chrisvoncsefalvay/vaers-outcomes huggingface dataset:
second vaccine administered in Feb2021. 17Jul2021 began covid symptoms; COVID-19; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unknown date in Feb2021 (at the age of 58-year-old) (Batch/Lot number was not reported) as dose 2, single at workplace clinic, via an unspecified route of administration in right arm on an unknown date in Jan2021 at 15:00 (at the age of 58-year-old) (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that second vaccine administered in Feb2021 and on 17Jul2021 began COVID symptoms. The adverse event was resulted in visit of doctor or other health care professional office/clinic visit. The patient underwent lab tests and procedures which included COVID test (nasal swab test): positive on 20Jul2021. Therapeutic measures were taken as a result of COVID-19. The outcome of the COVID-19 was reported as resolved on an unknown date in 2021.  The lot number for the vaccine, (PFIZER-BIONTECH COVID-19 vaccine), was not provided and will be requested during follow up.
to get a test on Sun. July 25 to be sure; to get a test on Sun. July 25 to be sure; This is a spontaneous report from a contactable consumer or other non hcp.   A 35-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 02:00 (at the age of 35-years-old) (Batch/Lot Number: Ew0153) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient started feeling sick in sat on 24Jul2021. Slight fever, body aches and congestion. Symptoms proceeded into the next day. Symptoms would fade and return. Went to Well Now Urgent Care to get a test on Sun. 25Jul2021 to be sure. The patient underwent lab test included nasal swab with positive result on 25Jul2021. No treatment in response to events was taken. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine, the patient was not diagnosed with COVID-19 prior to vaccination, the patient had been tested for COVID-19 since the vaccination with positive result. The outcome of the events was unknown.
Sore throat; chills; headache; lower back pain; muscle pain; sinus drainage; severe cough; This is a spontaneous report from a contactable consumer (patient).  A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL9262), via an unspecified route of administration on the right arm on 27Jan2021 09:30 at a single dose for COVID-19 immunisation.  Medical history included hypertension. The patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included losartan, atenolol, and atorvastatin. The patient experienced sore throat, chills, headache, lower back pain, muscle pain, severe cough with thick yellow phlegm on 29Jan2021 13:00. It was reported that the patient had sinus drainage on 29Jan2021 13:00.  There was no treatment for the events. The patient has not recovered from the events yet.
On Sept 3, 2019.  3 days after the vaccination rashes in front and back part of  the body was developed. When he came to the Pharmacy to show it to me I told him to take Benadryl over the counter. He made an appointment to his Doctor on Thursday and showed it to his MD and was told to continue taking the Beandryl. Today, 9-10-2019 all the rashes was all cleared.
Patient reports feeling like her face was swelling within an hour or two of vaccination. She stated that she never visualized and swelling. She stated that her face had a numb feeling like it was swollen. The feeling resolved on its own within a few hours without treatment. Since that initial incident she reports that she hasn't felt swelling again, but that she routinely feels tingling in her face for a few minutes most days since. This tingling resolves on its own after a matter of minutes each time it occurs.
Received influenza vaccine at 845 AM, experienced localized redness at injection site, (+) itchy neck, throat scratchy (+) SOB, (-) CP. Given epidase at clinic site. Taken to hospital - Tx with BENADRYL and Prednisone.
difficulty of breathing; chest pain; nearly passing out/fainting; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration on unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter called in behalf of her friend that has been experiencing serious adverse event. The patient experienced difficulty of breathing, chest pain, nearly passing out/fainting on unspecified date. They felt that the vaccination provider did not provide enough support about the adverse event that happened.  Follow-up activities are possible, information on the batch number has been requested.
Started having cough and respiratory issues approximately 1 week ago 02/23/2022.  Also significant weakness.  Urinary frequency.  Seen at an outside facility for same.  COVID testing negative at that time.  CT chest abdomen and pelvis with contrast was performed and essentially unremarkable.  CT head and C-spine unremarkable.  UA negative.  Urine culture negative.  Blood cultures negative.  Labs essentially unremarkable other than some lymphopenia.  Patient was discharged home.  Their family was monitoring his oxygen and was dropping in the 70s.  He was using someone else's oxygen to maintain saturations in the upper 80s and 90s.  After discussion with his oncologist opted to come to Campus for further cares.
on the EIGHTH DAY AFTER I received the vaccine on the same arm just below the injection site my arm had a large, perfectly round, red, very hot and itchy patch. It lasted 48 plus hours.
Things started getting weird; pain in the back; Pain in the joint/Pain on the joint, like on the ankle, on the joint between leg and foot/On the elbowand shoulder; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Things started getting weird), BACK PAIN (pain in the back) and ARTHRALGIA (Pain in the joint/Pain on the joint, like on the ankle, on the joint between leg and foot/On the elbowand shoulder) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Things started getting weird), BACK PAIN (pain in the back) and ARTHRALGIA (Pain in the joint/Pain on the joint, like on the ankle, on the joint between leg and foot/On the elbowand shoulder). At the time of the report, FEELING ABNORMAL (Things started getting weird), BACK PAIN (pain in the back) and ARTHRALGIA (Pain in the joint/Pain on the joint, like on the ankle, on the joint between leg and foot/On the elbowand shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment details were provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-118639 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-118639:
patient had some discomfort .  she went to an urgent care and it appeared to be an allergic reaction. she was advised by the healthcare provider at the urgent care not to take the second dose in the series and was given a steroid
STOMACH BRUISING; MILD IMMUNE RESPONSE; LITTLE ACHY; ARM PAIN; TIREDNESS/WORN DOWN; This spontaneous report received from a patient concerned a 47 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021, the subject experienced mild immune response. On 07-APR-2021, the subject experienced little achy. On 07-APR-2021, the subject experienced arm pain. On 07-APR-2021, the subject experienced tiredness/worn down. On 17-APR-2021, the subject experienced stomach bruising. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild immune response, little achy, arm pain, and tiredness/worn down on APR-2021, and had not recovered from stomach bruising. This report was non-serious.; Sender's Comments: :V0 Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Only adjuvant administered; Only adjuvant administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-MAR-2023, the patient received Shingrix (intramuscular). On 16-MAR-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Only adjuvant administered) and inappropriate dose of vaccine administered (Verbatim: Only adjuvant administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-Mar-2023 The patient was mistakenly injected with Shingrix adjuvant only (not reconstituted antigen). Nothing else was reported.  The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. The patient only received adjuvant only of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Started the day great and went and got the 2nd dose of Moderna on 6/12/21 at 940am. I felt fine throughout the day and I started getting a little dizzy and disoriented around 5pm  and as it was explained to me it would be expected to get side effects. Later in the evening around 8pm I started to get extremely dizzy, tired, and having a low grade fever of 100.5F. I Later developed a headache and I had to go lie down for the rest of the night. As I was sleeping throughout the night and waking up multiple times shivering and being extremely cold, I was taking my temperature throughout the night and It would be climbing up from 100.5F and it reached 103.7F. At that point I wanted to get up and take some fever reducer medicines but I was unable to get out of the bed as I was very dizzy and disoriented and I was having extreme muscle and joint pains that I wasnt unable to move at all. I needed to go to the restroom and get a drink and I was unable to do that.  I had considered going to the ER but I waited it out and wouldnt go unless my temperature kept rising. I eventually tried going to the bathroom but at that point I had passed out and woke up in the morning between my bedroom and bathroom. On sunday 6/13 I was continuing to have symptoms and felt extremely ill throughout the day.  I woke up and the fever had gone away but I still had the symptoms mentioned above and also had ringing in my ears. Throughout the day I was trying to do stuff around the house but I was unable to do that and go to work. I would randomly pass out at times either on my desk or just sitting on the couch. That was throughout sunday then on monday I was feeling a lot better almost all symptoms had gone away but I was still a bit dizzy and had body aches and was unable to go to work and do basic stuff around the house. Tuesday I was mostly feeling fine but still felt a bit dizzy and disoriented and extremely fatigued but I was able to go to work. Wednesday I am feeling almost 100% normal but I do get dizzy at times and I am still extremely fatigued.
This spontaneous report was received from a nurse refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy was not provided. On an unknown date, the patient was vaccinated with improperly stored PNEUMOVAX 23 (lot # L029073, expiry date: 19-APR-2017). Nurse stated that VAQTA, RECOMBIVAX HB, GARDASIL, M-M-R II and sterile diluent (Manufacturer unknown) appeared on the product list because temperature stability questions were asked, however, no doses of these improperly stored vaccines were administered to the patient. No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Left eyelid swollen and twitching, severe headache, body aches, fatique, fever 101.9, chills, diarrhea and cough all began on 03/17/2021.   Severe headache, body aches, fatique, fever 100.1, chills and cough on 03/18/2021. Severe headache, body aches, fatique, fever 98.8 and cough 03/19/2021. No symptons on 03/20/2021.  Tested positive for COVID by Rapid Atigen and by PCR COVID Test
Tightness pain in upper arm; Tightness in both shoulders; Muscle pain; Burning sensation in the elbow; Pain in left wrist; Pain in right wrist; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Tightness pain in upper arm), MUSCLE TIGHTNESS (Tightness in both shoulders), MYALGIA (Muscle pain), ARTHRALGIA (Burning sensation in the elbow) and ARTHRALGIA (Pain in left wrist) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bladder disorder. Concurrent medical conditions included Chronic pain and Neuropathy. Concomitant products included GABAPENTIN, TAMSULOSIN and HYDROCODONE for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (Tightness pain in upper arm), MUSCLE TIGHTNESS (Tightness in both shoulders), MYALGIA (Muscle pain), ARTHRALGIA (Burning sensation in the elbow), ARTHRALGIA (Pain in left wrist) and ARTHRALGIA (Pain in right wrist). On 08-Apr-2021, PAIN IN EXTREMITY (Tightness pain in upper arm), MYALGIA (Muscle pain), ARTHRALGIA (Burning sensation in the elbow), ARTHRALGIA (Pain in left wrist) and ARTHRALGIA (Pain in right wrist) had resolved. At the time of the report, MUSCLE TIGHTNESS (Tightness in both shoulders) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.   This case was linked to MOD21-071767 (E2B Linked Report).; Sender's Comments:  MOD21-071767:
Redness and swelling to entire upper right arm, pain. Unusual behavioral problems, intense anger; says he is going to "kill my baby sister." This is unusal for this child.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 06-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1802USA001558:
Onset of extremely red itchy eyelids and severely chapped lips beginning about 3 days after 1st dose
I was working for a home care business, and was provided a flu shot by them through Pharmacy. The person who gave the shot had some difficulty figuring out how to give the shot in my left shoulder. My arm was swollen and tender for some weeks after the shot. Gradually the swelling and warmth dissipated, but the area is still sore and achy more than a year after receiving the vaccine. I was afraid to have another flu shot this year.
This spontaneous report was received from a nurse and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 06-DEC-2012, the patient was vaccinated with a dose of PNEUMOVAX 23, lot # H014282, expiration date 09-APR-2014 (strength, dose and route of administration were not provided). On 19-NOV-2014, the patient was vaccinated with an extra dose of PNEUMOVAX 23 lot # K006681, expiration date 21-OCT-2015 (strength, dose and route of administration were not provided). The nurse stated that the patient had not experienced adverse effect. The reporter was asking to clarify whether or not the patient received PNEUMOVAX 23 or another pneumococcal vaccine for the physician. Additional information has been requested.
3 or 4 hours after shot; lethargy, vomiting, diarrhea, decreased appetite, double vision. Patient has contacted doctor & planning to see doctor soon still experiencing (except double vision).
bloating, constipation, heartburn easy bruising reoccurrence of pinched nerve and spinal disability that had healed several years ago
2 month old patient received both vaccines Pentacel and  Pediarix, no AE; Initial information received on 05-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a two month old patient who received vaccines DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [PEDIARIX] (extra dose administered).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ342AA and expiry date: 22-Jun-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect PEDIARIX not produced by Sanofi Pasteur (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to extra dose administered (latency on 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.
unspecified infection; This spontaneous case was reported by a health care professional and describes the occurrence of INFECTION (unspecified infection) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products MACITENTAN for an unknown indication and ILOPROST for an unknown indication.    Concurrent medical conditions included Pulmonary hypertension. Concomitant products included RIOCIGUAT (ADEMPAS) and WARFARIN for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, MACITENTAN (Oral) 10 mg once a day and ILOPROST (unknown route) 5 mcg. On an unknown date, the patient experienced INFECTION (unspecified infection). At the time of the report, INFECTION (unspecified infection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was unknown
"stuffy head" starting day after injection and continuing for 4 days. vertigo upon awakening on 5th day. Dix-hallpike and Epley physical therapy maneuvers on 6th day.  BPPV (right) confirmed by MD, low dose meclizine started 7th day and vestibular physical therapy continuous since.
Dizzy, nausea, pale, Lt arm was numb, had a hard time moving the arm. Said Lt arm was very hot.
Patient, aged 17, was inappropriately given Moderna COVID19 vaccine, not recommended under the age of 18. Pharmacy attempted to contact patient immediately upon realization, roughly 3 hours after vaccination. Pharmacy finally reached patient's mother the next morning, and she was informed of the error. Patient's mother will monitor patient, and in accordance with CDC recommendation, the pharmacy will plan to administer the second dose of Moderna to the patient at the appropriate time. Patient's mother agrees with this plan. At the time of contact, patient had only developed mild soreness at the injection site.
Sore arm; feeling tired/ fatigued saying the booster shot knocked her out.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:   A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 Immunization. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown", described as "feeling tired/ fatigued saying the booster shot knocked her out.".  Additional information: The patient described feeling a sore arm in the hours following the administration. She also described feeling tired/fatigued saying the booster shot "knocked her out". The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Mother states child fussy has red dots on feet & hands bad stomach ache 4AM to 630AM. Passed a lot of gas had slight fever. Temp not taken gave TYLENOL about 11 to 1130AM intends to discuss with MD.
extreme hair loss began on june 12th apx 4 weeks after the second dose of my shot.  it has continued to progress at an extremely fast rate.  everyday more and more hair is falling out.  i have developed severe anxiety and cannot sleep.  i have seen a primary care doctor and a dermatologist and I am afraid that I am going to lose all of my hair.  they are treating my anxiety with zoloft and hair loss with minoxidil 5%. no improvement at all