chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt reported having painful tingling/tight pressure in legs about 3 weeks after having the vaccine administered. Pt then stated he experienced a loss of control of leg movement. Pt contacted the pharmacy on 12/20/17 from hospital to report the event. Pt stated that medical doctors have not given a diagnosis yet but have ruled out Guillain-Barre Syndrome.
Weakness in arms and legs, onset 9/24/03. Admitted to hospital 10/2/03. Diagnosed w/ Guillain-Barre syndrome 10/3/03. Discharged after treatment 10/8/03.
Pfizer 6/14/21 and 7/5/21. Positive on 1/19/22
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 1:10 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature.  The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported. No treatment medications were provided.   This case was linked to MOD-2021-402935 (Patient Link).
Patient aged 14, received Pfizer Pediatric for second dose instead of Pfizer 12 and above dose (30mcg)
4-5min p/vax pt began to feel pressure in head;pt was put in lying position;hands, fingers & lower arms became white & cold w/purple nailbeds bilat;no BP found;no feeling in hands w/loss of ability to move them;
Information has been received from a parent concerning her son via e-mail a male who was vaccinated with MMR II and subsequently the child experienced autism. The patient was given the complete recommended "CDC shots". Upon internal review, autism was determined to be an other important medical event. Additional information is not expected.
Severe traveling chest pain for 5 days that traveled from my sternum area, left chest, then right chest and then behind my rear shoulder blade. Shortness of breath, painful breathing, and an exhalation that sounded like my chest was congested. Blood in my phlegm on the 3rd and 4th day. Nights were the hardest and on the 3rd night I had the most intense chest pain at the center of my chest I?ve ever felt. It lasted for 2 hours and then subsided. Doctor advised a treatment that moved from Aspirin to Ibuprofen. I started drinking hot teas as well and a Vapor Rub was extremely helpful.   Physical activity was not possible and I stayed in bed for 4 days straight. 7th or 8th day lingering pain was gone.
pt recv vax 24APR96 & devel a swollen gland on lt side below ear;30APR96 presented to reporting MD;reporter noted that pt was not convinced that the lymphadenopathy was r/t vax;
fatigue (mild to moderate); This is a spontaneous report from a contactable nurse via a Pfizer Sales Representative. A patient of unspecified age (reported as over 65) and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fatigue (mild to moderate) on an unspecified date with outcome of recovered after 1-2 days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a female patient who on 15-APR-2011 was vaccinated intramuscularly with 0.5 ml of the third dose of GARDASIL (lot # and expiration not reported). The physician reported that the patient had a syncopal episode (fainted) on administration of her third dose of GARDASIL last Friday (15-APR-2011). The physician reported that the same patient also fainted on administration of the first and second doses of GARDASIL, dates were unspecified. It was reported that the patient  went to the physician's office. At the time of reporting the patient had recovered on and unspecified date. No further information is available.
Site: Pain at Injection Site-Medium, Systemic: hotness in the arm 30 mins after numbness in fingers and weak arm-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Weakness-Medium
1st dose: 01Feb2021, 2nd dose: 18Feb2021; Cyst developed on head; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received the second dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Arm Left on 18Feb2021 (at the age of 41 years old) (Batch/Lot Number: EL8982) as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole (PRILOSEC) taken for an unspecified indication, start and stop date were not reported and statins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient took the first dose of BNT162B2 on 01Feb2021 (at the age of 40 years old) Batch/Lot No: EL8982, administered to Arm Left for Covid-19 immunization. On an unspecified date in 2021, the patient had a Cyst developed on head. The event resulted in a Doctor or other healthcare professional office/clinic visit. Therapeutic measures of Steroid injection in the cyst location and antibiotics were taken as a result of the event. The outcome of the event was recovered on an unspecified date in 2021. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (dose and route were not reported; lot # L017997 with expiry date 19-MAY-2017; lot # L004654 with expiry date 11-FEB-2017; lot # L013063 with expiry date 14-APR-2017 and lot # L006383 with expiry date 25-FEB-2017). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Patient started with watery red eyes and face was flushed. initial vital signs after notice of reaction was Bp 120/88 then noticed mild hives on neck and behind ears. Decided to give patient Benedryl 50 mg IM in Right Deltoid at 1:12pm and retook vitals at 1:20 Bp 118/74 pulse 86 and SAO2 99% on room air.  Vitals at 1:36 pm were BP 116/84 pulse 90 and SAO2 97% on room air.  Redness and eye watering and itching improved.  Spoke with patient again today she says she still has a slight itchiness between fingers and will consult physician prior to second dose.
Consistent headache lasting to date; This is a spontaneous report from a non-contactable reporter (consumer or other non HCP). The reporter is the patient.   A 32-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in right arm, administration date 13Jan2022 (Lot number: 33036130) at the age of 32 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medication included: LEXAPRO.  The following information was reported: HEADACHE (non-serious) with onset 18Jan2022, outcome "not recovered", described as "Consistent headache lasting to date". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache.  Additional information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The event headache occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.  No follow-up attempts are possible. No further information is expected.
Right upper arm arthralgia- pain in right shoulder and sometimes in right antecubital area.
Information has been received from a physician concerning a 15 year old female patient with no pertinent medical history, no drug reactions/allergies; who on 17-JUL-2008 was vaccinated with the second dose of GARDASIL. There was no concomitant medication. On 05-SEP-2008, about 5 weeks after vaccination, the patient developed hallucinations, both visual and auditory. The patient had also had syncope. The patient was seen in the office and was treated with KEPPRA with no effect. In the beginning of December 2008, the patient had recovered.  Follow up information has been received from a physician on 20-FEB-2009. It was reported that the 15 year old female patient had hallucinations. On approximately February 2009 the patient had recovered.Additional information is not expected.
Sudden hearing loss, unilateral. Minimally improved after two months and intratympanic steroid injection.
Severe muscle paid in Right arm where injection was administered.  Still continuing two months later. Hard to move arm up and down without severe pain.
This is a spontaneous report from a contactable nurse calling from physician's office who reported similar events for 15 patients. This is the 1st of 15 reports. A patient of an unspecified age gender and race/ethnicity received PREVNAR 13 (lot number N4385, expiry date 31Oct2017) via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the vaccine after temperature excursion and experienced severe reaction on arm on an unspecified date, with unknown outcome. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017060853 Same reporter/drug/AE, different patient.; US-PFIZER INC-2017060869 Same reporter/drug/AE, different patient.; US-PFIZER INC-2017060872 Same reporter/drug/AE, different patient.; US-PFIZER INC-2017060874 Same reporter/drug/AE, different patient.; US-PFIZER INC-2017060891 Same reporter/drug/AE, different patient.; US-PFIZER INC-2017060909 Same reporter/drug/AE, different patient.; US-PFIZER INC-2017060922 Same reporter/drug/AE, different patient. US-PFIZER INC-2017060901 Same reporter/drug/AE, different patient.; US-PFIZER INC-2017060906 Same reporter/drug/AE, different patient.; US-PFIZER INC-2017060916 Same reporter/drug/AE, different patient.; US-PFIZER INC-2017060917 Same reporter/drug/AE, different patient.; US-PFIZER INC-2017060920 Same reporter/drug/AE, different patient.; US-PFIZER INC-2017060923 Same reporter/drug/AE, different patient.; US-PFIZER INC-2017060927 Same reporter/drug/AE, different patient.
I waited the advised 15min to assess any allergic reaction.  I felt fine aside from a sore arm.  I called my wife and drove home.  Once on the freeway I felt dizzy.  This came on me very fast.  I thought I better get off at the next exit.. but instantly blacked out.  While unconscious I struck another vehicle going approximatley 65mph, rolled my vehicle on its side, skidded, then rolled back upright.  I awoke to my car spun sideways on the freeway, paramedics, and fire dept working the wreck from my window, and no recollection of what happend.  It felt instantaneous to me.    I ate a breakfast of granola, yoguirt.  I hydrated before the shot.  I even took extra Vitamin C.
by next morning had an all over body rash, went to urgent care and was prescribed pepcid and benedryl saw allergy specialist before getting second dose, also had reaction to second dose resulting in all over body rash the next day, went to urgent care and was prescribed oral steroids
Patient was given monovalent vaccination. Bivalent vaccine was not made available to patients until Sept 12 per company.
Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from another healthcare professional. This case is linked to case 2018SA290872. This case involves an unknown demographics patient who was vaccinated with FLUZONE QUADRIVALENT and with a 5/8th inch needle rather than a 1-inch needle (lot number not reported) via intramuscular route and in an unknown administration site on an unknown date. The patients past medical history, medical treatments, vaccinations and family history were not provided. It is an actual medication error due to wrong technique in product usage process. It was reported that influenza vaccine was given with a 5/8th inch needle rather than a 1 inch needle which is recommended for intramuscular administration. No reactions reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Got the Shot today But i was with mucus what are the consequance; This spontaneous case was reported by a consumer and describes the occurrence of SECRETION DISCHARGE (Got the Shot today But i was with mucus what are the consequance) in a  patient of an unknown age and 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 SECRETION DISCHARGE (Got the Shot today But i was with mucus what are the consequance). At the time of the report, SECRETION DISCHARGE (Got the Shot today But i was with mucus what are the consequance) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Med Info Agent: Maximiliano Cengarle AE submitted via Chatbot:"Hi i got the dhot today vut i was with mucus what are the consequance"  Consent for follow up with Safety: Unknown
We had a pediatric clinic. Gave patient Pfizer Bi-valent for patient 2nd dose
I awoke at 6:45 a.m. feeling a bit sore in my arm, but relatively okay.  I was up for approximately ten minutes and then extended my arms over my head to stretch out some of the achiness and immediately regretted the action.  I began to feel dizzy and nauseous and saw black spots encroaching on my peripheral vision.  I washed my face to relieve some discomfort with no change.  I walked toward the bedroom to grab my glass of water when the black spots increased, clouded my entire vision, and I collapsed on the bed.  I then began to hyper-salivate and after waking my husband and catching my breath, I returned to bathroom, experienced diarrhea, and simultaneously vomited into the trash can.  The vomit tasted chemical and extremely acidic.  My body was also shaking uncontrollably during this time and I kept switching between chills and being too hot.  After I felt comfortable leaving the bathroom, I crawled back in bed but was shaking so much that I couldn't stop my teeth from chattering and could not get warm no matter that my husband placed an extra blanket over me.  I had taken my temperature before while I was in the bathroom and it read 94.6 degrees Fahrenheit.  I took it again in bed about twenty minutes later and it read 99.4 degrees Fahrenheit.  My head was splitting and my arm ached, but I was eventually able to go back to sleep.  I felt better after sleeping for a few hours and drinking more fluids.
This spontaneous report as received from an unknown reporter refers to a patient of unknown age. On an unknown date the patient was vaccinated with M-M-R II (lot # H014649, expiry date: 08-MAR-2014, therapy type, dose, route were unknown), which was improperly stored vaccine. This is one of several reports that received from the same source. Additional information is not expected.
she had fever 100.7; she had headache and fever 100.7; she had chills; her arm was hurting; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (her arm was hurting), PYREXIA (she had fever 100.7), HEADACHE (she had headache and fever 100.7) and CHILLS (she had chills) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A (Unsure)) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (her arm was hurting). On 30-Mar-2021, the patient experienced PYREXIA (she had fever 100.7), HEADACHE (she had headache and fever 100.7) and CHILLS (she had chills). At the time of the report, PAIN IN EXTREMITY (her arm was hurting), PYREXIA (she had fever 100.7), HEADACHE (she had headache and fever 100.7) and CHILLS (she had chills) outcome was unknown.        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.   No treatment information were reported.
Pain and redness at injection site,  severe shivering, went to bed with heavy nightwear and four blankets that lasted for approximately 6 hours, afterward and continuation the following day tiredness, fever, muscle pain, upset stomach, headache....symptoms would be similar to flu
Runny nose, wheezing, cough. Administered Xopenex nebulizer treatment.
This spontaneous report was received from a registered nurse, and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications. It was reported that on 17-FEB-2019, the patient received improperly stored dose of VARIVAX (lot # N017394, expiration date 07-JUN-2019) subcutaneously (dose and anatomical location were not reported) for prophylaxis. The dose of VARIVAX was exposed to a temperature excursion of 11.9 Fahrenheit (F) during a timeframe of 117 hours, which was detected by a digital data logger. The vaccine was reconstituted with properly stored sterile diluent. There were no previous temperature excursions. No adverse event. This is one of seven reports received from the same reporter. Sender's Comments: US-009507513-1903USA001826: US-009507513-1903USA002595: US-009507513-1903USA002596: US-009507513-1903USA002597: US-009507513-1903USA002598: US-009507513-1903USA002599.
Patient is a 13 y/o female who received Moderna instead of Pfizer. It was not caught at the time, only when the patient presented for her second dose. Patient did not receive a 2nd dose Moderna today (12 November 2021). Patient's mother refused Pfizer for the 2nd dose.
7 days after the vaccine-developed onset of Pericarditis; This is a spontaneous report from a contactable Other HCP reporting for a patient.   A 31-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Lot # EK9231) intramuscular at single dose at left arm on 28Dec2020 13:00 for Covid-19 immunisation, administered at Nursing Home/Senior Living Facility.  Medical history included recurrent idiopathic pericarditis, hypertension, pre-eclampsia, Covid-19. No known allergies. Patient was not pregnant. The patient had experienced Covid-19 prior vaccination. The patient's concomitant medications were not reported. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine.  The patient developed onset of pericarditis 7 days after the vaccine on 04Jan2021. AE resulted in doctor or other healthcare professional office/clinic visit. Patient received Colchicine and Ibuprofen as treatment. Post vaccination, the patient has not been tested for COVID-19. The outcome of event was not recovered.; Sender's Comments: Based on the temporal relationship, the association between the event pericarditis with BNT162b2 can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Pt received his vaccination at approx.. 0952, directly after receiving vaccination pt appeared diaphoretic. Reaction team was notified, vital signs obtained. Pt was released after vitals were within normal limits.  1000 BP:121/56 O2:97% HR:44 1017 BP: 138/75 O2: 99% HR: 64 1032 BP: 111/64 O2: 97% HR: 78
Loss of energy, light-headedness, dizziness began in June 2021 Saw primary care physician on July 9. EKG, blood draw for dimer, CBC, metabolic panel conducted; EKG revealed heart rate of 43 July 12, PCP called and said I should go to the emergency room since the dimer test result was elevated; CT of chest and ultrasound of legs were performed, along with EKG and same blood work July 13 - saw cardiologist who performed another EKG which reveal heart rate of 45; scheduled for ECHO and stress test July 23 - ECHO and stress test performed; preliminary results revealed no heart structural abnormalities; stress test - only 6 minutes before unable to continue August 4 - scheduled to see cardiologist again I continue to fatigue with exertion.