chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 12-DEC-2018 , the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R002086, expiry date 22-APR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA000067:
This spontaneous report as received from a healthcare professional regarding unspecified number of patients of unknown age. There was no information about concurrent condition  and historical medication. On an unknown date the patient was vaccinated with improperly stored ROTATEQ lot # L013192/expiration date-19-JAN-2017, lot # L023870/expiration date- 20-APR-2017 and lot # L035511/expiration date-19-JAN-2017 (incorrect product storage). No adverse event was reported. Temperature of exposure was 52 F, timeframe was 77 days, Temperature of exposure was 52 F, timeframe was 156 days and Temperature of exposure was 52 F, timeframe was 840 hours and call was not because of digital data logger and there was no previous excursion. The outcome of the event was unknown. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
21st-pimple looking bumps, apply hydrocortisone cream. 23-took her to Dr-told not to apply anything. 27-rash has spread into patches of small bumps and was given antibiotic cream. 30th-cream hasn't helped, rash worsened. Started steroid/antifungal cream.
Vaccine at 1802-Patient had experienced HTN, tongue swelling and rash after first Modena vaccine. Patient here for 2nd dose of Moderna and had prepped with Benadryl, Allegra and an extra dose of her BP med per her PCP. She initially had an increase in her BP to 172/116, tongue feeling swollen. Bps checked every 5 mins for 30 mins and gradually came back down to normal.  She left with her husband at 1845.
PT VACCINATED AS NOTED ABOVE.  BECAME SYMPTOMATIC AND RAPID ANTIGEN POSITIVE ON 05/25/2021.
Patient contracted COVID after being fully vaccinated asymptomatic - patient was being tested for rehab placement.
Pt. returned to clinic several hours after vaccine adm. Left deltoid swelling, hard and warm to the touch. Some redness around eye orbits. No SOB/palpitations. Pt. transferred to ED by ambulance.
Patient received her 2nd Moderna vaccine @ pharmacy around 1030a. She then became short of breath & struggling to breath. She called our office as was told ER but wanted to come here. Provider seen her gave Duoneb which did help symptoms, XRAY, 50 mg Benadryl Provider feels Tracheitis & observed in office 2 hors was given Rx for duoneb and Benadryl. Patient was brought in by mom and both were informed not to leave patient alone. Stay hydrated and to go directly to ER if Recurrence, rash, S.O.B, difficulty swallowing or drooling, or any other Allergic Response.
patient reported swelling and cellulitis that has spread from 11/27 thru 11/29.
headache; cough; This is a spontaneous report from a contactable nurse reporting for herself. A 25-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176), via an unspecified route of administration on 07Jan2021 at single dose in right arm, for COVID-19 immunisation. Age at vaccination was 25 years. The patient has known allergies to avocado and amoxicillin. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EJ1685) received on 17Dec2020. The patient did not have COVID prior to vaccination and was not COVID tested post vaccination. The patient's concomitant medications were not reported. On 08Jan2021 at 08:00 PM the patient experienced headache and cough. No treatment was received for the events. The events were resolving.
at 10:30 on 12/30, nurse vaccinated Patient with Moderna vaccine. DOB was confirmed but nurse neglected to confirm age and vaccinated patient who is 16 years of age with Moderna. Patient proceeded to wait in recovery for standard time and left facility with no adverse reaction. Mother was onsite with patient and was made aware of the error. All questions were answered and follow up will be made with parent regarding how to proceed with second dose to complete covid vaccine series.
As per pt.'s mother he experienced chest pain, shortness of breath, and palpitations. Pt. was hospitalized overnight for 1 day due to tachycardic event. Mom was informed that pt. shouldn't receive Flu vaccine again.
This spontaneous report as received from a Licensed Practical Nurse refers to unknown number of patients of unknown age and gender. The nurse reported that an unknown number of doses of MMR II (dose, lot# and route not reported) that were improperly stored (outside of the range specified in the prescribing information) might have been administered. MMR II was exposed to 30F then 48F for 72 hours. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
1.5 weeks after immunization (Td, MMR, Hepatitis A and Hepatitis B) given, developed joint pain in both hands progressing now up arms and into shoulders. Joint swelling and stiffness. Reported to health center 9/26/02. Had second Hepatitis B vaccine; symptoms progressively got worse.
Next day fatigue, and brain fog.  Within 24 hours noticed swollen lymph node in left armpit and tenderness (same side as shot).  Swelling about the the size of a fist.   7 days later swelling remains, but reduced by 1/2 the size.  Within 48 hours notices pain and swelling lymph node under right collar bone and tenderness (opposite side of shot).  Swelling is minimal, but collar bone discomfort.  6 days later since onset and collar bone discomfort remains.
Shingles; Information has been received regarding a case in litigation, referring to a male pt of unknown age. Information regarding the pt's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not provided. On or about 27-AUG-2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (route of administration, strength, dose, lot # and expiration date were not provided) by a healthcare provider at a physician's office for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, the pt was treated at a physician's office for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, had and would continued to 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, included but not limited to medical losses and costs which included 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 would continue to suffer such losses, and damages in the future. At the time of the report, the outcome of herpes zoster was reported as not recovered. The lawyer considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
Along with the usual side effects of fatigue, joint and muscle pain, headache,  I had extreme vertigo .  I don't remember the exact time frame of the onset, nut it was the same day as the injection.  I thought it would subside after the first few days, but it didn't.  My PCP prescribed Meclazine which I took for a week, but didn't really help very much.  On th 9th day this symptom slowly resoled and I was fine the next day.  SHOULD  I TAKE THE BOOSTER???
9:10 am Tuesday vaccination 4:00 pm temperature began to rise 8:00 pm temperature 103 degrees F, took Tylenol 9:00 pm temperature 104.5 degrees, chills, headache 10:00 pm temperature began to decrease over next hours Continued to take Tylenol every 4 hours.  Temperature with Tylenol remained at 102 throughout Wednesday.  Temperature with Tylenol was 100 throughout Thursday. Temperature without medication was normal by Friday morning.
On day 4 I experience a severe headache with visual auras in my right eye.  The field defect was the medial field of vision from just my right eye and lasted at least 8 hrs.  I went to sleep with it and woke up to find it resolved.
Initial information reported by pharmacist to nurse on 12-Dec-2013: A 69-year-old male received FLUZONE HD (Lot number, intramuscular) on unknown date. Patient had severe muscle soreness, unable to get out of bed for the 2 days because he "hurt so bad". Patient experienced muscle pain for "couple days" and then symptoms resolved. No further relevant information reported.
Hospital Principal Problem (Discharge Diagnoses): Acute cystitis Acute mental status changes.  Resolved etiology questionable early sepsis  resolved 2.  Cystitis questional early urine with sepsis on empiric ceftriaxone and vancomycin dc vanco 2/1  ecoli  3.  COVID-19 positive asymptomatic Diabetes mellitus type 2 5.  Chronic nonhealing wound to the right foot digits 6.  Hyperlipidemia Severe chronic pain chronic  Neuropathy gabapentin and narcotics maps reviewed on admit and today dc date 8.  Hypertension 9.  Hypothyroidism 10.  History of recurrent lower GI blood loss has been stable 11.  Peripheral vas arterial disease follow-up Dr.  12.  History B12 deficiency 15.  History of chronic iron deficiency anemi
2 x 2 red indurated area to (L) arm, some axillary lymph nodes, lightheaded, dizziness, modest intermittent nausea.
A physician reported that a pt rec'd first dose of Prevnar in October 2001 and developed a rash two days later. On 10/27/01, a fine red papular rash was noted 1cm below the injection site. This rash spread to the infant's hands, feet, and part of her trunk. Additional information rec'd on 11/26/01, the infant had no pre-existing illnesses and was receiving no concomitant medications at the time of vaccination.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2013, at approximately 58 years of age, the patient was administered the ZOSTAVAX by a pharmacist (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated at a hospital for the following injury resulting from her use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to herself and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 16-MAY-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 0.5 ml (lot # L038917, expiration date 20-FEB-2018, route unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 120 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 72 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
experienced tachycardia; flushing of the neck , face and ears; This case was reported by a nurse via sales rep and described the occurrence of tachycardia in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included food allergy.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tachycardia and flushing. On an unknown date, the outcome of the tachycardia and flushing were unknown.   The reporter considered the tachycardia and flushing to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experienced tachycardia and flushing of the neck, face, and ears. The patient mentioned that he has not experienced such a side effect when receiving other vaccinations.  The patient also mentioned that he had a food allergy but could not remember to what food he had an allergic reaction to in his past.  The reaction to the food was a long time ago. The patient believes reaction was to Shingrix.
Patient did not have an adverse reaction to the vaccine. However clinic staff administered a third dose of the shingrix vaccine. The series only calls for 2 doses so the patient received an extra dose. Patient does not have any side effects or adverse reaction to receiving an extra dose of shingrix.
pt recvd vax on 10FEB93 & on same day exp fever, nausea & malaise; No further details were provided;
patient felt nauseous and had a warm feeling in body. went away in approx 5 minutes
GBS,muscle weakness & spasms insulin dependent diabetes (caused from medication given for GBS);muscle relaxants,physical therapy,pain med,antihypertensive,insulin,nerve medication;left w/nerve & muscle damage to legs & side
Temp 104 13MAY; Temp 103 16MAY; Hospitalized 17-18MAY;
Immediately dizzy/nauseous  A few hours later prickly rash on chest Next day headache and fatigue
Pt recvd vax in 1985 & w/in several minutes devel generalized hives as well as swelling of lips, eyelids & face; did not exhibit breathing difficulty & was treated w/med;
STROKE; PASSED OUT; DAMAGE TO FACE; BLACK EYE; CUT; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported batch number: unknown, expiry: UNKNOWN) dose was not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient had stroke and had to be resuscitated, also had frontal lobe damage due to stroke. Patient was passed out and had damage to face, black eye and cut and patient was hospitalized for unspecified days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke, passed out, damage to face, black eye and cut was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20230120832 and 20230120818.; Sender's Comments: V0-20230120898- Stroke, passed out, damage to face, black eye and cut- The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Nurse gave TDAP instead of DTAP. No adverse effects have been noted as of this date.
Light headedness, blood pressure drop from patient normal (120/80) to less than 80/50 with duration of approx 1 hr or greater.
Covered head to toe with multiple papules and hive-like lesions, front and back; many on the forehead and some with clear fluid in the centers.
Patient experienced L arm/shoulder pain starting 5-7 days after vaccination that continued to worsen. Patient went to see her PCP about a week after symptoms started, decided to watch and see what happened. Continued to worsen and more difficult to move arm/shoulder. MRI done which showed rotator cuff tear but in surgery no tear found at all but MD found and diagnosed frozen shoulder. Patient had PT prior to and after surgery.
24 hours post vax, the pt developed erythema, pain and swelling of upper left arm which persists to date 10/5/01.
Had 103 fever during night following vaccine. Muscle aches and headaches. Frequent diarrhea for 2 days following vaccine. Started menstrual cycle within 24 hours of vaccine. Severe menstrual cramps, bloating.
Pt recv vax on 4/1/98.  On 4/18/98 pt exp head, neck, and joint pain.  Pt rx=naproxen (Naprosyn).  On 6/11/98 pt saw rheumatologist for headaches and morning stiffness.  Pt dx with arthralgias with mild Achilles' tendonitis and elevated CPK
3 3/4" X 4 1/2" area of edema and hyperemia, hot to touch. (left arm) Instructed to take Benadryl 50 mg QID, cool compresses, decrease activity left arm
Patient was immunized with both Pneumovax 23 in right arm and Fluarix in the left.  The patient?s right arm bled after injection.  It was cleaned and bandaged.  No incident regarding the left arm immunization.  Patient?s mother was also in the room and was immunized.  The mother noticed the patient beginning to faint.  Patient was caught by mother before hitting the floor.  The patient was laid flat on the ground and began to shake and seemingly ?seized? for about 15 seconds.  Her mother had explained that she had passed out once before upon receiving an immunization, but had not experienced the shaking and apparent seizing.  The patient was given water and came to in about 15 seconds. She sat in the counseling room in which the immunization was given for about another 5 to 10 minutes. Her and her mother had left the pharmacy shortly after seemingly OK. I had called several hours later to make sure that the patient was OK. Her mother had explained that it had taken her about an hour or two to recoup, but she was OK and currently at work.  I had advised that it might be a good idea to have her daughter screened for any neurological or seizure disorder.  I had also explained that on the CDC website it was mentioned that young adults sometimes do experience syncope with shaking and muscle twitching and that it presents as ?seizure?,but in actuality it is not.
Difficulty breathing; Chest pains; Severe joint pain in my thumbs, shoulders, knees and ankles; painful, itchy full body rash, starting on my feet and lower legs, which then spread upward.; Rash has worsened; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Mar2021 at 16:45 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included history of asthma and fish allergy. Concomitant medications included vitamin d nos (VITAMIN D), ascorbic acid (VITAMIN C) and zinc (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 03Mar2021 at 17:15 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 02Apr2021 at 18:00, approximately one week after the second dose, severe joint pain in my thumbs, shoulders, knees and ankles. After the onset of joint pain, the patient also experienced painful itchy full body rash, starting on feet and lower legs, which then spread upward. On 07Apr2021 the patient experienced difficulty breathing and chest pains and went to the emergency room (ER). The breathing issue had subsided but the rash had worsened and the joint pain had remained over the last week. Therapeutic measures were taken as a result of adverse events which included treatment with prednisone (MANUFACTURER UNKNOWN) and antihistamines. The events difficulty breathing and chest pains resulted in emergency room/department or urgent care. On 07Apr2021, the patient underwent lab test which included PCR and Rapid (Nasal swab) and the results were negative. The clinical outcome of the events rash has worsened, severe joint pain in my thumbs, shoulders, knees and ankles, painful itchy full body rash, starting on feet and lower legs, which then spread upward, difficulty breathing and chest pains were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Smell of buring tires - occurred several times for a few minutes but eventually stopped after a few hours.  I did not receive any treatment,
developed hive at injection sit 6/29 and then uritcaria over whole body with facial and lip swelling seen in ER 7/1
Tdap expired on 5/2/09 and was administered on 5/6/09.
20 mins after the shot my chest was tight.  My arm was sore. A few hours later my whole body trembled. I was freezing cold and couldn't feel my feet. I sat in a bath as my body was so sore. The headache started coming on and progresses throughout the night. I was sweating all night. Joints are in pain. Sinuses in my face are sore with drainage. The next day my arm is sore, my bad is in pain. I have a strong headache.  I have the chills.
Initial information received on 26-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 81 years old male patient who experienced sore arm and rapid heart rate, while he received vaccine FLUZONE HIGH DOSE. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Oct-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route in the left arm. On 18-Oct-2018, the patient experienced a non-serious sore arm (pain in arm) and rapid heart rate (heart rate increased) one day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Other relevant tests included was on 18-Oct pulse rate was 87, on 19-Oct pulse rate was 92, on 20-Oct pulse rate was 90, on 21-Oct pulse rate was 92, on 22-Oct pulse rate was 92, on 23-Oct pulse rate was 95, on 24-Oct pulse rate was 60 and on 25-Oct pulse rate was 62. Final diagnosis was rapid heart rate and sore arm. It was not reported if the patient received a corrective treatment. On 24-Oct-2018, the patient recovered from the events. List of documents held by sender: none.
Red area up to 6 cm and warm to touch noted around injection site of varicella (RUE) after 20 minutes. Area marked and receded after an additional 5 minutes. No difficulty breathing or rash. Pt then able to be DCd home. Refer to allergist