chrisvoncsefalvay/vaers-outcomes huggingface dataset:
April 8, 2021 at 10:00 pm, I began to develop side effects. I started having chills and shaking. I was freezing but had a temperature of 102 degrees. I began to have swelling in my left arm and it turn red around the shot area. At 12:40am I threw up and had diarrhea.  On April 9, 2021, I continued to pain and extreme swelling in my left arm. I had a 101 temperature the entire day. I need assistance walking. I could not operate a motor vehicle. April 11, 2021, I returned to a normal temperature but my left arm is in excruciating extremely red. April 12, 2021, My left arm is in excruciating pain swelling is unbearable.
STROKE/PARALYZED ON THE RIGHT SIDE; FEELING BAD; This spontaneous report received from a consumer via a company representative via social media (JNJ corporate) and concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administrated for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administrated 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, right away after vaccination, the patient felt bad, and within weeks she had a stroke. Then 5 months later, the patient was still paralyzed on the right side and was unable to speak (dose number in series 2).  The reporter stated that "My girl got the shots and started feeling bad right away and within weeks had a stroke and here it is 5 months later she is still paralyzed right side and cannot talk. Thanks to NO long term study and your rush to make a profit of our taxes given you plus all your write offs. Just act like nothing bad is happening. I see your commercials and turn it off that channel right away can't stand you". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stroke/paralyzed on the right side, and the outcome of feeling bad was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20221166495-stroke/paralyzed on the right side. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Swollen lips, tongue and gums an hour after the 1st dose, then swollen left eye lid and rashes on legs  4 hours after vaccination, Benadryl every 4 hours Swelling slowly subsided in 24 hours, rashes disappeared after 2 days
dizziness; chest pain; weakness; Patient received a 1ml dose; This spontaneous case was reported by a health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received a 1ml dose), DIZZINESS (dizziness), CHEST PAIN (chest pain) and ASTHENIA (weakness) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On 30-Mar-2021, the patient experienced ACCIDENTAL OVERDOSE (Patient received a 1ml dose). On 31-Mar-2021, the patient experienced DIZZINESS (dizziness), CHEST PAIN (chest pain) and ASTHENIA (weakness). At the time of the report, ACCIDENTAL OVERDOSE (Patient received a 1ml dose), DIZZINESS (dizziness), CHEST PAIN (chest pain) and ASTHENIA (weakness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
In Oct 2016 I received my yearly flu shot, I have never had a bad reaction, in the last decade of receiving this vaccine. That day my pharmacist suggested I also receive my pneumonia shot. I asked all about it, ex: can I use with my meds, will I get sick, etc. She said it is perfectly safe don't worry. So I said OK. Then the other pharmacist came out and injected my right arm with both because she said it can get a little sore sometime. If so do arm circles. I went home within 3 hrs I was doing arm circles and noticing a horribly sore upper arm, never had anything like that, then developed very high fever, very swollen upper arm, (at least an inch bigger than left), headache, chills, severe muscle pain throughout body, but my arm pain at site of shots was horrible, just brushing against it hurt bad, by the next morning my one red patch at shot site had turned into red, raised 1 inch patches that spread from my shot site, to shoulder, armpit, the whole way to my neck, I was covered in patches. I felt horrible all over, different than the flu, but with symptoms that were horrible, that day I saw my doctor. He said give it one more day to see if anything changed I was icing, taking fever meds, etc, finally the 3rd day my fever broke and my symptoms started to reverse. My arm was so sore, for at least five days before I could even stand it to be touched. It was a horrible experience, and 72 hrs of horrible pain physically. I reported this when I read my doctor paper, to help someone else, as well as the doctors, but then learned of your recording there is also compensation for my pain and suffering. I deserve that. Please send my information on that, when I called, they still sent me no response, or no call.
Fever 102, Chills, Swelling and redness in left arm, pain in left arm, loss of appetite, headache, muscle pain...irritated, could not sleep.
pt recvd vax; pt devel soreness in all joints; pt saw MD  & lab work did not cofirm rheumatoid arthritis;
She is a soccer player and runner with high exercise tolerance. Today she went to track practice. She experienced chest pain, dizziness, severe headache, nausea, and fatigue. She was not able to complete the workout. Heat was not a factor. She continues to have episodic chest pain, headache, and nausea the rest of the day.
WED MID MORNING GOT REALLY ITCHY,  GOT REALLY COLD, CENTERED IN THE TORSO AND HEAD AREA. ON THURSDAY 6PM SCRATCHING REPEATEDLY, FRI RASH PRESENTED AND CONSTANT ARM PAIN DEVELOPED WELPS AND HIVES TOOK BENADRYL DEVELOPED TEMP OF 99 THEN IT SPIKE TO 101.5 TOOK 2 EXTRA STRENGTH TYLENOL FEVER BROKE
Sore left arm between Shoulder and Elbow after first shot; Muscle pain left arm between Shoulder and Elbow after first shot/ Left arm never got back to normal after first shot/ She believes it is the muscle pain and not bone (Arthritis) pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm between Shoulder and Elbow after first shot) and MYALGIA (Muscle pain left arm between Shoulder and Elbow after first shot/ Left arm never got back to normal after first shot/ She believes it is the muscle pain and not bone (Arthritis) pain) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm between Shoulder and Elbow after first shot) and MYALGIA (Muscle pain left arm between Shoulder and Elbow after first shot/ Left arm never got back to normal after first shot/ She believes it is the muscle pain and not bone (Arthritis) pain). At the time of the report, PAIN IN EXTREMITY (Sore left arm between Shoulder and Elbow after first shot) and MYALGIA (Muscle pain left arm between Shoulder and Elbow after first shot/ Left arm never got back to normal after first shot/ She believes it is the muscle pain and not bone (Arthritis) pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received the Second dose on14-APR-2021 in the Right Arm  (Lot#  040B21A)  No Concomitant medications were reported. No Treatment information was reported.
patient was admitted to in patient psych with a negative test. Facility to receive patient required a test before accepting her came back +. Patient is asymptomatic.
Breakthrough case admission after 2 vaccines Pfizer 4/15/21 LOt# ER8729;  Pfizer 5/5/21 Lot# Ew0175
Within couple of minutes developed uneasiness, some tingling sensation, tachycardia and stomach queasiness. HR was 156, sats were 100 % on room air. Seemed to subside after 30 minutes . However throughout the rest of the day, waves of similar symptoms recurred predominantly tachycardia and GI along with skin sensitivity. Overnight did ok, but the following morning, again re urged with sustained tachycardia at which time sought ED evaluation. Had one episode in ED with HR in 151, other vital signs maintained. Received solumedrol and Benadryl. After treatment and monitoring without recurrence, discharged home on prednisone , Benadryl. Ativan if needed.
yesterday she gave the TYPHOID Vi vaccine that was 8 weeks expired with no adverse event; Initial information received on 17-Jun-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 years old female patient who was given TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] vaccine that was 8 weeks expired.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included YELLOW FEVER VACCINE LIVE (17D-204) (YF-VAX) for Immunisation.  On 16-Jun-2022, the patient received 0.25 ml total dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot T2A371M, exp date: 13-Apr-2022) via intramuscular route in the left deltoid for Immunization.  On 16-JUN-2022 the patient developed a non-serious event "yesterday she gave the typhoid vi vaccine that was 8 weeks expired with no adverse event" (expired product administered) following the administration of TYPHOID VI POLYSACCHARIDE VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This is a spontaneous case initially received from other health professional (pharmacist) on 05-Nov-2018, concerning a 64-year-old, adult, male patient. The patient's medical history and concomitant medications were not reported. On 08-Oct-2018, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252673, expiry date: 30-Jun-2019). On an unspecified date (reported as two or three days) after vaccination, the patient developed swollen lymph node on left side of his neck. The patient had been treated with antibiotics and anti-inflammatory agent. Even after the treatment, the swelling was still present. At the time of this report, the patient had not recovered from the event. The reporter assessed this case as non-serious. This case was considered as lost to follow up as the reporter did not provide consent for follow up.
No additonal adverse event; The patient was inadvertently administered a dose of PROQUAD that was expired; This spontaneous report was received from the office manager concerning to a 17 months old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On 20-MAY-2020, the patient was vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) lot # R030804, expiration date 22-APR-2020 (dose, frequency and route were not provided) for prophylaxis. No additional adverse events were reported.
Within 7 minutes of getting shot, I experienced a sharp pain radiating up my neck.  The pain then started moving down on my right side.  Within an hour the pain started radiating throughout my whole body.  The intensity of the pain in all of my muscles and joints was very sharp and intense, like when you throw your back out.  I also ran a low fever, and my pulse became very low.  I  had extreme fatigue and headache for two days.  Arm was sore for a week.
Large 3in x 2 in reddened area, hard, tender, hot to the touch.
generalized rash, looking like small pinsized red/dark pink dots on belly, back, surrounding penis, around mouth, and next to right eye; Age at Vaccination: 2 yo; This is a spontaneous report received from contactable reporter (Consumer or other non HCP).  A 2-year-old male patient received BNT162b2 (Pfizer-BioNTech COVID-19), on 29Jun2022 at 13:45 as dose 1, single (Lot number: FT9142) at the age of 2 years, in left leg for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included(in two weeks): FLUORIDE [SODIUM FLUORIDE]. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 29Jun2022 at 13:45, outcome "unknown", described as "Age at Vaccination: 2 yo"; RASH (non-serious) with onset 29Jun2022 at 15:45, outcome "not recovered", described as "generalized rash, looking like small pinsized red/dark pink dots on belly, back, surrounding penis, around mouth, and next to right eye". Therapeutic measures were not taken as a result of rash. Additional information: Within 2 hours of receiving vaccine, developed generalized rash, looking like small pinsized red/dark pink dots on belly, back, surrounding penis, around mouth, and next to right eye. Didn't seem to be itchy or bothersome. No fever. Patient had no known allergies. The patient had not received any other vaccine in four weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
PATIENT REPORTED EXPLOSIVE DIARRHEA FOR 1ST 24 HRS & FEELING VERY EXHAUSTED. ALSO HAD LARGE RED CIRCLE AT INJECTION SITE THAT WAS NOT PAINFUL OR WARM & SMOOTH,NOT RAISED.  STOPPED IN PHARMACY ABOUT 1 WEEK AFTER RECEIVING THE SHOT TO REPORT THIS REACTION.  RED CIRCLE ON ARM WAS ABOUT THE WIDTH OF A GOLF BALL, BUT AGAIN NOT SWOLLEN, NOT PAINFUL OR RAISED.  SHE WAS FEELING FINE SHE SAID AFTER THE 24 HOURS.
A 49 year old patient was inadvertently given the Fluzone High Dose vaccine; A 49 year old patient was inadvertently given the Fluzone High Dose vaccine; Initial information received on 18-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 49 years old female patient received 0.5 mL dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ253AB via unknown route in unknown administration site on 17-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccines received.   It was a case of actual medication error due to Inappropriate age at vaccine administration and overdose.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with the ZOSTAVAX vaccine by a physician at a clinic as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated at a medical clinic by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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. The outcome of the events was unknown. Additional information has been requested.
Pain behind eye vomiting, nausea; paresthesia of right fingertips, aching in thighs; No treatment.
Day of Vaccine, typical sore arm. Day2 sore arm & feeling out of sorts. Day3 started in the early am with N&V, chills, fatigue & later in the day diarrhea.  Slept off & on throughout the day, drank nothing but Gatorade, Gingerale & water.  That night had a temp of 100.8 took Tylenol. Day 4 fever broke able to stomach dry toast & later Chicken Noodle soup but still continued with diarrhea. Day 5 starting to feel a little better, tried to eat normally, but later continued to have diarrhea. From Day 6 to today (Day 12) I still continue to have some nausea & diarrhea & fatigue.
stayed home from school; Thursday she took him to get tested and he came out positive; feeling really tired and fatigue; didn't feel well; kind of body aches; This is a spontaneous report from a Pfizer sponsored program via contactable consumer (patient's mother) A 18-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on 02Apr2021, as a single dose for COVID-19 immunization. Patient's medical history and concomitant medications were not reported. It was reported that the patient did not have any symptoms on that day, and he came at home. He started feeling tired. The next day, patient started feeling really tired, fatigue, and didn't feel well with kind of body aches. On Sunday, he still felt bad. Patient's mother thought this was still prolonged. Monday, he wasn't feeling better and stayed home from school. Thursday, patient's mother took him to get tested and he came out positive. It was unknown that when he contracted COVID, and he was asymptomatic when he got the vaccine. Patient's mother was wondering how the vaccine would affect him if he had COVID when he was vaccinated. It was reported that patient's second dose was scheduled on 25Apr2021. It was unknown if the symptoms that experienced by patient were because of COVID or the vaccine. Outcome of the events COVID-19 and stayed home from school was unknown while for remaining events was not recovered.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021398129 same reporter/drug, different patient/AE
Information has been received from a physician concerning a 15 year old female, who on 11-DEC-2007 was vaccinated intramuscularly with a 0.5ml first dose of Gardasil.  Concomitant vaccinations included MENACTRA administered in the other arm.  On 11-DEC-2007 the patient experienced pain, redness, and swelling at the injection site.  The patient sought unspecified medical attention.  No laboratory diagnostics were performed.  The patient recovered on an unspecified date.  No product quality complaint was involved.  Additional information has been requested.
Information has been from a nurse practitioner concerning a female who was vaccinated with GARDASIL. Subsequently, she fainted in the office after receiving GARDASIL. The patient recovered. Additional information has been requested.
This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of LIQUID PEDVAXHIB for prophylaxis, lot# N000238 with expiration date of 25-OCT-2019, lot# N003701 with expiration date of 01-NOV-2019, lot# N008079 with expiration date of 02-DEC-2019, lot# N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot# N020613 with expiration date of 05-MAY-2020, lot# N002202 with expiration date of 04-NOV-2019, lot# N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ orally, for prophylaxis, lot# N000175 with expiration date of 20-SEP-2018, lot# N005618 with expiration date of 04-OCT-2018, lot# N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VATQA for prophylaxis, reported lot# M019924 with expiration date of 02-SEP-2018, lot# N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32°F (degrees Fahrenheit) to 35°F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier. Follow up information was received from the registered nurse 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patients' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to a male patient vaccinated with improperly stored ROTATEQ (oral; lot# N005618 with expiration date 04-OCT-2018) on 28-SEP-2017. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received from the same reporter(link reports: 1710USA004069,  1805USA001661, 1805USA004617, 1805USA004618, 1805USA004590, 1805USA004591, 1805USA004592, 1805USA004593, 1805USA004675, 1805USA004676, 1805USA004677, 1805USA004678, 1805USA004679, 1805USA004680, 1805USA004681, 1805USA004682, 1805USA004683, 1805USA004967, 1805USA004968, 1805USA004969, 1805USA004970, 1805USA004971, 1805USA004972, 1805USA004973, 1805USA004974, 1805USA004975, 1805USA004976, 1805USA004977, 1805USA004978, 1805USA004979, 1805USA004980, 1805USA004981, 1805USA004982).
Site getting continually redder, hotter, itchier and thicker over time now with darker red center,sore lump and too painful to scratch. 4 cm dia. induration.