chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A spontaneous report has been received from a health professional concerning a nine year old, male patient. The relevant history of the patient was not reported. The concomitant diseases of the patient were not reported. Patient had been receiving nasal FLUMIST Quadrivalent started on an unknown date. It was reported that the patient pulled back some and a little bit of FLUMIST got into his right eye which started on 17-DEC-2014. Action taken with FLUMIST Quadrivalent was unknown. The outcome of the event of patient pulled back some and a little bit of FLUMIST got into his right eye was unknown. The report was considered to be non-serious by the reporter.
Excessive redness, swelling and pain at the injection site measuring about 3 inches across. Benadryl by mouth and cold compress.
Large buildup of fluid on right side (the side I received my shot). This was not swelling of the lymph nodes but rather a large amount of fluid under my armpit, on my right rib cage down to my hip, and also on my right pec muscle. The fluid went away after a few days.
p/vax pt became limp like a rag doll & difficult to arouse for 1-2 mins; mom reports loss of tone greater than nl loss of tone that accompanies sleep; pt held by RN who also feels loss of tone greater than nl sleeping baby;
Received vax at 09:30 AM. At 10:30AM, pt developed symptoms of shakiness, weakness, hot/cold sensation, slight shortness of breath, left upper arm discomfort. at 11:00 - 11:15. He was given Benadryl, 25mg IM. Full assessment conducted by physician.
bled a bit after getting the vaccine administered.; may not have received the full dose; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE HAEMORRHAGE (bled a bit after getting the vaccine administered.) and UNDERDOSE (may not have received the full dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (bled a bit after getting the vaccine administered.) and UNDERDOSE (may not have received the full dose). On 13-Mar-2021, VACCINATION SITE HAEMORRHAGE (bled a bit after getting the vaccine administered.) and UNDERDOSE (may not have received the full dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient have event like  bled all the way through the entire bandage and the bandage was soaked with blood. Concomitant medication was not provided. Treatment information was not provided.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Additional information received on 07 May 2021, No New Information was provided. On 07-Jul-2021: Follow-up received on 07 July 2021 and contains non significant information
The patient was given Moderna Bivalent vaccine instead of the monovalent for her first dose in the primary series. No adverse effects were observed.  Per the CDC recommendations, it was decided to give her another dose of the monovalent Pfizer vaccine.
Received flu and PNEUMOVAX23 shots at upper right arm. No swelling at injection sites the day received nor following days. However, the next  morning, right arm, swelling beneath the skin of biceps and from underside of elbow 2/3rds way down the forearm as if there was liquid in that area.
sliver dollar size spot that was swollen; sliver dollar size spot that is hot to touch.; Very sensitive to touch; This is a spontaneous report from a contactable healthcare professional, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 25Jun2021 at 12:45 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity and COVID-19. The patient was not allergic to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included phentermine (MANUFACTURER UNKNOWN), bupropion hydrochloride (WELLBUTRIN) and unspecified thyroid medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Jun2021 at 10:00, the patient experienced sliver dollar size spot underneath the injection shot that was swollen and hot to touch. It was also very sensitive to the touch. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events which included application of ice as suggested by physician. The clinical outcome of the events sliver dollar size spot underneath the injection shot that was swollen and hot to touch, very sensitive to the touch was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Cold, Disoriented, Dizzy, Fatigue, Chest discomfort starting the evening after the injection and continuing the day after until late that evening . All issues resolved starting the evening of 11/23.
Within 15 minutes of administration had very quick onset - Cough, inability to speak consecutive words, chest tightness, eyes tearing, headache, objective fever (102-103F), tachycardia.  1 dose epinpehrine administered IM which resolved headache and chest tightness.  Monitored for 1 hour and left clinic stable.  PT continued to have consistent cough and fever for several hours after he was home and called back.
other Contraindication/precaution/immunity not listed (must add text component with description) Pt arm swelled up from the shoulder down to the elbow.  It was hot to touch with redness.  Pt was in pain and would not use arm.  Pt had a hard mass in arm that went from the shoulder to the elbow.  Pt mother stated that after 2 weeks he developed a rash on the lower left arm that went to his abdomen.  Mother stated that he has had that off and on since October.  Mother has been treating with cortisone cream, lotion, ice pack, and vinegar (to draw heat out).  Mother was informed to seek medical attention if any other reactions occur.
RECEIVED PFIZER-BIONTECH MONVALENT (NDC 59267-1025-04) INSTEAD OF INTENDED BIVALENT (NDC 59267-0304-02)
This spontaneous report was received from a pharmacist via a field representative refers to a female patient in her 60s. Pertinent medical history was reported as none. On 18-JAN-2013, the patient was vaccinated subcutaneously with a single 0.65 milliliter (ml) dose of ZOSTAVAX (lot # not reported) for prevention of shingles. On 25-JAN-2013, the patient had a shingles outbreak on her nose. Patient received treatment with VALTREX. Patient sought medical attention (unspecified). The outcome of shingles outbreak on her nose was unknown. The causality for ZOSTAVAX with singles outbreak on her nose was unknown. Additional information has been requested.
I had a cough, shortness of breath, dyspnea. I used a home COVID19 test that came back negative. I went in to have a chest x-ray that came back showing I had radiation pneumonitis. I was given medication and I am currently healing from this.
GBS a slight weakness noted 2 wk post vax; gradual worsening- sent to neurologist mid nov. referred further dx finally made 27nov96, sat pt worsened & hosp 17dec96
Swollen lymph node under arm are left side; hot flashes and teeth aching on left side
MMR given R upper arm - minutes later 5 cm diameter welt with raised erythematous center painful.  Used ice, TYLENOL, educated pt's mom on bringing child back if increased size, increased temp, cellulitis etc
Patient reports extreme pain in shoulder radiating to neck, started the day after the shot and continues without relief through 11/2/13 (still ongoing). Patient has not examined injection site for signs of swelling, but will be seeing her physician.
Information has been received from a licensed practical nurse concerning a 66 year old male with no relevant medical history or allergies who on 15-JUL-2010 was vaccinated intramuscularly with a dose of PNEUMOVAX 23 (lot number 665707/1407Y) and a dose of tetanus toxoid shot. Other concomitant therapy included LIPITOR, NITROSTAT, aspirin, vitamin D (unspecified) and lisinopril-HCTZ (manufacturer unknown). On 16-JUL-2010 the patient experienced injection site reaction, fever and irregular heart rate. The patient's injection site was swollen and red. Unspecified medical attention was sought. No lab tests were performed. The outcome of the patient's events was unknown. Additional information has been requested.
0.25ml Fluvirin given, rec for >4 yrs.  Box marked but not on actual vial.  Pt had no reaction.
Information has been received from a physician concerning a 22 year old female with depression, insomnia, herpes simplex type II and no drug allergies who on 15-JUN-2010 was intramuscularly vaccinated with 0.5 ml the first dose of GARDASIL (lot # 665768/1377Y) into left arm. Concomitant therapy included VALTREX, hormonal contraceptives (unspecified) and trazodone HCl. On an unknown date the patient experienced hypopigmentation/depigmentation and dimpling to her left arm at the injection site. At the time of reporting, the patient had not recovered. No lab diagnostics studies were performed. The patient sought medical attention by visiting office. Additional information has been requested.
Fever, headache, chills, dizzy, body aches, used inhaler night of immunization. Better the next day 5/23 - still fever, upper body/shoulder achy.
The patient received the vaccine at approximately 1:30 pm, when we returned from lunch at 2:00 pm I checked on her at which point she began to feel itchy.  I administered 50mg of diphenhydramine and advised patient to obtain a driver for transportation to her house.  We continued to monitor the patient while she waited and she said that her throat was tightening so we administered 0.3 mg Epi-Pen at 2:30 pm.  EMS personnel arrived approximately 5 minutes later and took over care of the patient.
Dizziness 2 hr. after shot continued 2 days no treatment no big deal.
Rash on the lower part of both arms / located from the elbow down; Redness; Itchy rash; Crusting over; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced rash, red rash, itchy rash and crust. On an unknown date, the outcome of the rash, red rash, itchy rash and crust were not recovered/not resolved.   The reporter considered the rash, red rash, itchy rash and crust to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix, in the unknown arm. Soon after vaccination with dose of Shingrix, the patient experienced rash on the lower part of both arms, rash was located from the elbow down and was itchy, red and crusting over. Till the time of reporting, the patient still had rash and scheduled to get the 2nd dose. The pharmacist had limited information as she was not at the pharmacy at the time of the call.
Patient called the department 2-weeks after vaccination to report event. Within 2-3 hours of vaccination, the patient experienced left-sided facial and eye numbness and weakness. The patient stated the left-side of their face felt "hollow". The numbness began in the lower half of the left eye and traveled across the left cheek to the left ear. The patient further noted excessive eye drainage from the lower palpebra of the left eye. The patient is uninsured and could not present to an ED. The issue is still ongoing as of 5/3/21 and the patient was advised to seek care at the  clinic or a local free clinic. They are scheduling an appointment for this week.
Patient complained of persistent redness, edema, was febrile and noticed streaks down arm  post vaccination. Treated by on-call physician with an antibiotic which did not work, patient went to ER and treated with Bactrim DS + Cephalexin X 10 days (currently). Redness, edema and streaks have all but disappeared. No loss of movement or feeling. Hx splenectomy 2002.
Sore arm; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt tired) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt tired). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt tired) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient received their first dose of vaccine and developed a sore arm and felt tired. On 15-Jun-2021, the patient reported that the patient was fine, and the reaction settled in a few days. Reportedly, the patient received their second dose of vaccine and experienced no side effects.  No Concomitant product use was reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: TCR Report was received on 15-Jun-2021 and contains significant information. Updated the outcome of the event. Included the liner second dose was administered in the I-narrative supplement field.
Itching under the injection site; Injection site red spot of 2 inches; Little swelling; Pain; Tenderness; This spontaneous case was reported by a physician and describes the occurrence of SWELLING (Little swelling), PAIN (Pain), TENDERNESS (Tenderness), VACCINATION SITE PRURITUS (Itching under the injection site) and VACCINATION SITE ERYTHEMA (Injection site red spot of 2 inches) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     Concomitant products included CARVEDILOL, GLIPIZIDE, METFORMIN HYDROCHLORIDE (GLIPIZIDE AND METFORMIN HCL), LOSARTAN and SIMVASTATIN for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced SWELLING (Little swelling), PAIN (Pain) and TENDERNESS (Tenderness). On 08-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itching under the injection site) and VACCINATION SITE ERYTHEMA (Injection site red spot of 2 inches). At the time of the report, SWELLING (Little swelling), PAIN (Pain), TENDERNESS (Tenderness), VACCINATION SITE PRURITUS (Itching under the injection site) and VACCINATION SITE ERYTHEMA (Injection site red spot of 2 inches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported.
SEIZURES; STROKES; BLOOD CLOTS; This spontaneous report received from a health care professional via a company representative via social media and concerned multiple patients. 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, and batch number were not reported) dose, start therapy date were not reported, 1 total administrated for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced seizures, strokes, and blood clots. The reporter stated "I can not even begin to tell you how many patients we have had, since getting the vaccine that have all of a sudden started having seizures, strokes, blood clots We need more educated people speaking up that base their decisions off facts and actual tracked statistics vs mouthing off for personal political agenda". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the seizures, strokes and blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221257651-seizures, strokes and blood clots . Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
This spontaneous report was received from a Nurse practitioner referring to an unspecified number of patients of unknown age and gender. No concurrent or medical condition was reported. On an unknown date, 7 doses of improperly stored M-M-R II Lot # K004949, expiration date: 04-APR-2016 and Lot # K020188, expiration date: 22-OCT-2016, dose, route, frequency and anatomical location were not reported, were administered to unspecified number of patients. No concomitant medication was reported. No adverse event was reported. No further information was provided. No product quality complaint reported. This is one of several cases received from the same source (MARRS numbers 1508USA001815, 1508USA005092). Additional information has been requested.
This spontaneous retrospective pregnancy report as received from a consumer (patient's sister) refers to a 38 year old female patient with allergy to sulfur products. The patient did not have a pertinent medical history. Approximately in February 2011 (reported as "about 3 years ago") the patient was vaccinated with a dose of ZOSTAVAX (one time vaccine) erroneously. Dose, route and lot number were not provided. There were no concomitant medications. It was reported that the patient was under age for ZOSTAVAX. The reporter further stated that her sister was to get the Malaria vaccine, but was accidentally given ZOSTAVAX instead. It was reported that the patient had experienced 3 miscarriages since taking the ZOSTAVAX vaccine. The adverse event onset date was reported as "late 2011". This report concerns one of the three miscarriages. The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) is not known. The pregnancy outcome was spontaneous abortion. Reporter causality was not provided. The event "3 miscarriages since taking the ZOSTAVAX vaccine" was considered medically significant upon internal review. This case is linked to 1402USA011619 and 1402USA011620 (same patient). Additional information has been requested.
Very bad pain and limited arm movement started within two hours of injection. Couldn't sleep. Sept 29, saw Dr. He said the vaccine possible allergic reaction. Gave prescription of FLEXERIL. Didn't help. Still very much pain, limited arm movement. Office visits Oct. 15, still in pain. Dr. put me in physical Therapy. Didn't help. More systems. Severe neck and shoulder pain from left side, night sweats, fever, jaw hurting, scalp tenderness, muscle and hip pain. Couldn't walk in mornings or bend over. Headaches. Blurry vision, auras, dizziness. Can't sleep more than 3 hours. Went on and on. Doctors and PA's couldn't figure out. Finally Jan. 11, Dr. knew what could be. Gave a blood test of ESR and C-reactive protein. Called me that evening with diagnosis of Polymyalgia Rheumatica and Temporal Arteritis, positive biopsy of temporal artery. Been on Prednisone for over two years. I have been in so much pain.
Information has been received from a registered nurse concerning a patient who on 17-OCT-2000 was vaccinated with a dose of Varivax. Subsequently, on 23-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.
I injected the Flu shot first then after I injected the SHINGRIX shot the patient immediately stated to space out. Patient did not respond to any commands for about 15 to 30 seconds. After that the patient started to respond, but then started to feel like vomiting. After that the patient started to  say her vision was starting to go blurry which then it quickly resolved. After that resolved she started to say she was having trouble breathing, but resolved quickly. The patient started to feel better after that.
Injection site was very sore, and was hard to use my arm for two days.  Dizziness and fatigue.  I had a bad headache for several days
Patient was administered a Pediatric dose of Hepatitis A.  Caught before client left office.  Administered the correct dose of Hep A (Adult).  Patient informed of mistake and agreed to take the correct dose.
Flu-like symptoms; felt lethargic; This non-serious case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: Flu-like symptoms) and lethargy (Verbatim: felt lethargic). The outcome of the influenza-like symptoms and lethargy were resolved (duration 1 week).   The reporter considered the influenza-like symptoms and lethargy to be related to Shingrix.     The company considered the influenza-like symptoms and lethargy to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-AUG-2023 The patient age was reported as 6 decades. The reporter stated that the patient had 1 dose of Shingrix and felt lethargic and had flu-like symptoms for a week after. The reporter did not consent to follow up.
pt recv vax;six days later, devel raised,red,itchy bumps & warmth at inject site;
No adverse effects reported; received improperly stored VARIVAX; This spontaneous report was received from lead medical assistant refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. On 17-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R011805 and expiry date 23-APR-2020 (strength, dose, unit, route, anatomical location were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent. The administered doses of the vaccines experienced temperature excursion from above 6 degree Fahrenheit (F) to 14 degree F (7.5 degree F) for five minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.
After vaccine patient felt nausea, anxious, and light headed.  Vitals were taken:  BP 170/92, pulse 60, O2 98%, temp 98.0,  respiration 24.  Provided water and advised to take deep breaths.  Monitored for 15 minutes Patient stated he felt better.  Advised if he encountered symptoms' again call emergency services. He was cleared.
Patient develop a rash, has the area near injection site swollen, he can barely lift his right arm. We recommended cold compress, analgesics, antiinflammatory products and antihistamines.