chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 27-JUN-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004859: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889:
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  In 2013, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated by a healthcare provider for shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) use, patient had 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.
pt recv vax OCT94 & next day devel severe pain in groin, legs, arms, hips, feet, toes, & soles of feet;pain was not resolved despite trails of multiple meds;pt recv flu vax 95-96 w/o a change in sx;
The patient was presented to ER 4/27 with progressive swelling of R arm associated with shoulder pain.  Admitted to ER 4/27-4/29 admitted by the doctor for right subclavian vein thrombus, right axillary and right brachial vein thrombus and bilateral pleural blebs largest measuring 2.1cm with small pulmonary emboli within segmental artery to the right lung base posteriorly and within the segmental artery to the left lower lobe, right sided thoracic outlet syndrome She was on Heparin drip and started on Eliquis Discharged on Eliquis She was on Xulane patches for birth control and was taken off Xulane after finding the clots Also of note she received Pfizer vaccine 1 week prior to presenting to ER
Per pt, after 12 hours she developed a rash around the injection site and around her neck. Patient took Benadryl OTC and that seemed to help. A few days later patient started getting random rashes in both arms. On 10/21/19 patient came to the pharmacy and showed a quarter-size rash on the opposite arm below the elbow. There is still a small red area around the neck. Injection site does not bother her.
This case was reported by a other health professional via call center representative and described the occurrence of vomiting in a 56-year-old female patient who received TWINRIX adult (batch number L5SH5, expiry date 27th SEPTEMBER 2018). On 1st AUGUST 2016, the patient received TWINRIX adult 1ml. On 4th AUGUST 2016, 3 days after receiving TWINRIX adult, the patient experienced vomiting, nausea and fever. On an unknown date, the outcome of the vomiting, nausea and fever were not recovered/not resolved. The reporter considered the vomiting, nausea and fever to be related to TWINRIX adult. Additional details were provided as follows: This case was previously reported to a doctor. The reporter in the case was medical assistant. The reporter stated that, the patient experienced vomiting, nausea and fever after vaccination with TWINRIX adult.
Fast Heart rate 140's, dizzy, tingling all over body, nausea, fever 102 took Aspirin. Went to ER.
Mother reported baby crying unconsolably for over an hour, began ~ 4 1/2 hrs after immuz. administered. When seen in MD office ~ 6 hrs after admin, babe afebrile (99.6 F R); bandaids over sites on thighs bilaterally removed; sites erythematous RUT warm to touch. Tylenol 80mg adminstered PO. Babe quieted ~ 1/2 hr after. Babe nursed. After ~ 1 hr, sites remained erythematous; no edema; no warmth; exam WNL. D/C on Tylenol 80mg q 4-6hrs x 24 hrs. No further symptoms reported by mom after this. Baby acting normal. Redness/warmth resolved within 9 hrs of vaccine.
left arm numbness, left axilla mass, tenderness and swelling; left deltoid induration, swelling and tenderness
I (the patient) found it significantly harder to go about my day to day activities and experienced increased insomnia as well. My ability to think through work diminished to the point where I could not complete any meaningful amount of work or university activities for the next seven months. My brain hurt, and in December 2021, it was stinging to the point that I was crying and dry heaving.
Day 1-  about 4 hours after Moderna injection the site was sore.  Day 2- There was a quarter size reddened area with lump at injection site and warm to touch.   Arm felt weak and  heavy and difficult to raise.  Day 3-  reddened area around injection site had increased to 3x3 inches, warm to touch with lump at injection site.   Left arm felt weaker and heavier than the day before as well as more difficult to raise.   Had to take my right hand and lift the arm due to extreme weak and  heavy sensation and weakness and it was achy feeling.   Day 4-5- The reddened area is unchanged.  The arm is still difficult to raise and heavy feeling and symptoms are enchanced as the day goes on and as I tire.     The same situation and symptoms occured after I had the second vaccine on 02/26/21  lot # 011A21A.   In approx. 10 days all symptoms had  subsided.   There was no adverse reaction after the 1st dose other than soreness at the injection site.  First dose lot # 010M20A
On 8/14/2007 given Rotateq, Pediarix, PCV7, Hib on 8/15/07 developed emesis and decrease appetite by 8/17/07 had diarrhea that is very liquid, foul smelling, emesis continue as does diarrhea 1 week later with some low grade fever and mild dehydration. Still with symptoms.
About 2-3 hours after getting a FLU shot, I began to experience dizziness, shortness of breath and sporadic shaking. The same night I developed insomnia and have had recurrent episodes until today. I continue to get feelings of fainting and confusion, which I've never hd before.
? 1 15 minutes after vaccination patient was observed getting diaphoretic. Patient then reported getting sleepy and not feeling good. O2 desaturation, 5L o2 administered, o2 saturation checked at 93% with non-rebreather. Patient remained alert and responsive but with eyes closed. EMS called and patient sent to Emergency Department for further evaluation.  Patient was sent to ER and was discharged from ER.
Patient developed hives with in a few days of shots, no fever of other symptoms per mom. Child developed rash 7 to 10 days, went away but still with hives, usually occur with touching of skin. Hive have continued since. 11/24/04, Mon states nothing new in envireonment or new foods. Child behaves normally except for continual hives.
At night, Pt started coughing non stop and had some difficulty breathing. on the next day, she went and bought some OTC dextromethorphan and tylenol.
This spontaneous report was received from a consumer via company representative and refers to a 15-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies were provided. On 04-APR-2009, 02-JUN-2009 and 24-SEP-2009, the patient was vaccinated with GARDASIL dose (lot number, expiration date, route of administration and anatomical location were not provided) for prophylaxis. On an unknown date, the patient began feeling extremely tired and would need to take frequent naps. The patient was playing softball and dancing at the time and was previously very active. Through high school and into collage, she had several blood work-ups, referrals to the endocrinologist, multiple therapist looking at depression, a sleep study and nutritionist. She gained weight and her hair thinned. She was diagnosed with hypersomnia. The outcome of hypersomnia, fatigue, alopecia, weight increased and depression was reported as recovering. The causality assessment was not provided.
42 yo female patient with no PMH, here to receive the Pfizer COVID vaccine 1st dose. Approx. 10min after receiving the vaccine she felt "dizzy". Patient admitted that she just had Coffee this morning, also that she was scared and anxious before getting the vaccine. Denied any other symptom. Patient was evaluated by on-site EMS and MD. On physical exam noted to be AAO x 3; Initial VS: HR 80, RR 18, SpO2 98%, BP 150/95. Heart with RRR, lungs clear bilaterally. Patient was offered juice. After 15min observation patient felt better, repeated set of VS within normal limits. Patient was discharged with complete resolution of symptoms; was able to ambulate without any problems.
Information has been received from a registered nurse referring to a patient of unknown age. On 20-JUL-2015, the patient was inadvertently vaccinated with a dose of (Merck) PROQUAD (lot # L004005, expiration date 05-AUG-2016, 0.5 ml, subcutaneous) instead of the intended dose of (Merck) VARIVAX (wrong vaccine administered). No adverse experiences had been reported. Additional information has been requested.
Soft lumps appeared on the top/sides of scalp (both sides); Enlarged lymph node in left neck; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 17Apr2021 at 11:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to pain medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included escitalopram oxalate (LEXAPRO), imipramine (MANUFACTURER UNKNOWN), nebivolol hydrochloride (BYSTOLIC) and ibuprofen (ADVIL); all from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7553) via an unspecified route of administration in the left arm on 27Mar2021 (at the age of 49-years-old) as a single dose for COVID-19 immunization. The patient previously received hydrocodone bitartrate/paracetamol (VICODIN), paracetamol/oxycodone hydrochloride (PERCOCET) and hydromorphone hydrochloride (DILAUDID); all on unknown dates for unknown indications and experienced drug allergy. On 26Apr2021, within a week of the final vaccine, soft lumps appeared on the top/sides of the scalp (both sides) and the patient also had an enlarged lymph node in the left neck area that was currently being checked through an ultrasound. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events soft lumps appeared on the top/sides of scalp (both sides) and enlarged lymph node in left neck were not recovered at the time of this report.
Moderna COVID-19 Vaccine  Patient was given dose after puncture vial expiration had been reached.
Asking a lot of water to clear throat; Dry heaving; little bit of bile came up; Burping; Got pale; Vomiting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THIRST (Asking a lot of water to clear throat), DRY THROAT (Dry heaving), DUODENOGASTRIC REFLUX (little bit of bile came up), ERUCTATION (Burping) and PALLOR (Got pale) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concurrent medical conditions included Atrial fibrillation and Dementia. Concomitant products included APIXABAN (ELIQUIS) for Atrial fibrillation, DONEPEZIL for Dementia, METOPROLOL, SUCCINATE D'ESTRIOL, POTASSIUM (POTASIUM M), LEVOTHYROXINE SODIUM (LEVOTIROXIN), DOCUSATE SODIUM (COLACE CLEAR) and NYSTATIN (NISTATIN) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced THIRST (Asking a lot of water to clear throat), DRY THROAT (Dry heaving), DUODENOGASTRIC REFLUX (little bit of bile came up), ERUCTATION (Burping), PALLOR (Got pale) and VOMITING (Vomiting). On 27-Jan-2021, PALLOR (Got pale) had resolved. At the time of the report, THIRST (Asking a lot of water to clear throat), DRY THROAT (Dry heaving), DUODENOGASTRIC REFLUX (little bit of bile came up), ERUCTATION (Burping) and VOMITING (Vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.2°f.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported. During follow up reporter states that the patient is treated and discharged, denied hospital admission. Medical history includes atrial fibrillation and dementia.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: This significant follow-up was received on 16-APR-2021 which updated event outcome as recovered/resolved and reporter's mail address.
seen 5/31/07 4cm x 5 cm area with induration-severe tenderness (L) deltoid area. Diagnosed with Cellulitis secondary to Gardasil injection. Treated with antibiotic-Augmentin 400 mg chews Ztabs po BID x 10 days. Motrin 2 tabs Q6hrs, as needed for pain.
This spontaneous report as received from C.M.A. nurse refers to a female patient of unknown age. ON 07-FEB-2014 the patient was vaccinated with GARDASIL dose 2, and patient was vaccinated with her first dose of GARDASIL on 27-FEB-2012. Patient was in office on 15-APR-2014, requesting administration of third dose. Patient did not experience any adverse effects due to dosing of GARDASIL outside of prescribing information. Patient did not seek medical attention. Additional information has been requested.
Client was unaware he received a first-dose of Moderna due to possible developmental delay. He inadvertently was given Pfizer as if it was his first dose. He was monitored and no adverse effects noted or observed.
PATIENT A 77 Y.O MALE PATIENT, EXPERIENCED WHAT HE THOUGHT A REACTION TO COVID-19 VACCINE ON 01/12/21. DETAILS BELLOW:  HE RECEIVED THE VACCINE AT 3:15PM ON 01/12/21 AND EXPERIENCE RED SPLOTCHES ON FACE WHICH WAS WARM AND WOMEWAHT TENDER TO TOUCH. PATIENT DENIED SWELLING OF THE FACE, MOUTH OR ANY DIFFICULTY BREATHING.  HE WENT TO URGENT CARE AND WAS PRESCRIBED BENADRYL AND WAS INSTRUCTED TO TAKE BENADRYL PO EVERY 4-6 HRS AND WAS SENT HOME.  AS OF 01/13/21 PATIENT TOLD ME OVER THE PHONE THAT HE IS GETTING BETTER. HE STILL HAS THE RE SPLOTCHES BUT ITS NOT WARM OR TENDER TO TOUCH AS OF TODAY.  I WILL CONTINUE TO MONITOR STATUS.  PRIOR TO THE EVENT. PATIENT REPORTED THAT ON 12/14/20, HE WAS DIAGNOSED WITH CELLULITIS AND WAS PRESCRIBED WITH CLINDAMYCIN ANTIBIOTIC FOR SUPPOSEDLY 2 WEEKS, BUT ON JANUARY 2,2021, HE DEVELOPED THE SAME RED SPLOTCHES ON FACE AND WAS PRESCRIBED PREDNISONE TABLET AND WAS INSTRUCTED TO TAKE IT FOR A WEEK. PATIENT STATED THAT HE TOOK THE PREDNISONE UNTIL JANUARY 8,2021 AND IT RESOLVED THE ISSUE.  STATES HE THEN GOT HIS COVID-19 VACCINE ON 01/12/21 AND DEVELOPED THE ABOVE MENTIONED SIGNS AND SYMPTOMS, ALTHOUGH THIS TIME HE WAS NOT PRESCRIBED WITH PREDNISONE, INSTEAD WAS DIRECTED TO TAKE BENADRYL TABLET.
Client reported feeling dizzy at 14:44 after being vaccinated in the gravity chair.   Client remained in gravity chair, placed chair in semi fowlers position. Pt was alert and oriented x4, warm to touch, no cyanosis, and no pallor assessed. At 14:45 initial vitals: blood pressure: 106/62, heart rate:63, respiratory rate: 16, 0xygen saturation 98%. Vitals remained stable during client's evaluation. Client denied having shortness of breath, trouble swallowing, nausea, and vomiting.  Client denied any tingling in the hands or fingers. Client states, the top number is between 90 and 100's. Client did not drink water and only had a fruit the entire day  Patient given water and a snack. Dizziness resolved at 14:54 pm.  Client states, ?I feel fine and better than I was before.? At 15:15 vitals: blood pressure: 108/64, heart rate: 59, oxygen saturation: 99%, respiratory rate:16. Provided education on VAERS reporting, signs of anaphylactic reactions, and when to call 911. Recommended patient follow-up with MD regarding heart rate between 57 at 15:16. Heart rate returned to 64 at 15:19. Recommended patient follow-up with doctor regarding eligibility for second dose of Pfizer. Patient made aware to continue to inform vaccinators of dizziness episodes after vaccine administration. Patient verbalized understanding of all information given. Client stood from gravity chair with lead RN standing by, no complaints of dizziness. Client ambulated independently out of the facility at 1520, plans on taking the trolley, and escorted out by EMT.
Patient received dose of HPV vaccine. Patient thought this was her firs time receiving, but realized after receiving vaccine, that she already had this series.
I woke up with severe pain in my sacrum/coccyx are and could roll over or walk without severe shooting pains. 2 weeks later I still have a lump in my arm at the site of my injection and am still feeling pain at the site.
First dose began with severe sore throat and swollen lymph glands in neck.  Unable to eat solid foods.  This progressed to joint and muscle pain which moved throughout my body.  After the second dose on 04/02, I had the same reaction on the opposite side of my neck.  Again unable to swallow solid foods and joint pain was unmerciful. I had swelling in my knees, shoulders, and fingers.  I had difficulty walking, chewing and dressing myself.  After a week, the stomach distress began and continues to this day.  When I am able to consume food, I have pain in the abdomen followed by diarrhea. I am smaller than average. 5 feet tall under 100 lbs
Extremity numbness and tingling. Facial numbness. Several falls due to loss of sensation in feet.
Initial information received on 21-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves patient of unknown demography who received an expired dose of vaccine FLUZONE HIGH DOSE (lot UJ031AA and expiry date 01-May-2018) via intramuscular route in the right deltoid on 18-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used. It was not reported if patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Patient was to receive Tdap but instead was given DTaP. Staff in charge notified. CDC was called and we were told patient may have a slightly higher risk of pain at injection site. Vaccine does count and will be valid in place of Tdap. No action required.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL9262), in left arm, on 10Feb2021 as dose 2, single (Lot number: EN6201), in left arm, on 30Sep2021 as dose 3 (booster), single (Lot number: FF8841), in left arm and on 28Mar2022 at 15:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 78 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL. Past drug history included: Augmentin, reaction(s): "Known allergies: Augmentum". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 24Jun2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Jun2022) Negative, notes: tested COVIID negative Monday 20Jun; (25Jun2022) Positive, notes: COVID positive Saturday 25Jun. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Completed Paxlovid regimen on Sunday 19Jun2022, tested COVIID negative Monday 20Jun2022. Runny nose and slight fever began Friday 24Jun2022. Tested COVID positive Saturday 25Jun2022.