chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shingles; Information has been received from a lawyer regarding a case in litigation and refers to a male patient (pt) of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not provided), as prescribed and/or administered by a pharmacist, for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date (reported as subsequent to pt's zoster vaccine live (ZOSTAVAX) inoculation), the pt was treated by a healthcare provider for shingles (herpes zoster). On an unknown date, pt was hospitalized due to the event. As a direct and proximate result of pt used of the zoster vaccine live (ZOSTAVAX) vaccine, pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of herpes zoster was unknown. The reporter assessed that the event was related to zoster vaccine live (ZOSTAVAX).
Patient reported swelling at dermal filler injection sites (lips/face).  Was not reported on administration form so did not counsel patient on possible side effect.  Patient states that swelling was minor and lasted about 1 day.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Lot number: ER8733), on 20Apr2021 as dose 2, single (Lot number: EW0170) and on 05Feb2022 as dose 3 (booster), single (Lot number: FJ1614) at the age of 62 years for covid-19 immunisation. The patient's relevant medical history included: "adhesives" (unspecified if ongoing); "Environmental allergy" (unspecified if ongoing); "Known allergies: potatoes, tomatoes, almonds, pecans" (unspecified if ongoing), notes: Known allergies: potatoes, tomatoes, almonds, pecans; "ADHD" (unspecified if ongoing), notes: Other medical history: ADHD; "reactive hypoglycemia" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "gall bladder removed" (unspecified if ongoing), notes: Other medical history: gall bladder removed; "inguinal hernia repaired" (unspecified if ongoing), notes: Other medical history: inguinal hernia repaired; "Known allergies: potatoes, tomatoes, almonds, pecans" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID; FEXOFENADINE HCL, stop date: 19Oct2022; ZINC. Past drug history included: Amoxicillin, reaction(s): "Known allergies: amoxicillin"; Prednisone, reaction(s): "Known allergies: prednisone"; Biaxin, reaction(s): "Known allergies: Biaxin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional Information: Adverse event: Patient had a strong metallic taste in her mouth within a few hours of the first dose, like a mouthful of dirty pennies with overtones of brass keys. It continued pretty much the entire course of medicine. It powered through most food tastes. The things that banished the taste (for 5 minutes to an hour) were chewing crystallized ginger and drinking a honey/apple cider vinegar shrub. Patient took her last dose of Paxlovid in the morning and hope the taste will go away within a day or so. Con-med drug 'NatraBio', 'Welby' were unable to code due to Argus limitation and 'Raw garlic more than 2 cloves' not coded as it taken more than 2 weeks of dose 3 was updated in narrative.
inadvertently administer 2nd dose of Pfizer Vaccine today, 2/11/2021 which is  16th days from the 1st dose given on 1/26/2021 vaccinator was making a card for 2nd dose and subject showed his vaccine card from PLCM- Torrance  stating  he is traveling outside the country and needed a vaccination ASAP and his wife made the appointment and not aware of return date for second dose advised that 2/12/2021 is the earliest he can receive and did not disclosed his 1st dose received from PLCM- Torrance Covid Clinic on 1/26/21
left muscle pain that slowly spread over first week down arm, then up shoulder, than one week later across shoulder blades with chest tightness and cramping and pain, stomach pain and squeezing feeling in chest and nausea  like heart attack symptoms all that subsided with ibuprofen.
Loud tinnitus left ear, clogged/numb feeling left ear, headache, head pressure, increased dizziness. Have pre-existing mild tinnitus left ear - much worse after vaccine. Have pre-existing head symptoms - much worse after vaccine. Symptoms appeared within a few days of vaccine, still here two weeks later. Volume of high pitched tinnitus and clogged/numb sensation in ear is very distressing, Ear doctor gave me rx for prednisone which I've started. Also had fever of 101, chills, pain in both legs but these resolved by day two.
In the evening started to develop flu like symptoms.  Fever, shakes, weakness.  by the following morning around 8:00 am was slightly nauseous and quite dizzy.  Passed out 2 or 3 times.  went to the ER, blood pressure was quite low when I got there. tests ran and bloodwork came back normal.  Not dehydrated.  Nothing else out of the ordinary was different about that day or night other than the fact that I had the vaccine.  by 11:00 blood pressure was back up to 112/68
Feeling general body aches, vertigo, chills, fever, and migraines to the point of being unable to work for at least a day so far. Symptoms continue as of this report.
5 days after injection under arm soreness started, no swollen lymph nodes. Redness around injection site and soreness came back. The redness is spreading and is hot to the touch.
One week after the shot  (1-14-2021) Patient (19 y.o.)reported side pain and appeared constipated, Laxatives given along with Tylenol, on further assessment  Patient was noted to have left leg redness and abdominal fullness.   Dr. was updated  and we had orders for close monitoring, the next day when she got up, her leg appeared better, and she had passed a small BM, but by lunch she had developed significant pain and edema in her left leg, and the color of her leg was reddened again.  She was sent to the emergency room with  her symptoms.   She was admitted back to our facility  yesterday, her diagnoses included Acute provoked left external illiac, femoral, popliteal, and peroneal DVT.  Elevated Factor II levels, Elevated APC resistant, May-Thurner Syndrome, history of developmental disabilities, fecal impaction and urinary retention - suspected related to her fecal impaction.  Vascular surgery was consulted,  and pt. was  started on a heparin drip, and mechanical thrombectomy was needed for both legs due to multiple clots.  She was started on Eliquis and Plavix, and thigh high compression stockings were ordered, ace wraps being used until these are supplied.  Her Fecal impaction was addressed also and the urinary retention resolved.
Fever of 102 degrees, heavy chills (shaking), headache, severe fatigue. Lasted 30 hours.   Returned to normal health Sunday morning.
Patient presented to the ED with dizziness and left leg paresthesia and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was Possible hemorrhage of right temporal lobe.
9/17/2021 lethargic, chills, foggy memory, light headed, rash on fire arms  out of work til 9/24/2021 9/24/21 still lethargic 9/26/21 no prior symptoms ER with severe Kidney infection- peeing out blood clots out of work 9/28/21 9/28/21 back into ER tingling sensation in hand ,severe migraine 9/30/2- still continued sever headaches, lower back pain,  out of work, fatigue, neck pain until Oct 5th, 2021 Until present time 10/12/21 still have fatigue, lower back pain, laying down breathing hurts more on left side, sore neck pain, lethargic still, head aches mild
Redness Beneath the injection site; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness Beneath the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness Beneath the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Redness Beneath the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided No treatment information provided
Onset ~ 20 hours after FluMist; No Sx from immunization until 2 hours prior to presentation in office; erythema and mild swelling of skin surrounding the mouth, but not involving the lips or tongue; Benadryl and cool compress recommended for treatment.
headache, severe TMJ pain/spasm. fatigue, runny nose, redness and swelling at injection site (same night as injection-actual time of injection not known by me
2/5/21 around 9:30am - started developing shortness of breath, palpitations, and tachycardia upon exertion. I would become winded just walking to another room or brushing my hair. I reached out to the contact tracing center at hospital to find out if this was a reported side effect of the vaccine. The symptoms continued throughout the weekend and I was unable to work. My next workday was Tuesday and I was still short of breath so I reached back out to the contact tracing center who sent me to be tested for COVID. The results came back negative. I contacted my PCP who ordered a chest X-ray and had me get a pulse ox. My heart rate would go up to 138 with one flight of stairs. Sitting eating dinner my heart rate would sit at 108. Brushing my teeth my heart rate was 119.   Thursday, 2/11 - I woke up for my chest X-ray and was light-headed. I put on my pulse ox and my SpO2 was 87%. I went for my chest X-ray and then went straight to the ED. I was hypertensive and tachycardic when I arrived. My blood work and imaging were all normal.  2/12 - I saw a cardiologist who put me on a beta-blocker to temporarily control my symptoms. He believes I am having a secondary reaction to the vaccines as opposed to a primary issue with the heart. I am scheduled for an echo on 2/15 to cover all bases.  Symptoms have NOT subsided to date - I am still short of breath, have chest pressure, palpitations and tachycardia are being controlled with a beta-blocker (resting HR is 60s but will jump to high 90s with any movement), blood pressure being controlled with beta-blocker.   **I was evaluated for palpitations in 2018 but they were found to be minor and no specific cause was to be found, nor was the cardiologist concerned at the time. I have NO known heart issues or defects.
Temperature Excursion; Initial Report Received on 11-Jan-2023  A registered nurse in the reported that a patient (Patient 3) (gender, race, and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that had a temperature excursion issue.   Medical history, concomitant medications, and allergies at the time of vaccination were not reported.  On an unknown date, the patient received a dose of HEPLISAV-B (Lot # 937233, expiration date 11 Mar 2023 or Lot # 938794, expiration 09-Oct-2023). The NDC #s, injection site, and route of administration were unknown. The two HEPLISAV-B lot #s affected by the temperature excursion occurred between 22-Aug to 15-Nov (year not reported). For 97% of the time, the temperature was between 8°C - 12.31°C.   No further information was provided. Additional information was requested.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Information has been received from a consumer concerning her 66 year old sister with no drug reactions or allergies and a history of walking pneumonia who in 2005 was vaccinated with a first dose of PNEUMOVAX 23.  On 27-NOV-2009 the patient was vaccinated with the second dose of PNEUMOVAX 23.  Within 4-5 hours the patient developed throbbing pain and swelling at the injection site expending to the finger tips.  The patient was seen by her physician the next morning and was given a cortisone shot.  No laboratory diagnostic studies were performed.  At the time of reporting, the swelling at the site had resolved (04-DEC-2009) but the swelling persisted from the elbow to the wrist.  Additional information has been requested.
Patient's entire upper arm above elbow was painful, swollen, red, and hot.  Referred to PCP to rule out cellulitis.
Left deltoid with 2 inch erythema surrounding injection site - firm, tender, warm.
Headache, Myalgia, Fever, Diarrhea, swollen lymph nodes , R arm pit(4days) Narrative:
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 049C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-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 PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.  On an unknown date, the patient did not have adverse event to the COVID-19 vaccine. The patient received shot in the arm with a needle, or was a flu vaccine , the arm had soreness in the particular area for a day or two.       Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up received. Event outcome updated. Patient age added from initial.
On 03/14/2002 sudden onset of high fever and prolonged 20 minute episode of seizure with extremity stiffness, eyes rolled back, non responsive and intermittent jerking of all extremities. Fevers resolved after 24hrs with no further seizures.
Patient came in on 06/25/2003 for well child exam and was given DTaP in the right thigh IM.  Seen again 06/27/2003 due to complication of DTaP symptoms include swelling and a 8 x 7.5 cm redness and warm area on thigh.
Devel hives arms/chest 4APR92; inc urticaria 7APR92; DPH & Aristocort given; 8 & 9APR inc urticaria;10APR PM laryngeal edema/SOB; taken to ER given meds; 11APR92 n,v,d, pain/numbness lt wrist, hand/finger; adm to hosp;
Information has been received on 16-APR-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. During 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route, at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster also known as shingles. On or about 01-NOV-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving 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 and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Didn't feel great this morning; Stiff neck on the side she got the shot the second time the left side; Left arm soreness; A little bit chilled last night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 (Dose number :1, First dose administered on 25Mar2021 , Anatomical location (left arm)), administration date: 25Mar2021, for COVID-19 Immunisation. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 15Apr2021, outcome "unknown", described as "Stiff neck on the side she got the shot the second time the left side"; PAIN IN EXTREMITY (non-serious) with onset 15Apr2021, outcome "unknown", described as "Left arm soreness"; CHILLS (non-serious) with onset 15Apr2021, outcome "unknown", described as "A little bit chilled last night"; MALAISE (non-serious) with onset 16Apr2021, outcome "unknown", described as "Didn't feel great this morning".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
nauseous; This is a spontaneous report from a contactable consumer (the patient) from a sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient still had symptoms after the vaccine; she was feeling nauseous. The clinical outcome of nauseous was not recovered.  Information about lot/ batch number has been requested.
Red rash at injection site 9 days later.  Very slight soreness and itchiness.
I had a fever (100.6) and body aches. Missed one day of work. Symptoms lasted for one day and were managed with ibuprofen.
Information has been received from a RN concerning a 5 yr old female who, at 15 months of age, was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). The RN reported that the pt subsequently developed a high temperature. It was unk if medical attention was sought and the pt subsequently recovered from the high temp. Additional information has been requested.
Site of reaction started to itch day 2 to3 of vaccination, but I thought it was because my arm was still sore. I don't think I physically saw the rash until day 5ish...It is also around scar tissue so I don't know what /if it has anything to do with the reaction, I drew a border around the reaction on Friday (when I took the picture) and it is beginning to get smaller and look better.
This spontaneous report as received from a consumer (the mother) refers to her approximately 14-year-old non-pregnant daughter with no pertinent medical history and no drug reactions or allergies. On unknown dates, the patient was vaccinated with the first and the second dose of GARDASIL injection (dose, route of administration, anatomical location and interval were not reported). Approximately in September 2011 (reported as "finished GARDASIL series 4 years ago"), the patient was vaccinated with the third dose of GARDASIL injection (dose, route of administration, anatomical location and interval were not reported). There were no concomitant medications. Approximately in December 2011 (reported as "3 to 4 months after completion of their third and final dose of the vaccine"), the patient developed severe acne on her face and back. She was treated for this event with over the counter treatment methods. It was reported, that the patient sought medical attention - office visit. The outcome of the event was reported as recovered/resolved. The relatedness between the event and GARDASIL was not reported. This is one of the several reports from the same reporter. Additional information has been requested.
At 11:00PM on the night of the vaccine I started feeling sick. But 2AM I had a fever and body aches and just felt lousy. It lasted until I woke up later in the morning. I felt better but not 100%. I was still sluggish. I did not need to see my doctor.
Pain and numbness to left arm. Currently taking Steroid, NEURONTIN and is seeing a Chiropractor. Has been going on since 10/07/2018.
pt seen @ ER w/t105;mom states pt had cold @ time of vax;MD assistant was aware;
Patient called in two days after the receiving vaccinations to report  that on the night of vaccinations she experienced: lower spine pain, vomiting, rigors, swollen tights, delirium, pain in the hip, welt on thigh,  she could "feel it in her bone marrow", thrush and a 103 fever. Patient reported she did not seek emergency treatment the day of or the following  two days, declined to seek treatment after staff recommendation. On the third day after vaccinations patient reported that the welt on thigh had become as large as her palm, patient refused to seek treatment against staff recommendations.
pt recvd 3 doses of Engerix-B & did not seroconvert; Booster doses were administered;
Patient received the vaccine on Thursday, 4/22/21. Patient started having warmth and redness at injection site on Tuesday, 4/27/21. Patient hasn't take any over-the-counter medications. Patient stated the the swelling has increased. Patient stated the pain has stayed the same. Patient reported side effect to pharmacy on Friday, 4/30/21
PNEUMOVAX 23 received at approx 3pm on 2/13/19 in L delt. At approx 7pm site became swollen and tender. Pt awoke at 3am 2/14/19 and felt lightheaded. Pt returned to office 10:45 am on 2/14/19 for assessment. Lightheadedness has resolved. Pt advised to use antihistamine and NSAID as needed for symptom relief.
This spontaneous report was received from a medical assisstant and refers to a 15 year old patient of an unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 04-OCT-2017, the patient was vaccinated with GARDASIL 9 injection (strength, dose, frequency, route of administration were not reported, lot # N017697, expiration date 21-JAN-2020) for prophylaxis. On the same day, after vaccination with GARDASIL 9 the patient experienced syncope, abnormal pain, vomiting and fever. The outcome of the events was reported as recovered on 04-OCT-2017. The causality between the events and GARDASIL 9 was not reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA002338: US-009507513-1710USA012278: US-009507513-1710USA012279:
Parents found him gray in color and not breathing. Infant was vaccinated with DTaP and Rota 3 days prior. Infant was hospitalized x 24h with BRUE.