chrisvoncsefalvay/vaers-outcomes huggingface dataset:
wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml; No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (wrong dose for Bivalent Vaccine booster dose (underdose)/administered bivalent vaccine at a dose of 0.25 ml).    No concomitant product reported by reporter.  It was reported that the nurses had no standing order other than what they had for second booster, when first administering bivalent boosters. So, they assumed the same dose as the second booster and administered 0.25 ml instead of 0.5 ml to uncompromised adults. Patient received under dose of 0.25 ml of Moderna Bivalent Booster.  It was reported that CDC had recommended to re-vaccinate the patient with full dose of 0.5mL.  No adverse events were reported.  No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-646512 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-646512:Master case
Information has been received from a physician concerning a 65 year old male patient who on 21-JAN-2009 was vaccinated with ZOSTAVAX. On 23-JAN-2009, the patient began having discomfort around the neck. On 26-JAN-2009, the patient presented with a "typical" shingles rash. The patient's discomfort around the neck and "typical" shingles rash persisted. Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/27/2009.  Follow-up information has been received from physician that the patient still had the shingles.  The patient had improved but not recovered.  The patient was given VALTREX 3 grams per day starting on 30-JAN-2009.  Stop date of VALTREX was unknown.  Follow-up information has been from a completed questionnaire by a physician on 30-MAR-2009.  It was reported that the patient with a history of chickenpox in his childhood, kidney stone and knee replacement, was vaccinated on 21-JAN-2009 with one dose of ZOSTER vaccine live (MERCK) in the left deltoid.  On 24-JAN-2009, the patient developed absolutely typical case of herpes in right occipital and neck in dermatomal rash (but discomfort without rash on 23-JAN-2009).  Distribution was trigeminal nerve.  Eye not involved.  The rash did occur at the site of injection or elsewhere within 42 days of the vaccination.  Patient said this pain was worse than knee replacement or kidney stone (pain scale 10).  Other systemic symptoms were fatigue and malaise.  There was not a direct fluorescence antibody done and the specimen was not collected for Polymerase Chain Reaction (patient refused).  There was no a photo taken.  As of 23-MAR-2009, the patient was just getting back to normal.  Additional information is not expected.
Information has been received from a nurse referring to multiple unspecified patients. The patients' concurrent condition, medical history and concomitant therapy were not provided. On 17-OCT-2016 and 01-NOV-2016, multiple patients were vaccinated with improperly stored ROTATEQ (lot # M007298, expiration date: 19-OCT-2017; lot # M005732, expiration date: 19-OCT-2017) (dose and route not provided). The nurse reported no adverse effects noted. The temperature for the vaccine stored was 10.1 celsius degree with 2 hours time frame. There was no previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
full body joint inflammation, stiffness and swelling, high-pitched ringing in both ears, dizziness, disorientation, extreme exhaustion, headache, fever, chills
This patient received TD and Hep A on 07/05/00, at her county health dept. She called them to report "severe flu-like symptoms" that evening. She was told it was like due to the TD. The patient received her 2nd Hep A vaccine on 02/07/01 at another county health dept. Within in hours she developed "worse state of depression she's ever had", also complained of weakness, shaking, and dropping things. She developed a hoarse voice which she still has. The patient walked into the Health dept today to report all of this, she did not call there or her private physician.
Died in the hospital. Was admitted due to respiratory problems,  had urinary tract infection, had complications with medications administered at the hospital ( did not specified which ones).
Headache unrelated to Moderna's vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache unrelated to Moderna's vaccine) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy and Sinusitis.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced HEADACHE (Headache unrelated to Moderna's vaccine). At the time of the report, HEADACHE (Headache unrelated to Moderna's vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
Numbness (lack of feeling) in the index finger of the hand on the same side. Slight numbness on the palm near the base of the index finger. Finger doesn't have any loss of mobility.  Soreness and tightness in the left bicep and triceps. Some tightness in left shoulder.  Arm and shoulder require frequent stretching.
Slight temperature up to 100.4 F. since several hours after Covid vaccine given on 9/2, as well as diarrhea 4 x daily.
Diffuse marbilliform (pink tiny papules-some semi-coalescent) rash on cheeks (face) and entire trunk, some on arms and a few on legs-many in groin area. - itchy, - hives, - pustules, -vesicles.
1. Probable myopericarditis d/t Covid booster-  2. HL o Presented w/ ~2 weeks of chest pressure, however also some atypical features.  Afebrile.  Hemodynamically stable.  ECG with no sig ST or T wave changes, possible new T wave inversions in lead III.  Troponin 0.18.  BNP 312.  Creatinine 0.84.  D-Dimer 2.43.  Hemoglobin 8.9, was 11.7 on 6/16/21.  CT PE protocol w/o obvious PE, bibasilar atelectasis with trace pleural effusions.  Given full aspirin.   1. Continue pta Metoprolol  2. -Continue pta Statin  3. Colchicine 0.6 q24 x 3 months 4. Ibuprofen 600 tid 5. Cards ok w/ d/c home today
3 days after the first shot I felt achy lower back pain in the area of my kidneys.  10 days after, I felt feverish and woozy at the end of the day, and when I arrived home and took my temperature, it was 100.7. 20 minutes later, it was 101.6, which remains the highest recorded. By the time I went to bed about 3 hours later, it was back to 98.8.  The next morning at 9:00 am, it was 99.9 and hovered between there and 99.3 for most of the day. By 6:00 that evening, it had returned to 97.7, which is in my normal range.  I was tested for COVID during that day, and received a negative test result the next day.
On 1st the injection site was itchy, red, slight rash and knot developed.  Day 5 still itchy and round knot at injection site
3 large swollen lymph. Nodes discovered approximately 5 weeks after 2nd vax. Now at 11 weeks, still present and unchanged in size.
This spontaneous report as received from a physician via Company representative refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, route and lot number were not reported). Secondary and concomitant therapies were not reported. Physician reported that a patient no longer experienced having her period after receiving the GARDASIL (unspecified dose in the series) (date unspecified): it was also report that the patient was not pregnant. It was reported that the patient sought medical attention by seeing the physician. Additional information has been requested.
Itching on both arms and nape of neck; Hives on upper right arm; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6207), via an unspecified route of administration in left arm on 17Mar2021 at 16:00 (at the age of 67 years old) as a single dose for COVID-19 immunisation. Medical history included breast cancer, acid reflux and osteoporosis and seasonal allergies (tree and grass pollen). Past drug history included penicillin, erythromycin (Z pack) and surgical adhesive tape form which patient had allergy. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), FOSAMAX, fluticasone spray (MANUFACTURER UNKNOWN) and multi vitamins (MANUFACTURER UNKNOWN); all for unknown indication started on an unknown date and it was unknown if ongoing. Prior to vaccination, the patient had not had symptoms associated with COVID-19. Since vaccination, the patient had not been tested for COVID-19. On 17Mar2021 at 19:00 (within three hours of injection), the patient experienced itching and hives appeared on upper right arm which was opposite to arm from injection site. Symptoms went after another three hours. However, the next morning and every day since, both arms and nape of neck had itched, but no rash or hives appeared. The patient took a low dose antihistamine (unspecified) the morning after the shot and visited primary care physician (PCP) as part of a regular schedule visit that week. The physician advised taking a daily dose of CLARITIN or ZYRTEC. The patient did not receive any treatment for the event at the time of this report. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of event hives was resolved on an unknown date in 2021 while the outcome of event itching on both arms and nape of neck was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
After 2nd dose, I had N/V, fever, chills & extreme fatigue. The extreme fatigue is still present today (3 years later). My doctor advised me to contact CDC & inform them. I have chronic stiffness and my life has never been the same. My doctor says the auto immune disease I now have is probably the result of the shingles vaccine.
Information has been received from a 66 year old female consumer with no known drug reactions/allergies and breast cancer since January 2007, who on 11-MAY-2008 was vaccinated with a dose of ZOSTER vaccine live (Oka/Merck).  Concomitant medication included thyroid medication.  In August 2008, the patient started to have a rash with "fluid filled pustules from head to toe that burn and feel like someone was stabbing me with a needle".  The patient stated that she had sores in her mouth and had burning pain in her vaginal and rectal area.  The patient reported that so far she had gone to see four dermatologists and a gynecologist regarding the rash.  The firs dermatologist gave her PREDNISONE (manufacturer unspecified) for three weeks and the second dermatologist put her on Z pack (manufacturer unspecified).  The other prescription creams (names and manufacturers unspecified).  The patient went to see her gynecologist for the burning pain she was having in her rectal and vaginal area and was given more topical creams (names and manufacturers unspecified).  The patient stated that her oncologist the referred her to two other dermatologists.  The dermatologists did some blood test, which all came back fine, and a biopsy with was negative. The patient stated that all the physicians were stating that she appeared to be having an allergic reaction to the vaccine.  The patient still had the rash, she was homebound and in constant pain.  The patient received a small pox vaccine (name and manufacturer unspecified may) many years ago and her arm blew up to the size of a thigh and she had weeping pustules on her arms that lasted for the summer through the winter.  The specific date this happened was not mentioned.  In follow-up the patient's husband stated that his wife had a history of cancer.  And that it had been over a year since she had had any cancer treatments.  At the time of reporting the patient was not recovered.  Additional information has been requested.
Initial diagnosis of atrial fibrillation; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 29Sep2021 12:00 (Batch/Lot number: unknown) at the age of 77 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing); "known allergies: Sulfa drugs" (unspecified if ongoing). The patient took concomitant medications. No other vaccine in four weeks. No COVID prior vaccination. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL 9264, in left arm, at 03:00 PM), administration date: 29Jan2021, when the patient was 76 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9266, in left arm, at 03:00 PM), administration date: 17Feb2021, when the patient was 76 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 29Sep2021 12:00, outcome "unknown", described as "Booster"; ATRIAL FIBRILLATION (medically significant) with onset 09Nov2021 13:30, outcome "unknown", described as "Initial diagnosis of atrial fibrillation". The event "initial diagnosis of atrial fibrillation" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Dec2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of atrial fibrillation: cardioversion.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Severe hives, shots for school received on 06/18th at 9:30pm on 06/21st began breaking out over entire body, was taken to ER. Given steroids and a prescription for steroids, hives lasted until Monday 24th of June. ER DR stated believed Polio vaccine has cause due to redness.
Patient describes a large welt on the arm where the vaccine was given and feeling "under the weather"
non-swollen cord like lymph nodes; burning sensation and joint pain in injection arm; burning sensation and joint pain in injection arm; 19Dec2020 she received the 1st dose. 2nd dose received 11Jan2021; This is a spontaneous report from a non-contactable consumer. A 49-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: not provided), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose on 19Dec2020 and experienced numbness for an hour, and subsequently burning sensation and joint pain which subsided with Tylenol use. Patient's 2nd dose was received on 11Jan2021 and since 15Jan2021 she mentioned non-swollen cord like lymph nodes, burning sensation and joint pain in injection arm which transcends to the left arm. Tylenol helps sometimes. Outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 21-NOV-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N021475 and expiration date 03-JAN-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA001951; US-009507513-1810USA001952; US-009507513-1810USA001953; US-009507513-1810USA001954; US-009507513-1810USA001955; US-009507513-1810USA001957; US-009507513-1810USA001958; US-009507513-1810USA001959; US-009507513-1809USA003709.
Information has been received from a physician concerning a female patient who on unknown dates was vaccinated with three doses of GARDASIL. On an unspecified date, the patient came down with arthritis. It was reported that the patient required medical attention. The patient's final outcome was not reported. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
Patient noticed she felt short of breath after the vaccination, but didn't think too much of it. Thought maybe it was nerves. It went away. Then later that night, she developed very swollen lump in her armpit (lymph node) the size of a baseball. The following morning, she woke up with swollen eyes. She visited me on Monday and her eyes were still very swollen, and the swelling in her armpit was still very apparent and large (on the side she received the Comirnaty).
N/V immediately post vaccination 1:13 pm.  Paramedics consulted.   BP 151/103 ~1:18 pm   Pt in some distress/SOB and showing inc RR. Reports no other symptoms. Continues to vommit.  A/O.   Diphenhydramine 50 mg IM RD administered, no improvement. Patient remains SAME, sxs neither improved or worsened.    BP: 106 / 78 1:24 pm  Pulse 48 1:24 pm  Hx allergy: Norco, Bee Sting, Iodine PHI: possibly Graves, patient unable to verbally verify Meds: Vitamin D.   Transport to ER at 1:28 pm
Single subsegmental pulmonary embolism without acute cor pulmonale? (present on admission) A: UnprovokedSubsegmental pulmonary emboli noted on prelim report CT chest  with slight straightening of interventricular septum could reflect presence of right heart strain. Likely a larger embolism which dispersed. Currently not hypotensive. DVT negative  P: Check 2D echo: if showing evidence of R heart strain will consult IR for systemic thrombolysis Therapeutic anticoagulation with Lovenox subcutaneous . Will transition to DOAC in AM tomorrow. She will need to be on for life Malignancy screening to be done as an outpatient. - morphine 4mg IV q4h as needed for pain RIGHT SIDED ABDOMINAL PAIN X 2 DAYS STARTED 4/12/21, WENT TO ER ON 4/14/21,  DISCHARGED ON 4/16/21 IN STABLE CONDITION STARTED ON  XARELTO 15MG DAILY FOR 21 DAYS THEN 20 MG DAILY
The patient did not require any medical attention and was not harmed in any way.; needle broke away from the base; poor quality device used; device breakage; This spontaneous report was received from a consumer via Regulatory Affairs and refers to a 13-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 26-FEB-2021, the patient was being vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe (PFS), lot # 1687291, expiration date 11-SEP-2022 (strength, dose, anatomical location and route of administration were not reported) as prophylaxis. The customer reported that as they were using the product, the needle broke away from the base (needle issue, device breakage, poor quality device used) and the product broke into 2 or more pieces. A photo was provided by the customer and the product was available for evaluation. The patient did not require any medical attention and was not harmed in any way (no adverse event). The outcome of the events was unknown.  Causality was not provided. 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; productavailableforevaluation: Yes; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
01/03/21 soreness in left armpit 01/04/21 to present swelling of lymph nodes and increased soreness, pain spreading to  left breast and upper back 01/07/21 rash near left armpit
Tiredness; headache; chills; fever; muscle pain; This is a spontaneous report from a contactable Nurse(patient).  The 54-year-old female patient (not pregnant) received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ES1655) , via an unspecified route of administration at right arm on 09Jan2021 10:00AM at single dose for covid-19 immunisation.  Medical history included arthritis, asthma, sjogren, eczema.  The patient's concomitant medications were not reported.  The patient previously took cefotaxime sodium (OMNICEF) and "Bactria" and both experienced drug allergy.  The patient experienced tiredness, headache, chills, fever, muscle pain, all on 10Jan2021 at 12:00 AM with outcome of not recovered. There was no treatment received, no covid prior vaccination, no covid tested post vaccination.
Confirmed Breakthrough  COVID-19 (Janssen) 1 03/20/2021 Hospital Janssen 1802068   COVID-19 (Janssen) 2 11/23/2021 County Health Department Janssen 211D21A
He had a sore throat, and a low-grade fever. He tested negative for COVID-19, but positive for Strep. They prescribed penicillin for him. He was feeling better 24 hours after taking the medication.
pt recv vax;devel Bell's Palsy;lab eval revealed inc serum phosphorus and serum cholesterol;lyme titer neg;4aug95 almost completely recovered from Bell's Palsy;
Metallic taste as soon as shot was received  Approx 8 hours later ringing in the ears that lasted hours. Fever and night sweats Headache  Nausea lasting 3 days