chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt a little warmth in the body; This is a spontaneous report from a contactable consumer (patient).  A male patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number requested) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization.  Medical history included ongoing arthritis.  Concomitant medication included methotrexate (manufacturer unknown) for arthritis. The patient was taking methotrexate 0.8ml once a week for arthritis and on an unspecified date (reported as Saturday) received the COVID vaccine. He wanted to know if he can resume his therapy with methotrexate before getting the second dose. He stated that he just felt a little warmth in the body on an unspecified date. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
expired dose of pentacel being administered with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 15 months old female patient who was administered expired dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine (Pentacel) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination; and varicella zoster vaccine (Varicella vaccine) for Prophylactic vaccination.  On 29-Jul-2022, the patient received suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE at a dose of 0.5 ml total (lot UJ527AA, expiry date: 22-Jul-2022, lot: U6986AA, expiry date: 22-Jul-2022) via intramuscular route in unknown administration site for immunisation.  On 29-Jul-2022 the expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Pentacel) was being administered with no reported adverse event (expired product administered)to the patient (same day latency).  Action taken: Not applicable.  Outcome: Unknown for the event expired dose of pentacel being administered with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient received his first Janssen vaccine and after 3 minutes experienced a vasovagal. He fell off the chair. H e was placed on a bed inn Trandelenberg  position and his VS were monitored. They were as follows: 83/43, Pulse 48, O2 level 98%, Temp 97. After 15 minutes VS110/52, Pulse 50 and after 15 min 110/52 Pulse 56.  He did hit his head and ice applied. He did not lose consciousness. He was released to his father and brother. A follow up phone call will be made
Panic attack; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PANIC ATTACK (Panic attack) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PANIC ATTACK (Panic attack). At the time of the report, PANIC ATTACK (Panic attack) outcome was unknown.            No concomitant product use was provided by the reporter.  No treatment medication was provided.
no adverse event; Monovalent doses administered after the BUD to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient) and NO ADVERSE EVENT (no adverse event) in a 45-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 19-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent doses administered after the BUD to patient).    Patient ID was reported.  Concomitant medication was not reported.  Reportedly, in this report the patient was eligible for COVID-19 vaccine.   Treatment medication was not reported.
Day2 - 3 had a sore arm at site of innoculation.  Painful, but seemed in-line with expectations.  On Day 4  I (patient) was cold  and unable to get warm.  Day 5 at ~7pm I suddenly felt my lymph glands in my throat get very painful.  A few hours later noticed that lymph glands under my arms were very sore.  Very, very tired.  Slight headache.  Slightly nauseous.  Day 6.  Still exhausted.  Still swollen lymph glands.  Still slight headache
sudden onset of rapid heart beat lasting up to 10 mins at a time with HR as high as 110 when laying/resting. Over the course of the last 5 weeks it has lessened in severity
Patient started to develop positional, dull, left chest pain that worsened over the next 2 days and was diagnosed as pericarditis on 10May2016.  He was subsequently transferred to a hospital on the evening of 10May and admitted for further evaluation.  Was again diagnosed with myopericarditis while on the Cardiology service.  Myopericarditis was felt to be possibly related to recent vaccination for smallpox and Japanese encephalitis.
12/17/2001 11:30 Rapid pulse, chills, shortness of breath, fatigue, malaise and fever  of 104 .took ASA and slept.
ALMOST NO ARM SORENESS; LITTLE FLASH FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced almost no arm soreness, and little flash fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the almost no arm soreness and little flash fever was not reported. This report was non-serious.
H/a, fatigue, sweat, termor, muscle fatigue, anorexia; x-ray showed deterioration in 3 of the cervical vertibrae;
Not until 2 weeks later I got a very red somewhat itchy and painful arm at injection site
more than 35 days from 1st vaccination; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (more than 35 days from 1st vaccination) and COVID-19 (COVID-19) in a female 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 (more than 35 days from 1st vaccination) and COVID-19 (COVID-19). At the time of the report, PRODUCT DOSE OMISSION ISSUE (more than 35 days from 1st vaccination) and COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  Treatment information was not provided.
Pt came to pharmacy and said since she had flu shot she has has intermittent pain in that arm.
did not experience any other adverse event; Customer reported an AE for MMRII. The caller said she reported this to Merck previously, however original case was not able to be located. Company awareness date marked 7/12/2023. The caller said the patient received a dose of MMRII on 7/5/2023, aft; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not reported. The patient's concomitant medications included varicella virus vaccine live (oka/merck)(VARIVAX).          On 05-JUL-2023, the patient was vaccinated with a improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) Albumin status rHA lot # w039699 with expiration date 25-MAY-2024, for prophylaxis (strength, dose, route of administration and anatomical location were not reported). It was that the vaccines was exposed to a temperature excursion with a temperature of 48.8 °F for 7 hours and 45 minutes. The patient did not experience any other adverse event. It was reported that varicella virus vaccine live (oka/merck)(VARIVAX) was administered on the same date, but it did not undergo a temperature excursion.
Describes the fatigue as not being able to get out of bed; Headache; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number A725Y, expiry date 30th May 2023) for prophylaxis.   On 21st May 2022, the patient received the 1st dose of Shingrix (intramuscular). On 21st May 2022, less than a day after receiving Shingrix, the patient experienced fatigue and headache. On 23rd May 2022, the outcome of the fatigue and headache were recovered/resolved.   It was unknown if the reporter considered the fatigue and headache to be related to Shingrix.     Additional Information: GSK receipt date: 23-May-2022 Reporter's comment: The case was reported by the patient herself. The patient received Shingrix in unknown arm. The patient received a dose of Shingrix on the afternoon and that evening he developed a headache and fatigue. The headache and fatigue lasted about a day and a half and were now resolved.  She had nothing else to report. The reporter declined to provide email addresses but might follow-up with heath care professional. The reporter consented to follow-up. Additional Supportive Information: This case has been linked to the US2022082837 case reported by the same reporter. Note : Duration was auto calculated as per mentioned date as partial outcome date and duration of 1 and half day we won't captured.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022082837:Same Reporter
Initial misuse report received from a healthcare professional (nurse) on 22 November 2013 and the case was received on 21 March 2014 at GPV. A patient (no information of patient's were provided) had received a dose of YF-VAX) (batch number, route and site of administration were not reported) on an unspecified date. The vaccine was reconstituted with reconstituted with sterile water. No adverse event was reported. List of documents held by sender: none
woke up with beet red rash on left forearm, on abdomen and on back. Arm very itchy
Around an hour after I left the facility I became covered in hives and my face and lips swelled.
30 minutes after vaccines patient noted tingling in left hand, then in right, subsequently hands felt cold and were blue, lasted for 30 minutes.  No associated shortness of breath, palpitations, diaphoretic.  Recheck in office demonstrated normal exam except patient still felt slight tingling left hand.
Patient received COVID-19 vaccine at 3:02 pm - approx 26 minutes after vaccine administration patient became dizzy/lightheaded/nausea. B/P-140/102, 98% RA, 98 HR, R 20 even and unlabored. Patient brought to UC for Evaluation. During UC Evaluation vital signs remained stable. Patient drank water. Tylenol was given for headache - 1 gram Acetaminophen at 3:40 pm. Patient had improvement in symptoms ER precaution were discussed, patient verbalized understanding of treatment plan. Patient discharged home.
RN that was calling to report temperature excursion that was intermittent beginning 7/28/2020, but not previously reported, involving PROQUAD states that there have been administered doses.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.    It was reported that temperature excursion that was intermittent beginning 28-JUL-2020, but not previously reported, involving measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD).  On 20-AUG-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # T009929 with expiration date of 16-SEP-2021, for prophylaxis (route of administration was not reported).        It was stated that the vaccines underwent a temperature excursion of -14°C (degrees Celsius) to 10°C (max -9.5C), total 38 hours and 30 minutes. No previous temperature excursion was done. The call was because of a "data logger".
After 2 weeks post-vaccination, pt experienced arthralgia & numbness presenting in ankle/hands/back of leg. This pain/numbness woke her up during the night. Patient describes swelling & pain which felt like carpal tunnel in 3 fingers.
Injection site inflammation, injection site erythema, injection site swelling, wrong route of administration.
T101.4, malaise, severe myalgias w/i 12  hours of vaccine.
Covid19 breakthrough. 1st vaccine-03/16/2021.  2nd vaccine-04/06/2021.  3rd vaccine-11/10/2021. 84 y/o with PMHx of HTN, HLD, AFIB presents to ED with 2 day history of sore throat, headache and multiple falls.  Pt states that her knees keep giving out, denies injuries.  Afebrile, room air sat 95% and CXR with mildly increased Right basal interstitial opacities.  No covid treatment at this time, monitoring pt.
tingling in 3 fingers of right hand/tingling in 3 of right toes; feels itching and burning; feels itching and burning; leg muscles are not as strong; fingers and toes are numb, achy and painful; fingers and toes are numb, achy and painful; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in 3 fingers of right hand/tingling in 3 of right toes), PRURITUS (feels itching and burning), SKIN BURNING SENSATION (feels itching and burning), MUSCULAR WEAKNESS (leg muscles are not as strong) and HYPOAESTHESIA (fingers and toes are numb, achy and painful) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M201) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PARAESTHESIA (tingling in 3 fingers of right hand/tingling in 3 of right toes), PRURITUS (feels itching and burning), SKIN BURNING SENSATION (feels itching and burning), MUSCULAR WEAKNESS (leg muscles are not as strong), HYPOAESTHESIA (fingers and toes are numb, achy and painful) and PAIN IN EXTREMITY (fingers and toes are numb, achy and painful). At the time of the report, PARAESTHESIA (tingling in 3 fingers of right hand/tingling in 3 of right toes), PRURITUS (feels itching and burning), SKIN BURNING SENSATION (feels itching and burning), MUSCULAR WEAKNESS (leg muscles are not as strong), HYPOAESTHESIA (fingers and toes are numb, achy and painful) and PAIN IN EXTREMITY (fingers and toes are numb, achy and painful) 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. No treatment information was provided. Doctor prescribed a steroid for 5 days patient states today is last day of steroid, aspirin because platelet numbers went up, vitamin b12
Pain / soreness in chest area   OTC meds  Costocondritis    Has never resolved
Soreness in neck, arms, shoulder in Jan '17. 2/15/17 work up in excruciating pain; went to AED. Developed Parsonage Turner Syndrome (brachial plexopathy) diagnosed by neurologist.
11/17/2021: Discussed the positive result with son. He and both parents are positive for COVID-19.
Patient had a morning appointment, 0900 and  MA recalls opening a new vial for this patient. However, on 7/14/2023, there were 2 doses extra left over in the same lot number, when there should have been 0 per internal inventory, Since it is not possible to pinpoint which doses caused the overage, it appears 1 or more doses given between 6/9/2023 and 7/7/2023 may have been expired- 12 hours after opening and reused, therefore all doses given during that period are considered to potentially be expired.  Spoke to patient on 8/25/203 at 2:45pm.  Patient had no adverse reactions and would like to be called when get the new Covid vaccine in this fall.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 11-SEP-2014 the patient was vaccinated with (Oka/Merck) VARIVAX 0.5ml dose, subcutaneously (lot number and expiration date were not provided) that underwent a supported temperature excursion. No adverse event was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Had fever 1022 ax & congestion onset 24 hours after immunization-diagnosis. Viral vs immunization reaction
Very noticeable pale pallor; onset about 5 minutes, post vax, resolved in 1 hour. Able to talk, walk, normal pulse and BP. Vomited a small amount of emesis, post vax.
Tinnitus started 15 minutes after the second shot and I have had it non-stop since then.  Today will be almost six-weeks since the second shot and Tinnitus is not letting up/not stopping.
Lymph nodes swelled and closed off E tubes- had seen PCP and ENT ~weak- took 3 months of physical therapy to get energy back
Two cyst extractions that came about after the first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CYST (medically significant), outcome "unknown", described as "Two cyst extractions that came about after the first dose". Therapeutic measures were taken as a result of cyst. The patient is due to get second vaccine next week and wants to know does taking an antibiotic have any effect on the vaccine. The patient has not started it yet. He had two cyst extractions that came about after the first dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt complained of swollen tongue days after vaccine given, pt states no other meds taken or changes in daily routine.
Diagnosed with COVID after having been administered 3 doses of Pfizer for Covid.; Diagnosed with COVID after having been administered 3 doses of Pfizer for Covid.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EL9264), on 25Feb2021 as dose 2, single (Lot number: EN6200) and on 11Oct2021 as dose 3 (booster), single (Lot number: 301358A) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Type II diabetes mellitus", start date: 2015 (ongoing), notes: Type II Diabetes Onset date roughly about 7 years ago.; "High blood pressure" (unspecified if ongoing); "he had COVID" (unspecified if ongoing), notes: he had COVID and he did have COVID. Concomitant medication(s) included: TRESIBA taken for type 2 diabetes mellitus; METFORMIN taken for type 2 diabetes mellitus; LISINOPRIL taken for hypertension. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Diagnosed with COVID after having been administered 3 doses of Pfizer for Covid.". The event "diagnosed with covid after having been administered 3 doses of pfizer for covid." required physician office visit.  Clinical course: This consumer is the patient who called to report abdominal pain with Paxlovid. In the evening, after starting Paxlovid he had onset of abdominal pain. He wasn't having any kind of diarrhea, just hurting in the abdomen.  Abdominal pains: He had recovered completely from this event probably later in the day on 01Jun2022 after having stopped the Paxlovid; maybe within 6-8 hours of product stop. Prior to starting Paxlovid he went to the doctor thinking he had COVID and he did have COVID. He had already had the first 2 shots and the booster shot of the Pfizer for Covid, but they prescribed the Paxlovid for him to help him with his symptoms. He never had anything really severe, but the doctor thought because he had already had the Pfizer for Covid shots and booster that the doctor wanted him to have the Paxlovid to help. Paxlovid: Took a total of 3 doses, 9 tablets overall prior to stop. Caller verified that there has been no relevant testing, treatment or medical interventions performed relative to this event. NDC/Expiry: Unknown, not on CDC vaccine record card. Description of Product Complaint: PC is not on suspect product. Description of complaint: Diagnosed with COVID after having been administered 3 doses of Pfizer for Covid. Product strength and count size dispensed: Additional lot numbers: EL9264; EN6200; 301358A Expiries: Unknown, not on CDC vaccine record card. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Eye swelling, fever, chills, headache, difficulty breathing but not so bad as to need epinephrine.
Nurse gave vaccines TDaP, MCV4, Flu, HPV 9. When given HPV9 child fainted and fell from exam table but did not hit his head broke his fall w/putting hands in front of himself. Observed 15 min. given soft drink. BP 105/73, P 80. Waited 15 min. observed was able to walk out w/out complications.
About 9 hours after receiving the Janssen vaccine on April 9th, I started feeling ill. I had a fever of 102, difficulty walking/moving on my own, intense nausea, numbness in my left arm for about 2 minutes, and I spontaneously got my period (which was very regular up until then). I took Tylenol, went to bed, woke up with a 100 degree fever but feeling much better, and it soon dropped back to 98 degrees.  Today, on April 13th, I started having pain in my left arm and leg. Specifically, in my left bicep (not the injection site) and my left thigh. This pain does not feel like muscle soreness, but almost like a knot? I'm not sure how to describe it, but I find it odd the pain in my arm increases a bit when I walk/move.