chrisvoncsefalvay/vaers-outcomes huggingface dataset:
elevated cardiac enzymes; left ventricular damage; This is a spontaneous report from a contactable pharmacist. A 16-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as first dose, at single for covid-19 immunisation (At the age of 16-years). Medical history was none. The patient's concomitant medications were not reported. On unspecified date, the patient was with elevated cardiac enzymes and left ventricular damage followed by a dose of product. Physicians indicate it was directly correlated and the reported was asking for specific information on this topic as to reported tissue damage especially with the EUA update age range. The patient underwent lab tests and procedures which included cardiac enzymes with results elevated on unspecified date. Outcome for all the events was unknown.   Information about batch number and lot number is requested. Further information has been 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 events of elevated cardiac enzymes,left ventricular damage. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern 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
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On 07-AUG-2015 the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (lot # L011079, expiration date 01-OCT-2016, dose, dose# and route not reported). There was no adverse events reported. This is one of several reports received from the same reporter. Additional information has been requested.
Received immunization 10 mm at 10:15 AM. Burning at site immediately and arm continued to burn and "achey" after got home, temperature 101.3F. Aching all arm. Low greater fever. Fells like he's been "beat-up."
When patient arrived for her second dose of Moderna she complained of losing her voice after the first dose. After further questioning, patient said there was no throat or vocal cord pain, no swelling and no other symptoms.
Information has been received from a physician referring to a patient of unknown age and gender. The patient's medical history and drug reactions/allergies were not reported. The patient had received all three doses in the series of ROTATEQ orally (dose and lot# were not reported), which was at the correct dosing intervals on unspecified dates. On unspecified date, the patient developed rotavirus after receiving all three doses in the series of ROTATEQ and was hospitalized in a hospital at the reporting time. The physician stated that this was the second patient that developed rotavirus after receiving all three doses of ROTATEQ. The outcome of the event and the causality were not reported. This is one of two reports (MARRS# 1504USA011404 and 1504USA011252) from the same reporter. Additional information has been requested.
Patient began having hives to arms and back, and had facial swelling. Took to ER and was given BENADRYL and SOLU-MEDROL for allergic reaction. Concerned about possible latex or Neomycin or Hepatitis A vaccine allergy.
Pt started c/o feeling a "head rush" about 5 minutes after vaccine was given. Pt started it looked dark and he felt nauseous. Pt BP 88/58, HR 73, SP02 97%. Glucose checked peer NP and was 79. Pt stated he did not eat this AM. Pt given a snack and water. Pt laid down in exam room X 30 mins. Pt then reported feeling fine and was d/c to leave by Dr.
Approximately 10 minutes after vaccine administration, patient reported tongue tingling and throat tightness. Nurse reported flushing. After arrival to the ED approximately 10 minutes patient also reported voice hoarseness and sweating. On arrival to ED, patient received Epinephrine 0.3 mg IM, diphenhydramine 50 mg IV, famotidine 20 mg IV and methylprednisolone 125 mg IV Patient began feeling better shortly after. Currently (~2.5 hours after vaccine administration), patient is sleeping in ER. Anticipated discharge later today with a steroid taper.
Irregular pain on the left side of chest; This is a spontaneous report from a contactable consumer via a company representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on Aug2021 as dose number unknown, single for covid-19 immunization.  Medical history included chest pain occasionally occur with her anxiety.  The patient's concomitant medications were not reported. Patient experienced irregular pain on the left side of chest in Aug2021. It was reported that the chest pain occasionally occur with her anxiety but the patient had the Covid vaccine over the last weekend and had heard of Cardiomyopathy side effect. The event chest pain has occurred prior to taking provost as a result of anxiety. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
No adverse events at time of vaccines. I did test positive for COVID in October 2021 along with my 17 yo daughter who also got two vaccines of Pfizer
Enlarged/swollen lymph node under left collar bone (left subclavicular). Other enlarged lymph nodes noticed by a doctor.
positive COVID test after the COVID vaccine; This is a spontaneous report from a contactable consumer. A male patient (consumer) of an unspecified age received BNT162B2 (COMIRNATY; Formulation: Solution for injection, Lot number: Unknown) via unspecified route of administration at single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient reported that he received his first Covid vaccine dose on 27Mar2021 and 7 days later "he thought he was having allergy symptoms, every year he gets a stuffy head and headache's, symptoms that he gets with allergies every year". patient reports that he went to the convenient care center and received a prescription for allergies, he also "got a steroid pump for his nasal symptoms". While he was there, he was tested for covid and 2 days later the test came back positive. He was advised to quarantine for 10 days but his second covid vaccine dose is scheduled for Saturday, but his quarantine doesn't end until Monday. He asks, should I end my quarantine early and go for the second shot or can I get it later than 3 weeks?  Patient reports that his symptoms are gone and he doesn't want to miss his second dose. Outcome of the event was unknown.  Followup#1 (PRD 15Apr2021/SRD 15Apr2021) This is a Follow-up spontaneous report from a contactable consumer. Confirmed COVID vaccine received on 27Mar2021, patient went to the doctor and had a COVID test on 03Apr2021 and the results came back positive on 05Apr2021. Patient said now next Thursday his 10 days quarantine will be up and then he can go back and go retake the test again. On 19Apr2021, Monday, that will be the 10 days mark and then the following Thursday of that same week it will be his visit to follow up with the doctor. Patient reported product complaint says that he went down to get his first COVID vaccine on 27Mar2021 and it was 7 days later that he thought he had spring allergies that were kind of surfacing and starting to take place. When he had went to the doctor to get allergy medication the doctor gave him a prescription pill and a nasal spray and while the caller was there they gave him a COVID test and 2 days later it came back positive. Confirmed COVID vaccine received on 27Mar2021, he went to the doctor and had a COVID test on 03Apr2021 and the results came back positive on 05Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
the Pentacel vaccine and didn't realize she had to mix with ActHIB portion/no AE; Initial information received on 26-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a patient who did not received Act-hib portion of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a only portion of a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported.  It was of actual medication error due to Inappropriate reconstitution technique..  It was unknown whether any adverse event was observed or not...  The information on the batch number was requested.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Client verbalized feeling anxious and his heart was racing.  Client was observed/evaluated by  Fire Rescue.  Client was observed for additional 15 mins.  Client was cleared to exit the facility at 11:26am.  Per Fire Rescue, client stable no further evaluation needed.
My arm, hands, neck, and back all became tight, irritated, in pain, stiff, and sometimes numb/tingling. I heard some tightness and pain was usual after the first few days - but it has been over a month and I am still in incredible pain and I have limited range of motion. I am unable to carry and hold things in my hand. To hold a piece of paper hurts my hand/arm. My whole arm still feels inflamed; it hurts down my back and even up to my left ear.  I went to the pharmacy where I received my vaccination, they DID NOT record my adverse reaction nor the length of time. They did not notate it at all. The head pharmacist simply told me to go to the doctor.  The doctor I went to also did not report my symptoms to the CDC or Department of Health. How are people to know that there are complications if no one is recording/reporting them? Or if they are not obligated to do so? I am having to report my own adverse symptoms. At the doctor, they told me of patients having swollen lymph nodes and breast pain for weeks following. I am sure they did not report these complications.    At the doctors office, the doctor first prescribed me prednisolone and ibuprofen. I received very little relief. They then tried steroid and anti inflammatory injections & prescribed me flexeril. I received some relief but the problem is still ongoing. It has been over a month of me being in pain. I went to the doctor yesterday, and they prescribed me Nabumetone & Gabapentin. I am also to take physical therapy. All of this is costly and is costing me money as I have private insurance and have a high deductible. On the referral to physical therapy, the doctor wrote: "33yo female presents left arm arthralgia, limited ROM with stiffness and muscle spasms." Yet even this description does not sum up the problems and pain that I have received. My ear, shoulder, arm, hands, fingers, and back are all in pain, feel inflamed, and can hardly withstand me touching things. I have not been able to be without medication. I have been a very healthy person and now I feel disabled by the COVID Vaccine.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 2-month-old male patient who received PEDIARIX (batch number 2P79K, expiry date 27th MARCH 2017). On 7th OCTOBER 2015, the patient received PEDIARIX. On 7th OCTOBER 2015, less than a day after receiving PEDIARIX, the patient experienced malaise, injection site reaction and irritability. On an unknown date, the patient experienced fever and crying. On an unknown date, the outcome of the fever, malaise, injection site reaction, irritability and crying to be related to PEDIARIX. Additional details were provided as follows: This case was previously reported to a manufacturer (Sanofi-Pasteur). So, the reporter felt she did not need to report it again. This case was reported by the patient's mother. On the same day, the patient experienced injection site reaction, malaise and fussiness (irritability). In October 2015, less than a week after receiving PEDIARIX, the patient experienced fever and crying. The reporter did not have time to give a complete report as the patient needed her attention and she did not have time to report. The reporter was very concerned about the patient. She contacted the doctor, who advised her that this was normal.
Fever, chills, continuous pain in right arm, nasal congestion, sneezing, tears, chest pain when coughing or sneezing.
Within 24 hours of the 3rd dose, (Booster), I developed fever, chills, shortness of breath and headache. Between 24-48 hours after, I became very lethargic and confused. I do not remember Tuesday 12/13/21 at all.  I was hallucinating and not acting normal according to my wife. Starting on Wednesday 12/14/21, I began to have substernal chest pain, fluctuating in pain throughout the day with increased headaches and tachycardia. The chest pain has been increasing everyday and the tachycardia happens multiple times a day now unprovoked. With the tachycardia i get short of breath and dizzy. On Wednesday 12/23/21, the pain in my chest with the tachycardia was to the point that I went to Emergency Room. I have had a follow up with my PCP on 12/29/21 and now have an Echocardiogram scheduled for 1/6/22. I continue to have tachycardia throughout the day with palpitations that are only increasing in pain and duration. I never had these issues prior to my Covid Booster. Nothing in my medical history has changed in the past year.
10 days after vaccination, patient called our office and stated that she had hives around the site of the TDAP vaccine injection. She refused to come to the office, but wanted the reaction reported. The next day she called to say she had hives all over the body.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Oct2021 as dose 3 (booster), single (Lot number: Fc3184) at the age of 36 years for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history included: "Reactive airway disease" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; BUPROPION. Past drug history included: Sulfonamides, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", 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: (unspecified date) Positive; (24Jul2022) Negative, notes: I was negative on a home antigen test on July 24 or 25th. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical information: The patient received other medication in two weeks. She was negative on a home antigen test on 24Jul2022 or 25Jul2022. She started having congestion on 28Jul2022. On 30Jul2022 she felt fatigued and had a cough. She took another home antigen test that came back positive. Treatment details: Anti viral details, product: COVID 19 Treatment, brand: Paxlovid, treatment start date: 18Jul2022, treatment stop date: 23Jul2022, Indication: Treatment of COVID-19.
flu like symptoms; aches; Chills / shivering; very fatigued; stomach upset; headache; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced influenza-like symptoms, pain, chills, fatigue, upset stomach and headache. On an unknown date, the outcome of the influenza-like symptoms, pain, chills, fatigue, upset stomach and headache were unknown.   It was unknown if the reporter considered the influenza-like symptoms, pain, chills, fatigue, upset stomach and headache to be related to Shingrix.  Additional details were received as follows: The patient experienced aches, chills, shivering, very fatigued, stomach upset, headache. The patient was hoping dose 2 would be better. The patient got all the flu symptoms with the 1st vaccine and asked if the events would happen again. The patient asked if it was better to wait closer to 6 months to have the 2nd Shingrix vaccine. The patient stated that the insurance was changing and do not know if Shingrix would be covered.
muscle pain; headaches; joint pain; chills; hands are swelling; knuckles are swelled up; breathing issues; This is a spontaneous report from a contactable consumer. This male consumer reported.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 27Jan2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient had nothing but side effects since the patient got his first shot. The patient experienced muscle pain, headaches, joint pain, chills at times, hands are swelling, and knuckles are swelled up all on an unspecified date. The patient had breathing issues for a while one evening on an unspecified date. The patient called to ask what the patient should take for the side effects he had been experiencing since his first dose. The patient also asked whether he should take the second dose. Outcome of the events muscle pain, headaches, joint pain, chills at times, hands are swelling, and knuckles are swelled up were reported as Unknown at this time of the report. Outcome of the event breathing issues was reported as recovered on an unspecified date at this time of the report.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Relapsing polychondritis; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient received bnt162b2 (BNT162B2), on 06Oct2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "Polychondritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: POLYCHONDRITIS (medically significant) with onset 2021, 1 month after the suspect product(s) administration, outcome "unknown", described as "Relapsing polychondritis". The event "relapsing polychondritis" required physician office visit. Clinical Course: After she received her 3rd Pfizer vaccination she was diagnosed with relapsing polychondritis a month later. She was wondering if the vaccine had anything to do with it. Her doctor said there was not enough research on the side effects of Covid-19 vaccines.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300299978 same patient, different drug/event;US-PFIZER INC-202300300744 same patient/vaccine, different dose number/event;
Dosing error (pediatric use); A spontaneous report was received from a healthcare professional concerning a 17 year old patient who received first dose of Moderna's COVID-19 Vaccine (mRNA-1273) and experienced Product administered to patient of inappropriate age.  The patient's medical history, was not provided. Concomitant product use was not provided by the reporter.    On an unknown date, the patient received the first of two planned doses of mRNA-1273 (Batch number: 023M20A) intramuscularly  for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event Product administered to patient of inappropriate age.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event, Product administered to  patient of inappropriate age, was considered resolved.; Sender's Comments: This report refers to a case of Product Administered to Patient of Inappropriate Age for mRNA-1273 (Lot number: 023M20A) with no associated AEs.
patient found having syncopal episode after Shingrix shot. patient helped to seat by staff, responsive @ 11:20am, this RN called MD stat @ 11:21. RN noted pt breathing with grunting breath sound with small coffee ground emesis around comer of mouth, VS 143/97 HR 68 on RA 100% @ 11:23. MD stat team arrived @ 11:24am. SBAR report given to MD and RN. Care handed over. Patient was lethargic after taken over and 911 was call, Engine arrived @ 11:31am
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/1/2021 and 2/23/2021. Daughter in law tested positive for COVID and was with patient on 9/19/2021.  Patient reported to have had persistent dry cough and vomited on 9/23/2021. Patient prescribed medrol dosepack and doxycycline. On 10/10/2021 patient was brought to ED with decreased level of consciousness. In the ED her GCS was 7/15. She was intubated for airway protection. She became hypotensive after intubation requiring norepinephrine drip briefly. Her UA was abnormal and started on cefepime.  Patient diagnosed with sepsis, and acute kidney injury. Patient expired on 10/17/2021.
Facial numbness in cheeks and jaw. Started yesterday at 7:00pm. Headache and tiredness started about 6 hours after vaccine. Ocular migraine Sunday evening for about 20min.
dizzy/dizziness; This is a spontaneous report received from a contactable reporter (Consumer or other non- healthcare professional). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 05Mar2021 (Lot number: EN6203) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 05Mar2021, outcome "unknown", described as "dizzy/dizziness".  Additional information: NDC number, UPC number and Expiry Date of COVID-19 vaccine was Unknown. When probed for the concern, consumer stated that when she got her vaccine at (Clinic name) on 05Mar2021 then sat down for a while she was immediately dizzy and then after about 45 minutes it past and it happened experiencing a quick dizziness came to her about 4, 5 times since she have had her shot, so she just wanted to report that.  No follow-up attempts are possible. No further information is expected.