chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a healthcare professional on 29 August 2013. A 51-year-old female patient, had received a dose of ADACEL vaccine (lot number U4618AA, expiry date: 10/23/2015, dose number was not reported) intramuscularly in the left deltoid on 20 August 2013. The patient's medical history included: Hypothyroidism, Meniscus tears, Depression, Anxiety, High cholesterol, Latex allergy, Back pain and Sinus headaches. The patient had illness at the time of vaccination. On 22 August 2013, the patient developed redness, pain and swelling at vaccination site, lymphadenopathy and generalized rash with itching. Laboratory details were not reported. On an unspecified date, the patient had received DEPO-MEDROL Injection 80 mg and advised to take OTC BENADRYL on 20 August 2013 and OTC ALLEGRA. On 27 August 2013, the patient started treatment with MEDROL dose pack. At the time of this report the outcome of the adverse event was unknown. Documents held by sender: none. The follow up information received from health care professional on 07 October 2013: The patient's address details added.
I got the flu shot at 16:00 yesterday. By 19:00, I started feeling like I couldn't take a deep breath. It took alot of work to breath in and out. Each breath caused me to cough. At 20:30, I took BENADRYL, 50 mg, PO. This seemed to ease my symptoms and by 21:30, I fell asleep. This morning, I'm hoarse and still feel like my breathing isn't back to normal.
Extreme vomiting; stomach pain; back pain; Loss of appetite; fatigue; chest pain; This is a spontaneous report received from a contactable consumer, the patient. A 63-Year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) as a single dose via an unspecified route of administration in her right arm on 20Mar2021 at 16:45 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. The patients medical history included kidney stones. The patient had no allergies to medications, food or other products. The patient received hydrochlorothiazide (MANUFACTURER UNKNOWN) for unknown indication medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 21:00, the patient experienced extreme vomiting later same day of vaccination, chest pain, stomach pain, back pain, loss of appetite and fatigue. The patient did not receive treatment for the reported events. The events resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for the events vomiting, chest pain, stomach pain, back pain, loss of appetite and fatigue were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Initial unsolicited case received from a nurse on 28 Sep 2017. This case involves a male patient (age not reported) who was vaccinated with a dose of FLUZONE QIV (Batch number: UI678AA, expiry date, dose in series, dose, route and site of administration were not reported) on an unknwon date. Patient medical history and concomitant medications were not reported. On an unknwon date, following the vaccination, the patient had severe confusion for 7-8 hours and dizziness. It was reported as patient referred to neurology for follow up and Patient now concerned to receive flu shot going forward. Lab tests and corrective treatment were not reported. On an unknwon date, the patient recovered from the events. (Reported as dizziness persisted for about one week) List of documents held by sender: none.
Itchy rash covering entire body below neck treated with Prednisone, antacid and antihistamine by walk in clinic MD. Rash began but barely noticeable 2 days post vaccination. Pt started applying CORTAID, then Calamine lotion day 4 and 5. Then went to Dermatologist prior to walk in clinic for above mentioned tx.
A vial of Moderna Covid-19 monovalent vaccine got mixed into the Moderna Covid-19 bivalent vaccine and the monovalent vaccine was administered; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (A vial of Moderna Covid-19 monovalent vaccine got mixed into the Moderna Covid-19 bivalent vaccine and the monovalent vaccine was administered) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (A vial of Moderna Covid-19 monovalent vaccine got mixed into the Moderna Covid-19 bivalent vaccine and the monovalent vaccine was administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (A vial of Moderna Covid-19 monovalent vaccine got mixed into the Moderna Covid-19 bivalent vaccine and the monovalent vaccine was administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (A vial of Moderna Covid-19 monovalent vaccine got mixed into the Moderna Covid-19 bivalent vaccine and the monovalent vaccine was administered).    No concomitant medications were reported. Vial of Moderna COVID-19 monovalent vaccine got mixed into where the vials of the Moderna COVID-19 bivalent vaccine were stored and a dose of the monovalent vaccine was administered to the patient for the bivalent vaccine. No treatment information was provided.
Intense itching throughout my entire body; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9269; Expiration date was not reported) on 05Feb2021 (16:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. Medical history included asthma, high cholesterol and high blood pressure. The patient's concomitant medications were not reported. The patient previously took prochlorperazine maleate (COMPAZINE), and had drug allergy. The patient was not pregnant at the time of vaccination. On 05Feb2021 (18:00), two hours after the vaccination, the patient had intense itching throughout the entire body. There were no hives or rash, just the unbearable itching. The patient had received diphenhydramine (BENADRYL) as treatment for the event. The outcome of the event, intense itching throughout the entire body, was recovered in Feb2021. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.
sore arm for 3-4 days; feeling "a bit woozy; 99.4 temp about 24 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for 3-4 days), DIZZINESS (feeling "a bit woozy) and PYREXIA (99.4 temp about 24 hours) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm for 3-4 days), DIZZINESS (feeling "a bit woozy) and PYREXIA (99.4 temp about 24 hours). At the time of the report, PAIN IN EXTREMITY (sore arm for 3-4 days) and DIZZINESS (feeling "a bit woozy) had resolved and PYREXIA (99.4 temp about 24 hours) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.4 temp.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       No relevant concomitant medications were reported. No treatment medication reported.
Side effects include bouts of nausea resulting in vomiting, loss of appetite, headaches, increased mucus production require coughing up clear mucus throughout the day, fatigue and unpalatable taste in mouth that never goes away. Dose 1 received 4/13/21; side effects began 4/18 and have increased in severity day by day. As of date of submission, symptoms persist 16 days after shot.
7/9/21 only - Sharp excruciating neck and back muscle pain requiring pain medication (one dose of Aleve) Onset within 48 hours (beginning 7/10/21): Hives Itching Diarrhea Respiratory/chest pain Difficulty breathing/chest tightness Dizziness/lightheadedness Anxiety attacks High blood pressure As of 7/17/21 I presented to the emergency room 3 times with acute anxiety from difficulty breathing. Per doctors recommendation, began taking maximum dose of over-the-counter Benadryl, symptoms did not subside. On my 3rd trip to the Emergency Room I was prescribed Prednisone (40mg daily) and continue taking 75-100mg Benadryl daily when symptoms worsen to manage the discomfort and sleep.
Arm that received shot, and face, are burning as if there's a bad sunburn.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Apr2021 at 15:45 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and mild hypothyroidism. The patient had known allergies to latex, wheat, corn, soy, rice and aspirin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021 at 17:15, the patient experienced arm that received shot, and face, were burning as if there's a bad sunburn. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm that received shot, and face, were burning as if there's a bad sunburn was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unspecified dates, between 17-NOV-2016 and 13-DEC-2016, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot# L046320, expiration date 29-SEP-2017 (dose was not reported). The administered doses of vaccine were stored in the temperature of 0.1 degrees Celsius for 6 hours and 48 minutes, in the temperature of 0.8 degrees Celsius for 3 hours and 36 minutes and in the temperature of 0.5 degrees Celsius for 5 hours and 24 minutes. The temperature excursions took place on 17-NOV-2016 (also reported as "reported on 17-NOV-2016"). On 13-DEC-2016, another temperature excursion was reported with a temperature of 10.4 degrees Celsius for 1 hour and 10 minutes. However, no doses of ROTATEQ were administered following the recent temperature excursion. Digital data logger was involved. No adverse effects were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA007250: US-009507513-1612USA007251: US-009507513-1612USA007249: US-009507513-1612USA007121.
Vaccine administered in right deltoid. Patient felt dizzy and fainted in the observation area within a few minute of receiving the vaccine.  Patient was pale, nauseated, and felt light headed especially when standing or walking.  Blood pressure was 101/51.  Patient was taken to urgent care, kept under observation for three hours, and was released when he felt well enough to drive home.
Information has been received from a registered nurse concerning a 16 month old patient who on 18-JUN-2009 was vaccinated with a less than recommended amount dose of VARIVAX (LOT# not reported). Some of the vaccine solution leaked between the needle and the syringe during administration to the patient. No adverse event was reported. Additional information has been requested.
Pt. woke screaming, with left ear pain. Felt hot to touch. Next a.m. back of neck hurt, fever, malaise. Fever cont. ear hurt, face hurt, mandibular joint hurt, right ear hurt, light rash over whole body, different rash on neck and fac
On 12/06 I started feeling unwell I had a sore throat; head congestion; nasal congestion; coughing; low grade fever and fatigue. On 12/08 I tested positive. I was prescribed PAXLOVID at that time. I feel that I have recovered however I currently have a sinus infection that has lasted about 10 days.
Malignant hypertension Blood Pressure up to 220/108 within 12 hours after first dose vaccine  Chest pain, SOB, headache and dizziness,  ankles and wrists aches.. sever spinal pain. Debilitating pain and weakness
in the syringe exploded, while the needle was in the patient arm; More than half the dose was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (in the syringe exploded, while the needle was in the patient arm) and UNDERDOSE (More than half the dose was administered) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced DEVICE CONNECTION ISSUE (in the syringe exploded, while the needle was in the patient arm) and UNDERDOSE (More than half the dose was administered). On 06-May-2021, DEVICE CONNECTION ISSUE (in the syringe exploded, while the needle was in the patient arm) had resolved and UNDERDOSE (More than half the dose was administered) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment details were provided
Pt went vasovagal after dose of Johnson and Johnson vaccine. This has happened before. She did nit lose consciousness. We slowly moves pt from seated position to lying on the floor. She denied use of a cot and a juice box. We had a cold pack on the back of her neck. Eventually she was able to transfer from the floor to the chair and felt better. We started pts 15 minute observation time after she was stable in a chair. Pt felt better before she left.
Weakness dizziness chills confusion irritability fever muscle aches back ache headache neck pain fatigue. About a month after the 2nd dose of the vaccine I also experienced unusual symptoms (symptoms which are not regular for me, I have never experienced such symptoms before) including blood clots on legs, behind knee and by my ankle. Unexplained exhaustion and chest pain lasting for over a month. Diarrhea lasting on a constant basis for 3 months, which later calmed down and became fluctuations between constipation and diarrhea- lasting until today.
Patient was due for Polio but physician wrote order or PCV13. Grandmother, whom has legal custody of patient was made aware. Patient will receive polio at next visit.
Pain on his side and abdomen/pain in his shoulder and arm; Pain on his side and abdomen/pain in his shoulder and arm; Developed a painful rash on his back and side extending to middle of his abdomen; Pain on his side and abdomen/pain in his shoulder and arm; Pain on his side and abdomen/pain in his shoulder and arm; Suspected Vaccination failure; he was diagnosed with shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (history of shingles rash about 20 years prior to the reporting). Concurrent medical conditions included rheumatoid arthritis. Concomitant products included gabapentin (Gralise), infliximab (Inflectra), baclofen, methotrexate and leflunomide.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular) and the 1st dose of Shingrix. On 27th March 2022, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain localized and abdominal pain. On 31st March 2022, the patient experienced painful rash. On an unknown date, the patient experienced pain in arm and shoulder pain. The patient was treated with lidocaine (Lidocain Topical). On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain in arm, pain localized, abdominal pain and shoulder pain were not recovered/not resolved and the outcome of the painful rash was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain in arm, pain localized, abdominal pain, shoulder pain and painful rash to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's comment: The reporter was the patient. He received both doses of Shingrix, two months apart, in 2018 or 2019. On 27th March 2022, he developed pain on his side and abdomen.  He saw his physician on 31st March 2022 for a routine physical. During abdominal palpation, he experienced severe pain and his physician sent him to the emergency department for evaluation.  He was not admitted to the hospital. The next day, on 1st April 2022 he developed a painful rash on his back and side extending to middle of his abdomen. He also developed pain in his shoulder and arm that he describes as feeling like he was hit with a sledge hammer.  His physician again referred him to the emergency department where he was diagnosed with shingles. He was prescribed Lidocaine patches and also used roll-on lidocaine with no relief of pain. He states this shingles episode was twenty times worse. The rash had resolved. He still had pain, but it had lessened. The reporter consented to follow up. Additional supportive information: This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting.
Swollen arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An elderly female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset Apr2021, outcome "unknown", described as "Swollen arm". It was unknown if therapeutic measures were taken as a result of peripheral swelling.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt had swelling (golf-tennis ball size) and severe pain. No redness. Pt. given Benadryl.
That night I started getting headaches and have them at least once a day, my arm was a bit sore
Burning Mouth Syndrome; This case was reported by a consumer via call center representative and described the occurrence of burning mouth syndrome in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced burning mouth syndrome. The patient was treated with nortriptyline. On an unknown date, the outcome of the burning mouth syndrome was unknown.   It was unknown if the reporter considered the burning mouth syndrome to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced burning mouth syndrome after receiving Shingrix. The patient went to dentist and primary care doctor and they said that they fell it also could be the vaccination. The patient took Nortiptyline from primary care.
Severe pain, swelling and redness on injection side 6x6 inch. Tenderness to touch and difficulty moving arm.
Erthymagus indurated, slightly pruitic swelling on left arm, tender - noticed for 24 hours (01-18-2005) had shots on 01/17/2005 - DTAP, IPV on left arm MMR, HepA right arm.
Information has been received from a physician concerning a 9 year old female who on 09-JUL-1999 was vaccinated with a first dose of VARIVAX (Oka/Merck). At 10:30am 18-OCT-2007, the patient was vaccinated in the right arm with a second dose of VARIVAX (lot # 656287/1508F) with diluent (lot # 3013U). Concomitant therapy included FLUZONE which was vaccinated in the left arm at the same time. On 19-OCT-2007, the patient experienced erythema measuring 4.5 cm in diameter and pain at the injection site of VARIVAX (Oka/Merck) on the right arm, and mild edema was also noted. The physician was contacted. On an unspecified date the patient was treated with cold compresses and BENADRYL for itch if any. On 22-OCT-2007, the patient recovered. This is one of several reports from the same source. No further information was available.
Patient stated he has never received a Covid Vaccine. Patient did Not have any reaction happened. We putting Vaccine in Grits it was noted that Patient had received 2 prior doses.
Developed a productive cough, chills (temp not taken but had what was described as severe chills; congestion - sinus - chest - took MUCINEX.
Complaint of sore throat on 10/24/2014. Stuffy nose started on 10/25 at 6:00 PM and continues to 10/26, low grade fever of 100.56 F began on 10/26 7:00 PM.  Child is still sick 10/26/2014 at 9:36 PM.
Information has been received from a nurse practitioner concerning a 22 year old female who on 17-JUL-2007 was vaccinated with a dose of Gardasil. On 23-JUL-2007 the patient developed a nodule underneath the skin at injection site. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. Additional information has been requested. This is in follow-up to report (s) previously received from a nurse practioner and a registered nurse concerning a 22 year old white with PENICILLIN allergy who on 17-Jul-2007 was vaccinated intramuscularly in the deltoid with a second dose of GARDASIL (657868/0532U). On 23-Jul-2007 the patient complained of a hard lump at the injection site with soreness and exam revealed a pea sized module underneath the skin at injection site. The patient was treated with warm soaks and resting the arm. The patient reported doing heavy lifting. There were no laboratory or diagnostic testes performed. Unspecified medical attention was sought. Subsequently, the patient recovered. On 01-Oct-2007 there was no new information was reported. Additional information has been requested. This is in follow-up to report(s) previously sumitted on 8/14/2007
Patient was given Fluad. She had no history of adverse events with flu shots. Within 3 minutes of administration, patient was hot, felt nausea/vomiting, could not see well, and also had tightness in her chest.