chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via sales rep and described the occurrence of injection site cellulitis in a 56-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 7754S, expiry date 30th June 2016). On 14th September 2015, the patient received FLULAVAL QUADRIVALENT (intramuscular) .5 ml. On 15th September 2015, 1 days after receiving FLULAVAL QUADRIVALENT, the patient experienced weird feeling. On 16th September 2015, the patient experienced injection site cellulitis, injection site induration, injection site pain, injection site warmth and injection site erythema. The patient was treated with KEFLEX. On an unknown date, the outcome of the injection site cellulitis, weird feeling, injection site induration, injection site pain, injection site warmth and injection site erythema were unknown. It was unknown if the reporter considered the injection site cellulitis, weird feeling, injection site induration, injection site pain, injection site warmth and injection site erythema to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case as not previously reported to anyone. The patient received FLULAVAL QUADRIVALENT, at unknown deltoid. One day after receiving FLULAVAL QUADRIVALENT, the patient felt something funny. On 16th September 2015, 2 days after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site cellulitis, injection site induration, injection site pain, injection site warmth and injection site erythema. She did not look at her arm until th e16th September 2015, when she noticed redness and cellulitis on her arm and then went to the doctor. At the doctor's office it was noted that the area was a little sore, there was no fever, no chills, and an 11cm x 10 cm area of redness was associated with warmth and induration. The redness was about 4 to 5 inches below the vaccine injection site. The patient required an emergency visit. The patient was given KEFLEX 500 mg 3 times daily for 7 days as treatment. This case was linked to case US2015134385, as it concerned with the same reporter. This reported batch number 77546, which does not exist and was updated to be 7754S as per sales database.
The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 02-JUN-2009, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2014, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The events were considered to be related to zoster vaccine live (ZOSTAVAX).
Initial unsolicited report received from a patient on 25 January 2017. This case involves a male patient (onset age unknown) who was vaccinated intramuscularly with a dose of SMALLPOX (batch number, expiry date, dose and dose in series were not reported) and ANTHRAX (batch number, expiry date, dose and dose in series were not reported) in an unknown site on 20 January 2016. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as no known allergy (NKA) and Illness at the time of vaccination were reported as unknown. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On an unknown date, unspecified time following the vaccination, the patient had developed chest pain and pressure with irregular heartbeat and was advised to immediately call on 911 or Medics on the base to get to an emergency response. Laboratory investigations was not reported. No corrective treatment was reported. The outcome of the events were reported as not recovered. List of documents held by sender: none.
Patients wife Came in to health Dept for patients second dose but dud not have his card. Dose administered in car per patients request. Wife returned card into health Dept. Patient had received  first Covid Vaccine on 5-25-2021. patient then received second covid vaccine on 6-3-2021. No Side effects noted on 6-3-2021 and patient was contacted on 6-4-2021 and spoke to his wife and informed Health department he was doing fine.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On 26th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient asked that, was there more than one type of SHINGRIX vaccine. The patient received 1st dose of SHINGRIX was viscous, seems like the needle was in her arm awhile, it was a bit painful. On 7th February 2019, the patient received 2nd dose of SHINGRIX was a quick shot and not painful. Batch number of 2nd dose of SHINGRIX was 455KD. Both doses given in the deltoid muscle region of the same upper arm.
Feeling hot and cold; Shaking; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) and TREMOR (Shaking) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) and TREMOR (Shaking). At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Feeling hot and cold) and TREMOR (Shaking) outcome was unknown.            Concomitant medication use was not provided.  No Treatment information was provided.   This case was linked to MOD-2021-235424 (Patient Link).
Patient went to ER on Saturday, March 20, 2021 complaining of stroke-like symptoms. Medical staff determined that patient was suffering from symptoms similar to Bells Palsy. Presently he still suffers from being unable to close left eye without also closing right eye and the right corner of his mouth droops downward.
65 yo F presented for annual exam on 8/14/19.  First Prevnar immunization.  Given by CMA in her left arm at 0922.  The same day, patient developed pain and redness at the site of the njection.  Pain resolved within a couple of days but erythema and warmth had gotten worse.  Area of involvement on proximal side of left upper arm is pruritic, red, raised confluent rash.  Due to concern for cellulits, patient was started on 10 day course of Bactrim and a prednisone taper.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (tle temperature located in the area /  arm a little warm,), PRURITUS (Itchy) and RASH (rash in the arm after dose 2) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Diabetes, Cardiac disorder NOS, Adhesive tape allergy (rash) and Adhesive tape allergy (EKG adhesive plugs-rash).On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (tle temperature located in the area /  arm a little warm,), PRURITUS (Itchy) and RASH (rash in the arm after dose 2). At the time of the report, VACCINATION SITE WARMTH (tle temperature located in the area /  arm a little warm,), PRURITUS (Itchy) and RASH (rash in the arm after dose 2) outcome was unknown. Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.This case was linked to MOD-2022-456504 (Patient Link). Reporter did not allow further contact.
Initial unsolicited report received from a consumer (patient's parent) on 25 Apr 2017. This case involves a patient (age gender was not reported) who was vaccinated with a dose of DAPTACEL (batch number: C5148AA, expiry date: 09 Feb 2019) intramuscularly in right thigh on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, within 24 hours following the vaccination, the patient had developed redness to the right thigh, which developed into a welt from above the knee to the upper thigh, also developed a red, raised rash, not itchy, on the chest, back, and lower abdomen. On an unknown date, 10 days after vaccination, the patient had swollen tonsils. The patient was seen by physician. The patient's laboratory data included quick Rapid strep test showed positive result. The patient was treated with antibiotic (unspecified). On an unknown date, the patient was recovered from the events. Upon medical review, the case was considered as serious due to important medical event: swollen tonsils with a quick strep test was positive. List of documents held by sender: none. Sender's Comments: This case concerns a patient who was vaccinated with DAPTACEL and experienced Streptococcal tonsillitis, welts, localized erythema and erythropapular rash in trunk. There is a temporal relationship between the events and the vaccine. However, need additional information of medical history, further immune status at the time of vaccination, any concurrent infections, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies would be needed to fully assess this case. Based on available information the role of vaccine cannot be ruled out.
Exhaustion, headache, vertigo, which resolved within a few days. Severe prolonged swelling and pain at injection site, swilllen and red for over a month, followed by hard tissue as swelling subsided. Swelling and hard tissue is now gone but the muscle mass at the injection site is completely gone. There is a noticeable and visible muscle loss at the top of the arm when compared to the other arm. No pain or loss of use of the arm at this point.
This spontaneous report was received from a registered nurse refers to a 5 year old female patient. On 21-MAR-2016 the patient was vaccinated with a dose of PROQUAD (Merck) (dose, route and lot # unspecified). Other suspect therapy included: on 21-MAR-2016 patient was vaccinated with VARIVAX (Merck) (dose, route and lot # unspecified). It was reported that PROQUAD (Merck) and VARIVAX (Merck) were both given today (on 21-MAR-2016) (overdose). Staff error only (drug administration error). No adverse events reported at time of call. There was no product quality complaint reported. No further details provided. Additional information is not expected. No consent to follow up with the reporter.
This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 53-year-old male patient who received Hepatitis B vaccine. On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter considered the therapy non-responder to be related to Hepatitis B vaccine. Additional details were received as follows: The patient received a complete schedule of Hepatitis B vaccine, but was unsure of specified brand. The patient's hepatitis B antibody titers were never reached appropriate levels, causing the patient to be a therapy non responder. The reporter stated that, they were unsure if the patient's titers were drawn at the right time but because the patient is also a Health care professional, she was assuming they were drawn at the right time. No further information was reported regarding the event.
swollen arm; Arm bright red; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received DTP (A or W not known) (DTP vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received DTP vaccine at an unknown dose and Shingles vaccine at an unknown dose. On an unknown date, unknown after receiving DTP vaccine and Shingles vaccine, the patient experienced swelling arm and erythema of extremities. On an unknown date, the outcome of the swelling arm and erythema of extremities were unknown.   It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to DTP vaccine and Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received DTP boosters and the shingles vaccine a couple of years ago and patient arm was so swollen and bright red.  Get your pneumonia vaccine and tetanus also.
Pt was given vaccine and began telling his brother he felt lightheaded. Pt's brother began to inform his mother. Pt then slumped in chair and began to fall to the floor. Mother tried to brace pt's fall. Pt still hit the floor and lightly hit his head. LPN's stated pt had a 5 second episode of convulsions that appeared to be a seizure. Pt did lose LOC for about 15 seconds and came to. Pt did not realize what had happened. Pt was placed on a cot. Pt stated he felt warm and lightheaded. Pt's VS were taken at 1640 - BP 136/70, HR 61, RR 18, 99% O2. EMS were called and in route. Pt began feeling better. Another set of VS were taken at 1645 - BP 127/76, HR 80, RR 16, 99% O2. Pt had ice packs placed on his neck and forehead. Pt sat up on cot after another 5 minutes and another set of VS were taken at 1650 - BP 123/82, HR 89, RR 16, 99% O2. Pt stated he was feeling better but still had a minor headache. EMS arrived and advised pt to be checked out. Mother agreed to take her son to the hospital herself not via EMS. Refusal form was signed by mother from EMS. Pt, mother, and brother left to go get checked out.
Now it feels like pneumonia; Fatigue; Then extremely ill with fever; Fever; Chills for a couple of weeks; I am having a lot of wheezing over a month later; This is a spontaneous report from a non-contactable other hcp (patient).  A 39-year-old female patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: unknown), at the age of 39 years old, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's medical history and concomitant medications were not reported. The patient did not receive other vaccine in four weeks of vaccination. Fatigue the day after, and then extremely ill with fever, and chills for a couple of weeks. Now it felt like pneumonia, and patient was having a lot of wheezing over a month later. Events resulted in emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown results, fever. No treatment received. Outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Pneumonia.   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 identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
NauseaVomiting & HYPERtension Narrartive: Employee c/o nausea post 15 minutes of pfizer Booster vaccine. BP 182/105-BP 167/107, HR-52,, RR-20 , SAT 99% room air Employee transported to hospital via ambulance.
Approximately 5 minutes after giving influenza vaccine IM in left deltoid pt. reports itching and rash to this arm. No wheezing or respiratory symptoms. No lip or facial swelling. No other area of rash. BENADRYL 25 mg PO x1 given in office and pt. reports resolved symptoms. Instructed to monitor for any further symptoms.
extreme fatigue; could taste the vaccine in my mouth and felt like I wanted to throw up; Heart started to race; felt a little light headed; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: ER8737) via an unspecified route of administration in the arm left on 01Apr2021 at 06:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy, penicillin allergy and allergy to edible fungus (mold). Concomitant medications included vitamins (MANUFACTURER UNKNOWN), lorazepam (ATIVAN) .05mg, both from on an unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 06:15, the patient experienced racing heart, nausea and lightheaded. On 02Apr2021, the patient experienced extreme fatigue. As soon as she stood up from chair after injection her heart started to race (felt a little light headed). she sat in the observation area and could taste the vaccine in her mouth and felt like she wanted to throw up. The heart racing stopped after about 15 minutes but the nauseousness lasted for 4 hours. The next day all she felt was extreme fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event of the event heart racing and lightheaded was recovered on 01Apr2021 at 6:30. The clinical outcome of the event of nausea was recovered on 01Apr2021 at 10:15. The clinical outcome of the event of Taste abnormality was recovered on unknown date of Apr2021. The clinical outcome of the event extreme fatigue was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Phone number of reporter slide#1 and patient updated 2. Protect Confidentiality checked for reporter slide#2 3. Treatment received selected to NO for event Light-headed 4. Event could taste the vaccine in my mouth and felt like I wanted to throw up coded to Taste abnormality
Patient stated he received reaction after the first shot. The first shot was given 3-14-21. The lot number for the first Vaccine EN6200. He just thought that they were normal side effects. Patient stated that he was very athletic and now he can not exercise or walk to the car without becoming shortness of breathe.
Pt recv vax on 12/29/98; 1.5 hr post vax pt exp headache & vomited
Fever, Febrile seizure.  Tylenol and Motrin used to treat.
On Oct. 25 I noticed a strange, small purple mark on my chin. I'm certain it wasn't there before. My stool seemed unusually red as well that day, although I couldn't see any blood myself.  Also, I had had my vaccine at 4 pm on Friday, but the injection site on my right arm only started to turn red on Monday. My arm didn't start to hurt until 3-4 hours after the injection, and it hurt a lot on Saturday and Sunday.  On Sunday, I read the flyer given to me at the vaccination clinic, and it said to contact your health provider if I had increased pain or redness 24 hours after the injection. So, since I had not reported the increased pain over the weekend, since I had new redness, and because I was concerned about the purple spot on my chin, I emailed my doctor. She sked for a photo of my chin, and she said she wasn't concerned about it and to contact her if the arm redness got worse. It was better the next day. I also felt the same kind of pain on part of my right torso that I had felt when my dermatologist diagnosed me with a light case of the shingles a few years ago. It's a pretty unique pain, and I hadn't felt it in a long time. So, I marked on my v-safe questionnaire that I had contacted my doctor because I sent her an electronic message. I did not have an appointment with her.
Less than 24 hours after receiving the vaccine I started running a high fever (103), chills, body aches, sweats, headache and fatigue. On Thursday I went to an urgent care clinic and was tested for flu, strep and UTI. All tests were negative.  Five days later (10/19) I woke up with a rash all over my body, hands, arms, legs, feet and face were swollen. I visited the urgent care clinic again and they started me on an antibiotic thinking I had Rocky Mountain Spotted Fever. That night I swelled back up and my throat also started swelling. My family called the rescue squad.  Monday I visited my doctor and he had suspicions about a possible allergic reaction to the flu vaccine. He gave me a steroid shot and was waiting for other blood work to come back. That evening, my neck, joints and head started to become stiff and hurt bad. As of Friday, 10/24 after many hospital trips, dehydration, and multiple blood tests, my doctor said it was a severe reaction to the flu shot.
2 days after Shingrix 1st dose vaccine I broke out with a itchy rash  on my left thigh
HEADACHE,CHILLS,SWOLLEN UNDER LEFT ARM AND LEFT BREAST ,JOINT PAIN MUSCLE PAIN INJECTION SITE SWELLING AND PAIN
A week after my first Covid vaccine I developed the first symptoms of shingles. I was officially diagnosed on 3/21/21 at the Urgent Care. The shingles were on the left side of my lower face.