperhidrosis, flushing and feeling abnormal was unknown. The reporter did not assess the relatedness between the adverse events and suspect therapy. There was no PQC involved. Upon internal review the adverse events were considered as medically significant, as EPIPEN were administered. The reporter considered the events to be life threatening. Additional information has been requested.
Information has been received from a consumer concerning his daughter who was vaccinated with all three doses of Gardasil on unspecified dates (lot #'s not provided).  Concomitant therapy included influenza virus vaccine (unspecified).  On approximately 01-MAR-2008 the patient experienced an autoimmune disease after receiving the influenza virus vaccine and Gardasil.  The patient's autoimmune disease persisted and she sought unspecified medical attention.  No further information is available.
Patient seemed nervous at time of vaccination and afraid of vaccine. Shortly after vaccination patient fainted for 5 to 10 seconds, once patient regained consciousness patient became panicky and started crying. We promptly called 911, patient attempted to leave store, we advised her to stay for paramedics. Paramedics arrived and took over patient care.
Vaccine given 8/18/2011 w/in 24 hrs pt noticed swelling, redness, pain, & heat at injection site - and as of 8/20 rxn diameter about 2 1/2" continues to worsen 8/21.
Patient was taken into Med Obvs for throat tightness. Patient describes that she experienced tightness and dryness in the throat after receiving the second dose vaccination. VS were checked at 14:36, HR: 90, RR: 19, BP: 122/83, SPO2: 99. Patient was encouraged to relax and have sips of water. Next VS were taken at 14:53, HR: 73, RR: 19, BP: 119/81, SPO2: 100. She was made comfortable on the stretcher with head of bed elevated to allow expansion of her lungs and reduce the risk of aspiration while sipping on water. Last VS were at 1508, HR: 65, RR: 20, BP: 121/83, SPO2: 100. Patient was released at 1511 by herself after symptoms lessened.
Several hours after the vaccine on 11/18/2021, I had chills, became extremely fatigued, drowsy, and could not stay awake. The left-arm shot site hard and my arm was swollen.  11/19, 2021, chills and fatigue continued.  Pain under my left armpit commenced followed by the lymph nodes swelling to the point of extending down toward my breast. Painful and very tender to touch. Stripes of pain felt deep inside and moved down toward my left breast. Still feeling fatigued. Today is 11/22/2021, the lymph node condition has not abated. The vaccine shot sight is still a hard node and feels not hot, hot, but too warm to be normal.  I cannot wear my bra. I have been advised to treat with warm compresses, take 600mg ibuprophin. If the condition does not change in 24 hours, report to urgent care.
Redness, pain, swelling to local area ranging from shoulder AC area. Patient reported significant improvement with taking antihistamines. Provided recommendation was to continue current treatment and follow up should s/s worsen over the weekend. Patient followed-up today 03/19/2017 and had significant improvement. No follow-up care recommended by provider at this point.