chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US006290 is an initial spontaneous report received from a physician's assistant on 26 Mar 2014: This report refers to a patient of unknown age and gender. It was reported that the patient was vaccinated with the booster dose of MENVEO (batch number: unknown) intramuscularly on an undetermined date. The dose was administered too early. No adverse event was reported following this medication error (inappropriate schedule of vaccine administered).
There is suspicion that Pfizer-Biontech Vaccine was diluted with less than 1.8mL of Normal Saline and therefore the doses were more concentrated than 30mcg.
2 days after 2nd dose two lymph nodes on my right clavicle became swollen and are still swollen.  Also my right shoulder feels like muscle fatigue most of the time.
12/25/21 presents to ED for "suicidal ideation". PMHx of "schizophrenia, hypertension, depression"
weakness arms & legs; arms & hands turned very pale white; generalized joint pain & weakness; pt still having problems on 30MAR95-referred to MD
numbness & tingling down lt arm ulnar side including baby & ring fingers;rxn began the next day 14JUN96;pt was seen by MD regarding rxn & told rxn may subside independently;rxn involved nerves;
1/7/04: 11:30 AM shot given. 3:30 vomited 1x, diarrhea 1x. (No fever, encouraged fluids). 5:30 vomited 1x, diarrhea 1x. 1/8/04: No vomiting or diarrhea noted. Child feeling better.
Immunization received Thurs. 5/31/07. Next day arm was red and hot from injection site to elbow. Continued for 2 more days. Patient had bad H/A also day after. Mon. 6/14/07 arm was still red with a bump, but not as bad. (No treatment given)
Tingling and numbness in arms, hands, legs and feet. Soreness up the left side of the neck. Heart palpitations. Feeling swelling around the lymph nodes, a chronic sensation of the throat closing up about once every two days. Chronic headaches from the lower part of the back of the head, dizziness, lightheadedness. Joint pain, fatigue.
I fainted the day after receiving the vaccination. I had some chills and aches before that, but nothing else seemed out of the ordinary. Suddenly, I lost all function and passed out in a public space. I have never fainted before, so this is not normal for me.
A reaction commonly called "covid arm". About a week after the second dosage of the COVID vaccine I had a rash similar to chicken pox but localized to above and below my left armpit, extending sporadically down to my left nipple. The spots were itchy but did not rupture or ooze anything. After a few days they began fading and disappeared about a week later.
Redness noted to site within 12 hours; over 2 days time developed into cellulitis (diagnosed per ultrasound on 1/13/21). No treatment required at this time, MD office will continue to monitor.
Post vaccination, patient reports: palpitations, sweating dizziness, right sided chest tightness, dry mouth, tingling on upper and lower extremities.  PT reports receiving Tdap 7 days prior to second dose Pfizer vaccination.
truly sick; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (truly sick) and VOMITING (Vomiting) in a 50-year-old male patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (truly sick) and VOMITING (Vomiting). At the time of the report, ILLNESS (truly sick) and VOMITING (Vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
shingles; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In 2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration unknown) for the long-term prevention of shingles and/or zoster-related conditions at the pharmacy. At the time of patient's vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was an effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effect, which induced patient to be vaccinated. Alternatively, in 2015, the patient's healthcare providers, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine, believed that it was effective in preventing shingles on a long-term or permanent basis, and believed that it did not carry any significant risks of adverse effects. Subsequent to the inoculation (date not reported), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of event was unknown. The event was considered related to zoster vaccine live (ZOSTAVAX).
Information has been received from a certified medical concerning a 45 year old male who on 19Aug04 was vaccinated with pneumococcal  23v polysaccharide vaccine. It was reported that the pt believes he may received up to a 3ml dose of vaccine because he saw that the syringe was full. The pt shortly after vaccination developed swelling, redness, pain, dizziness and nausea. Unspecified medical attention was sought. It was noted that the pt's last (pneumococcal 23v polysaccharide vaccine) was last year. No product quality complaint involved. It was reported that the pt was recovering. Additional information has been requested.
Intense back aches and migraine shortly after the shot and less than 12 hours later had flare up of IC resulting in blood in urine. Already been 4 days without relief. Seeing urogynecologist tomorrow.
Information has been received from a pharmacist referring to a patient of unknown age and gender. In August 2014, the patient was vaccinated with first dose of ZOSTAVAX (lot number, dose and route were unknown). Then in May 2016, the patient was vaccinated with a second dose of ZOSTAVAX (lot number, dose and route were unknown). No adverse effects were reported. Additional information has been requested.
did not have any symptoms until late Monday 10/23/2023 and by 10/24/2023 it was worst severe headache, joint pain, sleepy/tired, felt extremely cold, shivering.  the entire upper arm was Extremely swollen and red, the area was hard and HOT to touch, and the area was very painful. visited urgent care and was encourages to notify the CDC. and was prescribed antibiotics and Tylenol, Zyrtec and hydrocortisone ointment.
Starting the night after the shots, the pt was fussy and crying X 2 weeks. No other symptoms or illness.
Information has been received from a nurse practitioner concerning a 17 year old female with no medical history or allergies, who on 30-Nov-2006 was vaccinated IM with a 0.5 ml dose of Gardasil vaccine (yeast). Concomitant therapy included an unspecified hormonal contraceptives (unspecified). On 30-Nov-2006, the patient experienced severe injection site pain. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a 12 month old patient. Medical assistant called regarding an expired dose of PNEUMOVAX23 administered to a 12 month old child, (Lot #918242 expiry date 20-NOV-2012) PNEUMOVAX23 was administered on 20-DEC-2012. No adverse effect reported. Follow-up information has been received from a licensed practical nurse. Additional information had been added: product was not PNEUMOVAX23, it was M-M-R II. Additional information has been requested.
Severe chest pain. Chest pain with breath.; This is a spontaneous report from a contactable pharmacist/patient. A 50-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL0142 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 07Jan2021(Age at vaccination-50 Years) 08:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypertension and hypothyroidism. Concomitant medications included levothyroxine (LEVOTHYROXINE) and losartan (LOSARTAN). The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EK5730 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 18Dec2020 at 05:00 PM for covid-19 immunisation. The patient did not receive any other vaccine in four weeks. The patient was having no allergies. The patient was having no covid prior vaccination. The patient was not tested covid post vaccination.The patient experienced severe chest pain. chest pain with breath on 07Jan2021 at 18:00. The patient received no treatment. Outcome of the event was recovered on an unknown date.  Follow-Up (28Jun2021): Follow-up attempts are completed. No further information is expected.
break through COVID positive test _ headache, body aches, fever, loss of taste, fatigue,  Was given 4 shots in the stomach as treatment on the 3rd day. Quarantined for 14 days.  Still have extreme fatigue, headache and loss of taste
Fever and chills, INTENSE body/joint pain - into the bones, tired, left armpit swollen (lymph glands maybe), headache.    Feels like COVID all over again. Fever appears to be gone this morning. Aches are significantly better but not great.   Concerned about the large swelling under left armpit. It is painful.
Localized redness at injection site (Rt deltoid) measuring approx 20mm in diameter. Also noticed small raised area measuring approx. 5mm X 4mm. Mom instructed to give benadryl as soon as arrives home. Did as instructed symptoms were all resolved by 335pm.
elevated liver enzymes; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC ENZYME INCREASED (elevated liver enzymes) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEPATIC ENZYME INCREASED (elevated liver enzymes). At the time of the report, HEPATIC ENZYME INCREASED (elevated liver enzymes) outcome was unknown.            No concomitant medications were provided by the reporter.   Treatment information was not provided.
Information has been received from a health professional concerning a 34 month old male with penicillin allergy who in 07-NOV-2007, was vaccinated with the first dose of VARIVAX. In the morning of 09-SEP-2009, the patient developed 5 vesicles on the left shoulder. The patient's rash started on 09-SEP-2009, his body temperature was 100.3, not itchy or painful. The patient's outcome was not reported. Additional information has been requested.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; 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: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On 27-APR-2021, the subject experienced suspected immunological vaccine failure. Laboratory data included: Antibody test (NR: not provided) nonreactive result for antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was non-serious.
An attorney reported that a male pt received two doses of both Hib-titer vaccine and Acel-Imune vaccines as part of his childhood immunizations. It is alleged that, as a result of the thimerosal and the mercury and/or other heavy metals contained in the vaccines, he had the following symptoms: severe learning disabilities, impairments in social relatedness, language and communication difficulties, abnormal movements, sensory dysfunction, depression, anxiety, hearing loss, severre bowel dysfunction, and other severe health disorders. The reporter also stated that the pt was exposed to heavy metals from the emissions of a chemical plant. These events were considered medically important. No further info was available as of the date of this was reported.
For a few days a large area of my arm at the injection site turned red. The red area was very warm to the touch and slightly raised.
pains, aches; chills; This case was reported by a consumer via call center representative and described the occurrence of pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2022, the patient received the 1st dose of Shingrix. On 14th January 2022, 1 days after receiving Shingrix, the patient experienced pain and chills. On an unknown date, the outcome of the pain and chills were not recovered/not resolved.   It was unknown if the reporter considered the pain and chills to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The reporter reported that she had Shingrix yesterday (from the date of reporting) and was at the time of reporting experiencing chills, aches and pains. The reporter consented to follow up.
Horrible rash that started in the underarm area and progressed to upper theigh area in about 3 hours.  Rash on back, arms, hands, stomach, upper legs.  Call the clinic and the lady who answered the phone found a doctor and asked what I should to.   The doctor suggested taking Bendryl.  I also washed the areas with soap and water which seemed to help.  In the morning I took a bath with baking soda; this also eased the rash.  I am continuing to take Benadryl, 1 tablet every 4 hours.
Pt developed hematuria and foaminess in urine 4-5 days after second Pfizer vaccine. Was admitted to hospital on 5/15 with AKI Cr 3s, underwent kidney biopsy showing MPO+ ANCA vasculitis with background IgA nephropathy. Started on pulse steroids and Rituximab with improvement of kidney function. Creatinine had peaked to 4 now improving to 3.
Near fainting; Abscess; Sleeplessness; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Near fainting), ABSCESS (Abscess), INSOMNIA (Sleeplessness) and FATIGUE (Tiredness) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced PRESYNCOPE (Near fainting), ABSCESS (Abscess), INSOMNIA (Sleeplessness) and FATIGUE (Tiredness). At the time of the report, PRESYNCOPE (Near fainting), ABSCESS (Abscess), INSOMNIA (Sleeplessness) and FATIGUE (Tiredness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On unknown date, the patient experienced almost fainted for covid shot, three abscesses and feels tired due to lack of sleep. It was unknown if patient was enrolled in a covid-19 vaccine trial.  Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the events of almost fainted for covid shot, three abscesses, feels tired due to lack of sleep unknown onset and feels tired due to lack of sleep unknown onset was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
ATRIAL FIBRILLATION; MULTIPLE LARGE EMBOLISM IN BOTH LUNGS; SYNCOPE; BLOOD PRESSURE HAD BEEN UP; This spontaneous report received from a consumer via a company representative concerned a 62 year old, male. The patient's height, and weight were not reported. Patient had no known drug allergies and medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: 23-AUG-2021) dose was not reported, 1 total, administered on 14-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported.  In FEB-2021 primary medical doctor (PMD) noticed patient's blood pressure had been up, laboratory data (dates unspecified) included: Blood pressure (NR: not provided) slightly elevated and has been monitoring it since then. Patient had a follow up appointment with primary medical doctor on 24-AUG-2021. On the 25-AUG-2021 when patient was moving in the lawn noticed a bit short of breath. Patient had yet to begin taking low dose antihypertensive medication. Reporter and patient was taking routine walks multiple times a week without incident. On 09-SEP-2021 patient was unable to complete routine walk due to being severely short of breath. Later that same evening, patient passed out (syncope) and was taken to the local emergency room where was admitted and diagnosed with atrial fibrillation and multiple large embolism in both lungs. Patient was admitted on 09-SEP-2021 and discharged on 12-SEP-2021. Patient was hospitalized for 4 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from syncope on 09-SEP-2021, and had not recovered from multiple large embolism in both lungs, atrial fibrillation, and blood pressure had been up.  This report was serious (Hospitalization Caused / Prolonged); Sender's Comments: V0: 20211049442-COVID-19 VACCINE AD26.COV2.S-multiple large embolism in both lungs, atrial fibrillation, syncope. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Body aches; headaches; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), HEADACHE (headaches), PYREXIA (Fever) and CHILLS (Chills) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     The patient's past medical history included Chronic obstructive pulmonary disease and Immunodeficiency.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN (Body aches), HEADACHE (headaches), PYREXIA (Fever) and CHILLS (Chills). On 05-Mar-2021, PAIN (Body aches), HEADACHE (headaches), PYREXIA (Fever) and CHILLS (Chills) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not reported.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Updated Batch/Lot number. Reporter information updated.
8:45 am 12/24 - severe rash on my left hand; and wrist; a mild rash went to my arm, chest and back hairline  and on my forehead. Benydryl - 25 mg. Went to ER after it spread at 11:00 am. Had another 25 mg benydryl and a pepsid 20 mg at ER. Rash lasted two days. Ended Dec. 26. It was also after I increased my seizure medicine on Monday 12/21. Received at 8:30 am today/8th - second dose of vaccine.
chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and NAUSEA (nausea) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced CHILLS (chills) and NAUSEA (nausea). At the time of the report, CHILLS (chills) and NAUSEA (nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included-blood pressure medications. No treatment reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: On 22-APR-2021 a follow up was received which contained no new information
p/vax #1 w/in 15sec pt fell forward began seizing 1 min&2-3min;arched moaned lt arm jerked a few times;turned blue nonrespnsive to deep pain;syncope secondary to vaccine;
COVIDVACCINE HURT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: unknown expiry date: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On MAR-2021, the patient experienced Covid vaccine hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Covid vaccine hurt was not reported. This report was non-serious.
Information has been received from a physician concerning a 19 year old female with no pertinent medical history and seasonal allergies who on 04-JUN-2007 was vaccinated with a first dose of Gardasil (Lot # "0524U") 0.5 mL IM. Concomitant therapy included YASMIN and CLARITIN. The physician reported that after receiving the Gardasil the patient experienced a syncope episode for 45 seconds. Medical attention was sought. The patient was back to normal within 2 minutes. The doctor feels the patient was not accustomed to receiving injections. At the time of reporting the patient recovered. No additional information at this this time. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007.  Follow-up information was received the adverse event was a brief syncope episode and no treatment was necessary.  Further information is not expected.