chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Drug ineffective; COVID-19; interchange of vaccine products; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), on 31Mar2021 as dose 2, single (Batch/Lot number: unknown), on 02Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), on 07Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) and on 06Apr2023 at 14:30 as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Sep2022, outcome "recovered"; COVID-19 (medically significant) with onset 20Apr2023, outcome "recovered" (26Apr2023); DRUG INEFFECTIVE (medically significant) with onset 20Apr2023, outcome "recovered" (26Apr2023). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Apr2023) Positive, notes: I first tested positive; (26Apr2023) Negative, notes: I tested negative on the evening of Wednesday 26Apr. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient has no known allergies. On 20Apr2023, the patient tested positive, immediately started Paxlovid treatment and finished it the evening of 24Apr2023. The patient tested negative on the evening of 26Apr2023 (day 7) and hoped she was in the clear.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300175661 same reporter/patient, different drug/AE;US-PFIZER INC-202300175985 same reporter, different drug/patients/AE;
A report has been received from a health professional concerning three patient of unknown gender. Medical history and concomitant medications of the patient were not reported. The patient had been received FLUMIST QUADRIVALENT (intranasal) started on 14-Oct-2014. The reporter stated that three patients who received FLUMIST QUADRIVALENT 2-3 days ago and they had come back into our clinic with flu-like symptoms started on 17-Oct-2014. Reporter stated patients had muscle aches, low grade fever. Reporter did not have any patient information or lot/expiration date info. Action taken with FLUMIST was unknown. The outcome of the event of three patients who received FLUMIST QUADRIVALENT 2-3 days ago have come back with flu-like symptoms, muscle aches and low grade fever was unknown. The reporter considered the events three patients who received FLUMIST QUADRIVALENT 2-3 days ago have come back with flu-like symptoms, muscle aches and low grade fever to be non-serious.
unknown. product administered when stored in freezer beyond the 21days that pfizer has data to support.
Pt is 3 years old and was administered influenza dose for age 6-35 months.
Difficulty controlling blood glucose; Shortness of breath; unable to lay down at night; swelling in legs; swelling all over; not able to exercise; weakness/tiredness; weakness/tiredness; palpitations; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Sep2021 as dose 1, single (Lot number: Fc3183) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Ace Inhibitors allergy" (unspecified if ongoing), notes: Ace Inhibitors allergy. The patient's concomitant medications were not reported. Past drug history included: Keflex, reaction(s): "Allergy". The following information was reported: BLOOD GLUCOSE ABNORMAL (non-serious), outcome "recovered with sequelae", described as "Difficulty controlling blood glucose"; DYSPNOEA (non-serious), outcome "recovered with sequelae", described as "Shortness of breath"; DISCOMFORT (non-serious), outcome "recovered with sequelae", described as "unable to lay down at night"; PERIPHERAL SWELLING (non-serious), outcome "recovered with sequelae", described as "swelling in legs"; SWELLING (non-serious), outcome "recovered with sequelae", described as "swelling all over"; EXERCISE TOLERANCE DECREASED (non-serious), outcome "recovered with sequelae", described as "not able to exercise"; ASTHENIA (non-serious), FATIGUE (non-serious), outcome "recovered with sequelae" and all described as "weakness/tiredness"; PALPITATIONS (non-serious), outcome "recovered with sequelae". The events "difficulty controlling blood glucose", "shortness of breath", "unable to lay down at night", "swelling in legs", "swelling all over", "not able to exercise", "weakness/tiredness" and "palpitations" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had not received any other vaccine within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was tested positive for COVID-19.
Received flu shot during shift at hospital. Started with prickly feeling in face and arms less than 1 minute after injection. Notified coworker. Lost awareness. When regaining awareness, was surrounded by coworkers who asked me to get into the gurney and gave me water. Per my coworkers, my skin flushed very red, was staring straight ahead, arms were shaking, breathing was irregular. They said it looked like seizure activity. As I started to look better, they said I was talking but have no recollection of saying anything. They said it lasted less than 1 minute. I noticed I was dripping in sweat when I became more aware.   Manufacturer: GlaxoSmithKline (Flulaval)
This spontaneous report as received from a Licensed Practical Nurse refers to unknown number of patients of unknown age and gender. The nurse reported that an unknown number of doses of PROQUAD (Merck) (dose, lot# and route not reported) that were improperly stored (outside of the range specified in the prescribing information) might have been administered. PROQUAD (Merck) experienced freezer fluctuations of 7-9F and possibly temperatures of 14-15F for 24 hours. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Pt. had vaccines 10/20/10- woke up at 5am 10/21/10 with nausea, fever, headache, and vomiting. Encouraged to seek care of MD for evaluation of symptoms. T 100-101. Phone call 10/22/10 no answer. 10/22/10 Phone call- Pt. feels fine now- on problems.
"A bad reaction"; "Panic attacks"; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Jul-2021 and was forwarded to Moderna on 16-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION ("A bad reaction") and PANIC ATTACK ("Panic attacks") in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION ("A bad reaction") and PANIC ATTACK ("Panic attacks"). At the time of the report, VACCINATION COMPLICATION ("A bad reaction") and PANIC ATTACK ("Panic attacks") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: abnormal (abnormal) blood pressure going crazy.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included unknown. Patient had COVID19 in January  No treatment information was provided
Pt devel vomiting, diarrhea (one episode), fussiness, fever 105 @ home; dx r/o bacteremia prob UTI;
product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19; product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19; Sore throat; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL SULFATE; SYMBICORT; CETIRIZINE oral; MONTELUKAST oral; BUDESONIDE nasal; AZELASTINE nasal. Past drug history included: None, reaction(s): "Allergy". The following information was reported: OROPHARYNGEAL PAIN (medically significant) with onset 27Apr2022, outcome "not recovered", described as "Sore throat"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Apr2022, outcome "unknown" and all described as "product=COVID 19 Treatment, brand=Paxlovid , indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test:  positive, notes: Positive Covid test on day 9; negative, notes: Patient tested negative and had symptom resolution on days 4-8. Therapeutic measures were not taken as a result of oropharyngeal pain.  Clinical course: Patient received paxlovid on 19Apr2022 via oral route of administration for COVID 19 Treatment and stopped on 24Apr2022. Sore throat and positive Covid test on day 9 after Paxlovid treatment (days1-5). Patient tested negative and had symptom resolution on days 4-8 adverse.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Drug Ineffective, Covid 19 and Sore throat and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Very severe pain in right arm unrelieved by taking two Advil or Tylenol and pain persisted unrelieved for 12 hours, unable to move or lift right arm for almost 12 plus hours.  Continue to have some limited movement of arm.
The patient came on 09/23/22 to get his bivalent booster. His CDC card showed the date he got the second booster as 06/22 and hence since 2 months have been passed he was given the booster. But when his wife came to get the booster on 09/28/22, the card showed 8/22 instead and  she did not qualify. She questioned why her husband was given the shot and looking at the card the 8 looked like a 6 and hence the mistake happened.
bad taste, burning sensation on arm, BP slightly elevated. Evaluated by EMS-Refusal to transport
Decrease in breast milk supply from 8-10oz in a given sitting to 3-4oz.
This case was reported by a consumer via call center representative and described the occurrence of confusion in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, several hours after receiving SHINGRIX, the patient experienced confusion. On an unknown date, the outcome of the confusion was unknown. It was unknown if the reporter considered the confusion to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced confusion, hours after receiving a dose of SHINGRIX and she did not find this adverse event as a listed. This was a common side effect. The patient asked if confusion was also a side effect not listed.
h/a, fever, stiff neck;MD dx acute h/a, r/o meningitis;pyelonephritis;poss tetanus rxn;
joint pain; She has chills; headache; arm soreness; muscle pain; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0179, NDC number and Expiry Date are unknown), via an unspecified route of administration, administered in Left arm on 10May2021 12:10 at the age of 32-years-old as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 10May2021, the patient experienced arm soreness, muscle pain and headache. On 13May2021, the patient experienced joint pain and chills. The clinical course was reported as follows: She received her first dose of the Covid vaccine about noon on Monday, 10May2021. On the first day, she had arm soreness. On the second day, her arm soreness was gone. She has started getting joint pain. She has chills, a temperature of 98.6, and she definitely has a headache. The muscle pain and arm soreness began two to three hours after the injection. It was reported that the joint pain and temperature of 98.6 started an hour ago. Clarifies that whenever she says joint pain, she also means muscle pain. Began one hour ago. Chills began one hour ago. Her temperature has also been 98.2ish. She definitely has a headache began on day one, 10May2021, about two or three hours after the injection. It started again, an hour ago today. It was 72 hours after she received the first dose of the Covid vaccine. She was asking if this was normal. She wanted to report these side effects. She was trying to figure out if other people have had these side effects. The patient underwent lab tests and procedures which included body temperature: 98.6 on 13May2021 and body temperature: 98.2 on an unspecified date. Reporter seriousness for Arm soreness, Joint pain, Chills and headache was unspecified. The outcome of event, arm soreness was recovered on 11May2021 while other events were not recovered.  No follow-up attempts are needed. No further information is expected.
Unable to fully move left arm due to severe pain.; Supraclavicular lymphadenopathy; This is a spontaneous report from a non-contactable consumer (patient). A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 22May2021 17:00 (at the age of 16-year-old) as unknown, single dose for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. There is no known allergies, no other medical history. The patient experienced unable to fully move left arm due to severe pain and supraclavicular lymphadenopathy on 31May2021 09:00. There is no other vaccine in four weeks, no other medications in two weeks. There is no covid prior vaccination. The patient did not test covid post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There is no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. AE resulted in emergency room/department or urgent care. The patient received treatment (Pain reliever) for the adverse event. The outcome of the event was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Information has been received from a pharmacist concerning a patient who two to three days ago was vaccinated with a dose of ZOSTAVAX vaccine (Oka/Merck) (LOT 662860/1617X). On an unknown date the patient developed a rash "the size of a half dollar" at the injection site where ZOSTAVAX vaccine (Oka/Merck) was given. At the time of reporting the patient had not recovered. Additional information has been requested.
24 hrs after admin. of Tdap she reports severe arm pain. 48 hrs after upper arm became swollen, red, and warm. 72 hrs she presents to medical provider for eval with continued swelling and redness but now reports pruritis. 96 hrs she reports all improving after taking BENADRYL that night.
Possible that patient did not receive full 0.5 ml dose of vaccine, due to draw up issue.
onset of chronic fatigue synd then fibromyalgia synd, worsening to the point of severe disability;numerous tx tried to no avail over 6yr w/worsening sx;special diet now seems to help immensely;
armpit hurts; armpit hurts and is extremely swollen; it feels like a lymphatic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 Immunization; Bnt162b2 (Second dose), for Covid-19 Immunization. The following information was reported: AXILLARY PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "armpit hurts"; PERIPHERAL SWELLING (non-serious) with onset Oct2021, outcome "unknown", described as "armpit hurts and is extremely swollen"; LYMPHATIC DISORDER (non-serious) with onset Oct2021, outcome "unknown", described as "it feels like a lymphatic reaction".   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a pharmacist refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with PNEUMOVAX 23 (lot # L024132, expiry date 21-JAN-2017, dose, dose number, vaccination site, route unspecified). The vaccines were exposed to a temperature of 33 Fahrenheit (F) for 1 hour and 57 F for 1 hour. No previous temperature excursions were reported. Product quality complaint (PQC) was not involved. No adverse effects were reported. Digital data logger was not involved. No additional information was provided. This is one of three reports received from the same reporter. Additional information is not expected because the reporter refused to contact further.
Baby fussy with temperature/fever. At 12:30 PM on 4/07/2005, baby was unresponsive.  9/25/2007 Received Death Certificate which reveals COD as SIDS.
I was in a golf course and all of a sudden I almost totally blacked out. I put my head down in the golf cart steering wheel. I have nitroglycerin tablets because I had a heart issue 2 years ago and that allowed me to breathe. That was on 11/11/2021. 911 was called and they took me to the hospital. I got to the hospital at around 10 am. I was discharged on 11/15/2021 around 12 PM. They did all kinds of medical tests, they found it was not a heart attack, but I had very large blood clots in my left lung. I had them in both lungs but the large ones were in my left ventricle. They were blocking the blood from going back to my lungs. They prescribed me Eliquis. Some of the tests they did were: metabolic panels, CBC with differential, glucose every day, IR angiography bilateral pulmonary, troponin levels, CT angiogram of my chest, Doppler of my veins in both legs. The clots were about 2 in large.
No adverse reactions, patient given High dose FLUZONE at age 61.  No problems when talked with patient.
Administered vaccine patient stated pain at site given, held head, pt pale went limp, held pt. gently got pt. to ground. pt. did not respond, fist clinched, muscle spasms, gurgling noise. Pt. responded <3-4 minutes. Rested 20-40 minutes. Mother and pt. left. Contacted pt 1-3-13 AM and pat stated she passed out when getting up this morning. She called her doctor and would follow up w/him.
Severe reaction - rash developed 12/3/15. Pt went to Dr and was diagnosed with Bell's Palsy on left side of face. Went to eye doctor 12/10/15 and cornea is intact. Given VALTREX for treatment.
felt pressure in my head followed by vertigo lasting about 20minutes then tinnitus in the right ear that has never resolved - 24/7 tinnitus
3 days after vaccine developed diarrhea, > 10 times per day initially, some mucus - straining noted, no blood.  No fever, no ill contacts.
Localized erythema and induration, without pain and without any signs of cellulitis or abscess . Developed within 24 hours of injection and patient sought attention 4 days post-injection. No systemic symptoms or side effects.
After being symptom free for 10 days following the injection, a mottled red area was noticed around the location of the shot and  about 6" down the arm on the 10th day.  There is a slight warmth, and some minor itching in the area but at this time no pain.
Fever to 103.0(R) lasting 6 days; blisters on inside of mouth that night went away next day. 18JAN91 started vomiting & diarrhea for 6 days. On 23JAn91 child turned white. Taken to hosp stayed 4 days dx  viral gastroenteritis.
8/22/21: Patient presented to the ED with complaints of SOB. Per patient, his symptoms started two days ago. He reports SOB, cough, diarrhea, and decreased appetite.  He was positive for COVID-19 on 07/27, and he also had a positive result today. admitted. Note: Had Pfizer Covid-19 vaccines on 3/9/21 & 4/30/21. Admitted with SOB due to CHF and fluid overload/ESRD on HD. No covid related diagnoses during admission.  8/24/21: Discharged.
Red, very sore, swollen arm, below the injection site, fever the next day of 101+ degrees.  Remained red, very sore and swollen until 09/10/2010.  Fever gone by 09/09/2010.