chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hearing loss; Vertigo; Dizziness; nausea; This is a literature report.  A 61 year-old female patient (unknown if pregnant) received bnt162b2 (COMIRNATY) (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: DEAFNESS (medically significant), outcome "unknown", described as "Hearing loss"; VERTIGO (non-serious), outcome "unknown", described as "Vertigo"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; NAUSEA (non-serious), outcome "unknown", described as "nausea". The events "hearing loss", "vertigo", "dizziness" and "nausea" were evaluated at the physician office visit.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event and suspect drug BNT162B2 cannot be excluded. 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.
Headaches, dizziness, stuffy nose. Headaches have come and gone since 10/26/21 and have lingered longer than any other side effect
Two hours after vaccine was administered, headache and neck pain onset. Six hours after vaccine, full body aches and chills onset as well as redness and swelling at the injection site. Eight hours after vaccine, fever onset and reached 101 degrees before breaking approximately 18 hours after the vaccine was administered. Patient called the Nurse Advice Line to try and determine vaccine adverse reaction versus incidental infection, nurse advice line advised likely adverse reaction to the vaccine given no known exposures to any individuals with COVID. No clinical treatment sought as fever broke by the morning after receiving the vaccine.
12pm 9-5-07 received Twinrix - sharp pain in stomach, then L arm & hand tingly, then L side numbness whole body.  L arm, leg & face no drooping on face.  Symptoms lasted 1 hour, gradual regression.
Itching, redness, and hardness/swelling (2-inch diameter) at injection site (right upper arm).  This progressed over 5 hours to redness and hardness/swelling of inside and back of upper arm along with pain in upper arm and in armpit lymphnode.  Swelling/redness progressively moved down upper arm to include inside of elbow area over next two days (through 11/08/2012).  Area feels warm to touch.  Patient went to Urgent Care at 6:00 PM on 11/06/2012 and was advised to take Benadryl and Aleve.  Patient was advised on 11/08/2012 by nurse to make appointment with Infectious Disease doctor for followup.
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
5-6 cm red, raised local reaction @ inject site immediately following inject; pt given APAP & DPH-cool compress applied to site;
The patient comes in today for swollen arm. He was seen for his checkup on 10/11/2010, 2 days ago, and mom noticed almost immediately there was some redness to his arm. It was a very small amount, approximately a dime size the first night, the second day it seemed to get larger and this morning seemed to be much beefier and redder. Mom gave a dose of MOTRIN, I believe earlier this morning and it seemed to help a little bit. He is a little tender to the area but better now. He has had a no respiratory distress. No coughing, no vomiting or diarrhea. The rest of his review of systems is negative. He has allergy to Penicillins and Cephalosporins, questionable allergy to BIAXIN but has done well with ZITHROMAX. Significant for the allergies as well as iron deficiency anemia, recently much better. Mom also reports today that he had what sounds to be an allergic reaction approximately 1 month ago, did not involve any respiratory distress. He was quite puffy and needed BENADRYL. There was also another reaction when he was an infant that sounded very similar. Temperature 98.2, heart rate 84, respirations 20, weighs 42 pounds. Exam was limited to his arm. Left arm has normal circumference, however, in the area of the vaccine, particularly the MMR and varicella vaccine, there is an area of redness and slight edema that is approximately 3.5 cm x 1.5 cm. There is another area of redness that is a slight pinkish hue without edema that is approximately 5 cm x 5 cm. Area is not indurated and is not particularly tender to touch. The area of the actual injection site is also just slightly puffy as well without drainage. Allergic reaction to the immunization. Told mom this is not infection at this point, this is an allergic reaction, maybe to component of the vaccine and possibly even to our shot blocker that is used during the vaccination process. Looking at his other vaccine he received that day he also has erythema from the Band-Aid itself, although was latex free. Clearly, the patient is a very sensitive child with some allergy history. He was given 2 teaspoons of MOTRIN today. I also wrote instructions for mom to give one and a half teaspoons of BENADRYL 3 times a day for the next 2 days and then go down to b.i.d. for the next 2 days. Do the same with MOTRIN 2 teaspoons 3 times a day for 2 days and then go down to b.i.d. I asked mom to call us in 48 hours, give us a progress report. It should only improve with these measures. If it seems to worsen, there is a possibility that he would require steroids. Lastly, regarding this current allergic reaction as well as the two that mom described today, I think we should probably do an allergy panel on him. He is due for anemia labs and plan is for mom to bring him back at some point to do anemia labs including his electrophoresis as well as a full allergy panel including environmental and food allergies.
This spontaneous report was received from a nurse, reporting on multiple unspecified patients of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications. On unknown dates, the unspecified patients received unspecified doses of improperly stored VARIVAX lot # N012134 and expiration date 17-APR-2019, lot # N002204 with expiration date 19-JAN-2019, for prophylaxis; GARDASIL 9, lot # N022584 with expiration date 15-JUN-2020, lot # N020353 with expiration date 28-APR-2020, lot # N019103 with expiration date 03-FEB-2020 and lot # N021732 with expiration date 01-FEB-2020, for prophylaxis; M-M-R II albumin status of rHA (recombinant human albumin), lot # N023153 with expiration date 24-AUG-2019 and lot # M039914 with expiration date 26-SEP-2018, for prophylaxis; PNEUMOVAX 23 lot # R002085 with expiration date 26-OCT-2019; and ROTATEQ lot # N013989 with expiration date 30-JAN-2019 and lot #  M041184 with expiration date 31-MAY-2018 for prophylaxis (the dose and route of administration on any of the vaccines were not reported). Sterile diluent that was properly stored was reported to have been used to reconstitute VARIVAX or M-M-R II albumin status of rHA. No adverse effects were reported. The data logger registered the following temperatures: VARIVAX was stored at a temperature ranging from -14 Celsius degrees to -10 Celsius degrees, for 1723 minutes (28 hours 43 minutes). Then, M-M-R II albumin status of rHA, GARDASIL 9, PNEUMOVAX 23 and ROTATEQ were stored at a temperature ranging from 9 Celsius degrees to 25 Celsius degrees for 4 hours 22 minutes.
Positive for Covid after receiving the vaccine; Positive for Covid after receiving the vaccine; This is a spontaneous report from a Pfizer Sponsored Program. This consumer reported similar event for two patients. This is the 2nd of 2 reports.    A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), via an unspecified route of administration on 22Dec2020 at a single dose for Covid-19 immunization.  The patient medical history and concomitant medications were not reported. On an unspecified date, the patient was positive for Covid after receiving the vaccine. It was reported that patient was positive and they were all in the breakroom without a mask. The patient (person that is positive) got the vaccine and got worse, so co-workers are thinking that she (patient) had the virus before getting the vaccine and just didn't have any symptoms. Outcome of the events was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020518090 same reporter/drug, similar event, different patient
Information has been received from a healthcare worker referring to a patient of unknown age. The patient was vaccinated with ROTATEQ (dose 1 on 18-NOV-2015, lot number # L008059, expiration date 18-DEC-2015, dose 2 on 14-JAN-2016, lot number # L013202, expiration date 27-JAN-2017 and dose 3 on 19-JAN-2016, lot number # L013202, expiration date 27-JAN-2017). No adverse effect was reported. Additional information has been requested.
After 1st vaccine it was just like I had COVID all over again - severe headache lasting 48 hours, sweaty/cold, diarrhea.  After 2nd vaccine severe body aches, extreme fatigue, sweaty/cold and diarrhea.
104 Fever on the 23rd-27th  Rash breakout on the 28th-29th Extreme fatigue 23rd-30th Zombie like 23-30th
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 07-NOV-2014, a physician administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 29-OCT-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Patient reports a rash at site of injection and on back of right leg and arm. It is itchy and the site has a knot now.
Patient states immediate itching at site with after needle removed. then area hot to touch swollen and red for 3 days. reaction remained localized. Denies fever. Nausea, vomiting.
The Shingrix wasn't diluted with the correct type on 07/27/2022.  No adverse event happened to the patient. Per CDC this dose was invalid and the patient returned on 07/28/2022 for an other dose of Shingrix same lot number.  No treatment was needed
injection site soreness onset 2/6/2021 at 8:30pm lasting until 2/9/2021 10:00am 101.2-102.1 temp -- onset 2/6/2021 at 10:30pm lasting until 2/8/2021 10:00am Severe body aches and chills from 2/6/2021 at 10:30pm lasting until 2/8/2021 10:00am fatigue from 2/6/2021 at 10:30pm lasting until 2/8/2021 7:00pm
This spontaneous report as received from a other health professional refers to a 12 month old patient. The patient's medical history and concurrent conditions were not provided. On 11-MAY-2017 the patient was vaccinated with M-M-R II (dose and route of administration were not reported, lot # L026551 with expiration date: 16-JUL-2017). Other suspect therapies included STERILE DILUENT and PROQUAD (dose and route of administration were not reported, lot # L050910 with expiration date: 14-JUN-2017). Concomitant medications were not reported. The nurse reported patient received a simultaneous administration of M-M-R II and PROQUAD both reconstituted with STERILE DILUENT. No adverse effects reported. Additional information has been requested.
Breakthrough case admission after 4 vaccines Moderna 2/3/21 Lot# 029L20A; Moderna 3/3/21 Lot# 0002121A;  Moderna 10/23/21 Lot# 011F21A; Moderna 4/25/22 Lot# 005M21A
At approzimately 2:00pm, patient returned to the flu clinic and advised me she had begun to have hives. There were two small areas, one behind her left ear and one on her right jaw line. She also said she was itching and her chest was a little "tight". She reported she had taken one Benadryl pill at approximately 1:30pm with no relief. I gave her 0.5 mL of Epinephrine by IM in her left Deltoid. I took her BP immediately thereafter at 2:03pm. BP was 112/80. Pulse was 80. I then called 911 and reported the incident. Rescue was dispatched. I rechecked her vitals at 2:15pm, which were: BP 114/74, Pulse 78. She opted not to have a second injection of epinephrine, saying she felt a little better, just shaky. Rescue and fire dept. arrived and checked her out. She refused any further medical care, saying she would have her mom take her home. She met with site contact, and left shortly after. Last report from rescue gave her vitals as: BP 155/92, HR 60, Oxygen at 100%. I reported incident at 2:08pm.
Vax 2/16/2021, Extreme, deep, ongoing shoulder pain began 2/17/2021  which continues unabated and propmted me to visit to the Emergency Room on 2/27/2021 after consulting the Dr by phone. Follow up visit with the Dr verified circular pattern and persistent intolerable pain, which continues as of today, March 4,  AM VERY UPSET AND CONCERNED WHAT TO DO?  Please advise. The patient.
Fever of Tmax 100.5, chills and headache 24 hours after receiving the covid vaccine
Splitting headache, vomiting, arm swelling as big as a golf ball and hot to the touch at injection site and itching like fire. It's still bruised 8 weeks later.  This was all after the 2nd shot. I had severe joint pain all over my body and my hand of the arm I got the shot in swelled and was stiff a couple days. I had a severe genital herpes outbreak about 9 days after the 2nd shot. I have not had an outbreak for over 10 years prior to the vaccination and the medicine I have used previously, Acyclovir, isn't working at all. Can this be a result of the vaccination?
The patient called today complaining of severe soreness in her arm; She states she cannot even move her arm.; she has a fever of 100, nausea, and chills; she has a fever of 100, nausea, and chills; she has a fever of 100, nausea, and chills; This spontaneous case was received from a pharmacist referring to non-pregnant 67-year-old female patient. The patient's concurrent conditions and medical history were unknown by the reporter. Her concomitant medication included acetaminophen (+) oxycodone hydrochloride (PERCOCET), lorazepam and "AFTADATIN". The patient's allergies included cefiderocol (FETROJA) and cefiderocol.   On 16-AUG-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) at a dose of 0.5 milliliter once, intramuscularly as immunization against pneumococcal disease (injection site, anatomical location was not provided; lot number T007790 has been verified to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent) with an expiration date on 03-DEC-2021).  On the same date about an hour after vaccination, the patient experienced severe soreness in her arm (pain in extremity). She stated she could not even move her arm (movement disorder). Also, she had a fever of 100 (units not reported), nausea, and chills (pyrexia, nausea and chills). She used an ice pack on her arm to relieve the pain and acetaminophen (TYLENOL). The patient call to her primary doctor to make him aware of her symptoms, but she left a message with the nurse and had not heard back yet. She was wanting to know if these are normal side effects of the vaccine.   At the reporting time the patient had not recovered from pain in extremity, movement disorder, pyrexia, nausea and chills.  The causal relationship between the aforementioned events with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: T007790; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
This case was reported by a pharmacist via call center representative and described the occurrence of nasal irritation in a 78-year-old female patient who received SHINGRIX (batch number 27K24, expiry date 2nd February 2021) for prophylaxis. The patient's past medical history included nasal operation (a few weeks before receiving the SHINGRIX). On 27th June 2018, the patient received SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced nasal irritation. On an unknown date, the outcome of the nasal irritation was not recovered/not resolved. The reporter considered the nasal irritation to be possibly related to SHINGRIX. Additional details were provided as follows: The patient complained of irritation on the bridge of their nose about 1 week later receiving vaccination. No additional information was provided.
patient states she had nasuea, vomiting and headache that night of the vaccine. The next day she said she felt achey all over her body and felt bad. Today at day 10 she said her arm is red, has a lump at injection site and is itching. She reported this to vsafe also.
No adverse event; Gave 0.25 of the Bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Gave 0.25 of the Bivalent booster) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Patient had comorbid conditions.     On 29-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 29-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Gave 0.25 of the Bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Gave 0.25 of the Bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Gave 0.25 of the Bivalent booster).    Concomitant medication information was not provided by the reporter.  It was reported that on 29-Sep-2022, a technician gave 0.25 of the Bivalent booster to 5 patients.  Treatment information was not provided by the reporter.  This case was created for elderly patient 1.   This case was linked to US-MODERNATX, INC.-MOD-2022-654608, US-MODERNATX, INC.-MOD-2022-654609, US-MODERNATX, INC.-MOD-2022-654610, US-MODERNATX, INC.-MOD-2022-654611 Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654608:Patient 2 US-MODERNATX, INC.-MOD-2022-654609:Patient 3 US-MODERNATX, INC.-MOD-2022-654610:Patient 4 US-MODERNATX, INC.-MOD-2022-654611:Patient 5
Information regarding influenza virus vaccine was received from a 41 year old female consumer who experienced severe joint pain within 24 hrs of vaccination. . At 40 years of age, the pt received a dose on an unspecified date in 2002. No additional info was available at the date of this report.
Localized reaction, rapid heart rate, high blood pressure, nausea, vomiting, dizziness, swollen cartilage in shoulder.
No initial adverse effects. Soreness on day 2. Headache on day 2.  101 fever day 3 with chills, nausea, fatigue and sever  cough.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were unknown. On an unknown date, the patient was vaccinated with a partial dose of PNEUMOVAX 23 (dose unknown, lot# M022947, expiration date: 12-NOV-2017) intramuscularly, due to dose leaking between the syringe and the needle hub. The nurse reported that she aspirated the PNEUMOVAX 23 from a vial into an administration syringe and failed to properly attach the needle to the administration syringe. The patient had not experienced any adverse effects. Additional information has been requested.
Pfizer vaccine was administered outside of entity - reported by patient  I21.4 ACUTE NON ST ELEVATION MI 2/27/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 4/17/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/17/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED R09.02 HYPOXIA 2/27/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I21.4 ACUTE NON ST ELEVATION MI 2/27/2021 ACUTE NON ST ELEVATION MI I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 4/17/2021 ACUTE NON ST ELEVATION MI J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/17/2021 ACUTE NON ST ELEVATION MI R09.02 HYPOXIA 2/27/2021 ACUTE NON ST ELEVATION MI