chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a 4-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions, or allergies was provided. On 10-APR-2017, the patient was inadvertently vaccinated with ZOSTAVAX 19400 plaque-forming units (PFU) (dose and route of administration were not provided; lot # M032360, expiration date: 18-AUG-2017) instead of VARIVAX. The dose of ZOSTAVAX was reconstituted with sterile diluent (manufacturer unknown) (lot# and expiration date were not provided). No adverse effect was reported. Additional information has been requested.
9 days after getting her shot we were admitted and transferred to medical center in PICU for 2 nights 3 days. We see a neurologist every year for facial/body paralysis.
Information has been received from a Physician's assistant concerning 3 patients who were vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck). No symptoms were reported. It was unknown if the patient sought medical attention. No further information is available.
About 30 seconds after injection was administered, the patient's face went blank and their head fell back. I took their mask off and they were snoring. I tried to get the patient to the ground and they started seizing and clutching at me. When the patient's knees hit the ground, they came to and asked what had happened. The whole incident took a total of less than 5 minutes. EMTs were called and they checked out the patient and confirmed their vitals were ok. Patient stayed for 30 minutes after incident for monitoring and had returned to normal.
Patient said his right arm was swollen and sore. He also stated that he had red streaking lines going around arm towards armpit. I suggest that he go to an urgent care or emergency room.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Patient fell and hit his head on a pole which resulted in minor cut-Medium, Additional Details: Patient was in line to pick up a prescription after recieving 2nd dose of moderna, became dizzy/lightheaded. Patient fell and hit his head on a pole and had a minor cut that bled a little. 911 was contacted. NP from medical facility measured patient's BP, HR and O2 which were all normal. Paramedics indicated also normal vitals but with low blood sugar. Patient stated he had not eaten all day and had a history of seizures 8 years ago for which he is not taking any medication.
After receiving the vaccine and waiting in the observation area, the patient became very lightheaded at approximately 15 minutes after injection. Her vision was blurred and she needed to lay down. She stated that this has happened before with another shot (not previous COVID vaccine; she did fine with those according to her statement). We gave her a bottle of water, checked her oxygen saturation and blood pressure which were both normal. After approximately 5 minutes of laying down, she felt much better. She was able to walk back to the observation area, where her mother sat with her for an additional 15 minutes. She left without problem.
pt recvd vax 28JAN93 & 30JUN93 pt devel intensified allergies which devel into bronchitis; pt was seen by MD; 19FEB93 sx had improved but declined further vax; No further details were provided;
pt recv vax & exp lt arm soreness & inability to use lt arm starting on 26JAN96;MD stated that inj was possibly intra-articular;sx have not been treated & cont as of 13FEB96;pt did not keep follow-up appointment;no addtl info is expec
Pt was hospitalized for COVID-19, hypoxia, sepsis, and acute kidney injury on 10/12/21 - 10/18/21
red rash around the shot site; red rash around the shot site that itches; red rash around the shot site thatitches and is slightly swollen; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0171) via an unspecified route of administration in the left arm on 07May2021 at 14:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. . Concomitant medication included prenatal (unspecified; MANUFACTURER UNKNOWN); from unknown date and just taking prenatal in case they decide. The patient previously took Tylenol and experienced drug allergy (sometimes). 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 vaccination. On 16May2021, 9 days after the shot, the patient had a red rash around the shot site that itches and was slightly swollen. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events red rash around the shot site that itches and is slightly swollen were not recovered at the time of this report.      No follow-up attempts are needed. No further information is expected.
Sharp pain shooting through the left side shoulder blade as well; everything on that side was kind of inflamed that was swollen and to the touch you couldn't touch it was painful; Sharp pain shooting through the left side shoulder blade as well; everything on that side was kind of inflamed that was swollen and to the touch you couldn't touch it was painful; Sharp pain shooting through the left side shoulder blade as well; everything on that side was kind of inflamed that was swollen and to the touch you couldn't touch it was painful; Sharp pain shooting through the left side shoulder blade as well; everything on that side was kind of inflamed that was swollen and to the touch you couldn't touch it was painful; Heart palpitations; Pressure in my chest area; Swelling on my left side underneath my arm around the rib cage; This is a spontaneous report from a contactable consumer (Patient) reporting for herself.   A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation; solution for injection, Lot Number: not reported), via an unspecified route in left Arm on 01Jan2021, as dose 1, single for COVID-19 immunization. The patient medical history included Thyroid condition, High Blood Pressure and Fibromyalgia and concomitant medications included Levothyroxine, Amlodipine. It was reported that, on 03Jan2021, the patient experienced sharp pain shooting through the left side shoulder blade as well; everything on that side was kind of inflamed that was swollen and to the touch you could not touch it was painful and on an unspecified date in 2021, she had Heart palpitations, Pressure in her chest area and swelling on her left side underneath her arm around the rib cage. Other medication that she took for high blood pressure, thyroid medication, and Pain relief for Fibromyalgia, she does not have any, but she does not take anything else, but supplements and lab Test was not had any test. She just has not totally back to herself again but no she was not experiencing those problems, they lasted for 7 days. The patient did not receive any treatment, but she did go to her physician because she was worried. The outcome of event was recovering (Improving with some persistence) for all events.  Information on the lot/batch number has been requested.
Mom and Dad reported child woke up crying, hot, acted like he couldn't focus on them. Bed was wet. Child was stiff and jerking a little bit.
Patient was given Pneumococcal 23 and should have received a Prevnar 13.
Received flu and pneumonia vaccine on 10-14-05. Both vaccines given in same arm due to pt preference. Pt noticed Left upper arm was red on 10-17-05. Area is approximately 3 inches by 2 inches on lower portion of upper arm. Is below where shots would have been given. Area red and warm to touch. No swelling noted.
My shoulder - left one where they administered it  - is sore and stiff. It has lasted for two and a half weeks so far and it still a low-grade pain when at rest and moving. And some movements are particularly painful.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2021 at 4:44 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 4:44 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 35.38 years.  Concomitant products were not provided.  On 23-Mar-2021, the vaccine with batch number 019B21A was moved to fridge. On 27-Mar-2021, 15 vials were moved to the clinic. On 28-Mar-2021 at 10 AM, vials underwent temperature excursion with temperature of 35 degrees Fahrenheit. The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 22-Apr-2021.  It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour.  It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree Fahrenheit.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Painful palms of hands and entire bottoms of both feet. Burning and inflammation type pain and extreme pain on contact (any use of hands and walking extremely painful). Lasted about 24 hours then began to subside (received shot on Friday, pain all day Saturday, gradually resolving on Sunday, gone by Monday).
Immunization for 2 months given today at 1130 am. Mom called at about 3pm, to report (R) leg was red and swollen, advised to bring baby in dr advised mom baby had localized reaction, mom instructed to apply ice to thigh 3 to 4 x a day and may give 0.4 mg of TYLENOL q 4-6 hrs until swelling goes down.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium
This spontaneous report as received from a physician refers to a 5 year old male patient. On 05-AUG-2014 the patient was vaccinated with a dose of VARIVAX, lot# K002913, 0.5 ml, subcutaneous. In August 2014 the patient experienced blanching, pruritic papules on his back after receiving VARIVAX. Patient was seen in an unspecified Emergency Room on 10-AUG-2014, for an unknown reason vaccine. "The outcome of the event was unknown". The physician requested lot check. This is one of several reports received from the same reporter. K002913 is valid for VARIVAX. Additional information has been requested.
Patient reports fever of 100.5 degrees Fahrenheit, aches, pain, nausea, and vomiting the day after she received her second dose of vaccine. Two days after vaccination, patient reports no nausea and no fever.
Case number PHEH2014US024333, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up report received from the nurse on 19 Jan 2015. This report refers to a 08 years old male patient. His medical history and concomitant medications were not reported. His past vaccinations (unspecified) were well tolerated. He was vaccinated with FLUVIRIN (batch number: 14511P expiry date: Mar 2015) intramuscularly in left deltoid at a dose of 0.5 ml on 05 Nov 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. Patient did not experience any adverse event. No adverse event was reported following this medication error (incorrect storage of drug). Follow up report received from the nurse on 19 Jan 2015: Updated vaccination history, recent vaccination site and reporter's statement.
About 30 minutes after the shot, I started to have shortness of breath and chest tightness. It lasted about 10 minutes and went away. Two hours later, I began to have jerk motions on the left arm. I rested and woke up on day two with mild vertigo and headaches. The shortness of breath returned two days after the shot with soreness to the chest while taking deep breaths. I also have stiffness to my left arm and left leg. The shortness of breath is worse while climbing stairs or talking. Day 3, these symptoms became worse with movement. I?m currently reaching out to my doctor for a visit for an assessment.
Developed a blood clot in his arm; Had afib; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A male patient in his 50's received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant), outcome "unknown", described as "Developed a blood clot in his arm"; ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "Had afib". Therapeutic measures were taken as a result of thrombosis. Clinical Course: The doctor himself was sharing his own personal story; the physician who reported this was the patient also and stated he had developed a blood clot in his arm so he was being treated for that and about three weeks later he had afib and these events occurred after his Pfizer COVID vaccine. Reporter had no patient details to provide but stated that she guessed about his height and weight as she saw him every week. The patient was probably in his 50s and was otherwise healthy. The reporter did not had had the lot number at the time of reporting to provide.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events (THROMBOSIS, ATRIAL FIBRILLATION) and 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300180253 Same product, different patient;
Loss of appetite evening of 2/11/2021. 6:30 AM 2/12/21 became weak, diaphoretic, blood sugar 474, primary care physician contacted, instructed by physician on call to go to the Emergency Room, IV fluids, insulin in ER, admitted
Information has been received from an unspecified health care professional, referring to multiple unspecified patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the multiple unspecified patients were vaccinated with an improperly stored doses of PROQUAD lot # M032496 and expiration date 02-JAN-2018 (dose, administration route and anatomical location were not reported) for prophylaxis. No adverse effects were reported. The vaccine had one temperature excursion of 7.1 Fahrenheit (F) for 1 hour and a previous excursion of 6.4 (F) for 3 hours; with a data logger involved. This is one of several reports received from the same source. Additional information is not expected because the reporter did not want to be contacted. Sender's Comments: US-009507513-1701USA001223: US-009507513-1701USA001224.
Experienced ringing in ear; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 26Mar2021 at 01:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously took sulfamethoxazole/trimethoprim (BACTRIM), vancomycin (MANUFACTURER UNKNOWN) and cefaclor (CECLOR) for unknown indication on an unknown dates and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 26Mar2021, the patient experienced ringing in ear. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were not taken as a result of reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of ringing in ear was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
headaches everyday/ Headaches will stop for a little bit and will come right back/ Head is aggravated; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches everyday/ Headaches will stop for a little bit and will come right back/ Head is aggravated) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced HEADACHE (headaches everyday/ Headaches will stop for a little bit and will come right back/ Head is aggravated). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (headaches everyday/ Headaches will stop for a little bit and will come right back/ Head is aggravated) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.  Treatment drug include Tylenol  Action taken with mRNA-1273 in response to the event was unknown
Severe body aches, fever, joint pain, headaches, fatigue. Began day of vaccine at night. Symptoms have worsened over time.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies provided. On 15-MAY-2017, the patient was vaccinated with an expired dose of M-M-R II 0.5 ml, once, subcutaneously (lot # L004656 and expiry date 11-FEB-2017) reconstituted with sterile diluent (STERILE DILUENT). No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Sore arm at site of injection; Some mild muscle/shoulder aches; Some mild muscle/shoulder aches; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Sore arm at site of injection), MYALGIA (Some mild muscle/shoulder aches) and ARTHRALGIA (Some mild muscle/shoulder aches) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In September 2023, the patient experienced VACCINATION SITE PAIN (Sore arm at site of injection), MYALGIA (Some mild muscle/shoulder aches) and ARTHRALGIA (Some mild muscle/shoulder aches). At the time of the report, VACCINATION SITE PAIN (Sore arm at site of injection), MYALGIA (Some mild muscle/shoulder aches) and ARTHRALGIA (Some mild muscle/shoulder aches) outcome was unknown.            Concomitant product use was not provided by the reporter.  After receiving Moderna Vaccine in first 48 hours patient experienced sore arm at site of injection, some mild muscle/shoulder aches. The patient had nothing that has interfered with daily activity.  Treatment information was not provided.
CHEST PAIN (HAS PACEMAKER); CHEST PRESSURE; LETHARGY; DRY HEAVES; FEELING TIRED; DIARRHEA; VOMITING; FEELING VERY WEAK; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213021A expiry: UNKNOWN) dose was not reported, administered on 24-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-DEC-2021, the patient experienced chest pain (has pacemaker), chest pressure, lethargy, dry heaves, feeling tired, diarrhea, vomiting, and feeling very weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling tired, diarrhea, chest pain (has pacemaker), and chest pressure, and the outcome of vomiting, lethargy, dry heaves and feeling very weak was not reported. This report was non-serious. This case, from the same reporter is linked to 20211237999.
DEAD; This spontaneous report received from a consumer via a company representative via social media concerned 03 multiple patients. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patients were healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients died from unknown cause of death. It was unknown whether an autopsy was performed or not. It was reported as "Johnson & Johnson Stop with your bs concern J&J. You ARE the problem. You have killed more than you have helped. 3 healthy dead in my circle after J&J jab. Stop lying" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221166018- Dead. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH