chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist referring to a 68 year old male patient with diabetes. the patient' drug reactions/allergies were not reported. On 01-APR-2015 the patient was vaccinated with ZOSTAVAX, lot # K020802 with expiry date 31-JAN-2016, (dose, frequency and route were not reported). Information regarding concomitant therapy was not reported. On 01-APR-2015 the patient experienced a headache, aweird taste in his mouth and a funny feeling, like nausea immediately after receiving ZOSTAVAX. The reporter also reported that the patient throw up once and was in pharmacy about 30 minutes. He was 'white as a sheet' so it seemed like a 'hefty dose of nausea'. The pharmacist stated no treatment was given at the pharmacy. The pharmacist referred patient to his primary care physician. The reporter reported that the patient didn't think those events were related to his blood sugar. The outcome of the events was not reported. The causality was not reported. Additional information has been requested.
pneumovax 6x3" local erythema;T100, worsening lt knee pain, pain @ site;Td 4" local erythema;local rxn to vax, ice packs, anti inflammation 2-3 days;
It started just redness, but it worsen over a week.  With sharp pain and thinned redness.  I went to urgent care because of the pain.  They thought it was cellulitis.  They gave me antibiotic for it.
Swelling on most of the bicep near injection, redness, heat, no fever, no nausea, extremely painful.
A 53 year old man had been treated with OncoTICE for chronic interstitial cystitis. After the last treatment he experience a worsening of his increased urinary frequency and a burning sensation when urinating since that same night. Levaquin, Pyridium and Uroblue.
pt recvd vax;devel fever;mom reported pt had sz activity;rolled up eyes,breathes rapidly & little salivary foam in mouth;T 100;seen in ofc 22feb95,nl exam;
Inability to taste or smell; Inability to taste or smell; This is a spontaneous report from a contactable nurse. A 25-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK5730/expiration date) dose number 1, intramuscularly on 06Jan2021 12:00 at a single dose on the left arm for COVID-19 immunization. There was no relevant medical history. Concomitant medications were not reported. No other vaccine was received within 4 weeks and no other medications were taken within 2 weeks. The patient experienced inability to taste or smell on 10Jan2021. The patient underwent Nasal Swab/PCR on 11Jan2021 with unknown results (pending). The outcome of the events was not recovered.
Yesterday after child received shots; he started to cry, turned blue, seemed to stop breathing. Eyes rolled to back of head, body turned stiff, shaking occurred. Shaking lasted about 5 seconds whole episode lasted about 2 minutes. Ambulance brought child to ER; had temperature of 102 degrees F. Diagnosed there with febrile seizure.
The arm started tingling and was heavy and I started to feel tightness around my throat. Weakness.
This spontaneous report was received from an office manager via a company representative and refers to a patient of unknown age and gender. Concurrent conditions, medical history and alelrgies were not reported. On 08-MAY-2015, the patient was vaccinated with a dose of PNEUMOVAX23 strength reported as 25/0.5 Y, (dose, freuqency, route, anatomical location, lot number and expiration date were not reported) which had expired. The patient did not experienced any adverse effects. Additional information has been requested.
On Thursday December 6th in the AM patient began experiencing urticaria. He started taking Benadryl 50 mg Q3 hours except when sleeping. He stopped taking the Benadryl on Sunday because symptoms were improving and patient states symptoms were gone by Monday December 10th. For patient's remaining vaccines (2 total) he will receive Rabavert. Today, December 13th, he received his 4th shot with Rabavert (Novartis) Lot # 419011A EXP 07/10.
Patient start filling hot about 2 minutes after vaccine administration. She said she was not feeling well and that she is having a reaction to vaccine, few minutes later when she start feeling dizzy I called 911, patient was very pale and had excessive sweating. Paramedics arrived in about 6 minutes. Her BP was low. Later patient was complaining of stomach cramps and that she couldn't feel her arms. Patient was taken by paramedics to ER.
Initial report received on 25 August 2011 from a consumer who is also a health care professional. A 52 year-old female patient had received an intramuscular left deltoid injection of FLUZONE (lot number UH454AD), and an intradermal dose of TUBERSOL 5 TU (lot number C3584AC, site not reported) on 16 August 2011 and the same day experienced involuntary movements of the left arm and weakness in the left leg, which did not require medication evaluation. The patient had no concurrent illnesses at the time of the vaccinations, but had current medical conditions of breast cancer, ADHD and fibromyalgia. Concomitant medications included: RITALIN, DEMEROL, DARVON, DARVOCET, ROCEPHIN, ZITHROMAX, and unspecified pain medication. Indications for the concomitant medications were not provided. It was noted the patient had received TB tests and flu vaccinations before, and had not experienced any other adverse events with past vaccinations. At the time of this report, the patient was reported as being recovered, but it was also reported the symptoms were persisting. Recovery status is unknown. Documents held by sender: None.
REDNESS, SWELLING- AREA SURROUNDING UPPER ARM. WARM TO TOUCH
3 weeks past MMR devel transient hives followed by macular rash & arthralgia.
Follow-up received provided additional patient details, medical history, event details, and test results. Information regarding PREVNAR was received from a healthcare professional regarding a 15-month-old male patient who experienced pneumococcal infection of lungs, ears, nose, and adenoids and recurrent pneumococcal infection. At 15 months of age, the patient received the fourth dose on 14-Aug-2008. In Oct-2008 the patient experienced pneumococcal infection of lungs, ears, nose, and adenoids and a recurrent pneumococcal infection in 2008. In early Oct-2008 the patient presented with a three week history of fever, wheezing, snotty nose, and ear infection unresponsive to antibiotics. The patient was brought to the hospital on 12-Oct-2008 since he continued with symptoms of fever, and wheezing and became blue around the nose and mouth with oxygen levels in the 80's. On 13-Oct-2008 the hospital performed rigid and flexible bronchoscopy, suctioned mucous plugs and cultured the patient's lung secretions (see test result below). Post-procedure treatment consisted of PULMICORT nebulizer treatments, ORAPRED and IV VANCOMYCIN for 18 days via a PICC line with a return to normal health, symptom free. Forty-eight hours after the PICC line was removed, the same symptoms returned. He had bilateral otitis media and was treated with IM CEFTRIAXONE. On 13-Nov-2008 the patient had adenoids removed and ear tubes inserted. The lungs were suctioned again and sputum was sent for examination. Post-operative treatment consisted of oral AUGMENTIN and CIPRO drops to ears. On 17-Nov-2008 a follow-up appointment with the pediatric pulmonary physician was performed (see results below). The patient is recovered from the events. No additional information was available at the time of this report.
Information has been received from a Registered Nurse (R.N.) concerning a 11 year old female who on 21-SEP-2009 experienced a syncopal episode with tonic-clonic movements after receiving her second dose of GARDASIL (lot# 0216Y). It was reported that when she fell during this episode she fractured her nose. The patient sought medical attention and was seen by the nurse. X-rays of nose indicated fractured nose. The outcome was unknown. Follow up information was received from a Licensed Practical Nurse (L.P.N.) on 24-SEP-2009 via telephone reported that the patient with no pertinent medical history and allergic to AUGMENTIN (hives) was vaccinated with her second dose of GARDASIL (lot#0216Y) on 21-SEP-2009. No other vaccines and concomitant therapies were given that day. After fall, the patient was not sent to emergency room but for an x-ray of the nose and a CT of the head. Both revealed a nasal fracture. The patient's current status was recovering. She was referred to an ENT (name not provided) and surgery was planned. It was also reported that the patient was given the first dose of GARDASIL (lot# 662300/0100Y) in the left arm on 15-JUL-2009. Other vaccines given on that day included a dose of MENACTRA (lot# U2925AA) and a dose of VARIVAX (Oka) (lot# 0690Y). There was no problem after the first dose of GARDASIL. The reporter considered the fractured nose to be disabling. Additional information has been requested.
body aches; dizziness; mild headache; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), DIZZINESS (dizziness), HEADACHE (mild headache), FATIGUE (fatigue) and CHILLS (chills) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (body aches), DIZZINESS (dizziness), HEADACHE (mild headache), FATIGUE (fatigue) and CHILLS (chills). At the time of the report, PAIN (body aches), DIZZINESS (dizziness), HEADACHE (mild headache), FATIGUE (fatigue) and CHILLS (chills) had resolved.            Patient advised all AEs have resolved and has nothing further to report  No concomitant medications was reported by the reporter No treatment medications was  provided by the reporter
On 05/14/2022 around 11:00, my right leg starting from knee up and down felt weak and became wobbly. I was shortly after dragging my foot then right arm started the same. About 15 minutes, my speech started slurring and I couldn't write anything. All of these symptoms happened within 30 minutes. My brother took my blood pressure and it was 204/unsure. They took me to the ER and they also took my blood pressure was 184/unsure. They took my blood and as I was waiting in ER my symptoms gradually started getting better. I was at the ER around 5 hours and then they sent me home. I seen my family doctor on Monday morning and he ordered CT, MRI and heart monitor. CT was normal, MRI showed stroke in the deep part of left side of my brain and I will wear the heart monitor until June 1, 2022.
Severe headache, Nausea, fatigue , lethargic, tiredness, pain at injection site
Pt vaccinated with DTP developed seizures. Had EEG diag infantile seizures. 8 days in hosp on ACTH. seizures stopped after 4 days. Grunted & jerked arms & legs & head. Another EEG 2 wks later was improved. Has not had any seizures in 6 mo.
Three days after I got the vaccine, I noticed a very abnormal heart palpitation lasting about 3 seconds. Everything felt fine so I sat down for a few minutes. Once I got up I came very close to passing out. I lost my balance and my vision was dark.  Never experienced anything like this before
Medical Assistant accidentally administered a Ped Pfizer COVID vaccine to the patient who is currently 4 years old and 8 months
Developed a mouth/oral  infection.  Included mouth sores and yellowing of tongue. Compromised sense of taste, which continues to this day. Yellowing of tongue is still partially present.
no additional AE; HCP reporting a patient was administered PNEUMOVAX 23 today 9NOV2022. The PNEUMOVAX 23 expired on 11SEP2022.; This spontaneous report has been received from a medical assistant, referring a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 09-NOV-2022, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (expiration date 11-SEP-2022) (strength, dose, frequency, route of administration, and lot number were not provided) indicated as prophylaxis (expired product administered).  No additional adverse events were reported.
Fever, Chills, Body aches, Headache, Nausea, tiredness, chest pain
Left sided facial numbness/tingling radiating to left elbow, with throbbing headache.
Rx to injection in (L) arm. Had tetanus shot. Red swollen (L) upper arm with no rash. Prescribed Prednisone 40x2, 30x3, 20x2, 10x2.
Boostrix administered instead of Infanrix; Inappropriate age at vaccine administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 18-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number TR292, expiry date 03-NOV-2024) for prophylaxis.   On 07-JUN-2023, the patient received Boostrix. On 07-JUN-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: Boostrix administered instead of Infanrix) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 07-JUN-2023 This would had been the 4th dose of DTap but was administered Boostrix instead . The reporter consented to follow up via email. The reporter reported that an 18 month old child was administered Boostrix Instead of Infanrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
On 11/18/00, the pt developed a fever of 105 and rapid breathing. The pt was dx with pneumonia and possible bacteremia. Hospitalization was presumed but not documented.
Narrative: COVID infection of COVID vaccine series: 02/16/2021 COVID vaccine dose #1 03/08/2021 COVID vaccine dose #2 07/11/2021 Pt reported having congestion and cough and having close contact with COVID positive cases 07/16/2021 COVID positive per nasopharyngeal swab 07/17/2021 Pt reported continued cough
Approximately 5 minutes post vax, the pt had shrill cry, facial redness, face as warm to touch and he had whelps to forehead and cheeks. Sent to ER for evaluation and treatment.
Severe rigors involving core and extremities, making it difficult to breathe.; Severe rigors involving core and extremities, making it difficult to breathe.; muscle pain; joint pain noted in hips; loss of appetite; profound fatigue; This is a spontaneous report from a non-contactable nurse (patient). A 31-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK9231, expiry: unknown), via an unspecified route of administration on 11Jan2021 11:45 on the left arm at a single dose for COVID-19 immunization. The patient received the vaccine in a hospital. The patient had no other vaccine in four weeks. Medical history included clinical depression. The patient has no known allergies. The patient was not tested for COVID prior and post vaccination. Concomitant medications included bupropion and multivitamin. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK5730, expiry: unknown) on 21Dec2020 at 11:00 in the right arm for COVID-19 immunization. On 12Jan2021 at 01:00, the patient experienced severe rigors involving core and extremities, making it difficult to breathe. Flexeril 10 mg was taken to help relieve rigors. Rigors stopped and ease of breathing resumed in 1 hour. Other symptoms include muscle pain, joint pain noted in hips, loss of appetite, and profound fatigue x48 hrs. The events difficult breathing, muscle pain, joint pain noted in hips, loss of appetite and profound fatigue were not treated. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of "severe rigors involving core and extremities, making it difficult to breathe". 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
On Tuesday evening after receiving the vaccine, patient developed a rash on his face, neck and back. The same red bumps appeared the following day on his chest and legs.  Patient never complained about them or attempted to scratch them. He said they did not itch or hurt. In speaking with a friend a couple days later, she said her son developed the same rash after receiving his vaccine. That?s when I decided to report what my son experienced. I consider it a minor side effect though.
This spontaneous report as received from a registered nurse refers to a 4 year old patient. Nurse reported that the accidental administration of both PROQUAD (Lot #, dose/frequency and route were unspecified) and VARIVAX (Merck) (Lot #, dose/frequency and route were unspecified) occurred today, 27-MAR-2013, to the patient. The outcome and drug relationship were unknown. Additional information has been requested.
Sore arm.  Fever  Aches  Fatigue  Nausea
Red swelling at injection site 8 days after vaccination.  Almost like a bug bite.  Treated with antihistamine, bactine for itching and cold compress for swelling.  Preceded by sharp pain at the injection site, then intense itching and swelling.
The first night that I got the vaccine I began to feel in my legs and arms like an electricity, burning and itching that today after 2 days I still have.; The first night that I got the vaccine I began to feel in my legs and arms like an electricity, burning and itching that today after 2 days I still have.; The first night that I got the vaccine I began to feel in my legs and arms like an electricity, burning and itching that today after 2 days I still have.; I also feel that burning in my face.; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 620-099) via an unspecified route of administration in the arm left on 12Apr2021 at 13:15 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia and migraines. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN) 100mg for unknown indication from an unknown date. The patient previously received scopolamine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 12Apr2021, the first night of the vaccine the patient began to feel in legs and arms like an electricity, burning and itching even after 2 days. Sometimes the patient also felt that burning in the face. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events feel in legs and arms like an electricity, burning, Itching and feel that burning in face was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
On 12/7/99 the pt developed a mild case of chickenpox with approximately 12-20 lesions. He also experienced cold symptoms described as "slight temperature" and runny nose. The pt sought unspecified medical attention. Subsequently, the pt recovered form all his experiences.
received the first dose with dose with Engerix-B pediatric volume; received the first dose with dose with Engerix-B pediatric volume; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 30-year-old female patient who received HBV (Engerix B pediatric) (batch number YY2R3, expiry date 12th May 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2022, the patient received the 1st dose of Engerix B pediatric (intramuscular) and Engerix B Pre-Filled Syringe Device. On 3rd August 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-JAN-2023 Reporter's Comments: The pharmacist asked for information on Engerix B, an adult patient received the first dose with dose with Engerix-B pediatric volume in instead of an adult, should the patient receive another additional dose to complete the first or restart the schedule. No more information provided. The reporter consented to follow up. Additional Supportive Information: The patient received Engerix B pediatric instead of Engerix B adult, which led to underdose and adult use of a child product.   Follow-up information received on 23-JAN-2023. Reporter's Comments: At the time of reporting, the reporter was asked two times from where he was calling from, but he refused to answer and directly answered the inquiry and ignored the  question.  Summary of Changes: Country of occurrence, reporters country, product details and narrative updated.
Site: Itching at Injection Site-Mild, Site: Redness at Injection Site-Mild, Systemic: burning, watery, lack of sensation (can not feel eye drops) in left eye-Medium, Systemic: Weakness-Medium, Additional Details: weakness/lack of energy
has a bigger than a beebee smaller than a pea size red bump.  it hurts.  She did have a flu and covid shot in same arm one per week the 2 weeks before this.
Took flu vaccine. a little more than 24 hrs later, developed rash and hives all over the body. Itchy over the entire body.  taking Benadryl not really helping, this is still ongoing and more than 24 hrs since initial onset.