chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from approximately 71 year old female consumer. The patient's medical history includes drug reactions/allergies to penicillin (manufacturer unknown) and BIAXIN (manufacturer unkonwn) (dosages and frequencies unkonwn). On 17-APR-2014 the patient was vaccinated with booster shot of PNEUMOVAX23 (lot # J009827), 0.5 ml, subcutaneous. Concomitant therapies included betaxolol hydrochloride (manufacturer unkonwn) (dosage and frequency unknown) and SINGULAIR (dosage and frequency unknown). On 18-APR-2014, the patient developed a fever of 102F which kept her bedridden (disability), and there is redness that spread 5 more inches past the injection site (disability). The patient also reported that she had a lump at the injection site (disability), and her arm is now sensitive to touch (disability). The patient received the treatment with the cold compress. There were no lab diagnostic studies performed. The patient sought medical attention by visiting the physician. There was no hospitalization reported. There was no PQC involved. The outcome of the events, developed a fever of 102F which kept her bedridden, there is redness that spread 5 more inches past the injection site, my arm is now sensitive to touch, and she has a lump at the injection site was reported as not recovered/not resolved. The causality of the events was unspecified. Additional information has been requested.
vomiting; Headache; Fatigue; fever; chills; diarrhea; extreme exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 17-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 05Apr2021 at 15:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as none. The patient did not have any known allergies to food, medications, or other products. The patient did not receive any medication within two 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. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06Apr2021, the patient experienced headache, fatigue, vomiting, fever, chills, diarrhea and extreme exhaustion for 48 hours. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Therapeutic measures were not taken as a result of adverse events. The clinical outcome of the events headache, fatigue, vomiting, fever, chills, diarrhea and extreme exhaustion were resolved on 08Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Broke out with chicken pox on 12-7-05. Form completed as much as possible. Vaccine not given in our office
Woke the following morning with extremely swollen face.; The patient received third/ booster dose of BNT162B2; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3590) via an unspecified route of administration in the left arm on 29Oct2021 at 14:30 (age at vaccination of 65-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as patient had a good health. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 20Mar2021 at 09:00 (age at vaccination of 64-years-old) and received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0153), via an unspecified route of administration in the left arm on 10Apr2021 at 09:00, as a single dose for COVID-19 immunisation. On 30Oct2021 at 04:00, the patient woke up the following morning with extremely swollen face. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extremely swollen face was resolved on an unknown date in 2021.
The patient came to pharmacy 9/19/18 and showed us her left arm which was swollen and had red patches and also a  red area that wrapped around her arm going down to the elbow. She said the reaction began 9/18/18  but was much better today on 9/19/18. I told her to take an antihistamine, use antihistamine cream & ice pack to bring down redness & swelling.
pt had reported HA, lymph node swelling  neck , sore throat , and erythema 1/2 dollar size at site and chills
bilateral sharp leg muscle pain; difficulty to move around; severe fatigue; This is a spontaneous report from a non-contactable Other Healthcare Professional reporting for herself.   An adult female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose on 04Jan2021 for Covid-19 immunisation, administered at hospital.  Medical history included corticosteroid lower lumbar injections. Patient was healthy. Vaccine Facility information available. Concomitant medication within 2 weeks of vaccination included 1 dose of over the counter ibuprofen (manufacturer unknown) on 03Jan2021 a day prior to vaccination.  The patient experienced bilateral sharp leg muscle pain, difficulty to move around, severe fatigue in Jan2021. The events lasted daily for more than 1 week. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The events were considered non serious by reporter. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has been tested for Sars-cov-2 test nasal swab: negative in Jan2021. As result of the events the patient took TYLENOL after vaccination. The outcome of recovered in Jan2021. the 2nd dose will be administered the week of 25Jan2021.   Information on the lot/batch number has been requested.
Swelling and severe soreness at the site of injection. Some itching developed. Onset was within 24 hours of receiving vaccination. Patient was seen by primary care provider and reaction was said to be allergic. Type not specified. No signs of infection or trauma at site of injection. Complete resolution of symptoms within 1 week.
Vaccinations administered 7/13. Mother reports rash began to thighs 7/17 and had spread significantly on 7/18.
Information has been received on 26-JAN-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 18-DEC-2006, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 27-AUG-2016, the patient was treated at a hospital for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed acetaminophen, hydrocodone bitartrate (NORCO) and acyclovir for management of his painful breakouts. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Patient reportedly received first dose of COVID vaccine (unknown manufacturer or lot #) on 2/2/21.  Patient was tested for COVID on 2/8/21 and resulted positive.  Patient was transfered to our hospital on 2/14/21 with complaints of hypoxemia and COVID 19 infection.   Patient required intubation, convelescent plasma, and 10 days of remdesivir therapy.  Additionally patient was treated with levofloxacin, Zosyn,  Augmentin, and vancomycin.  By 2/19/21 patient was extubated and recovering from COVID illness.  By 3/19, the patient was discharged home.
Dizziness, weakness, headache, cough increased sweating , confusion, difficulty speaking, and difficulty with coordination
I experienced a burning sensation in my chest. A few hours later, the burning sensation was accompanied by chest pain,  Today, day 2, there is a tingling sensation in my left arm. There is still a burning sensation in my chest (left side), albeit mild as well as intermittent pain.
sudden onset severe headache; head CT neg  LP;190 wbc; 5 rbc 16% PMN 84% mono; gram stain neg gluc 63 protein 47 diagnosed with asceptic meningitis 11/3/09:  Hospital records and Discharge summary received for dates of service 10/29/09 to 10/30/09.  Final DX:  Viral Meningitis.   Assessment:  Presented with sudden onset of severe HA that woke him from sleep, also had fever. A CT scan of the head was normal.  Lumbar puncture performed and c/w viral or aseptic meningitis.  Admitted overnight for observation.  Woke feeling fine the next day and was discharged to home.
Today morning one of the employee at nursing home had a reaction to Covid vaccine. I or technician gave the shot to her around 9 am to 9:15 am this morning initially she had no reaction to shot but around 10:30 am ( by this timewe were at the another clinic ) She called the nurse who was with us and informed us that she is having dizziness and feeling weird (we asked her to measure the blood pressure the reading was 122/99) then she mentioned she Is feeling good butin next 2 minutes she fainted and fell and hit her head on countertop then they called 911. My last conversation related to this incident was she is diagnosed with low blood pressure and they will do other test to make sure she is fine.
7/25/21 positive COVID test; pt died at home per death certificate of respiratory failure and COVID 19
No additional AEs; GARDASIL 9 was administered to a patient on 2/22/2023 after possibly being stored outside of it's recommended storage range. HCP reports that there were 16 days of no recorded temperature readings; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On 22-FEB-2023, the patient was vaccinated with an improper stored (after possibly being stored outside of it's recommended storage range) dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1775827 with expiration date of 27-JUN-2024, for prophylaxis (route of administration and frequency were not reported) (product storage error).    It was reported that there were 16 days of no recorded temperature readings and it was unknown if hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was out of range.  No additional events reported.  No further information was provided to further clarify any details.
Patient was given PENTACEL and HIB on the same day. He was given the PENTACEL with 28 days for Dtap. Pt was not due for vaccines.
This spontaneous report was received from a physician via company representative regarding unknown number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date the patients were vaccinated with PNEUMOVAX 23. Patient contacted physician to seek medical attention. No PQC (product quality complaint) was involved. No concomitant medication was reported. On an unknown date the patients experienced injection site pain. The outcome of injection site pain was reported as resolved. Causality was unknown. Additional information has been requested.
Information has been received from a physician concerning a 59 day old female who on 16-JUN-2008 was vaccinated with her first oral dose of ROTATEQ (human-bovine). Concomitant therapy included other routine 2-month old vaccinations. The physician reported that when the patient was vaccinated with her first dose of ROTATEQ (human-bovine) on 16-JUN-2008 vomited the entire contents of their stomach almost immediately after receiving the vaccine. The physician reported that the patient was given a re-dose of ROTATEQ (human-bovine) vaccine on 19-JUN-2008. Unspecified medical attention was sought. No product quality complaint.  Additional information has been requested.
Patient began to feel achy all over and tired within 1 hour of vaccine administration.  Symptoms continued and progressive achy all over effect with fever starting on Tuesday night with low grade temp.  Ibuprofen started to control fever, but unable to check due to out of town during episode.  Ibuprofen given throughout Tuesday night and Wednesday.  On Wednesday around 3pm patient started to complain of stiff neck, throat hurting and difficulty swallowing, low back pain, achiness.  Patient taken to ER on Wednesday night, spinal fluid checked at this time with negative for meningitis. Tylenol given in ER for fever of 101.  No other meds given at this time.  Patient began to feel better Thursday am.
It started by me going in and out of consciousness for approximately 1 minute while brushing my teeth at the bathroom sink, and then losing consciousness for 5 hours, during which I had a seizure, dislocated my left shoulder, suffered a mid-back strain, and chewed up my tongue.
I had a cough, congestion, a low-grade fever, very lethargic. I used a home COVID-19 test that came back positive. I called my doctor to have a telehealth visit, we discussed my symptoms. I asked her if I could get the PAXLOVID so that I could start the medication that day. I was able to start the medication the next day, by Friday of that week I was feeling better.
This spontaneous report as received from a pharmacist refers to a 61 year old female patient. The concurrent condition included high blood pressure. The medical history was not reported. On 14-SEP-2015, the patient was vaccinated with ZOSTAVAX (lot # L007222, Expiry: 03-JUN-2016). The concomitant medication was not reported. On 15-SEP-2015, the patient developed a cold sore on her lip. The patient sought medical attention by visiting the pharmacist. The patient was administered an unspecified antiviral medication on the same day to treat the event. The patient then developed a flat, red circle about the size of a half dollar at the injection site on 16-SEP-2015. No lab tests were performed. No rash was present. No treatment was given for the flat, red circle at the injection site. The action taken with the vaccine was not applicable. The outcome of oral herpes and injection site erythema was not resolved. The causality was not specified. Additional information has been requested.
Low grade fever; Body aches; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. This patient of unspecified age and gender received the first dose of BNT162B2 (lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation, and the second dose of BNT162B2 (lot number unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported.  The patient reported they received both doses of the vaccine and they experienced some really significant reactions of the vaccine; low grade fever and body aches for 36 hours, further reporting their test results were outside the upper limit of normal. The clinical outcomes of low-grade fever and body aches were unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
accidentally administered 1ml of the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (accidentally administered 1ml of the vaccine) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced INCORRECT DOSE ADMINISTERED (accidentally administered 1ml of the vaccine). At the time of the report, INCORRECT DOSE ADMINISTERED (accidentally administered 1ml of the vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not reported. Treatment information as not reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-090426, US-MODERNATX, INC.-MOD-2021-090611, US-MODERNATX, INC.-MOD-2021-090625 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090426: US-MODERNATX, INC.-MOD-2021-090611: US-MODERNATX, INC.-MOD-2021-090625:
FAST HEART BEAT; DIZZINESS; RINGING IN THE EAR; FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 18-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 fast heart beat. On MAY-2021, the subject experienced dizziness. On MAY-2021, the subject experienced ringing in the ear. On MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine  was not applicable. The patient recovered from ringing in the ear on MAY-2021, and the outcome of fast heart beat, dizziness and fever was not reported. This report was non-serious.
lesser known side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (lesser known side effect) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 VACCINATION COMPLICATION (lesser known side effect). At the time of the report, VACCINATION COMPLICATION (lesser known side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Fever, chills, nausea, body and joint aches, headache, fatigue
A report has been received from a Health Professional concerning a 52 year old, Female subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. It was reported that we inadvertently administered to patient of inappropriate age) which started on 05-Nov-2014. The outcome of the event of FLUMIST administered to a 52 year old patient is unknown. The report was considered to be non-serious.
My tongue felt like it was scolded and the back of it felt like it was swollen; This is a spontaneous report from a contactable consumer reported for herself. The 63-year-old female patient received first dose of bnt162b2 (BNT162B2, COVID 19, Brand: Pfizer, Lot number: El9262) , via an unspecified route of administration on 30Jan2021 10:00AM on left arm at single dose for covid-19 immunisation. Medical history included asthma, gastrooesophageal reflux disease (Acid reflux (GERD)), dry eye syndrome, fibromyalgia, osteoarthritis, pre-diabetic, allergies to medications, food, or other products and all from an unknown date and unknown if ongoing. Concomitant medication included colecalciferol (VITAMIN D [COLECALCIFEROL]) supplements, melatonin and allergy medicine. The patient experienced "my tongue felt like it was scolded and the back of it felt like it was swollen" (medically significant) on 30Jan2021 10:30AM with outcome of recovered with sequelae (Recovered with lasting effects). Therapeutic measures were taken as a result of the event included "IV Anti-histamine and prednisone I believe". She is not pregnant or not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The consumer reported that "Just after the shot I was fine while talking to my husband while waiting I had a fast onset strange feeling in my tongue and back of the throat. My tongue felt like it was scolded and the back of it felt like it was swollen." Ae resulted in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Pfizer-BioNTech COVID-19 Vaccine EUA Waves of vertigo Waves of tingling and numbness in lips, face, and extremities (especially left side) Heaviness in calves/feet
My daughter 13 year old received her second dose of the Gardasil 9 syringe vaccine on 6/30/2021 at pharmacy. The Lot#T028583 expiration date 03/04/2023 VIS Version Date 10/30/2019. The area of injection became a knot in her arm after and remained a hard lump for six weeks, slowly getting larger. Around the third week of August it became more red and more swollen. Her pediatrician saw her on 8/26/21 and my daughter had an ultrasound of the area on her arm and was prescribed Cephalexin 500mg 3 times per day for 7 days. The infection continued to grow more swollen and red while she was taking the antibiotic. She again saw her pediatrician on 9/2/21. The pediatrician changed her antibiotic to Clindamycin 300 mg for 10 days. The infection continued to grow and became an abscess. On 9/7/2021 I took my daughter to the Emergency room. The doctor there opened the abscess and drained it and advised that we should follow up with a pediatric surgeon as the infection may need to be drained again. I have many questions about this adverse reaction to the Gardasil 9 vaccine and what caused this reaction. Is she protected from HPV infection and what caused this infection?
Site: Pain at Injection Site-Severe, Additional Details: Patient (12YO Male) reported severe pain at site of injection beginning immediately after injection that radiated down his arm, causing him to have restriced movement from shoulder to fingers. Ice was applied and after consultation with mother, weight-appropriate OTC ibuprofen was administered approx. 10-15 min post-injection.  Patient reported that upper arm was feeling better but lower arm was feeling worse.  No respiratory symptoms were noted and patient was alert and able to communicate.