chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MAY INJECTED MORE THAN 0.5ML; This spontaneous report received from a health care professional concerned a female of unspecified age. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced may injected more than 0.5ml. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of may injected more than 0.5ml was not reported. This report was non-serious.
schedualed for second dsoe 55 days from the first dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (schedualed for second dsoe 55 days from the first dose) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (schedualed for second dsoe 55 days from the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (schedualed for second dsoe 55 days from the first dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Case number PHEH2014US015695 is an initial spontaneous report received from a medical assistant on 01 Aug 2014. This report refers to a 11 year old patient of an unspecified gender. The past medical history and concomitant medications of the patients were not reported. On 22 Jul 2014, the patient was vaccinated with MENVEO (batch number: M13030, expiry date: 30 Sep 2014) at a dose of 0.5 ml intramuscularly which had multiple temperature excursions while in storage. The temperature of the vaccine reached a maximum of 47.5 F for one hour and 17 minutes on 18 Jul 2014, a maximum of 47.5 F for 42 minutes on 21 Jul 2014, a maximum of 47.5 for one hour and three minutes on 24 Jul 2014 and a maximum of 47.5 for one hour and three minutes on 31 Jul 2014. No adverse events were reported following this maladministration (incorrect storage of drug).
Immediately after vaccine administration bilateral swelling of thighs. Treated with cool compresses. Lasted about 4 to 6 hours or maybe more.
Swelling at injection site, red, hard, itching. Happened 8 days after first dose.
Expired Product Used; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received HBV (Engerix B) (batch number J7H4D, expiry date 23rd March 2022) for prophylaxis.   On 31st March 2022, the patient received Engerix B. On 31st March 2022, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 31-Mar-2022 Reporter's Comments: Nurse reported through webform, that patient was given accidentally expired Engerix-B vaccine in left deltoid. The reporter enquired, was this vaccine considered valid or do we need to administer again and do we need to take any other action other than following internal policies. The reporter consented to follow up. Additional Supportive Information. On 31st March 2022, patient received dose of Engerix B that was already got expired on 23rd March 2022, which led to expired vaccine used.
Pt complaint of mild symptoms ie. itchy mouth. Interview and vs taken as noted. Pt given Benadryl 25mg PO x1. Per standing order. Emergency medication management of vaccine reactions. Symptoms Remain present after 10 min of observation. Pt taken to urgent care and checked in. She stated that her face was starting to feel itchy while being checked into UC. Report given to Urgent care RN.
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (9 year old received full dose of Moderna) in a 9-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (9 year old received full dose of Moderna). On 11-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (9 year old received full dose of Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. No Treatment medications were provided
This spontaneous report was received from a medical assistant, referring to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions and concomitant medications were not provided. On an unknown date, the patients were vaccinated with and incorrect stored PEDVAXHIB (strength, lot #, expiry date and route were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of 47 Fahrenheit grades range for a time frame of 5 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007303: US-009507513-1709USA007306: US-009507513-1709USA004085: US-009507513-1709USA007305.
At first it was achy muscle pain all over. Advil taken for that.  10/19 PM it also included fever, alternating chills and sweats. Advil taken for that. 10/20/2010 added wheezing. Ventolin taken for that. Fever so far has reached 103 degrees.
Dizziness, Myalgia, Fever & NauseaVomiting Narrative:  . My symptoms were lightheaded, dizziness, nausea, fever, chills and body aches. Today is my 3rd day and I am still experiencing a lot of  dizziness, chills, light headed, head tenderness and nausea.   Other Relevant History:
Miscarriage on 11/8/2021. 2nd miscarriage 10/9/2022. After my second miscarriage, Dr requested additional blood work to be taken. I had an abnormal blood clotting test result for lupus anticoagulant that will be retested in January.
At about 2am l woke up with a lot of Muscle pain all over the body, chills and low fever (101.3 F) After l called my insurance nurse over the phone she prescribed ibuprofen, which helped to ease pain and lower the fever
This spontaneous report as received from a certified medical assistant (reported also as: healthcare worker) refers to an unspecified number of patients of unknown age and gender. Information regarding patients drug reactions or allergies and medical history was not reported. On an unknown date, unspecified number of patients received improperly stored vaccinated with VAQTA (dose, route of administration, anatomical location, lot#, expiration date were not reported). Concomitant therapies were not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received Zostavax Lot 0585U exp. 30 Sep 08 on 9/27/07 at 9:30 am. Within 8 hours, reported weakness and dizziness. Reported almost fainting twice on Friday, 28 Sep 07. Reported feeling much better on 29 Sep 07 and completely normal by 30 Sep 07.
66 year old female patient complaint of dizziness and general body warmness after received Moderna as her booster at 10:12.  Patient verbally reported history allergies to tetanus vaccination, morphine, aspirin, and Neurontin. Patient verbally reported to not have any medical conditions and was not taking any medications at the time. Patient reported to had received Janssen as her primary COVID vaccine on May 25, 2021. Patient choose Moderna as her booster.  Patient was vaccinated with Moderna booster dosage via intramuscular injection to left deltoid at 10:02. At 10:12, patient reported complaint of dizziness and general warmness to her body. Patient was alert and oriented to person, time, place, and event during the incident and she was monitored by medical staff while emergency services arrived to scene. After arrival, patient was taken to ambulance where further medical treatment was provided in private setting aside from our clinic. Patient refused emergency medical transport with E.M.S. at around 10:45. Patient was encouraged to seek further medical help if condition continued or worsened.
The day after the vaccine her arm was a bit sore and she was tired, then the next day (second day after receiving vaccine) she noticed a huge rash on her arm, was very lethargic and had irritating pain. She saw a physician who prescribed antibiotics for a possible infection.
COLD; CHILLS; FEVER; FATIGUE; THROBBING HEADACHE LIGHT SENSITIVE/BLURRY HEADACHE; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 20-MAR-2021 13:00 for prophylactic vaccination on right arm. No concomitant medications were reported. On an unspecified date, the subject experienced cold, chills, fever, fatigue, throbbing headache light sensitive/blurry headache, and injection site pain. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever, fatigue, cold, throbbing headache light sensitive/blurry headache and injection site pain was not reported. This report was non-serious.
Patient attended a drive-thru flu clinic hosted by the Health Center and was mistakenly given Flublock, which is licensed for 18 and older. Patient turns 18 on 12/9/2020. Attempt was made to contact patient's mother of the error. Message was left on voice mail to call the Health Clinic. Patient tolerated vaccination well at the site of the clinic. To date, no known symptoms or adverse reactions occurred as  the Mom did not return the call.
fever (101.4) started at 330pm, lethargy, vomiting at 7 pm, fever up to 103.6 at 7 pm
12 cm diameter erythema, hot to palpation (R) upper arm. No abscess formation. Temp 102.4 on 10/2/09. Treated with ROCEPHIN 1gm every 24 hours. TYLENOL PRN, K-PAD. D/C home 10/4/09.  11/18/09 Medical records received for DOS 10/02-10/04. Final DX: Right upper extremity cellulitis secondary to intramuscular injection, resolving. D/C to home after abx therapy. Stable.
Fever and shivering 12 hours after receiving 2nd dose of SHINGRIX vaccine. I received the first dose of the vaccine about two months ago, and did not experience any side effects.
Information has been received from a 30 year old female patient with no pertinent medical history and no known drug allergies/drug reactions who on 07-APR-2009 was vaccinated with a dose of MMR II (Lot # 662815/1362X).  There was no concomitant medication.  It was reported that on 09-APR-2009 the patient experienced Bells palsy.  The patient sought unspecified medical attention.  An "unspecified blood work" was performed (results not provided).  It was reported that the patient had not recovered at the time of the report.  This is one of several cases from the same source.  No further information is available.
This spontaneous report was received from a pharmacist concerning to an unspecified patient of unknown demographics. The patient's medical history, drug reactions/allergies and concomitant therapies were not reported. In March 2017 reported as the last week, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number were not reported); however, the patient was HIV positive or on antiretroviral therapy (contraindicated product administered). No adverse effects were reported. Additional information is not expected because there was no consent to contact the physician.
pt recv vax 21NOV96 & on 27NOV96 pt exp a hardened raised area @ the inj site;no tx was given;sx persist;
This spontaneous report as received from a healthcare worker refers to a 5 month old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 12-OCT-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally (incorrect product storage). The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
4/7/04 saw PCP rash, given Zithromax 4/8/04 Emergency room visit- rash maculapapular on checks, neck, chest, abdomen and extremities, no urticaria, no petechiae, no purpura, was told stop Zithromax, given Benadryl, possible reaction to vaccines.
Pt caregiver states arm pain, and a bruise in the deltoid region. Bruise faded after a week, arm pain persists.
Initially one week of eye allergies: itching, burning, swelling of eyelids. Then one week of hives on neck front and back. Now over a week of increasing hives at neck, elbows and knees, now itchy hives on trunk, back, knees and entire arms.
The pt cried unconsolably for two days after Prevnar vaccination. No other symptoms mentioned.
Redness, swelling and itching started in right arm around injection site and skin was warm to touch. It last for 3 days. Patient was seen by his primary care physician next day. No treatment was prescribed.
Initial redness, swelling, and painful itching beginning less than 24 hours after the injection.  Over the next 4 days it seemed to be subsiding.  Then on day 8 an increase in the swelling, redness and itching has begun.  There is more swelling the second time, and the itching is more constant. Redness seems to be about the same as the first time.
bad headache, swollen and painful glands in neck, severe body aches and pain,  fever of 102, dizzy stayed in bed all day and slept. lasted 36 hours.
After receiving Adacel vaccination, patient intially had a "good tingling" feeling in shoulder region for the follow 4-6 days.  Then the tingling turned painful.  The pain seems to jumps around.  He described it as dull and achy.  He stated it was not a sharp pain.  Pain persisted for 14 to 21 days before patient went to see physician.  Dr gave a steriod shot and patient is now feeling better.
I was having chills and coughing and a headache and my left arm was sore.
pt recv vax 21AUG95 & 1APR97 pt devel chicken pox w/50 lesions in all stages w/major craters; pt exp no complications & recovered;
Pt describes Left Arm pain...like a toothache. Limited mobility with arm. Arm when attempting to lift self out of chair. When attempting to wash back with left arm painful.
Mild body aches 2/18 evening through 2/19, mild chills night of 2/18. Persistent headache 2/18 night through 2/19.  Tiredness all day 2/19. No fever, diarrhea or vomiting.
10 days after injection (03/15/2021) developed an increasing patch of red, raised rash, warm to the touch. Eventually covered most of the upper arm from shoulder to elbow, wrapping to the inside of the arm. Itching and discomfort, but no fever. Severe symptoms lasted 5 days before decreasing in intensity. Today (03/24/2021) appears as a slightly itchy discolored area on the arm. Advised by doctor to take Benadryl and apply hydrocortisone ointment.
Member lost conscience and tongue swelled. Given epi with pen and Benadryl injection. Member transport to hospital via ambulance and admitted.
having moderate asthma/worsening asthma symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed; unknown manufacturer), for COVID-19 Immunization. The following information was reported: ASTHMA (non-serious) with onset 03Jan2023, outcome "unknown", described as "having moderate asthma/worsening asthma symptoms". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of asthma.  Additional Information: The patient experienced event rebound symptoms with worse symptoms than original infection. Date started was reported as 13Jan2023. The patient was not admitted to hospital due to adverse event. The patient was treated with pf-07321332, ritonavir (PAXLOVID) for indication of Positive COVID with Asthma 3X a day starting from 03Jan2023 to 07Jan2023. The patient was not taking any other product (s). The patient was diagnosed with COVID on 03Jan2023 and started taking Paxlovid the same day due to having moderate asthma. Started feeling better by 08Jan2023. No symptoms negative test 09Jan2023-12Jan2023. The patient woke up on 13Jan2023 feeling sick with headache ad congestion. Tested positive again and was sick with worsening asthma symptoms through 24Jan2023. Tested negative again on 24Jan2023. The patient was sick with rebound COVID plus had worse symptoms than original sickness. The patient was fully vaccinated with all my boosters.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This is a spontaneous report from a contactable consumer. A 22-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9261) at right arm, via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. Medical history was none. Historical Vaccine included unspecified flu vaccine taken in Oct2020 for immunisation. The patient experienced bleeding after shot and bruise on 21Jan2021. The patient said she got her first dose last night and after the pharmacist finished and pulled the needle out there was quite a lot of blood after she pulled the needle out, and there was a bruise there. She didn't know if a blood vessel got nicked when all that happened. She would like to know if the dose was efficacious or if it is possible some of the vaccine came out with the blood. The patient said that the bleeding from the injection stopped probably within just a minute after she gave it or less, and there was no treatment given. The outcome of event bleeding after shot was recovered; of event bruise was unknown.
COVID rebound.; COVID rebound.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 23Feb2021 as dose 2, single (Lot number: en6200), in left arm, on 07Sep2021 as dose 3 (booster), single (Lot number: fc3184), in left arm and on 16Mar2022 as dose 4 (booster), single (Lot number: fk9894) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "MDS" (unspecified if ongoing); "heart disease" (unspecified if ongoing); "prostate cancer" (unspecified if ongoing). Concomitant medication(s) included: TAMSULOSIN; ARANESP, start date: 16Jun2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID rebound.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14May2022) Negative; (16May2022) Positive. Therapeutic measures were taken as a result of covid-19.  Additional information: Serious, Seriousness criteria-Results in death, Seriousness criteria-Life threatening, Seriousness criteria-Caused/prolonged hospitalization, Seriousness criteria-Disabling/Incapacitating, Seriousness criteria-Congenital anomaly/birth defect reported as no. if vaccine received reported as Yes. other medication in 2weeks reported as Yes. anti viral details product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 07May2022, treatment stop date: 11May2022, indication: Treatment of COVID-19. COVID rebound. I tested negative and felt great 2 days ago. Today I woke up and felt awful. Retested and came up positive in less than one minute. I am immune compromised and have MDS. Awaiting word on whether or not my oncologist will prescribe another round. known allergies reported as no. Did you/the patient previously receive a COVID-19 Vaccine reported as yes.
Presented with prod cough, low grade temp, dyspnea x 1 week; decreased sense of taste and smell; L arm weakness; + covid at home PTA; CT/MRI negative for cerebral event; ; Tx: started on IV steroids, lovenox, Vit C, antibiotics,  and acemra, (no remdesivir as symptom onset >10 days); Initiallly on 2-3 LPM NC; 12/10 worsening dyspnea; O2 increased HFNC; 12/11 Transitioned to AirVo and transferred to to ICU with worsening O2 requirements; resulted on Continuous bipap; 12/14 CXR with bilat pul opacities; placed on AirVo; 12/15 abd pain and dizziness; CT with RLQ retroperitoneal hemorrhage; pt became hypotensive, req levo and PRBC transfusion; protamine, Intubated;  Pt with PEA arrest with ROSC; max pressor support;  family requested comfort care and pt ultimately extubated and died at 02:17
Initially: body aches over entire body, a fever that peaked at 101.2 °F, and by the second day very severe pain and numbness at the right arm injection site.  Fever and body aches subsided in 2 days.  The very severe pain and at the injection site continued for 3 weeks.  The numbness at the injection site still continues, and is in a strip 2 fingers wide by 6 inches long.  The deltoid muscle has completely atrophied.  The shoulder joint is very stiff crackly and painful, though loosens after some stretching.  I couldn't raise the right arm for over 8 weeks.  Though stretching and some strengthening exercises it's now possible to awkwardly raise the arm using alternate muscles.  12/07/09 MR for DOS 09/17/09 and 11/30/09. DX: R arm pain, localized pain discomfort. Pt c/o R arm pain discomfort, heart irregular beat and rhythm. Pt was to use warm compresses. On 11/30/09, on examination: local reaction, R deltoid paresthesias, R arm atrophy, chills, myalgias, fatigue, tiredness, fever, weakness of shoulder. Physician considered DX of deltoid and probable local nerve atrophy post pneumonia/flu vaccines, localized muscular atrophy and probably localized nerve injury. Tx prescribed: Symbicort, Naprosyn. Pt to follow up with orthopedic consultation.