chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Un able to walk, unable to sit straight, very weak and not responsive. I call Doctor office I was told to take to Urgent care. I could not move her. I call emergency paramedic came. reassure me she was not having stroke or heart attack. She probably was having reaction to Booster shot. to let her rest. Next day she was able to walk
This spontaneous report as received from a medical assistant refers to a patient of unknown demographics. No information about medical history, drug reactions and allergies was specified. Medical assistant reported that a patient was administered an improperly stored dose of VARIVAX (lot#, dose, frequency, route, indication not reported) on 07-AUG-2014. No concomitant medications were reported. No adverse events were reported. There was no product quality complaint. Additional information has been requested.
A pharmacist reported that a 40 year old female received an IM injection of Flu Shield on 02/20/01. The patient was noted to have "Flu symptoms" at the time of the vaccination. Two days following vaccination, on 02/22/01, the patient was admitted to an ICU in an unconscious state. The reporter thought that the patient was intubated and she was unarousable. She was treated with Acyclovir and unspecified antibiotics.
Shortly after 6 vaccine injections were given today, her cousin states that she got up from the table and felt nauseated and vomited and passed out completely, landing on the floor and hitting the back of her head against the bottom of the IPAD stand, and then regained consciousness almost immediately and felt weak. At that point cousin stepped out of the room and asked for help. Dr and Dr along with the clinical nurse supervisor and MA's went into the room immediately and patient was getting up with assistance from cousin. Rapid response was called and immediately after Urgent care nurse and urgent care provider also arrived. Incident was noted to have occurred at 10:10 am. Blood sugar was 90. She was noted to be alert and oriented with strong pulses and regular rhythm and even respirations. Initial BP 100/62, pulse 72, temps 94.9° F, respiratory rate 16, O2 sat 100% pain 0 out of 10. She was given some food and a repeat BP was 102/70 pulse 80, respirations 16, 02 sat 100% pain 0 out of 10. Orthostatic BP were taken 15 minutes later, prior to discharge and were at the same at 100/70 and 100/59. She then left with cousin, was back to her usual self.
5 minutes after vaccine administration, patient complains of throat tightening. Given IM Benadryl 100mg in clinic. Patient taken by ambulance to ER.
The patient received 0.8ml of the covid 19 vaccine instead of the 0.3ml dosing for their age group on 11/1/2021 at 3:52pm. The patient  also received a second dose on 11/22/2021 with th ecorrect dose of 0.3ml.
Patient was given his 0.25mL dose of Moderna COVID-19 and his mother's 0.5mL dose of Moderna COVID-19. LPN was aware of the error as soon as she went to enter lot numbers into the chart.  Notified provider, provider notified family.  Pt appeared well 15 minutes after vaccine was given.  Discussed things to watch out for including hives, increased respiratory rate, chest pain, shortness of breath and fever.  Encouraged ER visit with any of these symptoms.  Mom verbalized understanding.  Recommended waiting to complete influenza vaccine (1-2 weeks).
Neurological problems, convulsions, twitching, pain, irritability, decrease in immunity.
Unusual strong urine odor, extreme change in taste and smell, mostly a metallic berry taste for all food and drinks, other foods and drinks leave a very stale and unpleasant taste to where I have had to change my diet tremendously, all fuels have a bold and nauseating smell. Headaches have become very frequent.
Child received varicella vaccine 11/07/2000 on 6/15/2004 he had clinical chickenpox
I expected possible side effects from getting the vaccine. I had a fever of 102° F beginning about 12 hours after inoculation, lasting about 36 hours, then an unrelenting severe headache lasting about 20 hours along with fatigue and weakness. I also experienced muscle/joint aches and nausea throughout the first 72 hours. All somewhat expected but to a greater degree and longer lasting than the many. What was not expected, and which began after about 48 hours after inoculation, was hyperhydrosis (even after fever was gone), lightheadedness, imbalance, intermittent palpitations and a neurologic tingling and buzzing in my body. Some of these are symptoms I experience intermittently with Long Covid, but they had been heightened by the vaccine. These symptoms along with the headache and muscle/joint aches continue though not as severely today, four days after receiving the vaccine. I do not believe these symptoms are due to any issue with the vaccine itself, but rather my pre-existing condition of Long Covid. To my knowledge there is no data on people with Long Covid getting the vaccine and I felt it was important to report my experience and unusual adverse reactions to the vaccine. Again, the vaccine had such a severe or prolonged reaction.
arm was very painful; fatigue; body aches; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was very painful), FATIGUE (fatigue), MYALGIA (body aches) and HEADACHE (headaches) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A or 0BM20A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMIN [VITAMINS NOS] and BETA VULGARIS, FOLIC ACID, MALUS SPP. VINEGAR EXTRACT, PUNICA GRANATUM, VITAMIN B12 NOS (GOLI APPLE CIDER VINEGAR) for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was very painful), FATIGUE (fatigue), MYALGIA (body aches) and HEADACHE (headaches). At the time of the report, PAIN IN EXTREMITY (arm was very painful), FATIGUE (fatigue), MYALGIA (body aches) and HEADACHE (headaches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medications were reported. No medical history was provided by the reporter.   This case was linked to MOD-2021-404309, MOD-2021-404413 (Patient Link).
Large reddened area at injection site, occurring about 10 days after the injection. Slightly tender and somewhat itchy
Patient called about 4:30pm 10/7/2020 and reported tingling in hands and feet and tiredness. He did not have any reaction at the injection site. He did not have trouble breathing. Patient wondering if it may be a Guillain Barre Syndrome reaction. He was going to call his doctor and if he could not reach him he was going to go to Emergency Dept.
a patient received a 1 mL dose of Fluzone Quadrivalent instead of a 0.5 mL dose, no AE.; Initial information was received on 23-Sep-2020 regarding an unsolicited valid non-serious case from a Nurse.  This case is linked to cases 2020SA263271, 2020SA263260 and 2020SA263223 (same reporter).  This case involves a 64 years old male patient who received a 1 mL dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUAD T] instead of 0.5 ml (overdose).  Medical history, medical treatment, vaccination, and family history were not provided.  The patient did not receive any other vaccine concomitantly.  On 22-Sep-2020, the patient received 1 mL dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [lot UJ475AA, expiry date: 30-Jun-2021] instead of 0.5 mL via an intramuscular route at the right deltoid for prophylactic vaccination (overdose).  It was a case of overdose (actual medication error case, latency same day).  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.
Swollen Lymph Nodes; This is a spontaneous report from a contactable nurse (patient himself). A 39-year-old male patient received first dose of bnt162b2, intramuscularly at site of left arm at 12:00 on 17Dec2020 at single dose for COVID-19 immunization. Medical history included COVID-19. There were no concomitant medications. The patient experienced swollen lymph nodes at 09:00 on 19Dec2020. No treatment received for the adverse event. Prior to vaccination, patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was recovering.  Information on the lot/batch number has been requested.
Fever of 99.7 on 12/30/2020 Fever of 100.3 on 12/31/2020 Debilitating headache Chills
Initial information received on 10-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves an eight-years-old patient who received an expired dose of vaccine TENIVAC (lot number: U5280AA, expiry date: 16-Mar-2018) via unknown route in the left deltoid on 10-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE for Immunisation; HEPATITIS B VACCINE for Immunisation; and IPOL POLIO VACCINE for Immunisation. It was a case of actual medication error due to expired vaccine used. It was unknown if any adverse event occurred or not following the vaccination. 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.
Starting 07/11/2022, I got a bad sore throat and head congestion. At first, I thought it was allergies but I knew it was the wrong time of the year. The next morning I felt relatively good but by mid-day I was having more symptoms and by that evening I took an at-home COVID-19 test which was positive. The next morning, I had severe body aches, fever, cough, head congestion and sore threat. I contacted my doctor's office right away. They got back to me and recommended the monoclonal antibody (bebtelovimab) treatment. So, I got that on 07/13/2022 and by the next day I felt substantially better. On 07/15/2022, I was feeling even better. By 07/16/2022, I was feeling much better but still fatigued. The next day I felt almost completely back to normal but by the end of the day I still had some mild fatigue. Yesterday, 07/21/2022, I thought I was feeling back to my normal self so I went for a bike ride for about 2 miles, but by the end of it I was having symptoms again (body aches, headache and malaise) and was concerned. I am hoping that with more rest, I will get back to normal. I contacted my doctor this morning who said to rest and I took an at-home test which was positive. They told me to ignore it and that I could test positive for another 45 days.
PAIN AND SWELLING AT INJECTION SITE. AWAKENED FROM SLEEP FROM BITING TONGUE. LATER DEVELOPED CELLULITIS AT THE INJECTION SITE (RIGHT ARM)
possible death, might not be able to make it; This spontaneous case was reported by a consumer and describes the occurrence of TERMINAL STATE (possible death, might not be able to make it) in a 45-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TERMINAL STATE (possible death, might not be able to make it) (seriousness criterion medically significant). At the time of the report, TERMINAL STATE (possible death, might not be able to make it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   The patient might not be able to make it and the doctors did not know the reason. No treatment information was provided.  Company comment:  Very little information is available as the case was reported by a "friend" who gave no information except age and event as stated with no details and refused follow-up. This spontaneous case concerns a 24-year-old of unknown gender with no medical history reported who experienced the serious (medically significant) event of LLT/might not be able to make it, PT/terminal state at an unknown time after an unknown dose of mRNA-1273. Testing, treatment and outcome not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Non Significant follow up(No new information received); Sender's Comments: Very little information is available as the case was reported by a "friend" who gave no information except age and event as stated with no details and refused follow-up. This spontaneous case concerns a 24-year-old of unknown gender with no medical history reported who experienced the serious (medically significant) event of LLT/might not be able to make it, PT/terminal state at an unknown time after an unknown dose of mRNA-1273. Testing, treatment and outcome not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Vaccine was stored on refrigerator on 22-Aug-2022 and vaccine was administered on 26-SEP-2022; No Adverse event; Patient given vaccine after BUD date, expire beyond date 22-Sep-2022, vaccine administered 26-SEP-2022; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 22-Aug-2022 and vaccine was administered on 26-SEP-2022), EXPIRED PRODUCT ADMINISTERED (Patient given vaccine after BUD date, expire beyond date 22-Sep-2022, vaccine administered 26-SEP-2022) and NO ADVERSE EVENT (No Adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     It was unknown whether patient ever been diagnosed with or tested positive for COVID-19.     On 26-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given vaccine after BUD date, expire beyond date 22-Sep-2022, vaccine administered 26-SEP-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 22-Aug-2022 and vaccine was administered on 26-SEP-2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 22-Aug-2022 and vaccine was administered on 26-SEP-2022), EXPIRED PRODUCT ADMINISTERED (Patient given vaccine after BUD date, expire beyond date 22-Sep-2022, vaccine administered 26-SEP-2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 22-Aug-2022 and vaccine was administered on 26-SEP-2022) and EXPIRED PRODUCT ADMINISTERED (Patient given vaccine after BUD date, expire beyond date 22-Sep-2022, vaccine administered 26-SEP-2022).    Concomitant Medication use information was not provided by reporter.  It was reported that vaccine coordinator was calling to report that some patients (Adults and Pediatrics) received expired Moderna COVID-19 vaccine after 30 days beyond use date 22-Sep-2022.  There were unbroken cartons. Vial size for 6 months to 5 years was 2.5 ml. The vial was initially stored in the refrigerator on 22-Aug-2022. The patient was given vaccine after BUD date.   The vial did not undergo any temperature excursions.  No reported adverse events.  Treatment Medication use information was not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2022: Non significant follow up received contains no new information.
rash on legs; This is a spontaneous report from a contactable consumer (patient) received via Pfizer study. An 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in right arm, on 05Feb2021 at 01:00 PM (Batch/Lot Number: EL342Z) (at the age of 83 years old) as dose 1, single for COVID-19 immunisation. Medical history included diabetic and chronic obstructive pulmonary disease (COPD). The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient has no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced rash on legs on an unspecified date in Feb2021 after receiving the first dose. The patient was administered the second dose of BNT162B2 on 26Feb2021, single (at the age of 84-years-old) (Batch/Lot Number: EN62NZ) in the right arm for COVID-19 immunisation and experienced rash on the arm and rash on the legs on 26Feb2021. The patient has not taken any treatment for the event. The patient did not recover from the event on the time of the report.  No follow-up attempts are possible. No further information is expected.
Red spots on upper arms on 12/31/2020 at injection site. it was dry, itchy and hot to touch and lump in my left armpit. By the next day it had swollen and was welted.  That evening went to ER and was diagnosed with cellulites  treated with Keflex. on 1/3 went back to ER as it was not getting better. Diagnosed again with cellulites and give sulfa,
Extensive swelling at injection site with reddness, fever, chills, nausea, vomiting, diarrhea, generalized body aches, and pain at injection site lasting several days. Symptoms persisted nine days after injection received. Ibuprofen, Tylenol, and Benadryl given. Two days of work missed.
it itches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 12Aug2021 as dose 1, single (Lot number: EWD171) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing), notes: Cholesterol; "gastrointestinal problem" (unspecified if ongoing), notes: I have a gastrointestinal problem; "kidney problem" (unspecified if ongoing), notes: I was having a kidney problem; "kidney stone", start date: 2000 (unspecified if ongoing), notes: I passed a kidney stone and that was way back in early 2000. Concomitant medication(s) included: LOVASTATIN taken for blood cholesterol abnormal. Vaccination history included: Hepatitis b vaccine. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "it itches". Relevant laboratory tests and procedures are available in the appropriate section.
Patient returned 10 minutes after flu shot reporting weak legs.  No other symptoms. She had eaten recently but not a lot. BP 135/93 and HR 73. Patient (a nurse) agreed this BP was ok for her. Looked over Fluzone side effects with her but she said it wasn't those but just weak legs.  She refused 911 and waited 15 more minutes.  Then she said she was going to get her mom to pick her up.  We called assistant manager who walked her to her car to wait for mom.  called pt but not but couldn't get her.
Initial pregnancy report received on 13-Aug-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2018SA225852 (same reporter). This case involves adult female patient (age not reported), who was exposed to 0.5 ml dose of vaccine ADACEL (Batch number: U5979AA and expiry date: 13-Jun-2020) (dose in series and route was not reported) in the right deltoid on 09-Aug-2018, while she was pregnant. The date of last menstrual period was not reported. The estimated due date was not reported. It was reported that the patient was in her 29 weeks 4 days of gestation. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. The patient had no previous pregnancy/ies. It was a case of actual medication error due to incorrect product storage because the patient received injection that was out of shipping stability. It was also a case of vaccine exposure during pregnancy. It was unknown if any adverse event was occurred or not following the vaccination. 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 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 the sender: None.
The patient reported experiencing nerve tingling the day after she received the vaccine and that it has not gone away. She did not seek medical attention or contact her doctor.  I told her that she should let her doctor know.
Waited 15 min without issue. While driving home after approx 10 min developed acute throat fullness, lip tingling, hand tingling, nausea, clammy & lightheaded. Felt like going to pass out. Was able to call 911, pull over. After EMS arrival throat fullness & lightheadedness improved, still with lip tingling. Refused ER went home took Benadryl 50 mg with improvement after a couple hours.
Pt experienced bi-temporal headaches. Onset day after shot. 3 to 4 out of scale of 10 for pain. No relief with Motrin.
Episodic mood disorder. ED visit and hospital admission to behavioral health. This visit was within 6 weeks of receiving the COVID vaccine.
pt had redness and itching to hands and arms after receiving the Moderna vaccine. Pt given 25mg Benadryl po. Pt stated she was feeling better, no longer itching.