chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was accidently administered an expired dose of ENGERIX B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 20-year-old female patient who received HBV (Engerix B) (batch number f73dg, expiry date 03-JUL-2023) for prophylaxis.   On 16-JUL-2023, the patient received Engerix B. On 16-JUL-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: patient was accidently administered an expired dose of ENGERIX B). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 18-Jul-2023 The reporter consented to follow-up. The patient was accidently administered an expired dose of Engerix-B, which led to expired vaccine used.
Red; Swollen; Itchy; Arm Hurt; Shoulder hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Hurt), ARTHRALGIA (Shoulder hurt), INJECTION SITE ERYTHEMA (Red), VACCINATION SITE SWELLING (Swollen) and PRURITUS (Itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm Hurt) and ARTHRALGIA (Shoulder hurt). On 22-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (Red), VACCINATION SITE SWELLING (Swollen) and PRURITUS (Itchy). At the time of the report, PAIN IN EXTREMITY (Arm Hurt), ARTHRALGIA (Shoulder hurt), INJECTION SITE ERYTHEMA (Red), VACCINATION SITE SWELLING (Swollen) and PRURITUS (Itchy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6199), in left arm, on 26Mar2021 as dose 2, single (Lot number: ER8727), in left arm and on 17Nov2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 37 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (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 "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had Paxlovid Treatment from 13Jun2023 to 17Jun2023. Patient's Known allergy: Not applicable.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300230771 Same reporter/patient, different product/AE;
2 weeks after the second shot I woke up with Neuropathy in one foot and then the next day I had it in the other foot.  It has been 6 or 7 weeks and the neuropathy is still there in both feet. I have met with PCP and Neurologist.  Neither can tell me why I have neuropathy, even after neuro tests. GBS usually comes and goes withing 4 or 5 weeks but I still think it may be GBS???
pt states lt deltoid feels achy, looks red, swollen; also feels hard when touched; 5JUN92 returned call today red & warm-was painful & hard;
consumer reports: pt recvd vax & devel a fever 104, vomiting, chills & a rash 10 days p/vax; 20FEB93 pt is exp weakness, h/a, burning & itching of eyes; being evaluated by cardiologist & infectious disease specialist;
Pfizer-BioNTech COVID-19 Vaccine EUA Patient reported swelling of her Lymph nodes under the armpit of the vaccinated arm as a reaction to a previous influenza vaccine.   She was told she must be monitored at the pharmacy for at least 30 minutes after the Pfizer COVID-19 vaccination and she agreed.  No symptoms were present on the day of the vaccination to COVID.  Two days after the vaccination on 4/19/2021 she called the pharmacy and explained to me she had a reaction to the COVID vaccination.  The reaction was noted as very similar to her previous reaction to an influenza vaccination.  She described it as swelling of her lymph node under the armpit of her vaccinated arm.  The circumference was that of a lemon.  The depth was described as pronounced and significant but not large enough to impede arm motion.  The patient called me back as a follow-up request 4/20/21 and stated the eruption had gone down a little but it was still present.  On 4/23/21 she stated the eruption was the same size as her report on 4/20/21 and that there was no longer any discomfort in the affected area.  She called back on the day all symptoms had resolved, which was 4/28/2021.  I recommended she not get the 2nd Pfizer vaccine without being supervised in a facility with emergency equipment at hand.
She felt really uncomfortable; she have pain in her knee and in her back; she have pain in her knee and in her back; arms are tender but it went really terrible; My hearing is not good; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received BNT162B2 (formulation: Solution for injection, Batch/Lot Number: EW0169, Expiration Date: May2021), via an unspecified route of administration on 21May2021 as 1st dose, single for covid-19 immunization. Medical history included arthritis from an unknown date and ongoing. Concomitant medication included ibuprofen (MOTRIN) taken for pain, start and stop date were not reported; naproxen sodium (ALEVE) taken for arthritis, start and stop date were not reported. On May2021, the patient felt really uncomfortable, she had pain in her knee and in her back, arms were tender but it went really terrible, her hearing was not good. She was advised to take Tylenol and she mentioned that she took Tylenol and she had two remaining and she wanted to know if she could take two remaining Tylenol until tomorrow. The patient asked whether she could take Tylenol that would have given her a little relief. Her arthritis was bothering her. The outcome of the events was unknown.
After the vaccine my body got severely achy resulting in me having to use a heating pad all next day. My back was extremely achy. All the achiness subsided within 24 hours with no additional symptoms. I took Tylenol to help elevate the symptoms.
Approximately 2 weeks after booster of Moderna, he had full body hives. Saw MD. Spoke with his spouse. The hives are subsiding, but still there over 2 months post booster.
"Dizziness, Nausea, elevated BP.  Pt brought to triage area by vaccinator TRN after receiving first dose PFIZER. Pt present with spouse. Pt reported feeling dizziness. Placed on recliner chair. Pt denied experiencing any other abnormal sx - no SOB, chest pain, pain. Hx of fibromyalgia. NP on-site and lead made aware.    V/S: 2:40PM - BP: 178/113 HR: 123, O2: 97% 2:45PM - BP: 144/96, HR: 120, O2: 94% 3:00PM - BP: 128/84, HR: 100, O2: 96%   Monitored pt for 30 min. Offered fluids.  Pt brought via W/C to observation area. NP reevaluated and encouraged pt to seek ED services for further eval d./t pt c/o numbness to Lt arm length. Pt and spouse decide to seek ED at another site: Kaiser. Encouraged to call 911 for any sudden change or worsening of sx. Pt and spouse left site."
Pain in arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number CF9K4, expiry date 11th September 2021) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injected site pain (received 1st dose on 4th March 2019 and experienced Injected site pain).   On 16th May 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter stated that, the 2nd dose administered to patient reactivated the soreness at the injection site in the left arm from the first dose. The reporter was unable to provide any additional information. This case has been linked with cases US2019AMR126798, US2019125918, reported by the same reporter.
Symptoms: Pain in area of shot, fatigue, and headache Shot was on Sunday morning, the symptoms started towards the end of the day. Monday 24 hrs later, the symptoms worsen, but were manageable.
Woke up in the middle of the night unable to breathe, administered daughter?s asthma inhaler (expired), could not catch my breath if laying down, tried side, back, prone. Found relief when standing- was able to breathe enough not to feel like I was dying, although still shallow. Sat upright for 3+ hours until breathing normalized.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 1:41 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 1:41 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 76.08. No concomitant medications were reported. On 11-Jan-2021 at 02:00 P.M., the temperature recorded was 35 degree Fahrenheit and vial was initially moved to the fridge on 08-Jan-2021 and beyond use date was 07-Feb-2021. Product moved to clinic on 11-Jan-2021 and the vial was in not frozen Condition at the administration.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Pt fainted after receiving his second vaccine while he was in the observation lot and reported weakness, lightheadedness, and nausea. He was evaluated by EMTs onsite and found to be significantly bradycardic and hypotensive. He was transported to ER for evaluation. Pt was anxious about the vaccine and reported not eating prior to receiving it.
Hospitalization for Sepsis due to UTI on dates 12/29/22- 1/4/23.  Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
Reaction to second dose of moderna (no reaction to first dose; Ten hours later, had sharp pains in lest side of my head (thought I was having a stroke).  Before I called 911, I got extreme shakes.   after that, no pain - nothing. Shakes lasted 5-10 minutes.
Fever 100-101 degrees for 2 days on 08/13 & 08/14. Rash on 08/15/11 & 08/16/11. Saw Dr. on 08/16/11.
cyst on the shoulder 2 weeks later; This spontaneous report was received from a physician and refers to a 16 year old male patient. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.     On 01-MAY-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # W008445 with expiration date of 09-NOV-2024, for prophylaxis (strength, dose, route of administration and were not reported).    It was reported that the patient presented to the healthcare professional with a cyst on the shoulder 2 weeks later, unknown date in May 2023.   The outcome of cyst was unknown.     The causal relationship between cyst and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Severe body aches, fever (greatest 102), fatigue which lasted for ~48 hours with the worst symptoms ~20 hours post vaccine
Arm swelled up big and got hard with some red, raised bumps out from it. Continued to eat ok and he pretty much left it alone.
9/29/21 about 4am woke up with sharp pain under right arm and right breast, took tylenol, no swelling noted. The next  morning the right arm lymph nodes were tender and swollen. Thursday 9/30/21 a coworker was able to palpate a lump in the right arm pit and it was tender. At 10pm on 9/30/21 experienced mid sternal pain "like I needed to burp".  Friday 10/1/21 during the night when lying down experienced  the sternal pain worsened and was difficult to catch breath, and noted right neck lymph node swollen. Was taking Tylenol regularly (9/29/21 @noon and bedtime, 9/30/21 @midnight. On 10/1/21 unable to go to work due to sternal pain. Reported to Emergency room and was admitted for observation overnight. CT scan showed cellulitis of the right arm, CXR with lung volumes slight and parenchynal stranding noted lower lungs with possible atelectasis,  Dr. diagnosis at discharge was  presumptive diagnosis of pericarditis post vaccination.
Hives; This case was reported by a other health professional via call center representative and described the occurrence of hives in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The patient received Shingrix and experienced hives across her chest and back. Reporter did not consent to follow-up.
This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (palpitation (pulse went up above 100)) and RESPIRATION ABNORMAL (breathing symptom) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. Concurrent medical conditions included Asthma. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PALPITATIONS (palpitation (pulse went up above 100)) and RESPIRATION ABNORMAL (breathing symptom). At the time of the report, PALPITATIONS (palpitation (pulse went up above 100)) and RESPIRATION ABNORMAL (breathing symptom) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication was provided. Concomitant medications includes taking medication for Asthma. This case was linked to MOD-2021-162412.
SEVERE NERVE INFLAMMATION; RESTLESS LEG SYNDROME; MUSCLE CONTRACTIONS; PAIN FROM HEAD TO TOE, INCLUDES FINGERS, TOES, EYELIDS, CHEEKS, ABDOMEN; SLEPT INTERMITTENTLY 5 TO15 MINUTES AT A TIME; CHILLS; EXTREME BURNING OF MUSCLES; MUSCLE PAIN THROUGHOUT BODY; SEVERE HEADACHE; This spontaneous report received from a patient by a Business partner on 27-MAY-2021 was received on 27-MAY-2021 and concerned a 44 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included codeine allergy, and other pre-existing medical conditions included the patient had codeine allergy and no other illness. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 25-MAY-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 25-MAY-2021 23:30, the subject experienced severe nerve inflammation. On 25-MAY-2021 23:30, the subject experienced restless leg syndrome. On 25-MAY-2021 23:30, the subject experienced muscle contractions. On 25-MAY-2021 23:30, the subject experienced pain from head to toe, includes fingers, toes, eyelids, cheeks, abdomen. On 25-MAY-2021 23:30, the subject experienced slept intermittently 5 to15 minutes at a time. On 25-MAY-2021 23:30, the subject experienced chills. On 25-MAY-2021 23:30, the subject experienced extreme burning of muscles. On 25-MAY-2021 23:30, the subject experienced muscle pain throughout body. On 25-MAY-2021 23:30, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe nerve inflammation, restless leg syndrome, and extreme burning of muscles on 26-MAY-2021 11:30, muscle contractions, and muscle pain throughout body on 26-MAY-2021 15:00, and severe headache on 26-MAY-2021 20:00, and the outcome of chills, pain from head to toe, includes fingers, toes, eyelids, cheeks, abdomen and slept intermittently 5 to15 minutes at a time was not reported. This report was non-serious.
After the vaccination, within a few hours, I felt soreness on my left arm. The soreness increased throughout the day and eventually expanded to my left hip and left neck. I think about a week or 2 later, I started to also feel a slight pain in my right chest (to the right of sternum) when I occasionally took deep breaths. For the past two weeks, in addition to the pain, I feel an overall tightness/heaviness across my chest.  Sometimes, I push or gently pound on my chest to try to massage the area. That said, I do not have any difficulty breathing and am overall quite an active person (exercise at least 3x/wk).
Client presented to mass vaccination POD where 1st, 2nd and booster doses were being administered. Registered staff checked the state registry and stated they found no previous doses so nurse administered what she thought was patient's first dose. When the client tried to get monetary incentive it was noticed that he has received previous doses. This patient received Pfizer vaccine on 5/25/21 and 6/16/21. Also received Moderna on 8/9/21. Received Pfizer on 9/28/21.Isues that contributed to this error, client presented with an altered ID. Personnel in registration need to accurately  look up records in the state  registry.
3 days after second dose, developed severe vertigo and disequilibrium. Associated with intermittent presyncopal episodes. Have continued to have disequilibrium as well as occipital migraines since that time. Daily episodes of disequilibrium.
VIIS ID: 1554393 witnessed syncopal episode s/p COVID vax (Pfizer Ew0178). Pt lowered to ground and no injury. placed in trendel position while decrease LOC during episode, pt appeared pale, unresp briefly to pain/verbal stimulus, skin cool and clammy to touch. some decort posturing noted with possible seizure like motion noted. initial GCS=5. All activity was brief <20 secs and full return to baseline with 1 minute of onset. Per mom, she also witnessed event, denies hx of sz disorder, hypoglycemia, psyche insults and confirms similar episodes of syncope s/p blood draws and heat exposure. Minus posturing, similar s/sx noted before in similar events. After rtn to most color and able to sit with out assistance, pt moved with help to cot. vitals taken, water/crackers given as tolerated. +BBS clear to ausc, no abnormal heart tones noted-strong radial pulse. After 30mins eval, pt ambulated with out asst. has pre-scheduled appt with peds tomorrow am and will speak about incident with MD if chooses not to take to ER tonight. Leaving site, able to ambulate. mom denied EMS xprt at this time and will transport if needed. pt denies loss bowels/urine. Vitals:16:21 p70 r16 97% 16:23 p72 111/69 r16 97% 16:28 p90 r16 100% 16:35 p80 102/62 r14 98% 16:47p80 r14 97%
Erythema half dollar in size, receding; itchiness, mild heat, no pain;
Information has been received from a physician concerning an 18 year old female who on 25-JUN-2008 was vaccinated with the first dose of GARDASIL (lot number was not provided). On 02-JUL-2008 the patient developed sore muscles all over, swollen lymph nodes underarm and a small patch of herpes zoster on her back. At the time of this report, the outcome was unknown. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Patient stated she felt nervous and anxious inside the tent . More post vaccine. Felt better outside in colder air.
Not a reaction. Patient should have received Tdap, but received Quadracel instead. Patient has had no symptoms.
This spontaneous report as received from a pharmacist (who was also the one of the two patients) via company representative refers to the pharmacy technician of unknown age and gender. Approximately on an unknown date in May 2013, the patients were vaccinated with a dose of ZOSTAVAX (lot # J000853, expiry date was 23-APR-2014, route and dose were not reported) that had been accidentally left in the refrigerator for a week. The reporter had enquired about this and was told that it was ok to use this vaccine during the next three months. Approximately on an unknown date in May 2013, (reported as the week of 12-MAY-2013, 3 days after vaccination), the patients broke out in large, painful hives, broke out with rash and welts. One of the patient who was a pharmacy technician had described the pain as being similar to a bee sting. No medical attention was sought. No treatment was provided for the event painful hives. The outcome of all the reported events was unknown. Additional information has been requested. Case 1305USA015472 was split for the pharmacist and the pharmacy technician into case # 1306USA001369.