chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She feels a little bit of chills and weakness; She feels a little bit of chills and weakness; Cold and hot feeling on [her] body; This is a spontaneous report from a contactable consumer (patient). This 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient experienced delayed symptoms after the first injection of the COVID-19 vaccine, received on 06Jan2021. Patient explained feeling fine the first three days post injection, and later on 09Jan2021 having "chills" and weakness. She then described her experience as "cold and hot feeling on her body". She felt good, her breathing was okay. Her oxygen and everything was okay. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Information has been received from a health professional concerning a 15 year old female patient who on 28-SEP-2011 was vaccinated IM with a 0.5ml dose of GARDASIL. On 28-SEP-2011 the patient experienced pharyngitis. Subsequently, the patient recovered from pharyngitis. It was unspecified if the patient sought medical attention. The reporter felt that pharyngitis was related to therapy with GARDASIL. Follow-up information has been received on 21-SEP-2012 from a physician (local reference # A201108242) concerning the same patient with no primary disease, concurrent conditions, past medical history or allergy. It was reported that on 28-SEP-2011 the patient was vaccinated with the first injection of 0.5 ml GARDASIL (batch # 9QN02R, lot # 0108AA, expiration date 26-JAN-2014) intramuscularly. There was no concomitant medication. From the evening (9 hours after vaccination) of 28-SEP-2011 the patient developed pain pharynx (so that she could not eat and swallow). On 29-SEP-2011, around noon, pain subsided and the patient could drink water. In the evening of 29-SEP-2011, the patient recovered from pain pharynx. On 28-NOV-2011, the patient received the second injection of GARDASIL (lot # not reported). The reporting physician felt that pain pharynx was definitely related to GARDASIL and there was no other factor. Physician's comment was stated as follows: The patient was not taking other medications and also judging from the temporal course of the onset and disappearance of the symptom, the event was considered to be adverse reaction to the vaccine. The reporting physician considered that pain pharynx was serious as other important medical event. Additional information is not expected.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On 14-OCT-2015, the patient was vaccinated with improperly stored dose of PROQUAD (Merck) (lot # K010211, expiry date 17-JAN-2016, dose, route of administration and anatomical location were not reported). No adverse symptoms were reported. The temperature excursion was due to daily vaccine counts that caused the storage unit to have temperature fluctuations because of door opening. This is one of several reports received from the same reporter. Additional information is not expected as no further follow-up is required.
This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration in Jan2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got their first shot in January and was then hospitalized with sepsis. Did not come out of the hospital for 35 days. Dates of hospitalization not specified. The patient also experienced arm hurt on an unspecified date. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on currently known drug safety profile, the reported event sepsis more likely represented intercurrent illness, but not related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.
Woke up the day after the injection with high-frequency tinnitus at a low level. The tinnitus worsened on day 2 after the injection to a point where I couldn't hear people speak very well. It sounds like constant, non-pulsing running water around the 14000 frequency level on multiple notes. It worsened on day 3 and my lower legs got pins and needles from the knees down. I canceled my activities for the day and called a friend who is a doctor, and he referred me to contact an ENT, whom I haven't had a chance to meet with yet.  Luckily by day 4 the pins and needles were gone, and the tinnitus is still there but is only about 25% as loud as it used to be.
Enlarged nodule under right armpit, numb feeling, approximately the size of a quarter sized marble.
GIVEN A DT SHOT LEFT DELTOID. COMPLAINED OF RED-HOT ARM. PAIN RADIATION DOWN ARM. SHOT GIVEN 5-24-04, AT 1230 PM. REPORTED SXS ON 5-26. SAID NOTED SHORTLY AFTER SHOT. HAD EVAL BY MD ON  5-26-04. TOLD TO USE BENADRYL AND ICE. TO GET TETANUS ONLY, IN FUTURE, INSTEAD OF DIP/TET.
Fever 103, WBC 23, pain at inj site, severe swelling/pain of axilla.  Occured 1 day post pneumovax/flu shot.  Pt admitted for fluids, supportive care. Diagnosed with arthrus reaction..pt most likely had received prior pneumovax in 2005. No sequelae.
Information has been received from a medical assistant concerning a pt who recently, in 2002 was vaccinated with pneumococcal vaccine 23 polyvalent. Concomitant therapy possibly included infleunza virus vaccine. In 2002, the pt developed a local site reaction after vaccination with pneumococcal vaccine 23 polyvalent. This is one of two reports concerning a total of four patients. It was noted that this pt was "a re-vaccinee." It was also reported that three of the patients possibly received "a flu vaccine" in the opposite arm on the same day (WAES0210USA02648). The pt sought unspecified medical attention. Additional info has been requested.
Reported fever, chills, fatigue, insomnia, shortness of breath, cough, sore throat, runny nose/nasal congestion, dizziness, diarrhea, nausea, vomiting, headache, weakness. Onset - 4 days post vaccination. Sought medical care. Hospitalized. Diagnosed with H1N1 infection about 1 week post vaccination. Had a miscarriage 1 week later, 2 weeks post vaccination. Patient was nine weeks pregnant at date of miscarriage.
During the night woke up with mild headache, took a Tylenol PM. Woke up, walked to kitchen then sudden dizziness, nausea and sweating began.  I sat in a chair and was unable to get up or pick up head for about 30 mins.  (disoriented, semi conscious)  Day after, (today) feels like after effects of a migraine episode I used to get. Very tired, low energy.
seizure; signs of confusion; Fever; shoulder pain; A spontaneous report was received from a husband, concerning a 26-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shoulder pain, fever, signs of confusion and a seizure.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unknown date, the patient received the first of two planned doses of mRNA-1273 intramuscularly (lot number: unknown). On 29 Jan 2021, the patient received the second of two planned doses of mRNA-1273 intramuscularly (lot number: unknown) for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient's husband reported that patient experienced shoulder pain, 10-12 hours later the patient started to have a fever.   On 30 Jan 2021, the patient had signs of confusion and then suffered a seizure and was taken to the hospital. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the events, shoulder pain, fever, signs of confusion and a seizure, were unknown.; Reporter's Comments: This case concerns a 26-year-old, female patient, who experienced a serious unexpected event of Seizure, non-serious unexpected event of Confusional state, and non-serious expected events of Pyrexia and Arthralgia. The events of Pyrexia and Arthralgia occurred on the same day after second of two planned doses  of mRNA-1273, lot # unknown. The events of Seizure and Confusional state occurred approximately 2 days after second of two planned doses of mRNA-1273, lot # unknown. Treatment information is not provided.  Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
puffy & mattered eyes; chest tightness & dyspnea, hives, general malaise, cough sx started w/in 3 hrs & lasted about 36 hrs; hives started @ about 24 hrs;
Parent called clinic to report child had several small raised red "bumps" on left leg, remembered nurse told him could be side effect of varicella vaccine but calling to be sure. Asked how long bumps take to go away and should any precautions be taken.
he tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 08Mar2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient got his first shot on 8Mar2021. However, he tested positive for COVID-19 on an unknown date in Mar2021, but now he was able to overcome it and tested negative on an unknown date in Mar2021. He was scheduled to get his second dose on 29Mar2021. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unknown date in Mar2021 and negative on an unknown date in Mar2021. The outcome of the event was recovered on an unknown date in Mar2021.  Information on the lot/batch number has been requested.
By noon of same day of injection, his same injection site left arm was in excrutiating pain, 'horrendous pain' and hard to move.  The pain radiated down to his wrist and throbbed with each heart beat. The symptoms remained internal with no external visual changes, lasting 4 days and diminishing over time to complete recovery at the end of the 4th day.  The patient did not call a physician nor visit a clinic/hospital, but did continue his acetaminophen that he takes for arthritis pain.  The patient states there were no other concomitant symptoms.  He phoned me to report this event on Saturday December 19th, 2020
This spontaneous report as received from a healthcare worker refers to a 48 year old male patient. The patient's medical history included stroke. The reporter informed that the patient thought that he was vaccinated with PNEUMOVAX dose 1, on an unknown date in 2012 (lot, expiry date and dose unknown). On 18-OCT-2013, the patient was vaccinated with PNEUMOVAX23 dose 2 (0.5 milliliters), via intramuscular route in left arm for vaccination. Lot number was reported as J010332 and expiry date 14-JAN-2015 (reported as unspecified). Concomitant therapies included hydrocodone (manufacturer unknown), acetaminophen(manufacturer unknown), insulin(manufacturer unknown), LYRICA, ZOLOFT and LIPITOR. On an unknown date in October 2013 the patient developed redness and swelling of the arm that continued for 10 days post vaccination. The outcome of redness and swelling of the arm for 10 days post vaccination was reported as already resolved at the time of report. The patient had contacted doctor office to seek medical attention. No treatment was provided for the events. Lab diagnostic studies performed were none. There was no intervention to prevent seriousness. No treatment was provided for the events. Lab diagnostic studies performed were none. There was no intervention to prevent seriousness criteria. The reporter informed that they did not have any documentation of the patient vaccination in 2012. Additional information has been requested.
pt recvd vax & w/in 12-15 hrs post vax pt exp generalized red & itch rash over chest & both arms;sx persist;
Pt called and stated she had fever and chills for 36 hours following vaccine, then had a sore, swollen arm today with redness.  She denies signs of rash or anaphylaxis.  Pt was advised to take NSAIDS/ice for swelling on arm and to call back if symptoms worsen.
When going to update database it was noted that the resident named had already received 2 doses of Pfizer earlier in the year of 2021.  Family POA stated to facility that resident did not received any of the vaccines until given in 12/21.  Family informed facility that they would look into her last stay facility to see if it was given while in another facility.  Family failed to provide the information of the vaccines given and even though database has it reported that she received the vaccine the family insisted that she receive the 2nd dose on 2/10/22.
contracted COVID-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (contracted COVID-19) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (contracted COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (contracted COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Patient contracted COVID-19.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   They are now eligible for a second booster dose per the prescribing criteria.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the unexpected non-serious AESI of COVID-19 (contracted COVID-19) which occurred unknown number of days after receiving the booster dose of mRNA-1273 Vaccine. The patient was also given the first two doses of mRNA-1273, dates of administration not provided. He qualified for and took Paxlovid. There was also no information regarding clinical course. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender, with no reported medical history, who experienced the unexpected non-serious AESI of COVID-19 (contracted COVID-19) which occurred unknown number of days after receiving the booster dose of mRNA-1273 Vaccine. The patient was also given the first two doses of mRNA-1273, dates of administration not provided. He qualified for and took Paxlovid under the EUA. There was also no information regarding clinical course. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
Patient had a fever followed by what was described as a seizure the day after shots. He was admitted to Hospital for 5 days. Records rec/d 11/7/2005 - no additional terms./sr
Approx. 30-60 seconds after receiving her first Trumenba injection, the nurse reported that the pt slouched over, had impaired consciousness, and began to have tonic-clonic movements of her upper extremities which lasted 5-10 seconds and was followed by a brief post-ictal state. I was the called to the room and approx. 1-2 minutes later the pt had another seizure-like episode, which I witnessed, identical to the first. The pt had not received any other vaccines.
C/o severe diarrhea w/cramps, SOB, which started on 10/13. Saw DR upon recommendation of nurse. Pt stated symptoms lasted x2 days, no Tx. Spoke w/DR, pt c/o dyspnea/diarrhea, but was not dyspenic at time of exam.
Received a first dose of the Pfizer vaccine back in May,received the Moderna vaccine on 25Aug2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received a first dose of the Pfizer vaccine back in May,received the Moderna vaccine on 25Aug2021) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.    Co-suspect product included non-company product (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   In May 2021, the patient received first dose of  (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 25-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received a first dose of the Pfizer vaccine back in May,received the Moderna vaccine on 25Aug2021). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Received a first dose of the Pfizer vaccine back in May,received the Moderna vaccine on 25Aug2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medications are provided. treatment to the events not reported. patient did not experienced any symptoms after taking vaccine.
Healthy man, previously high level athlete, semi professional in cycling and speedskating. Well controlled hypertension. Received 2nd Moderna vaccine 3/20/21. Developed severe neurological symptoms.  Strong tremors in the upper extremities at rest and with exertion, fasiculations of muscles in legs at rest. Severe weakness (whole body), unable to support upper body after repetitive exercise. No prior neurological diagnoses or symptoms before the 2nd Moderna vaccine. It has been 4 months without improvement.
This non-valid, spontaneous report was received from a registered nurse, referring to an unspecified number of patients of unknown age and gender. No information was provided regarding the patients' medical history, previous drug reactions, allergies, concurrent medical conditions or concomitant medications. On unknown dates, the patients were vaccinated with improperly stored doses of PEDVAXHIB lot number N034005 (expiration date 31-JAN-2020) and lot number reported as "N021920" (expiration date 07-FEB-2020) for prophylaxis (doses, routes and anatomical locations of administration were not reported). Additionally, the patients were vaccinated with ROTATEQ by oral route, lot number N005078 (expiration dates 22-NOV-2018 and 04-OCT-2018) for prophylaxis (doses were unknown), GARDASIL 9 lot number N020352 (expiration date 10-APR-2020) for prophylaxis (doses, routes and anatomical locations of administration were not provided) and M-M-R II for prophylaxis (dose numbers, routes and anatomical locations of administration were not provided; lot numbers N010496 [expiration date 31-MAR-2019], N014485 [expiration date 10-MAY-2019], and N023149 [expiration date 24-AUG-2019]). The vaccines were reconstituted with sterile diluent which was reported to be properly stored. The doses of all vaccines were exposed to a temperature excursion below 32 degrees Fahrenheit (F) (also reported as 31F) during a time frame of 15 days, which was detected by the Digital Data Logger. There was no prior temperature excursion and no adverse effects were reported. Follow-up information was received from the nurse on 17-DEC-2018. The reporter provided patients' demographics which made the case valid. This report refers to a 11-year-old patient of unknown gender. On 20-JUN-2018, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot number N020352 (expiration date 10-APR-2020). This is one of multiple reports received from the same reporter. Sender's Comments: US-009507513-1807USA011661.
Patient started feeling severe pain on left arm on February 26, 19 due to the shots he received on 02/25/19. He woke up with a Fever and headache as well. Patient's left arm was swollen, hot and Red as a tomato. Redness lasted for about a week. On Friday March 01, 2019 we noticed a bump the size - of a cherry under the left arm pit. I MOTHER TOOK PATIENT TO SEE HIS PEDIATRICIAN ON FRIDAY MARCH 08 2019 @ 4:30 p.m.  I EMPHASIZED EVERYTHING THAT HAD HAPPENED WITH PATIENT'S LEFT ARM AFTER HE RECEIVED THE VACCINE (MENINGOCOCCAL) DR. CHECKED PATIENT'S ARM PIT AND CONCLUDED THAT PATIENT HAS A CYST THAT MIGHT HAVE BEEN CAUSED BY AN INFECTION, DUE TO THE VACCINE. HE PRESCRIBED AMOXICILLIN FOR 10 DAYS. UNFORTUNATELY, THE CYST DIDN'T GO AWAY AFTER FINISHING THE MEDICATION THAT DR. PRESCRIBED.  PATIENT FEELS PAIN EVERY TIME HE TOUCHES THE CYST.  I WOULD LIKE TO MENTION THAT THE CYST HAS SHRINK FROM A CHERRY SIZE TO A 1-2 CM BLUEBERRY SIZE.
1-2 days after 4 year vaccinations (DTAP, IPV, MMR); complained of fever 102, emesis 3 x 2 and induration at the inoculation site ~ 3-4 inches.
Side effects started 3/30/2021 around 8 pm last night and continuing all day today:  Injection Site Pain, Headache, Fever, Chills, Body Aches/Pains, Nausea, Ear Pain
Prolonged numbness and pain in arm which vaccine was administered.  Recommended warm compress and topical analgesic.
Muscle tenderness, hardness from shoulder to elbow in vaccinated arm morning after vaccination, followed by onset of nausea, vomiting, dizziness, and headache at 4:45 pm day after vaccination. N/V resolved after a few hours. Tender, firm arm soreness, not at injection site, with rash continued > 48 hours after vaccination.
Pain in shoulder area, decrease of usage in deltoid and bicep and numbness. Sleeping is difficult. Believes neck muscle trying to compensate therefore stiff neck.
Patient received vaccine at 11:45am, shortly after vaccine administered patient began to have muscle spasm/contractors and then had an syncope episode that lasted approximately 2 minutes. Patient began to regain consciousness after approximately 3-4 minutes.Nurse took initial set of vitals at 11:50am; BP- 110/70, HR- 58, R- 14. Patient began to complain of shortness of breath/respiratory distress, turned pale and started profusely sweating. EMS was called at  11:54am.  Second set of vitals was taken at 11:56am; BP- 91/47, HR- 60, R-12, 02-35% room air. Nurse administered epipen 0.15mg to left thigh, mild to no changes in condition. EMS arrived on scene. Patient condition remained stable, and EMS transported to the hospital.