chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was part of off site-health care event. I went over consent form with patient, he signed release of li-ability form, and I confirmed no medical conditions or allergies. After I gave patient a flu shot, he put his head down on the table in front of him. For the second it looked like he was just relaxing. I tapped his shoulder couple of times asking him if he was ok, but I haven't received any answer. I just then realized that pt had fainted. I got help from lady who was together with me in the room as part of the health care event. We gently put patient from the chair to the ground protecting his head at all the time. We then elevated his legs. At that moment I saw that patients was responsive again. I asked him if he wanted me to call 911. He said no. His face was really pale. I asked the lady to go and call nurses  who also were present at the event. In the same time I checked patient BP. His BP was normal 119/72 but HR was 44. Two nurses stepped in the room, one of them was with the patient till recovery. Nurses put ice packs behind patient's neck and on upper chest, just below the neck. Patient  started feel better but he was still weak. We transferred patient to adjustable chair that nurses use for blood donations. They gave patient apple juice ( he had 2) and bag of pretzels. I checked his BP again This time 128/78 and HR 56. Patient was recovered and after 20 minutes of observation and he stood up.
Received phone call from physician reporting significant swelling in left theigh.  Client refused to walk or crawl.
Transverse myelitis; left leg weakness and left thigh numbness; This is a spontaneous report received from contactable physician.  A 78-year-old female patient received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: MYELITIS TRANSVERSE (medically significant), 6 days after the suspect product(s) administration, outcome "recovered", described as "Transverse myelitis; left leg weakness and left thigh numbness". The patient with multiple underlying medical problems developed left leg weakness and left thigh numbness 6 days after receiving the listed COVID-19 booster along with an influenza vaccine. She was later diagnosed with transverse myelitis possibly associated with one of the vaccines. Treated successfully with corticosteroids. The event took place after use of product.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The limited information provided in this report does not allow a full assessment of the case, however, a possible contributory role of the suspect drug BNT162b2 to the reported event "Transverse myelitis; left leg weakness and left thigh numbness" cannot be completely excluded based on temporal association. Concomitant influenza vaccine may also play a conytributory role. This case will be re-assessed when additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient received the booster-  bivalent Pfizer vaccine 1+ months prior to 12th birthday.  Patient age was verified, mother concurred with the age of the patient being 12 y.o.  Mother wanted her son to receive the bivalent dose, although it should not have been administered until Nov 16, 2022.
This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema of extremities and injection site pain. On an unknown date, the outcome of the erythema of extremities was recovered/resolved and the outcome of the injection site pain was unknown. It was unknown if the reporter considered the erythema of extremities and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in the upper arm. The patient received SHINGRIX vaccine by a pharmacist and she had a concern that she did not get the vaccine properly because the pharmacist pinched her upper arm really hard. Her arm hurt during administration of the vaccine and the area where the pharmacist grabbed her arm was pink for over one week and it hurt. The patient has denied permission to contact their physician. The patient refused to answer any additional questions and requested to be anonymous.
Nausea, sharp pain in lower calves, pain in temple, tight pressure around forehead, pain in lower left back of head, slight temperature, lightheaded dizziness, swollen stomach and nausea, tightness in chest, rapid heart rate, ice cold feeling in feet, some chills, tight constricting feeling in neck.
Vaccination site swelling; Welts Injection Site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE URTICARIA (Welts Injection Site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE URTICARIA (Welts Injection Site). At the time of the report, VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE URTICARIA (Welts Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitent medications were provided.  No treatment medications were provided.
After the vaccination I had horrible headaches. I have had headaches and migraines well before getting the vaccine, but that one was really strong. So I decided to take many NSAIDs. I knew I shouldn't be taking that many NSAIDs, but the headaches were severe so I kept taking them anyway. One day when I was at work and taking a break, I had a horrible burning in my stomach. I thought I should go to the ER, but I was working and didn't want to lose my job. I also didn't have any insurance. I ate some pita chips then the burning stopped. 2 weeks later I vomited up a white opaque substance that looked like purple blood clots was in it. I suspected that I might have an underlying ulcer. I knew I shouldn't of have taken that many NSAIDs but the headaches I was having were that intense. When I more recently seen the doctor, I was prescribed meloxicam because of being diagnosed with osteoarthritis. The doctor didn't want me to take anymore NSAIDs. The upper stomach bleeding was a  reaction I had with the edema which is in my sinuses and stomach. I had some intestinal bleeding. I have a lot of health issues. When I vomited that came from bleeding in my upper stomach. The meloxicam caused me to have lower stomach bleeding.
pt recv vax 9JUL97 same day in the evening pt exp pain & limited ROM;pt was seen by MD 11JUL97 w/good passive but poor active ROM;pt pain & limited ROM persisted;pt tx w/APAP;reporting MD felt sx r/t vax;
I did not have an adverse reaction to the vaccine. I starting feeling symptoms of congestion, severe sore throat and I had a low grade fever on 08/08/2022. I took a home test for COVID-19 on 08/09/2022 and it was positive. I contacted my doctor's office via telehealth and was prescribed PAXLOVD. After 8 days, I tested again and it was negative.
About 1-2 weeks after receiving the vaccine, I developed a very itchy rash under skin folds that then spread to my entire torso and arms. After seeing a PCP and trying multiple treatments that did not work, I saw aDermatologist, who diagnosed with widespread first onset psoriasis.
Body aches; Headache; Vomiting; Diarrhea; Chills; lasted about 12 hours.
The LVN administering the vaccines at the  Unit placed a vial with one dose left in it in the refrigerator yesterday (4/15/21), and administered it to the patient this morning. The vial had been opened 23 hours prior.
Scratchy throat; Swelling in left arm; lymphedema; This is a spontaneous report from a contactable consumer (patient). A 82-years-old non pregnant female patient received BNT162B2 (COMIRNATY, formulation solution for injection) via an unspecified route of administration, administered in right arm on 26Jan2021 14:00 (Batch/Lot number: Unknown) as single dose for covid-19 immunisation. Medical history included Knee replacement surgery.Breast cancer for several years from 1996 surgery. Patient did not had allergies to medications, food, or other products. Concomitant medication included simvastatin taken for an unspecified indication, dorzolamide hydrochloride/timolol maleate (COZOPT) taken for an unspecified indication, acetylsalicylic acid (ZORPRIN) taken for an unspecified indication, ubidecarenone (COQ 10) taken for an unspecified indication. On 29Jan2021 the patient experienced scratchy throat, swelling in left arm, lymphedema. The events were considered as non-serious by reporter. No treatment was given to patient.The outcome of events was unknown. The action taken in response to the events for bnt162b2 was not applicable. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Information has been received from a physician concerning a 15 year old 245 lb. approximately 67 in. (last measured 2006) immuno-compromised male with chronic neutropenia who on 11-JAN-2008, was vaccinated with a first dose in the right arm of varicella virus vaccine live (Oka/Merck) (lot#/ "1339V"). Concomitant therapy included unspecified medication. Illness at the time of vaccination was reported as sinusitis. It was indicated that he immediately broke out in a rash after he had received the vaccine. On 04-FEB-2008, the physician indicated that the rash was papular rash; he was covered head to toe; had 5 to 6 millimeter sized welts, also described as blanchy raised patches. The patient itched badly and developed fevers to 103 degrees Fahrenheit. With regard to the patient's history, the patient was sent to an emergency department. It was indicated that the emergency department initiated therapy with acyclovir. Diagnostic studies performed included complete blood count, liver function studies, and basic metabolic panel. Results of the diagnostic studies were not reported. It was indicated that he was released the same day from the emergency department. It was mentioned that on an unspecified date the acyclovir significantly improved the rash, and stopped the fever. On an unspecified date, the patient had recovered. A product quality complaint was not reported. Additional information is not expected.
Shingles; 2nd dose not received; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles) and incomplete course of vaccination (Verbatim: 2nd dose not received). The outcome of the shingles was not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received first dose of Shingles vaccine and experienced terrible reaction and one year later now he or she suffering from shingles. Till the time of reporting, the patient did not receive the 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. Follow-up would not possible as no contact details were available.
daily headaches, frontal, waxing & waning, pressure-pain; father reports these occur yearly after influenza vaccinations and last about 1 week; this time duration is 2 weeks so far.
Pt c/o hypoglycemia. Healthcare provider indicated pt has been trending down ( in the 50's) with blood glucose over the past few days prior to receiving the vaccine. Mother of patient insists the hypoglycemia is from the vaccine.
2 days post vaccination pt developed a sore neck. 6 days post vaccination pt developed large itchy, red area on arm and had soreness under arm. Advised topical hydrocortisone and cool compress. Pt on medication.
pt recv vax 6MAR95 & 10MAR95 pt devel a fever;12MAR95 pt devel sz & presented to hosp ER;pt recovered & was discharged p/ a lab eval;
Information has been received from a nurse through the pregnancy registry for HPV vaccine concerning a 17 year old female with attention deficit/hyperactivity disorder who on 31-DEC-2008 was vaccinated with a dose of GARDASIL (lot # 660616/0570X), 0.5 ml, intramuscular route. Concomitant therapy included CONCERTA and RITALIN. On 07-JAN-2009, the patient called the office to inform office that she was pregnant. No adverse effects were reported. The patient's LMP and EDD were not reported. Follow-up information was received on 27-AUG-2010 from a medical assistance who reported that the patient had a miscarriage. According to the medical assistance, the doctor said the miscarriage happened early on her pregnancy but she could not provide a specific date. When asked if there was a pathology report she said there was no indication in chart that any testing was performed. She added that the patient was fine afterwards. Upon internal review miscarriage was considered to be an other important medical event. Additional information is not expected.
Moderna COVID 19 Vaccine EUA patient complained of having low grade fever (99.1), headache and bad (really bad) cough on the 3rd day after her shot. Stated that something like this happened with her 1st dose as well.
HPV "vaccine injury"/patient is in wheelchair and has chronic pain; HPV "vaccine injury". patient is in wheelchair and has chronic pain; HPV 16,11,18 (first vial tested and turn out to be positive); PQC Present: Yes/Local pediatrician sent me at the first vial so I tested & it turned out to be positive altogether 16 vials"; This spontaneous report was received from a consumer via social media referring to a 16-year-old female patient. The patient's concurrent conditions, medical history, drug reaction/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, lot/batch # and expiry date were not reported) for prophylaxis. On an unknown date, the patient had "vaccination injury" (vaccination site injury). The patient was on a wheelchair and had chronic pain (pain). It was reported that, the first vial was sent to the reporter by the local paediatrician. The reporter tested the vial and was turned to be positive with strains HPV 16, 11, 18 (Human papilloma virus test positive and product quality issue). Outcome of the events vaccination site injury, pain, human papilloma virus test positive and product quality issue was unknown. The reporter considered the events vaccination site injury and pain was related to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). Causality assessment for human papilloma virus test positive and product quality issue was not reported.  The reporter considered the events vaccination site injury and pain to be disabling.
Information has been received on 01-MAR-2019 regarding a case in litigation concerning a female  patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2013, the patient was administered the ZOSTAVAX vaccine (lot# and route not specified) by a pharmacist. The patient was treated by a healthcare provider for shingles as a result of vaccination with ZOSTAVAX. The outcome was not provided. Additional information has been requested.
Chest pain, shortness of breath, exercise fatigue, dizziness lasted for 2 months.  admitted to Emergency Room 5/26/21 riles out Afib and Pulmonary Embolism. Saw Cardiologist at recommendation of ER Dr. on 6/25/21.  Further tests scheduled.  I am a runner and have been for 30 years - was not able to run more than 1/2 mile and had to keep stopping due to weakness, shortness of breath and chest pain.
Stridor, pallor, and reports throat closing up, EpiPen given at 1:08pm and EMS called, improvement noted shortly after Epi administered.  B/P 100/50@ 1:18pm, EMS arrived at 1:20pm and at 1:22pm c/o breathing difficulty, chest tightness.  Transported to ER
NOTED AT ROUTINE PE TO HAVE FREQUENT PREMATURE BEATS (1 IN 5), NO SYMPTOMS (9/17/22) DEVELOPED TRANSIENT TACHYCARDIAS (140-180 BPM) 11/27/22 RECURRENCE OF TACHYCARDIA WITH ATRIAL FIBRILLATION 1/21/23
Post Marketing Evaluation of the Safety of Influenza Virus vaccine live intranasal FluMist in healthy children and healthy adults 5 through 49 years of age. This is a 43 year old female who received FluMist on 11/14/05 and was diagnosed with Guillain Barre syndrome. On 1/26/06 at approximately 2am, the patient woke up and walked to the bathroom. She reported having difficulty using her right hand and almost fell down while she was walking to the toilet. She was seen at a hospital and was found to have a low potassium level of 2.8 which was repleted to 3.2. She also complained of a headache and neck stiffness, head CT was negative and a lumbar puncture was negative aside from and elevated CSF protein of 67. She was discharged home. A week prior to this event, she complained of flu like illness. At home, she was unable to walk and became almost quadriplegic. She was then brought to the emergency room. In the ER, neurology was consulted and an EMG was done with findings that were was strongly suggestive of Guillain Barre syndrome. She was then given Dilaudid 1mg IV and intravenous immunoglobulin IVIG was started at 400mg KG day to complete a total of 5 days. Other treatment include plasmapheresis. During the course of her hospitalization, she was also diagnosed with depression and was placed on Prozac (Fluoxetine). She was discharged after 31 days to a skilled nursing facility. In the SNF, Dilaudid was continued for pain management together with Fentanyl patch. As of 4/18/06, the rehabilitation notes indicated that the patient remains dependent on all activities of daily living although she continues to show increased strength for trunk and hip control. The SNF consult notes also indicated that she does not have sufficient motor neuron recovered to give significant gains in functional mobility. Physical therapy in ongoing. Medications in the SNF included. Subcutaneous Heparin, Tylenol, Nevacor (Lovastatin), Prilosec (omeprazole), Quinine sulfate, Elavil (amitriptyline), Fentanyl patch, Dilaudid, Ativan (alprazolam), Colace (docusate sodium), Senna, Dulcolax (bisacodyl), milk of magnesia, oil enema, Nasarel and artificial tears. The patient has not yet recovered. The reporter has assessed this event as not related to FluMist.
patient complained of arm pain; experiencing left, shoulder pain (not injection site); has lost some range of motion in that arm; Initial information regarding this unsolicited valid non-serious case was received from a consumer and transmitted to Sanofi on 16-Oct-2020.  This case involved a 30 years old female patient who complained of arm pain (Pain in extremity) and experiencing left, shoulder pain (not injection site) and has lost some range of motion in that arm (Arthralgia associated with Vaccination site movement impairment), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Relevant medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.   On 05-Oct-2020, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2009, expiry date: 30-Jun-2021) via unknown route in the left arm for prophylactic vaccination. No other vaccines or medications were received at that visit.  On 05-Oct-2020, the patient complained of arm pain (Pain in extremity) and experiencing left, shoulder pain (not injection site) and has lost some range of motion in that arm (Arthralgia associated with Vaccination site movement impairment), the same day following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Final diagnosis was that the patient complained of arm pain and experiencing left, shoulder pain (not injection site).   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported events.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 15-OCT-2015 10:28, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L004754, expiry date: 10-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 12.0 and 0.5 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
18 month old male received DTaP and PCV7 #4 at about 16:30 on 11/13/03. At 21:00 he was a little fussy, warm and pulling at legs. He was given Tylenol and went to sleep. At 06:12 AM on 11/14/03, mom awoke to see him seizing and by the time he got to the ER, temperature 103.6 (rectally). Seizure lasted about 1.5 minutes. Patient was hospitalized. The discharge summary states anemia, otitis media and DTaP reaction.