chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This consumer report (initial receipt 08-Oct-2014) concerns a 1 year and 7 months old female patient who had not received H1N1 vaccine. On 07-Oct-2014, the patient received intramuscular AFLURIA, (batch number not reported) at 0.5 ml. On 08-Oct-2014, 05:00 AM, the patient developed fever at 101.3 degree Fahrenheit (measured via mouth). The fever went down to 101 degree Fahrenheit after the administration of TYLENOL. One hour later, the patient received MOTRIN and the fever was reduced to 99 Fahrenheit. The fever persisted with no other associated symptoms and no seizures occurred. The patient did not consult with the doctor, or presented at the emergency department or hospital. The outcome was reported as not yet recovered.
Pain in left arm has returned and is more intense than the first occurrence; Received second dose in right arm and experienced more pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in left arm has returned and is more intense than the first occurrence) and VACCINATION SITE PAIN (Received second dose in right arm and experienced more pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, 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 PAIN IN EXTREMITY (Pain in left arm has returned and is more intense than the first occurrence) and VACCINATION SITE PAIN (Received second dose in right arm and experienced more pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in left arm has returned and is more intense than the first occurrence) had not resolved and VACCINATION SITE PAIN (Received second dose in right arm and experienced more pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use not provided. Additional treatment medications include Advil.
Information has been received from a pharmacist and a registered nurse concerning a 51 year old female who on 08/03/2000 was vaccinated with a third dose of hep B vaccine recombinant IM. On 01/03/2001 the pt was presented to Employee Health with a skin rash which the pt had since August 2000. In August 2000 the pt developed an intermittent pruritic rash on her trunk and abdomen. The pt was seen and treated by family medical doctor and dermatologist. On 02/23/2001 the family medical doctor reported that the pt has been experiencing multiple myalgias for the past two months. It was noted that the pt is under the care of a rheumotologist. Additional info has been requested.
The patient reported to the Site with swelling, redness and pain in her Left Arm.  The redness covered an area of 16 cm long by 8 cm wide. (Info from SF 600).
Patient came in and requested a Pfizer Covid-19 vaccine. He stated that he received a Janssen Covid-19 vaccine 4/12/21. He received the Pfizer vaccine 07/22/21. He stated that he was advised by his MD to receive the Pfizer vaccine.
No additional AE's.; Medical assistant stated that the GARDASIL 9 that underwent a temperature excursion was administered to multiple patients; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 12-MAR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# 1687291, expiration date 11-SEP-2022; lot# T008101, expiration date 01-MAY-2022, strength, dose and route were unknown) for prophylaxis. It was unspecified which dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered to the patient.   The administered dose of the vaccine experienced a temperature excursion of 36 degrees Fahrenheit to 46 degrees Fahrenheit (34.3 degrees Fahrenheit) for 0 hours 10 minutes 0 seconds, as recorded by a data logger (product storage error). There was no previous temperature excursion reported. No additional adverse event was reported.   combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002493: US-009507513-2104USA002494: US-009507513-2104USA002492: US-009507513-2104USA002495: US-009507513-2104USA002490: US-009507513-2104USA002451:
Fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, SARS-CoV-2 test positive: positive (Positive) positive.         The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments  Treatment medication was not provided. Concomitant product was not provided   This case was linked to US-MODERNATX, INC.-MOD-2021-162161 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-162161:crosslink
Within hrs stated running a fever, has excruciating pain in all joints, fatigued, difficulty walking, shortness of breath, dizzy,  let up after about 5 days, but fatigue and loss of muscle control in thighs and hips continued,  pain returned,  saw my Dr. in April,  was diagnosed with RA, by July was removed from work. At this time I receive treatment. I take steroids daily,  methotrexate weekly,  and remicade infusions every 4 weeks.
TACHYCARDIA; DRY MOUTH; DIZZINESS WITH STANDING AND INTERMITTENTLY WITH SITTING; PULMONARY EMBOLISM; FEELING OF DOOM/ FEELING OF PASSED OUT; FATIGUE; This spontaneous report received from a patient via a company representative via the VAERS (Vaccine Adverse Event Reporting System) concerned a 50 year old female unknown ethnicity . The patient's height, and weight were not reported. The patient's concurrent conditions included osteoarthritis, gluten intolarance, and diflucan allergy. The patient was previously treated with fluconazole.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, expiry: UNKNOWN) with unspecified dose on left arm, on 27-MAR-2021 11:00 for prophylactic vaccination. Concomitant medications included amino acids NOS, biotin, cannabidiol, collagen, ethinylestradiol/norethisterone acetate, and hyaluronic acid.  On 07-APR-2021, the patient experienced dizziness with standing and intermittently with sitting, tachycardia, dry mouth, chest pressure, shortness of breath, and feeling of extreme doom. On an unspecified date, the patient was transported to the clinic. In the clinic the patient had heart rate of about 140 with irregular beats. The patient had undergone Electrocardiography test which showed ST Depression. The patient's symptoms were improved by taking nitroglycerin. As the clinic did not have the technology to provide care so the patient was emergently transported to the hospital. In the hospital the patient's D-dimer level was positive. Later the patient undergone Computerized Angiogram for lungs which showed pulmonary embolism. The patient undergone Dopplers studies of both legs which showed as negative. The patient had received Heparin treatment for several hours and then later switched to Eliquis. After 6 hours being on Eliquis treatment the patient had same original symptoms and for that again nitroglycerin was administered. The patient was placed back on heparin for a longer period of time. Later on the patient got switched to Eliquis 10 mg twice daily for 7 days and further to 5 mg twice daily for 6 to 9 months. The patient had undergone Angiogram of head and neck which was normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia, feeling of doom/ feeling of passed out and dry mouth on APR-2021, had not recovered from fatigue, dizziness with standing and intermittently with sitting and pulmonary embolism. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Life Threatening). Sender's Comments: V0 -covid-19 vaccine ad26.cov2.s-Pulmonary embolism , Feeling doom, Tachycardia, Dry mouth, Dizziness with standing, Fatigue 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).
This spontaneous report as received from a pharmacist refers to a 71 year old male patient. The patient had no medical history, drug reactions or allergies and did not take any concomitant therapies.  On 08-MAR-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 0.5 ml, intramuscular injection in the left upper arm (lot #M038216 and expiration day: 09-MAY-2018). On the same day, an hour after receiving the vaccination the patient had induration, a little redness, and hard around the area of the injection on the left upper arm. The patient sought for the medical attention and contacted with a pharmacist. The pharmacist advised to the patient to treat the adverse effects with an ice pack, acetaminophen (TYLENOL), and diphenhydramine hydrochloride (BENADRYL) for itching if it occurs, and go to urgent care if needed. The outcome of the event and the relatedness between the event and PNEUMOVAX 23 were not reported. Additional information has been requested.
Patient came to IMMS complaining of rash, redness, and itching at and around ACAM2000 vaccination site.
Pt presented with red rash on upper arm, where vaccination adminsitered day before (2" x 5"). Pt was advised to seek MD help if any symptoms of SOB, increased rash, increased T or other S/E.
Pain right shoulder, pain interferes with sleep, normal daily activites.  Dr. (orthopedist diagnosed rotator-cuff tendinopathy, prescribed ongoing physical therapy.
Immunizations on Wednesday 05/05/04, fever by 10pm, 2 seizures in 4-8 hours, following vaccine. Seizure 10am 05/06/04.  Fever 102 degrees moderately by seizure 14:00 05/06/04. Controlled by Ibuprofen & Tylenol. No PMD follow up care. Pt has no insurance. Better today 05/10/04.  Referred to evaluation.
Information has been received from a Registered Nurse concerning a 9 month old male patient who on 15-JUL-2009 was vaccinated with VAQTA (lot # not reported) instead of hepatitis B virus vaccine rHBsAg due to an office error. No adverse reactions were reported. Additional information has been requested.
High fever; headache that lasted over a week; significantly elevated liver enzymes that were not there 2 weeks prior.
This spontaneous report as received from a physician refers to a 19 year old female patient. On 22-AUG-2013 the patient was vaccinated with a dose of GARDASIL (Lot number J006587, expiration date 04-DEC-2015, dose was not reported). On 22-AUG-2013, the physician mentioned the patient developed syncope following the administration of GARDASIL. The patient visited doctor's office. Action taken with  GARDASIL was unknown. The outcome of the event was unknown. Additional information has been requested.
severe pain and soreness. She describes it as so painful; 15 months later that (right) arm is still hurting; Initial information received on 07-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case is linked to case 2020SA007885.  This case involves a 68 years old female patient who experienced severe pain and soreness she describes it as so painful (pain) and 15 months later that (right) arm is still hurting (pain in extremity), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 15-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious severe pain and soreness she describes it as so painful (pain) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On an unknown date (15 months later), the patient developed a non-serious (right) arm is still hurting (pain in extremity) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  (Other relevant tests included no lab data.) Final diagnosis was pain and Painful R arm.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for severe pain and as Not Recovered for Painful R arm..  Information on the batch number was requested.
Janssen COVID-19 Vaccine EUA- nausea first at 4:45am, followed upon rising by severe joint pain and an extreme migraine.  It felt like my bones were made out of glass and someone had taken a hammer to my bones.  My face was swollen and red.  Unable to sit up.  Walk from bed to toilet only.  Overall, I would say extreme flu-like symptoms.  Temperature 99.6 all day.   I could not take the pain any further at 4:20 pm and took 1,000 mg of Tylenol.  I finally fell asleep and woke up at 8:30pm and could walk again and my fever had broken.  I still don't feel great, but I think the worst is behind me.
Pt presented to hospital after fall, tested positive for covid only symptom was runny nose. Pt positive for GI bleed but when EGD was canceled pt left AMA.
This consumer spontaneous report (initial receipt 25-SEP-2015) concerns an adult female patient who had no known allergies or medical conditions. On an unspecified date in 2008, the patient received flu vaccine (manufacturer and batch number not provided). The name of the flu vaccine was not known. On an unspecified date following the flu vaccine administration, the patient experienced swelling of her body and face, chest tightness, throat pain and coughing. The outcome was not reported.
No symptoms to vaccine, Vaccine was given i=unintentionally to patient after the expiration date on bottle.
had Covid in Jan, left ear jaw pain, slight tinnitus, tinnitus now significantly worse in both ears
One day post vax, this pt developed injection site warmth, erythema, and edema. The pt was seen by a physician who treated the pt with prednisone 5 mg PO x 1. ON 12/01. the swelling had reduced dramatically and there was no further sequelae."  The pt recovered 2 days later.
Pt recvd vax & devel redness, swelling @ inject site, pain which extended into neck; also had fever & chills;
On 10/14/04 child have Hib, DtaP, MMR, Varivax , PCV7 and flu shot , returned 10/15/2004 with a facial edema. Treated with Benadryl every 6 hours. Has several allergies: soy, mil, cotton seed, lamb
Scab formed where he received the influenza injection/The scab peels off, bleeds, itches and grows back; Itching on his shoulder/The scab peels off, bleeds, itches and grows back".; the scab comes off and bleed/The scab peels off, bleeds, itches and grows back; the scab comes off and bleed/The scab peels off, bleeds, itches and grows back; This spontaneous case was received on 09-Jun-2021 from physician via communication (reference number: SEQW21-01421) and concerned an elderly, male patient. At the time of this report the patient was 72-year-old.   The patient's concurrent conditions included osteoarthritis and high blood pressure. The patient's concomitant medications included unspecified high blood pressure medications.   On an unknown date in 2017, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine; indication, dose, route of administration and anatomical location: not reported) for prevention of seasonal influenza. The batch number was not reported.   On an unknown date in 2017, unknown amount of time after receiving Afluria Quadrivalent, the patient experienced itching on his shoulder.   On an unknown date in 2017, two months later, a scab formed where the patient received the influenza injection. As it itched, the patient scratched, and the scab came off and bled. Then grew back. The patient rubbed alcohol on it and tried everything else as corrective treatment.   At the time of initial reporting on 09-Jun-2021, the patient had not recovered from the events, as the patient's injection site still kept itching and formed a scab.   The reporter did not provide causality assessment.  Company comment: An elderly, male patient was vaccinated with Afluria Quadrivalent. An unknown amount of time after receiving Afluria Quadrivalent, the patient experienced itching on his shoulder. Two months later, a scab formed where the patient received the influenza injection. As it itched, the patient scratched, and the scab came off and bled. Then grew back. Causality is assessed as possibly related for pruritus and vaccination site scab. Skin exfoliation and skin haemorrhage are assessed as not related, as it was scratched.; Sender's Comments: An elderly, male patient was vaccinated with Afluria Quadrivalent. An unknown amount of time after receiving Afluria Quadrivalent, the patient experienced itching on his shoulder. Two months later, a scab formed where the patient received the influenza injection. As it itched, the patient scratched, and the scab came off and bled. Then grew back. Causality is assessed as possibly related for pruritus and vaccination site scab. Skin exfoliation and skin haemorrhage are assessed as not related, as it was scratched.
Pt was given Rotateq at 16 weeks of age Pt had no problems, vaccine should  be started at 12 wks or under
Dizziness and fatigue 15-20 minutes after administering vaccines HPV and Tdap. Took vitals/BP/pulse. Waited in office for 30 min. Called 911 after attempting to stand 2x, felt dizziness again.
On Tuesday 10/09/2001 in the evening, child had a convulsion. Took to ER. Had 101.2 fever was examined ad no problem found. Lab done, child sent home.  No more convulsions, had fine pink rash the next day all over body except face, lasted 2 days. No further problems. Gave child Augmentin for respiratory condition.
Headache - everyday since receiving the vaccine on 8/27 (4 days so far) Passing blood clots while urinating - nickel size (8/30, 8/31 so far) Dark brown vaginal discharge (8/29, 8/30, 8/31 so far)
Info has been received from a health professional concerning an 8 year old white female who on 3/3/98 was vaccinated with a 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination and no adverse events following prior vaccination. On 4/14/05, the pt experienced chickenpox breakthrough, during a middle school outbreak, described as a generalized rash, with a moderate case of pox, lesions mild to severe and no fever. There were no complications. It was noted that the pt was out of school for 5 days. It was reported that the pt recovered without hospitalization. Unspecified medical attention was sought. No product quality complaint was involved. No other info was provided. Additional info is not expected.
Initially seen 09/19/2002 for spell went limp, shaking, questionable seizure. As vomtable not normal afterwards. Has undergone extensive work- up. Unclear if events were seizure vs reflux. Eventually thought to be seizure.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 17-year old male patient, who had no known drug allergies and no illness at time of vaccination. This report did not correspond to a patient vaccinated with ROTATEQ. Instead, the reporter informed that this patient was vaccinated with a third dose of GARDASIL (intramuscular injection, batch/lot # J008423, expiration date 20-JAN-2016, in the left arm, route not reported) on 23-JAN-2014 at 10:00 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). Parent were going to consult with physician. No adverse event was reported for the patient. The outcome was reported by the reporter as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.
redness & inj site,hive x 1 noted immed called in MD to observe blanching et redness disappeared p/10mins;no s/sx of resp distress
Received shot in left shoulder, up high near joint. Typical arm soreness experienced with previous vaccinations, except the soreness has not went away and on a scale from 1-10 is about an eight in the shoulder joint, making movement of arm difficult and painful. Some pain relieve with Ibuprofen but pain returns. It isn't a muscle pain, but deep and in the bone/joint. Was concerned initially that needle had broke off in my arm, but skin isn't sore to touch or swollen, nor feels hot (not infected), it feels like my upper arm bone/shoulder joint is aching.  It has been almost 3 weeks.
He had a quick pulse rate, symptoms like heart is beating fast even when he is resting; He is feeling a little bit agitated; This is a spontaneous report from a Pfizer Sponsored Program Regulatory Authority. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date in Jun2021 as Dose 1,Single for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient experienced quick pulse rate, symptoms like heart is beating fast even when he is resting on an unspecified date in Jun2021 and he is feeling a little bit agitated. The patient underwent lab tests and procedures which included heart rate: quick in Jun2021. He had a quick pulse rate, symptoms like heart is beating fast even when he is resting. The outcome for the events was Unknown.  Information about lot/batch number has been requested. Additional information is expected.
SEVERE HEADACHE  IBUPROFEN 300MG FOR 2 DAYS
patient was not eligible at the time of vaccine for the Pfizer bivalent (12 yo+). Patient reports no other symptoms.