chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE; it's unclear if the nurse reconstituted the vaccine ( MMR II or VARIVAX) with DILUENT or if she mistakenly used the vial of BOOSTRIX in its place.; it's unclear if the nurse reconstituted the vaccine ( MMR II or VARIVAX) with DILUENT or if she mistakenly used the vial of BOOSTRIX in its place.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On an unknown date, the patient possibly received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5ml/ series, expiration date: 20-JUN-2024, administered for prophylaxis (strength, lot #, and route of administration were not provided) or varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5ml/ series, lot #w011622, expiration date: 06-APR-2024, administered for prophylaxis (strength, and route of administration were not provided) along with  diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX). It was unclear if the nurse reconstituted the vaccine with MERCK STERILE DILUENT or if she mistakenly used the vial of diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (BOOSTRIX) in its place (Product preparation error, product confusion). No other adverse events were reported by the patient in the form of side effects.
I felt fine after receiving the vaccine and was waiting my 20 minutes before leaving.  At 15 minutes I felt a strange feeling in my chest.  I would describe it as a warm tightness, primarily on the left side.   Just as I was about to notify someone at the vaccine site, it went away.  It only lasted a few minutes.  The exact same thing happened on my second vaccine on 3/26/21 Pfizer ER8727 at the same Pharmacy location.  I was standing at the front door of the Pharmacy waiting for my last 5 minutes to leave when the same thing happened.  I went back to the pharmacy and sat in a chair right in front of the pharmacy so someone could see me if something happened. The feeling lasted a couple minutes in my chest and then I felt fine again.   I pulled up the site to report the info, but never took the time to do it until now.
Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 degrees C for an estimated total time out of range of 4 hours. On 03-APR-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Post vaccinations on 1/14/10, patient developed fever of 102, chills and pain in left deltoid and arm. Was seen on 1/15 at which time a rash had developed on her upper left arm. She was admitted to hospital on 1/17/10 for cellulitis. A doppler study revealed a clot in the anterior brachial vein. She was placed on IV antibiotics and started on LEVONOX.
rash, swelling on her left arm below the injection site.  We believe it is Covid Arm.  Called her primary doctor and he provide medicine called Cephalexin 500MG 3 tablets per day for 5 days.  Arm and swelling much reduced after taking medication.
Pt. stated, "I felt dizzy 10 minutes after getting vaccinated."   Vital signs within normal range.  At 11:36am pt. stated, "I feel much better now."  At 10:43am pt. stated, "I'm ok now, I can go home."  Pt. went home at 10:44am.
Dizziness; Chronic headache; Loss of appetite; This spontaneous case was received on 22-Nov-2021 from Other Non Healthcare Professional via Agency (reference number: SEQW21-05605) and concerned a 65-year-old, male patient.  The patients' medical history and concomitant medication were not reported.  On 15-Nov-2021, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; route of administration: intramuscular (IM), anatomical location: deltoid; dose: 0.5 ml as reported) for influenza prophylaxis. The batch number reported was 308484 and expiry date was 30-Jun-2022.  On the same day, after vaccination the patient experienced chronic headache, dizziness, and loss of appetite. The patient was taking Excedrin (acetylsalicylic acid, caffeine, paracetamol) as treatment.  At the time of initial reporting the outcome of the events was not reported.  The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  Company comment: A 65-year-old male patient experienced chronic headache, dizziness and decreased appetite on the same day after vaccination with Flucelvax Quadrivalent. Causality for the event chronic headache is assessed as not related due to implausible temporal relationship. Based on plausible temporal relationship, causality for the other two events is assessed as possibly related.; Sender's Comments: A 65-year-old male patient experienced chronic headache, dizziness and decreased appetite on the same day after vaccination with Flucelvax Quadrivalent. Causality for the event chronic headache is assessed as not related due to implausible temporal relationship. Based on plausible temporal relationship, causality for the other two events is assessed as possibly related.
Information has been received from a registered nurse concerning a female patient (age unspecified) who in November 1999 ("12 years ago") was vaccinated with a dose of PNEUMOVAX 23 (Lot# was unspecified), 25/0.5 ml, IM or SQ. The nurse reported that in November 1999 ("12 years ago") the patient experienced seizures and convulsions after receiving PNEUMOVAX 23. The patient sought unspecified medical attention. The patient recovered "12 years ago". The office who reported the event was from a private practice. Upon internal review, seizures and convulsions were determined to be other import medical events. Additional information has been requested.
pt recv vax & pt devel chickenpox d/t lack of seroconversion;
arm continues to be sore; headache; delirious; talking nonsense/speech did not make sense; unable to fall asleep; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (delirious) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 022L20A and 602A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included CELECOXIB (CELEBREX) for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INSOMNIA (unable to fall asleep). On 07-Nov-2021, the patient experienced DELIRIUM (delirious) (seriousness criterion medically significant) and SPEECH DISORDER (talking nonsense/speech did not make sense). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm continues to be sore) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 06-Nov-2021, INSOMNIA (unable to fall asleep) had resolved. At the time of the report, DELIRIUM (delirious) outcome was unknown, SPEECH DISORDER (talking nonsense/speech did not make sense) was resolving and PAIN IN EXTREMITY (arm continues to be sore) and HEADACHE (headache) had not resolved.            Patient reported that she decided to not take her Celebrex the night she received the booster dose of the vaccine.  Company Comment This case concerns a 59-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected event of delirium. The event occurred 1 day after the third dose of mRNA-1273. The rechallenge was not applicable since the event happened after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-378066, MOD-2021-378105 (Patient Link).; Sender's Comments: This case concerns a 59-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected event of delirium. The event occurred 1 day after the third dose of mRNA-1273. The rechallenge was not applicable since the event happened after the third dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Double dosage of Flu vaccine given to the patient. No adverse reactions reported. Patients mother is aware.
This spontaneous report was received from a consumer (who is also company representative) refers to his 55 year old female wife. The patient has erythromycin allergy, betadine allergy and sulfa allergy. On 25-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date and route was unknown). Concomitant therapies included HYZAAR and estrogens, conjugated, PREMPRO. On 27-OCT-2013, the patient experienced a significant raised, painful and red area surrounding the injection site after receiving ZOSTAVAX that measured about two inches in diameter. The patient also used BENADRYL cream on the area but has not noticed any improvement yet. The outcome of the events were reported as not recovered. The patient did not seek medical attention. Additional information has been requested.
First dose was administered into gluteal region; Case reference number US-BN-2021-000280 is a spontaneous case report initially received from consumer on 22-Mar-2021, and concerns a male patient.  The patient's medical history was not provided.  The patient's concomitant medication details were not provided.  On 17-Mar-2021, the patient started therapy with RabaVert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dosage regimen for animal attack administered into gluteal region (Product administered at inappropriate site).  On 20-Mar-2021, patient received second dose of RabaVert (Inactivated Rabies Virus Vaccine, Batch no. was not provided) at unknown dosage regimen for animal attack administered in deltoid region.  At the time of this report it was not known whether the patient developed any adverse event.  No further information was provided.  This case is linked with cases US-BN-2021-000281 and US-BN-2021-000282 (same reporter).; Reporter's Comments: Product administered at inappropriate site is listed by convention. Reportedly, the patient received the first dose of RabAvert in the gluteal region. No adverse events were reported. Product administered at inappropriate site is not related to the RabAvert but to a human action.; Sender's Comments: Product administered at inappropriate site is listed by convention. Reportedly, the patient received the first dose of RabAvert in the gluteal region. No adverse events were reported. Product administered at inappropriate site is not related to the RabAvert but to a human action.
Information has been received from a physician concerning a female who on approximately 23-OCT-2007, was vaccinated intramuscularly with a second dose of Gardasil.  On approximately 24-OCT-2007 the patient broke out in hives.  The hives were not at the injection site but rather on her body.  The patient did not seek medical attention.  Subsequently, the patient recovered.  The patient did not experience hives after receiving the first dose of Gardasil.  Additional information is not expected.
pt received MODERNA COVID VACCINE #3 ON 11/2/2021, LOT #076C21A; pt tested positive for COVID on 7/24/2022; SOB, hypoxia; given supplemental O2; CXR showed pneumonia; ATB given; family refused antiviral for further treatment; transitioned pt to comfort measures; pt passed away.
Pt is a61y.o. year old male presents to a local HCF due to progressive shortness of breath and increasing lower extremity and abdominal wall edema. He assumed his symptoms were all associated with relapsing CHF. ( patient with known ischemic cardiomyopathy/reduced EF, DM, Cirrhosis of liver.) He has tested positive for COVID 11/17. Patient believes he may have had onset of symptoms about 1 week ago. He has received 3 vaccines for COVID. I have counseled him regarding COVID disease and in view of his not requiring supplemental oxygen at this time I have presented the EUA criteria for Monoclonal antibody. The patient agrees with proceeding with MAB.   CXR 11/17 consistent with pulmonary vascular congestion COVID 19 INFLAMMATORY MARKERS: Recent Labs Component 11/17/21 1154 11/17/21 1111 11/17/21 0916 FERRITIN  --  262  --  AST  --   --  58* FIBRINOGEN 245  --   --  CK  --  418*  --  LDH  --  335*  --  CRP  --  41.8*  --    Procalcitonin Recent Labs Component 11/17/21 0916 PCTPL 0.37*
Patient received the vaccine and asked to sit down to wait for 15 minute observation period.  Pharmacy staff heard the patient fall and hit the ground. Pharmacist, reached patient first followed by pharmacist.  Patient was visualized on the ground with eyes open. Visualized the patient's neck bent backwards and muscles rigid including neck and arms.  Went to get cold compress while stayed with the patient.  At the same time, 911 was contacted by the pharmacy staff and a fire fighter in the pharmacy area was brought over to assist. Assisted the patient to a sitting position and noticed her pupils to be dilated. Returned with cold compress for neck and forehead. Went to get cold water while comforted the patient.  Fire fighters present took the patient's vitals and blood sugar and all was within normal limits.  Further questions with the patient found that she had not eaten breakfast or lunch that day.  She also indicated that she had passed out before at a concert while dehydrated in the past.  She had not passed out or reacted to any previous injections or vaccines.
This 24 year old  female received the Covid shot on  4/2/21    and went to the ED on  4/5/21    with the following diagnoses listed below.  - COVID-19
Headache, Arthralgia & NauseaVomiting Narrative: Persistent headache, took OTC medication
Information has been received from a health professional concerning an 8 year old male with Epstein's anomaly (congenital heart disease) (previously reported as no pertinent medical history) and unknown allergies, who was vaccinated IM (previously reported as SC) at 2:00 PM with a second 0.5 ml dose of Varivax (Oka/Merck) (lot number: 658178-1013U). There was no illness at the time of vaccination. Concomitant therapy included "other vaccines" such as Havrix. On 12-SEP-2007, following vaccination the patient experienced an anaphylactic reaction. The patient was treated with epinephrine as an intervention. It was noted that this was a life threatening event. The outcome is reported as recovered "within 24 hours". There was no product quality complaint. The reporter considered the anaphylactic reaction to be an other important medical event. Additional information has been requested. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the agency and was released. Follow-up information stated that the patient was seen by the physician for testing of allergies to any vaccine additives but these results were not available at the time. The vaccine was administered by the patient's primary care doctor. Follow-up information was requested. Follow-up information received stated that on 12-SEP-2007 at 2:15 PM the patient experienced lip swelling followed by complaints of difficulty swallowing. Required epinephrine SC and oral steroids. There was no illness at time of vaccination. No other information. Lip swelling and difficulty swallowing were considered to be other medical event by the reporter.
Muscle spasm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle spasm) in a female patient of an unknown age who received mRNA-1273 for COVID-19 vaccination.     Concurrent medical conditions included Muscle pain.    On an unknown date, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Muscle spasm). At the time of the report, MUSCLE SPASMS (Muscle spasm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.   Reporter did not allow further contact
Arm noted swollen and red by Parent on 10/5 2019 Patient also was febrile at 101.1 . Bought to ED on10/5 at 1145pm
Chills; Fever 101.2; Headache; Dose received 3; This is a spontaneous report from a non-contactable reporter (consumer). The reporter is the patient.   A 58 year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 27Nov2021 at 16:00 (Batch/Lot number: 33026BD) at the age of 58 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU, start date: 13Nov2021 for immunisation and unspecified cholesterol lowering medicine and vitamins. Past drug history included: Codeine, reaction(s): "Drug allergy" and Tetracycline, reaction(s): "Drug allergy". Vaccination history included: BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 1, SINGLE, Lot number: UNKNOWN, Route of administration: Unspecified), administration date: on an unknown date in Feb2021, when the patient was 57 years old, for COVID-19 immunisation and BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, DOSE 2, SINGLE Lot number: UNKNOWN, Route of administration: Unspecified), administration date: on an unknown date in Mar2021, when the patient was 57 years old, for COVID-19 immunisation.  The following information was reported: CHILLS (non-serious), PYREXIA (non-serious), HEADACHE (non-serious) all with onset 28Nov2021 at 16:00, outcome "recovering" and described as ''chills, fever 101.2 and headache''. Therapeutic measures were not taken as a result of chills, pyrexia and headache. Relevant laboratory tests and procedures are available in the appropriate section.   Additional Information: The patient received other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
According to parents, near-immediate onset of fever. Fever up to 103F. Intermittent vomiting. Persisted until May 2nd (6 days). Pt was brought to ER twice, 4/29 and 5/1. Hydration status was maintained. Fever treated with acetaminophen. No tenderness at injection sites. No other symptoms.
heart burn; Chest pain got worse; indigestion; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (heart burn), CHEST PAIN (Chest pain got worse) and DYSPEPSIA (indigestion) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     The patient's past medical history included Pain management (Pain medication) since an unknown date.    On 21-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPEPSIA (heart burn), CHEST PAIN (Chest pain got worse) and DYSPEPSIA (indigestion). At the time of the report, DYSPEPSIA (heart burn) and DYSPEPSIA (indigestion) outcome was unknown and CHEST PAIN (Chest pain got worse) had not resolved.            Concomitant medications- Pain medication & Tegutall NO Treatment drug reported Patient reported - stent in his heart. Patient had undergone  ultrasound of his heart and results unknown.   This case was linked to MOD-2021-262324 (Patient Link).
I started feeling like I had the flu & I was very tired & my arm was very sore but later that night I was exhausted & my arm was in severe pain I was sleeping all day & I felt very tired, so I went to clinic & was told to take Tylenol & go to ER if it got worse.
hives on the back of leg, prickly feeling on face and head, odd sensation with tongue and some shakiness and hot flashes.  no breathing issues. occurred around 11ish on 3/3 - I stayed awake until it subsided.  i did not take any Benadryl to correct it.
1st dose 26May2020, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received initial dose on 26th May 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 6-Feb-2023 Reporter's comment: A pharmacist was transferred over by a member of the product team, whom gave the information of the pharmacist.  When the pharmacist was transferred over to the line, they were asked to verify their information, which they did, and asked if it was necessary to restart a Shingrix series if the initial dose was given on 26th May 2020. Information was collected about the patient and the provider was told that the call would be transferred to a second line agent, but during the hold period, they hung up. The Vaccine Administration Facility was the same as Primary Reporter. The provider sounded extremely exasperated about the fact that he needed to, quote, 'be transferred 3 times for a simple clinical question'. The tone of voice used by the provider was perceived as exasperated and they were explained the protocol due to the nature of his inquiry, but he responded in an abrasive manner and hung up the call whilst a second line agent was being contacted. They did not give information about the vaccine and did not give information for follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination. Vaers details were captured for the first dose of Shingrix serie.
R facial numbness and tingling 3-4 weeks following vaccination, "I thought I was having a stroke". L deltoid pain: rates from 3-5 in pain, described as "deep aching" and sometimes "sharp/shooting", no limited range of motion, "hurts to lay on left arm".
6NOV97 noticed a dark purple stain on breast w/tenderness & swelling of both breast w/2 swollen gland on lt arm-tx w/anti inflammatory drugs & ATB;test negative but sx persist;
parents reported child had vomited since 630AM this morning & just staring @ them;dad states just laying there & wouldn't eat egg this morning;referred to clinic;vital signs 97 ax, 120 Apical pulse, resp 34;color pink;skin warm, dry;
Sore throat, body aches, fatigue Treating with over the counter medicine for 2 days