chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer (patient) via Accredo specialty pharmacy based on the information received by Pfizer from United Therapeutics (E2B Report Duplicate: UNT-2021-002875). A 72-year-old female patient began therapy with IH Tyvaso (treprostinil sodium, concentration of Inhalation Gas, (0.6 mg/ml) via Inhalation on 01Sep2020 to Unknown date then 18-54 µg, qid, Inhalation on 09 Jan 2020 to unknown date (Lot #: 2101898, Exp. date: 31Oct2021) after that via Inhalation (Lot: 2101910 Exp. date: 31Oct2021); then 42 µg, Inhalation, after that 30 µg, Inhalation on Jan 2021 to unknown date for primary pulmonary arterial hypertension. On unknown dates in Mar 2021, the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, first and second dose as single doses for COVID-19 immunisation. The patient's medical history included ongoing pulmonary arterial hypertension. Concomitant medications were not provided. On an unreported date, the patient experienced shortness of breath with COVID-19 vaccine, hot face and then freezing, heart rate up to 100 bpm (beats per minute) and increased O2- to 6l, average O2 saturation 87 %, dizziness. On an unreported date, the patient experienced the event term of 'cough had bright red bleeding. Co-suspect medication included COVID-19 vaccine. Patient was on continuous oxygen at 3.5 liters. The reporter did not provide causality for the events of dyspnoea, feeling of body temperature change, heart rate increased, and oxygen saturation decreased. Relevant Tests/Laboratory Data: Heart rate 100 /min and Feb 2021, Oxygen saturation 87 %, oxygen levels have dropped to 70 (%) and 80 (%); on 22Mar2021, low oxygen saturation in 50(%) and 60 (%) was 85(%); stays lower than the normal 94(%) [Oxygen saturation decreased]. The reporter did not provide causality for the events of dyspnoea, feeling of body temperature change, heart rate increased, and oxygen saturation decreased. The patient further had cough that had bright red bleeding. The outcome of the events of increased O2- to 6l, average O2 sat 87% was not recovered; shortness of breath with COVID-19 vaccine and dizziness was recovering; cough had bright red bleeding and hot face and then freezing was unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided in the narrative, the causal association between the suspect drug and the events cannot be excluded. 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.
Sudden onset of severe bilateral shoulder girdle pain with radiation down both arms, into hands and fingers.  Pain was severe, deep aching and unrelenting day and night. Unresponsive to two courses of oral steroids.  Notable elevated Rheumatoid Factor. Diagnosed by Rheumatologist as Systemic Inflammatory Disease secondary to COVID-19 Pfizer vaccine and responded to treatment with Plaquenil 200mg BID.
This spontaneous report as received from a healthcare worker, refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 25-MAR-2016, the patient was vaccinated with 0.5 ml dose of improperly stored (Merck) VARIVAX (which had a lot # of L040419 and an expiration date of 14-OCT-2017; however, dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported. Another batch of (Merck) VARIVAX (which had a lot # of L043624 and an expiration date of 03-NOV-2017) had also been improperly stored but it was not reported whether it had been administered. The vaccines experienced a temperature excursion of 10 F for 2 hours and 15 minutes on 24-MAR-2016. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Individual was 15 years at the time of vaccination and currently the EUA for the Pfizer vaccine indicates vaccine approved for age 16 and up.
pt recv vax 23AUG96 & 6SEP96 pt devel more than 20 lesions;@ the time of report pt had no other sx;reporter was uncertain if pt exp was r/t vax;
Anaphylactic shock? Shortly after receiving the vaccine my arm was sore and I had a severe headache. Approximately 24-48 hours after I received the vaccine I started developing a red, hot, itchy raised rash on my ears and buttocks which became more prevalent and peaked around 80-90 hours later. Approximately 82 hours after I received the vaccine, I began to feeI nauseous, dizzy, and fatigued so I stood up to get ready for bed early. While brushing my teeth, I went pale white and felt like I was going to vomit. I put the toothbrush down and got on floor. My pulse felt like it had stopped. I tried to check my pulse and I could only detect one beat every other second. I called for my spouse and by the time he got to bathroom I was passed out. I came back to after about 30 seconds and was convulsing from chills. He put a blanket on me and grabbed my Apple Watch to try to get my pulse which read in the 50s (so I assume it was much lower when I passed out). My hands and feet were tingly and I stayed on the floor until my pulse got back up. I then had diarrhea. At this point in time the rash was most prevalent and was present mostly on my buttocks but also on my ears, scalp, pointer finger on right hand, thighs, and hips. I went to doctor the following morning an my vitals, blood sugar, EKG, urine screen were stable and indicated no issues. 106 hours later I still have the rash on all areas mentioned and am dizzy, nauseous, and fatigued.
This spontaneous report was received from a medical assistant refers to unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of GARDASIL(lot#, expiration date and route not reported). The vaccine was exposed to an unsupported temperature excursion (48.9 Fahrenheit (F) for 10 days). No adverse effect reported. No further information is available. This is one of the several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a physician concerning a 3 year old patient (gender unknown), who on an unknown date was vaccinated with a varicella containing vaccine which could be possible VARIVAX (Merck) or PROQUAD (Merck) (vaccines, routes, doses, lot numbers and expiration dates were not provided). Other suspect therapies or concomitant medication were not provided. The physician reported, that she was told that a patient's younger relative developed febrile seizure and on an unknown date died after getting the varicella containing vaccine. The physician stated that she was not sure the brand name of the vaccine (possibly VARIVAX (Merck) or PROQUAD (Merck)). The patient cause of death was febrile seizure. It was unknown if an autopsy was performed. Upon internal review, the event of febrile seizure was considered to be another important medical event. This is one of several reports received from the same source. Additional information is not expected because the physician did not have much information about the patient and refused to continue with the AE reporting.
2 month immunizations given yesterday (10-15-07). Child developed a temp of 102 after receiving immunizations.
Patient c/o "feeling funny" with numbness & tingling bilateral hands and left side of face. She was flushed and slightly diaphoretic and breathing rapidly. She was 8 1/2 months pregnant and had expressed anxiety about receiving the vaccine. At 10:15 AM, she was taken back to the Tx room where she layed down under observation. Her facial features were even and symmetrical. B/P 120/70, pulse 112 and respirations 24. She denied any difficulty swallowing or breathing or any abdominal pain. 10:20 AM B/P 118/74, pulse 96 and respirations 18. She stated the numbness and tingling in hands and face had subsided; resting quietly. 10:40 AM, patient assisted to a sitting position where B/P 112/68, pulse 88 and respirations 18. She stated she felt much better and asked to go home. D/C'd at 10:40 without incident. 12/07/09, 12/08/09.  Antenatal records received for DOS 04/14/09. Notation by MD on 11/28/09: pt delivered:  mom and baby stable and healthy.
01/03/22 presents to ED for "SOB". PMHx of "ESRD s/p permacath placement, CAD s/p stent placement"
bruising and pain around vaccination site; pain around vaccination site; This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 02Mar2021 at 09:45 (Batch/Lot number was not reported) as dose 2, single at the age of 23 years old for COVID-19 immunisation.  Medical history included known allergies to scallops. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on unspecified date for COVID-19 immunisation. The patient experienced bruising and pain around vaccination site on 07Mar2021. No other vaccine in four weeks. No history of COVID prior to vaccination and has not been tested for COVID post vaccination. The patient did not receive treatment for the events. The patient has not yet recovered from the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Vaccine administered at approx 10am on 8/20/08 in right deltoid. No side effects were noted. By report from this individual she stated that she was cooking supper around 5:30pm and she had a nosebleed then she started feeling achy and tired. She took TYLENOL P.O. She stated she made Potato Salad but though she must have put too much vinegar in it because it burned when she swallowed it. She stated the vision in her left eye became blurred (blind in right eye). She stated that when she laid down it was harder to breathe so she remained elevated on pillows but could not sleep. She presented with no wheezing in lung sounds but had dyspnea/asthma-like symptoms. She stated that by morning the vision in left eye was double and blurred. All her joints were stiff very hard to bend and had difficulty getting her breath. Stated that she continued to feel nauseated but did not vomit. Upon examination vital signs were: T 97.4, P 74, BP 117/77, R 24 SpO2 93%. (VS on 8/4/08 were T 98.9, P 85, R 16, B/P 135/95, SpO2 95%). Presented with difficulty with ROM of all extremities and digits r/t stiffness and pains in joints, red and swollen and warm to touch. Skin cool and moist. Vesicular lesions behind Right ear with clear drainage from ear apparent. Complaint of tinnitus in Left ear. Examination of oral cavity revealed stomatitis. Was transported to ER for direct admit. 9/22/08-records received for DOS 8/21-8/25/08-DC DX: Possible reaction to hepatitis A & B vaccines. Arthralgias. Urticaria. Presented to ED with C/O arthralgias in both knees and right elbow, shakes and weakness in arms and legs. Nose bleeds. Sores on tongue and behind ear. Pain when ambulating, difficulty swallowing.  Difficulty getting enough air in.  Returned to ED on 8/26/08- with C/O confusion. Ambien prescription of 10 dispensed on 8/25/28 now shows 3 remaining and Lortab 30 dispensed only 21 left. Neurological exam non-focal.
Extremely tired, aches, nausea, chills, no fever within hours after injection. Very immobile shoulder with pain. One week after I started with hives on upper arm of injection site, itchy, then a diffuse rash for several days.
Event began with general body aches on the first day and then the next day fatigue and swelling of the left knee so that it became difficult to bend the leg.  Other joints ached.  The swelling of the left knee ended about 5-7 days later but was followed by a lesser swelling of the right knee.  Fatigue lasted about a week.
I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 4/25/2023 HYPOTHYROIDISM I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 4/25/2023 PNEUMONIA I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 4/25/2023 ALZHEIMERS DISEASE, LATE ONSET
Next morning after receiving second dose of Moderna Covid 19 vaccine, my left arm became red, itchy, and swollen
Flu-like symptoms developed later in day following vaccination. Continued for several days. April 2 she followed with PCP. On April 3 she was Admitted to hospital for uncontrolled hypertension and stroke treatment/prevention. CAT Scan and other tests followed. Released from hospital on April 3 with Rx  for hypertension control.
After receiving the second dose, my eczema flared up again and it was worst this time. I had blisters that had formed so I went to Dermatology where I received a steroid to calm the blisters down.
My upper lip is swollen. The swelling started in the upper right area at approximately 6 pm on April 25.  At a 7 am on April 26, my entire upper lip is swollen. Doctor has been notified, but have not spoken directly to physician.
Approx 12hrs after receiving MENACTRA pt developed severe/intense HA, fever 100.3, chills, nausea abd pain. Seen in office 8/18/16 1045 by Dr. BW done-will recheck Pt 8/22/16.
The pediatric dose was administered to the patient instead of the 12+ dose, no other reactions at this time
Breakthrough Covid19 case.  Symptoms:  Extreme fatigue and back spasms and soreness on the lower right side.
Approximately  2 hours after the vaccination I felt very minor side effects (headache / soreness on injection site). The next morning I felt the more intense side effects (fever of 101.1, chills, fever,  extreme sweat, loss of appetite, body aches and fatigue).  While the majority of the side effects have passed I still have no appetite.  I am a very healthy adult that does strength training  4x a week, I typically eat and snack every 3 hours.  Since the vaccination day I have no desire to eat and I am down to 2 meals (breakfast and dinner). I am also experiencing headaches and dizziness but this could be from the lack of nutrients.  Because I feel dizzy I am forcing myself to eat as I almost fainted during a morning workout and had shortness of breath. This particular morning I had coffee, a protein shake and a banana prior to my workout.  I have not read or seen any additional information on the loss of appetite lasting this long and I am getting concerned
After a exposure to COVID-19 patient developed stuffy nose/upper respiratory symptoms; After a exposure to COVID-19 patient developed stuffy nose/upper respiratory symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent.  A 15 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), intramuscular, administered in arm left, administration date 06Jun2021 (Lot number: EW0191) at the age of 15 years as dose 2, single and intramuscular, administered in arm left, administration date 15May2021 (Lot number: EW0183) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 08Jan2022, outcome "not recovered" and all described as "After a exposure to COVID-19 patient developed stuffy nose/upper respiratory symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: No COVID prior vaccination. Tested positive post vaccination. No other vaccine in four weeks. Facility type vaccine reported as Hospital.  Follow up attempts completed. No further information is expected.
Extreme nausea, headache, lightheadedness and drop in blood pressure. Legs, head and arms all had strong "buzzing" sensation. After sitting down to potentially throw up, may have briefly passed out, and was slumped against the wall. Buzzing lessened once back in bed under covers. Nausea and headache persisted for several hours.
Patient was given a Tdap in the left deltoid.  No reaction was seen, and she was still talking and smiling.  This was followed by Menactra, given in the left deltoid also (about an inch apart from the previous injection site).  Within 10 seconds of the Menactra injection, patient said she felt a funny feeling in her throat.  She then got very pale and diaphoretic.  I laid her down on a cot and took her blood pressure, which was 80/40. She never showed signs of any labored breathing, but she continued to say her throat felt tight and that she could barely hear.  After 5 minutes her color began to improve, and she stated that her hearing returned.  She also said that she had a queasy feeling in her stomach, which improved while lying on the cot (within 10 minutes).  After 15 minutes, patient's BP was 110/60 and she said she felt fine.  Her mother was with her, and after gathering the info for this report, patient walked out with her mom. This occurred about 1:30 pm on 8/11/08.  Follow up call made at 9:00 am on 8/12/08, and patient feels fine.
After the 15 minute waiting period from the vaccine, pt noticed stiffness in his neck. Pt states difficulty moving neck to the left, pt states movement of neck to the left caused pain.  Pt used a heating pad for temporary relief. Pt states pain is chronic since injection 4 weeks ago, with the pain fluctuating from a 2-6 on a pain scale of 1-10, with one being no pain and 10 being the most pain ever experienced. Pt states still in pain 4 weeks later. Pt has an appointment with his primary care physician this week.
some rashes on her face; This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had some rashes on her face on 06Jan2021. She would like to know if it's okay to take diphenhydramine hydrochloride (BENADRYL). The outcome of event was unknown.  Information on the lot/batch number has been requested
Right deltoid bruising, redness and swelling and warm to touch. Per patient symptoms started next day (5/14/2016). Patient complains of pain starting on 5/14/16 and continues. Seen on 5/16/16.
7 days since the vaccine administration my night-time resting heart rate has been significantly elevated; Chest tightness for 24 hours following administration of vaccine; 7 days since the vaccineadministration my night-time heart ratevariability (HVR) has been significantlylowered (15-20ms) compared to my 30-day average night-time heart ratevariability (50-55ms).; This is a spontaneous report received from a contactable pharmacist. A 34-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 28Apr2021 15:00 (Batch/Lot Number: EW0161) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced 7 days since the vaccine administration my night-time resting heart rate has been significantly elevated, chest tightness for 24 hours following administration of vaccine and 7 days since the vaccineadministration my night-time heart ratevariability (hvr) has been significantlylowered (15-20ms) compared to my 30-day average night-time heart ratevariability (50-55ms) on 28Apr2021. The patient underwent lab tests and procedures which included heart rate increased: 55-60bpm on an unspecified date 7 days since the vaccine administration my night-time resting heart rate has been significantly elevated (55-60 bpm) compared to my 30-day average night-time resting heart rate (44-48 bpm) , heart rate variability decreased: 15-20ms on an unspecified date days since the vaccine administration my night-time heart rate variability (HVR) has been significantly lowered (15-20ms) compared to my 30-day average night-time heart rate variability (50-55ms). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event chest tightness for 24 hours following administration of vaccine was recovered on an unspecified date in Apr2021 and not recovered from other events.  No follow-up attempts are possible. No further information is expected.
My husband is having fever and chills, his hands are shaking. He has become confused and his legs aren't working properly. He fell to the ground and was unable to get up. I had the paramedics come and they helped him into his chair but he has fallen again. They said that if he is not better by Friday to take him to see his PCP.
injection site became red/hot to touch also itch area was 8.5cm by 4cm. patient went to emergency room and the doctor who saw her told her to have us report it as an adverse event
Vial used was stored in refrigerator but past the beyond use date by 30 days.  Full effectiveness of vaccine could not be guaranteed.  Revaccination offered; parents deferred.
Erythema, pruritus, welts/wheals likely secondary to an allergic reaction. Educated patient that this is self-limiting illness that requires conservative management. Avoid triggers and irritants. Tepid, and colloidal oatmeal baths to help with pruritus. H2 blocker and prednisone started. Take benadryl as needed. May benefit from OTC allergy medication (Claritin, Zyrtec). Hydrocortisone cream PRN for pruritus and erythema. Emollients (Eucerin, aquaphor) PRN for eruptions. Calamine lotion PRN for pruritus. Can use a moisture barrier PRN (zinc oxide). If any tongue swelling, shortness of breath, fever, or feeling like throat is closing go to nearest ER. If rash is not getting better please notify pcp. f/u with PCP in 2-3 days for lack of improvement or sooner for worsening s/s
This case was reported by a physician via sales rep and described the occurrence of injection site edema in an unspecified number of adult patient's who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site edema, injection site erythema, injection site pain and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site edema, injection site erythema and injection site pain were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the injection site edema, injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient experienced local adverse events described as edema, redness and pain which resolved in 2 days. The physician suspected that the patient received the SHINGRIX via subcutaneous route and not intramuscular route which led to inappropriate route of vaccination. The physician declined to be followed up.