chrisvoncsefalvay/vaers-outcomes huggingface dataset:
blackhead; Cold; Hand pain; low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (blackhead), NASOPHARYNGITIS (Cold), PAIN IN EXTREMITY (Hand pain) and PYREXIA (low grade fever) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included Surgery (Rotator cuff) on 25-Oct-2021. Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe Rheumatoid arthritis ).   On 30-Oct-2020, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ACNE (blackhead), NASOPHARYNGITIS (Cold), PAIN IN EXTREMITY (Hand pain) and PYREXIA (low grade fever). At the time of the report, ACNE (blackhead) and PAIN IN EXTREMITY (Hand pain) had not resolved, NASOPHARYNGITIS (Cold) had resolved and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  It was reported that, the patient had of rotator cuff surgery on left shoulder, pain in left hand, blackhead on back get infected and cold.  On 25-Oct-2021, the patient had a rotator cuff surgery on her left shoulder. The physician had instructed to hold Rinvoq before and after procedure. The patient would continue to follow physician orders and physical therapy. The patient also got a slight cold after low grade fever. She had pain especially in left hand. She had a blackhead on her back to get infected.  It was unknown if she was enrolled in a COVID-19 Vaccine Trial.   No treatment medications were reported.  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.
Patient had redness and swelling from injection site all the way down the arm past the elbow.   This started the day of the injection.  Her condition improved when I viewed her arm on 4/10.  The site involved was about 4 inches in diameter around the injection site.
I developed a sudden hearing loss, which I noticed on May 6. It's possible it was creeping up on me before then, but that night it was very pronounced, especially in my left ear. I also developed tinnitus. I saw my ENT within a few days who tested my hearing and confirmed the loss (it was in both ears but especially the left, compared to 1.5 years prior). He put me on a low dose of steroids which helped a little. Then he put me on a high dose of steroids, which helped more. I still have tinnitus, though.
pt recv vax 8AUG96 & fever 9AUG96 reported to 104-104.9 on 10AUG;17AUG96 broke out w/a viral exanthem-probable roseola;
Patient reports raised red rash at the injection site slightly larger than an oreo cookie, warm to the touch, and swollen. Patient denies any other symptoms.
TDAP, Menactra, HPV  given on incorrect dosage schedule.   Prevnar given as an extra dose.    Child was 7 years old.  Vaccines was accepted by system.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 10-OCT-2013, patient was vaccinated with first dose of GARDASIL injection, dose (unknown) and route of administration (unknown). No concomitants were reported. ON 10-APR-2014, the patient was in office to receive the second dose of GARDASIL. No adverse effects reported. The outcome of events was unknown. No PQC 9product quality complaint) was reported. No other information was reported. Additional information has been requested.
I started having itching and hives about 3 hours after receiving the vaccine. No shortness of breath or other discomfort . I did an unscheduled Telehealth visit through my insurance and the doctor prescribed me Hydroxyzine, Fexofenadine and an anti itch cream. I took 1 Hydroxyzine and went to bed. i was completely fine the next morning.
Severe pain in left shoulder and muscles to the point where I could not lift my arm.   This was very different than a normal shot where there may be slight pain at the site.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Mar2021 at 11:00 as dose 1, single (Lot number: EN6199), in left arm and on 03Apr2021 at 11:00 as dose 2, single (Lot number: ER8730) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing); "prev heart attack" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient did not received any Other medication in 2 weeks.Anti-viral details: Product- COVID 19 Treatment,Brand-Paxlovid. Treatment Start Date: 24Oct2022. Treatment Stop Date: 29Oct2022.Indication: Treatment of Covid-19. No Known allergies.
Severe muscle and joint pain, shaking uncontrollably and high fever x 6-8 hours. Continues with low fever and muscle/joint pain the following day.
No additional AE; temperature excursion in which PROQUAD and V ARlV AX may have been administered to patient(s).; This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-APR-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # T024284, expiration date: 15-JUL-2022, dose 1 (formulation, strength, exact dose, frequency, route of administration were not reported) for prophylaxis. On an unknown date, the dose of the vaccine was exposed to temperature excursion at 17.32 Fahrenheit degrees (F) for 1 hour 22 minutes. There was no previous temperature excursion reported. The call was due to digital data logger. No additional adverse event was reported.
Patient received her vaccine and fainted. She did fall forward and bust her lip. After a few minutes of dizziness she was feeling better. Had her stay and drink some water with no other side effects.
felt hot immediately after vaccines administered, described tingling sensation in hands, lightheadedness, dizziness and sweating.  All resolved by around 1:45pm
1/6/21 bruising on under arm (not injection site) .  1/7/21 inflammed and painful left axilla and neck. Continues to be sore 1/14/21.  1/14/21 reddened , hardened, inflammed and painful/burning sensation to area on left upper arm and radiating into forearm/wrist
Change in menstrual period - menstrual cycle immediately following dose 1 stopped abruptly several days prior to normal (stopped day 3, normal 6 days), with ovulation following the next day. After second vaccination, menstrual cycle was delayed by 8 days (abnormal, years of history of consistent cycle), followed by a longer period (9 days).
Information has been received from a consumer concerning her son with no allergies or pertinent medical history who on 07Oct02 was vaccinated with a second dose of hep B virus vaccine rHBsAg (yeast) (lot 643757/0781M), on 21Jan03 was vaccinated with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live  (lot 641882/0531M), and on 20May03 was vaccinated with a first dose of varicella virus vaccine live (lot 644147/1068M). It was noted that in Jun 2005, after receiving these vaccines, the pt was diagnosed with autism at approx three yrs old. It was further noted that the pt was nine months old when he received the first vaccination and was 16 months old when he received the last vaccination. Unspecified medical attention was sought. Lab tests included a CBC, MMR titers, Chromosomal tests for Fragile X, and a Rett's syndrome test. No results were provided. At the time of the report, the pt had a not recovered. A product quality complaint was not involved. Upon internal review, autism was considered to be an other important medical event (OMIC). Additional information has been requested.
ADMISSION DIAGNOSIS: 1. COVID-19.  2. Gastrointestinal bleed.  GI has deferred endoscopy to outpatient.  3. End-stage renal disease via left arm AV fistula Monday, Wednesday, Friday, ??.  4. Coronary artery disease, sees Dr.  5. Hypertension.  6. Diabetes.  7. Hyperlipidemia.  8. Ex-smoker.   DISCHARGE DIAGNOSIS: 1. COVID-19.  2. Gastrointestinal bleed.  GI has deferred endoscopy to outpatient.  3. End-stage renal disease via left arm AV fistula Monday, Wednesday, Friday, ?.  4. Coronary artery disease, sees Dr.  5. Hypertension.  6. Diabetes.  7. Hyperlipidemia.  8. Ex-smoker.    The patient feels well.  The patient completed his 3-day of remdesivir.  If the patient is non hypoxic, the patient can be discharged after dialysis today.
Initial slight fever and tired beginning around 1900hrs the evening of the injection.  Patient took 1 Tylanol and went to bed.  At approximately 2200hrs, fever surged through entire body, coupled with significant specific muscle pain at polio previously afflicted sites.  Patient took another Tylenol.  By 0600, next morning.  Fever was reduced but still present.  Muscle pain still present and significant.  Pain precluded patient's ability to walk safely.  Patient took ibuprofin for pain.
8/3/21 Patient called with positive test results from 8/1/21 test.  Patient currently asymptomatic.  Advised to continue with isolation from other members of the household (isolated since 7/29/21 with positive test result from Pharmacy) for 10 more days and to callback on 8/11/21 for clearance.  Patient is not immunocompromised and did not participate in the study. She also did not want an antibody test
Information has been received from a healthcare worker concerning a 25 year old female patient who "3 weeks ago", on approximately 19-NOV-2009, was vaccinated with the first dose of GARDASIL (LOT# not provided) 0.5 mL. The healthcare worker reported that "3 weeks ago", on approximately 19-NOV-2009, the patient developed rash on her chest and arm after that lasted for four days after vaccination with GARDASIL. No lab tests were performed. The patient sought unspecified medical attention. On approximately 23-NOV-2009, the patient had recovered. Additional information has been requested.
This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Feb 9, 2021, single dose, for COVID-19 immunisation. Medical history included cholesterol (abnormal blood cholesterol) and asthma. Concomitant medication included Praluent (alirocumab) taken for abnormal blood cholesterol. On an unspecified date, patient experienced myalgia and influenza-like illness, (muscle aches and flu-like symptoms), which she also experienced with Praluent in the past. On Feb 9, 2021, patient experienced severe muscle spasms (like Charlie horses all over her body). This was an immediate, short-term reaction after receiving the COVID-19 vaccine. Her skin and throat turned bright red, and she had difficulty breathing. She needed her asthma pump but had 3 occurrences (one after the other) and required on-site observation for 1.5 hours. She no longer felt that afterwards. She was told to take Benadryl and a couple of puffs of her inhaler before her appointment for the 2nd dose on Mar 2, 2021, and she would be kept for observation. They made a note in her file and advised her primary care physician. At the time of this report, the outcome of events: unknown. Follow-up attempts completed. No further information expected.
She report receipt of vaccine and 30-45 minutes later experienced severe headache, nausea, scratchy throat and loss of voice and breathing was 'heavy'. She reports pallor, increased heart rate and near syncope. She denies pruritis, urticaria, flushing, watery eyes, face/tongue or lip swelling, CP, cough. She was seen in ER and treated with zofran, pepcid, solumedrol, monitored and then released.   ER records note tachycardia at 107 but otherwise normal VS and exam. .
Chills and 104F fever for four hours.  Pain in left arm and down left side to waist for 48 hours.
7AUG pt irritable tx w/APAP;9AUG emesis x 1;10AUG vomited 1;11AUG lt leg gave way x2;seemed weak-had tremors;12AUG unable to stand, legs demottled, pt crying in pain-hosp;dx acute transverse myelitis;paralyzed;skin mottled & blue;
Initial report received from a health care professional on 05 Jan 2010: This two year old patient inadvertently received S-OIV FLUVIRIN, batch no: 1021314P1, intramuscularly, on 04 Jan 2010.
p/vax pt stopped crying, became pale & hypotonic;rxn lasted approx 1min & subsequently pt pink, crying;vitals stable & not tx was required;
Progressive discomfort and decrease in range of motion in the left shoulder. Diagnosed of adhesive capsulitis of the left shoulder in May 18, 2021 at Hospital Currently undergoing physical therapy started in early July with some improvement
patient received an expired dose; No further AE; Information has been received from a pharmacist reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 01-FEB-2021, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection for prophylaxis, lot # R011628 and expiration date 11-DEC-2020 (route of administration was not reported). No further adverse events 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: R011628; expirationdate: 11-DEC-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Pt called 9-16-13 stating his arm was swollen down to elbow and felt feverish. Told pt to go to doctor. He was diagnosed w/ staph infection.
2 patients got a result of (-) IGG and (-) IGM; This is a spontaneous report from a contactable physician. This physician reported similar events for 3 patients. This is 3rd of 3 reports. This physician reported for a patient of unspecified age and gender who received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 03ml single dose for covid-19 immunization. The patient medical history included historic vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization, The patient's concomitant medications were not reported. Physician stated that he has 3 patients who received their Pfizer Covid vaccine,the dose given was 1 patient: 1 dose of 0.3 mL vaccine, 2 patients: 2 doses of 0.3 mL vaccine and had their antibody tests done. 1 patient got a result of (-) IGG and (+) IGM and didn't receive the 2nd dose of the vaccine while the other 2 patients got a result of (-) IGG and (-) IGM which was taken 3 weeks after their 2nd dose. The patient underwent lab tests and procedures which included blood immunoglobulin g: negative on unspecified date and blood immunoglobulin m: negative on unspecified date Result of (-) IGG and (-) IGM which was taken 3 weeks after their 2nd dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162117 same reporter/drug/event, different patients;US-PFIZER INC-2021116299 same reporter, drug and event/different patient
FLUMIST expired on 12/3/12 & was given on 12/10/12. Mother denies any adverse reactions.
Arm extremely sore redness from just under shot site and down almost to elbow. High fever, throwing up, headache. Ibuprofen and drank lots of watet
The day after my shot I developed an itchy rash that felt like a bad case of poison ivy that progressively got worse over the next few days. It got to the point that my throat started swelling shut and I went to the hospital emergency room.
numbness; tingling; weakness on the side of the body where the injection was given; This is a spontaneous report from a contactable nurse (patient's fiancee) received via Medical Information Team.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On Jan2020, the patient experienced numbness, tingling and weakness on the side of the body where the injection was given, from the shoulder to the arms, hands and feet. The reporter stated his fiancee felt the numbness and tingling was paresthesia. The patient outcome of the events was not recovered.  Information about lot/batch number has been requested.
Immediately, post vax of his daily injection of Humatrope, he had a seizure which lasted approx. 45 seconds. Mother stated "he went rigid, held his breath and went blue". No previous history of seizures. No reaction with previous doses of Flu or Humatrope. Complained of headache the next day.
Client received Booster dose of COVID vaccine Janssen (lot # 1855194, exp 04/09/2022) in left arm and Fluarix in right arm today at 9:05 am. At 9:10 client was sitting on park bend and stated she felt ?dizzy? to PHN. Client denied itchiness, denied nausea, skin was dry and appropriate to Ethnicity. Client stated she hasn?t eaten yet today, denies history of syncope with vaccines. Vitals taken at 9:20 am: BP 123/90, HR 87 bpm, SpO2 95%, RR 20. Client has no known allergies. Client reports history of chronic pain, Hypertension, Anxiety, and Depression. Client takes ibuprofen and antibiotics currently. Client reports primary PMD is doctor with facility. At 9:23 am PHN assisted client to lie down, and client ate some food. At 9:25 am client sat up, stated she ?felt better? and the dizziness was gone. Vitals taken at 9:30 am: 130/88, HR 86 bpm, SpO2 98%, RR 18. PHN educated client s/s of concern and when to call 9-1-1. Client stood up at 9:37 am and walked off with a steady gait.
Redness all over body, swelling to lips. Presents to ED 1 hour after vaccine administration.  Treated with Prednisone, diphenhydramine.
Pt was 12 years old at the time of the dose, too young for Moderna.
This spontaneous report as received from a other refers to a patient of unknown age. On an unknown date the patient was vaccinated with PROQUAD lot # M038862 with expiration date of 13-MAR-2018 for prophylaxis. Other suspect therapies included sterile diluent (manufacturer unknown). On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to PROQUAD and sterile diluent. The reporter considered no adverse event to be not related to sterile diluent and PROQUAD. Additional information has been requested. Sender's Comments: US-009507513-1708USA011842.
Received PROQUAD (MMRV) 8/15/16 in office. Returned 8/18/16. the chief complaint is: c/o: rash on mouth and body and venous lead. This is a 1.0 year old male with the following history: He presents with a rash around the mouth and spots on the hands, feet and genitalia for the last few days since getting his vaccines. He has not had fever. He is fussy. he is eating normally.
G62.9 PERIPHERAL NEUROPATHY 2/28/2022 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 11/9/2021 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY R09.02 HYPOXIA 4/18/2022 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY G62.9 PERIPHERAL NEUROPATHY 2/28/2022 PNEUMONIA I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 11/9/2021 PNEUMONIA R09.02 HYPOXIA 4/18/2022 PNEUMONIA
This spontaneous report as received from a medical assistant refers to a 5 year old patient of unknown age. On 23-SEP-2014 the patient was subcutaneously vaccinated for the first time with M-M-R II albumin status HSA (0.5 ml, lot # J000202, expiry date: 09-JAN-2015). No adverse effects reported. The reporter stated that that for unspecified reason the patient did not receive M-M-R II at 12-15 months of age (as recommended in prescribing information) and received first dose at age 5. Additional information has been requested.
On 05/07/2019, about 4 hours after the Menactra Vaccine was administered, the patient started to c/o pain and mild redness at the injection site. The following morning, (05/08/2019), pt's mother noted swelling, redness and warmth to the left arm around the injection site. Pt. went to school and after about 2 hours  mother was called by the school nurse to pick child up due to worsening reaction. Mother brought child to our office at which time the patient was seen by Dr. and noted to have swelling/edema to the left arm with erythema extending past her elbow. Parent was instructed to give Motrin for pain, Benadryl for swelling, and was prescribed Clindamycin to cover for possible cellulitis. On 05/09/2019 the patients symptoms continued to worsen with erythema, swelling/edema and warmth to the left arm from above her shoulder down to her fingertips. Her mother brought her to Hospital emergency room where she was given IV Ceftriaxone, and labwork was drawn which was reportedly normal.  Pt. was discharged home and told to continue the Motrin, Benadryl and Clindamycin. Pt. followed in our office again today 05/10/2019 where she was seen by Dr. The swelling/edema and erythema have significantly improved and the upper left arm is still mildly warm to touch but has improved.
4 inch red swelling Rigors, chills and fever. (patient said she knew she had a fever but never took her temp)
The pt experienced a fever beginning 2 hours post vax with swelling of arm which was localized. The swelling resolved but evolved into red blotchiness. The pt also experienced a headache and vomiting.