chrisvoncsefalvay/vaers-outcomes huggingface dataset:
in about 2 weeks after pain to the right arm slowly increasing; palpable string of painful small veins in the inner part of the right arm that have subsided after a few weeks; presently pain along the chest wall like neuralgic pain; appearance of small spots here and there in the chest and neck region; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 87 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Feb2021 (Lot number: EN62201) at the age of 86 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Atrial fibrillation" (unspecified if ongoing); "mild hypertension" (unspecified if ongoing); "Shrimp allergy" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL taken for hypertension; HYDROCHLOROTHIAZIDE; WARFARIN; ESTRADIOL. Vaccination history included: Bnt162b2 (product= COVID 19, brand= Pfizer , Lot #EL8982: 14Jan2021 (name provided), lot number= Lot # EL8982, lot unknown= False, administrator route= Intramuscular, administration date= 14Jan2021, administration time= 11:00 AM, vaccine location= Right arm, AE- initially right arm pain and tenderness), administration date: 14Jan2021, when the patient was 87 years old, for covid-19 immunization, reaction(s): "initially right arm pain and tenderness", "initially right arm pain and tenderness", "lymph node swelling". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 24Feb2021, outcome "recovering", described as "in about 2 weeks after pain to the right arm slowly increasing"; VASCULAR PAIN (non-serious) with onset 24Feb2021, outcome "recovering", described as "palpable string of painful small veins in the inner part of the right arm that have subsided after a few weeks"; MUSCULOSKELETAL CHEST PAIN (non-serious) with onset 24Feb2021, outcome "recovering", described as "presently pain along the chest wall like neuralgic pain"; RASH MACULAR (non-serious) with onset 24Feb2021, outcome "recovering", described as "appearance of small spots here and there in the chest and neck region". Therapeutic measures were not taken as a result of pain in extremity, vascular pain, musculoskeletal chest pain, rash macular.  Additional information: It was reported that the patient was not known allergy at present but when she was young, likely to shrimp that has disappeared. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and not tested for COVID-19 since vaccination. About 2 weeks after pain to the right arm slowly increasing, palpable string of painful small veins in the inner part of the right arm that have subsided after a few weeks, presently pain along the chest wall like neuralgic pain, and appearance of small spots here and there in the chest and neck regions, none so acute but uncomfortable.  No follow-up attempts are possible. No further information is expected.
soreness in the arm and pain in the legs; body ached a little bit; not feeling ok; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1), for Covid-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "soreness in the arm and pain in the legs"; PAIN (non-serious), outcome "unknown", described as "body ached a little bit"; MALAISE (non-serious), outcome "unknown", described as "not feeling ok".  Additional information: Caller stated his wife had the second dose Saturday and reported soreness stronger than the first time and body ached a little bit, not feeling ok , nothing major, Caller stated yesterday her arm was still a  little sore but today she is better. Caller reported his mother got the second dose on Saturday and reported about the same as his wife noting soreness in the arm and pain in the legs stating it is gone now  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
tooth ache; This is a spontaneous report from a contactable consumer (the patient) from a Pfizer-sponsored program t. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a tooth ache and wanted to take antibiotics. He asked if he can do so after getting the COVID vaccine. The outcome of tooth ache was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I contracted COVID-19 on 06/24/2022 with symptoms of cough, muscle aches, and congestion. I was prescribed Paxlovid, Pednisone, and Trilogy Inhaler on 06/27/2022. I was ill for 10 days before my symptoms began to resolve. I am still experiencing a lingering cough and needing to use the inhaler.
Mom reports after vaccines at 4 mos pt was fussy, in pain, decrease appetite, cried when touched for 1 week after. No treatment.
report a medical outcome; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (report a medical outcome) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (report a medical outcome). At the time of the report, VACCINATION COMPLICATION (report a medical outcome) outcome was unknown.            No concomitant medication was provided by reporter. No treatment information was provided by reporter.
?Covid arm?. 36 hours or so after injection, a large, red spot appeared about 5-6 inches below and to the side of the injection site. This spot is very itchy and hot.  I also experienced significant headache starting about 13 hours after injection. Headache successfully treated with Tylenol. Am using cool compresses on red spot.
Temperature over 12 hour period ranged from 99 to 102; major aching throughout body; slight headache. Also had a bruise and light red rash at and below injection site, which has been noticeable for four days.
ADMINISTERED OVER 4 DAYS PRIOR TO 21ST DAY FOR PFIZER VACCINE
This vaccine triggered my meniere?s. It has proceeded to to get worse. I have been dizzy now for 4 weeks along with a headache and nausea. It is very debilitating and cannot continue to cope this way. I need to get back to a normal life.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 54 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Jan2021 as dose 1, single (Lot number: EK5730), on 22Jan2021 as dose 2, single (Lot number: EL0142) and on 26Oct2021 as dose 3 (booster), single (Lot number: 3D155BA) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "not recovered" and all described as "COVID-19". The clinical course was reported as follows: The patient tested negative on 02Apr2023 after treatment with PF-07321332, ritonavir (PAXLOVID). The patient started experiencing symptoms on 05Apr2023 and tested positive again for COVID-19. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Apr2023) negative; (05Apr2023) positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 which included PF-07321332,  ritonavir (PAXLOVID) from 25Mar2023 to 29Mar2023 and fluticasone propionate (FLONASE) from an unspecified date to 25Mar2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300145983 Same reporter/patient, same drug/different dose, different AE;
Pt recv vax on 10/21/98; on 2/16/99 pt exp flu-like illness
pt recv vax 15AUG95 @ 2200; mom noted pt turned pale & stop breathing; mom had just breast fed & gave APAP prior episode; no sz; low grade fever;
SEVERE BILATERAL NERVE PAIN IN LEGS THAT STARTED 4 DAYS AFTER INJECTION THAT STILL CONTINUE. BILATERAL NERVE PAIN IN BOTH ARMS THAT STARTED APPROXIMATELY 30 DAYS AFTER INJECTION STILL CONTINUE.
Pt recvd Hep B vax on 1JUN92 & on 5JUN92 devel itching; work-up showed no acute distress & no macular papular rash but did have some erythema & pruritus; poss allergic reaction;
ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/30/2023 SEVERE OBESITY EQUIVALENT, BMI 39-39.9, ADULT W CO-MORBIDITY
Severe pain in left arm at and around injection site, tiredness / fatigue, headache, body aches, joint pain, lack of appetite, stomach discomfort, chills
Case number PHEH2016US029271, is an initial spontaneous report received from a nurse on 07 Nov 2016. This report refers to a 91 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX Quadrivalent (seasonal influenza vaccine, batch number: not reported) at a dose of 0.5 ml intramuscularly following temperature excursion at 52F for 1 hour on 18 Oct 2016. Second temperature excursion occurred on 23 Oct 2016, dropped low 06 times to 34F and lasted 30 minutes each time. Third temperature excursion occurred on 02 Nov 2016, down to 32.2F three times over the course of 12 hours. Vaccine had been administered. It was unknown if vaccine was frozen. Nurse did not know which lot was given to which patient. No adverse event was reported following this administration error.
she developed hives /  dermatologist who diagnosed her with hives; This case was reported by a consumer via call center representative and described the occurrence of hives in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd September 2020, the patient received the 1st dose of Shingrix (intramuscular). In November 2020, between 2 and 3 months after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was not recovered/not resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were reported as follows: The patient developed hives 2 weeks ago (from the date of reporting) on her feet, hands, back and stomach.  The hives on the back and stomach began a day or two after the hives started on the feet and hands. The hives were not as bad but were still ongoing. The patient went to a dermatologist who diagnosed her with hives. Did not consent to follow-up.
abnormal sensation throughout the left side of his face associated headache in the back left side of the head  normal examination
Received bivalent vaccine 22Sep2022. Symptomatic for COVID on 01Sep and tested positive for COVID on 03Oct.; Received bivalent vaccine 22Sep2022. Symptomatic for COVID on 01Sep and tested positive for COVID on 03Oct.; This is a spontaneous report received from a contactable reporter (Pharmacist). The reporter is the patient.  A 45-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 as dose 4 (booster), single (Lot number: 6h9694) at the age of 45 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 13Jan2021 as dose 1, single (Lot number: 012L20A), on 11Feb2021 as dose 2, single (Lot number: 030620A) and on 02Nov2021 as dose 3 (booster), single (Lot number: 032F21A) for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 22Sep2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history was not reported. Concomitant medications included: ROSUVASTATIN; FIBERCON; ESCITALOPRAM. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Oct2022 (also reported as 01Oct2022), outcome "recovering" and all described as "Received bivalent vaccine 22Sep2022. Symptomatic for COVID on 01Sep and tested positive for COVID on 03Oct.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Oct2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and covid-19 and BNT162B2.
Rash on legs, arms and torso on second day after vaccine. I noticed the rash in the evening around 6:00pm. I took a benedryl at 5:00pm on Wednesday 3/03/2021. Called my family doctor on Thursday morning and he told me to take 1 Zyrtec in the morning and 1 at night to help clear the rash. My Doctor said it was not anaphylaxis as it did not happen immediately after the vaccine but 24 hours later. I have no trouble breathing as I check myself with oximeter and my oxygen level is 97%.  I did have Covid on January 3, 2021 and after the vaccine on 03/02/2021 I experienced nausea, chills and a dull headache and then the rash. I have experienced this type of rash before after a stomach virus and it lasts for 3 or 4 days and clears up.
missed the 2nd appointment for the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the 2nd appointment for the vaccination) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-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 PRODUCT DOSE OMISSION ISSUE (missed the 2nd appointment for the vaccination). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed the 2nd appointment for the vaccination) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not reported.  Treatment medication not reported.
pt recv vax & same day pt seen for rt finger fx;parent reported 11DEC96 rt deltoid & arm swelled & turned red;
PT WOKE UP WITH LEFT-SIDED FACIAL NUMBNESS AND EYE IRRITATION.
Lightheaded with pressue and dizzy, nausea, brain fog, Shooting pains across cranium between temple but smaller pains across whole head, changed heart meds for low heart rate. Increasing issue since onset. Narcolepsy; petit mal.
10 year old female became dizzy and clammy following vaccination. Brought to medical bay in pediatrics and placed on cit. Vitals were 100/70 HR 77 oxygen saturation 97%. Symptoms resolved. Left bay after 10 minutes ambulatory. Monitored for 30 minutes. NO further symptoms.
Widespread skin rash on trunk, arms,  top of legs Inflammation decreased after 1 week but rash still persists Applying 2.5% hydrocortisone, taking a daily antihistamine
Possible throat swelling, facial numbness/droop to the rights side. Vaccine administered in right arm. Benadryl 50 mg administered to left arm IM, transport recommended but the family stated she would seek medical care and declined transportation.
hx of pt arriving in ER in full arrest & expired @ hosp;sl bloody vaginal discharge noted in ER;
In the night, I had constant shivers and could not get any sleep. I woke up with a tension headache and slight cough. I also felt very tired as if I had just starved for 5 days. I was also nauseous.
Systemic: syncope-Mild, Additional Details: pt was okay after shot. he blacked out and fell face down as he was lowering himself to sit in chair for observation. his face hurt and was bleeding from hitting and rubbing the carpet, and his glasses broke. he stayed on the ground for about 15 minutes, then called girlfriend to come be with him. then he called some other friends to come help drive his car back.
Ringing, whooshing sound in ears for 7+ hours. Progressively became lighter and after a couple of days, the ringing stopped.
Narrative:  Pt called COVID-19 vaccine hotline to report dizziness that has been going on for about 3 days following the second dose of the Moderna vaccine on 2/10/21. Pt reports he believes it may also be due constipation and has been feeling sinus pain/pressure. Per chart review, pt also discussed with RN telephone triage. Pt plans to call primary care clinic, but states he is improving.
Left Arm was sore; Could hardly move her left arm after receiving first vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Could hardly move her left arm after receiving first vaccine.) and PAIN IN EXTREMITY (Left Arm was sore) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Could hardly move her left arm after receiving first vaccine.). On an unknown date, the patient experienced PAIN IN EXTREMITY (Left Arm was sore). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Could hardly move her left arm after receiving first vaccine.) and PAIN IN EXTREMITY (Left Arm was sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient was receiving concomitant medicine which include high Blood Pressure Medication. No treatment medication was provided. It was reported that patient received her second  Moderna Covid-19 vaccine on 31MAR2021  lot number 025A21A. The patient received her second vaccine in her left arm. The patient had no side effects to her second Moderna covid-19 vaccine.   This case was linked to MOD-2021-402994 (Patient Link).
Fever two degrees above normal; fever dissipated after two Tylenol and a night of sleep
took the shot and still had them (shingles)/suspected vaccination failure; still had them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: took the shot and still had them (shingles)/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still had them ). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 31-Mar-2023 The case was received from the patient via interactive digital media. The patient stated that you can say what you want about shingles but she took the shot and still had them.  This made her second time to had them so as far as the patient was concerned their was absolutely nothing you can do to prevent shingles. The patient's friend was diagnosed with shingles and could not believe how painful it was.  The patient was at a chapter in her life where she should be enjoying it to the fullest and she did not want to be on the sidelines because of shingles. Prevention was possible, learn more about the risk of shingles for people 50 plus. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
SkinRash, METALLIC TASTE IN MOUTH Narrative: DEVELOPED RASH ALL OVER TORSO AND METALLIC TASTE IN MOUTH 30 MINUTES AFTER RECRIVING INJECTION.
Patient came in for 2 immunizations- flu and meningococcal. The immunization selection tool was used for both vaccinations. He came into the immunization room  with his parents who also received their flu shots. Patient stated he had no history of severe reactions to immunization in the past and had received flu shots with no issues. He also had no history of seizures and no known drug allergies. Patient got the flu shot in the right arm and meningococcal in the left. He waited by the door (standing) in the room while his parents received their shots. The family was about the leave when he fainted by the door. He fell to the floor and was unresponsive. The technician called 911. Patient came back to consciousness about 30 seconds(estimate) later. Patient laid down until EMS arrived. Patient was responsive and talking until they arrived. EMS inspected and checked blood pressure. Blood pressure was within normal limits. Patient/mother  declined transportation to hospital and the family went home. The immunization room had a yellow substance on the floor after the patient left. This was mentioned to the paramedics and they verified they checked for bleeding and found none. Perhaps the patient soiled himself. The room was cleaned and sanitized. No CPR or Epipen was administered.
PATIENT BECAME SHORT OF BREATH AFTER VACCINATION. EMS PRESENT AND TOOK CARE OF PT.  O2 SAT 91%, O2 ADMINISTERED, O2 SAT 97%  ON 2L/MIN. PATIENT'S DAUGHTER STATED HER MOTHER WAS "VERY ANXIOUS ABOUT GETTING SHOT". PATIENT TRANSPORTED TO HOSPITAL.
Patient called into the pharmacy on 2/17/2021 to ask if she should seek help with symptoms seemingly related to getting her 1st dose of COVID-19 vaccine (Moderna). She says approximately 24 hours after her vaccination (she received the vaccination 2/13/21), a large, itching, burning rash developed on her chest. As time went on she says the rash grew in area and gradually appeared in the areas from her chest leading down to her legs. At the time I spoke with her on the phone (2/17/21), she says the rash was still present on her chest, and all the way down her legs, and still reported significant itching and burning sensation in these areas. At this time she denied any swelling or trouble breathing. Due to the progression of her symptoms, I recommended she be seen at an urgent care facility or emergency department.
Information has been received from a health professional concerning a 6 year old patient who on 4/4/2002, at 36 months of age, was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live (Lot 641267/1294L). On 7/7/2005 the patient experienced breakthrough chickenpox. Unspecified medical attention was sought. No product quality complaint was involved. No other information was available at this time. The patient's sibling WAES0507USA01061, also developed breakthrough chickenpox after vaccination with varicella virus vaccine live (lot 641267/1294L). Additional information has been requested.