chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller states the patient had COVID-19 in Jul2022; Caller states the patient had COVID-19 in Jul2022; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group, Program ID.  A 16-year-old female patient received BNT162b2 (BNT162B2), on 17May2021 as dose 1, single (Batch/Lot number: unknown), on 07Jun2021 as dose 2, single (Batch/Lot number: unknown) and on 11Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 15 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Meningitis b vaccine (Lot Number/ Expiry Date: Unknown, Route, Anatomical Location: Unknown, No. of Previous Doses: Unknown), for Immunization; Meningitis vaccines, for Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Caller states the patient had COVID-19 in Jul2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive.  Clinical information: Patient received Dose 4 Bivalent vaccine on 27Oct2022. Treatment: None.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events and the suspect drug BNT162B2 cannot be excluded.
My daughter has not had a menstrual cycle since getting this vaccine. She recently confided this in me as she seems to now be having psychological struggles with the fact that as a young women she may no longer be able to bear children. She has seen her doctor and has tried some supplementary medications in the hopes these might trigger her body into normal functions once again but to no avail.
Local reaction. Next day had itching and edema. Injection site was very firm to touch in an area about 5" in circumference from vacc site. Still itching and firm 10 days later, although swelling had decreased.
Immediately after vaccine patient blacked out, broke out into profuse sweat and threw up. Patient's blood pressure was 142/87 a few minutes after vaccine. He reported feeling lightheaded, dizzy, nauseous, and cold.  Ambulance came.
itchy rash; Rash on legs,feet,arm,face and back; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash) and RASH (Rash on legs,feet,arm,face and back) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Hypertension. Concomitant products included POTASSIUM for Potassium supplementation, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 19-Jan-2021, the patient experienced RASH PRURITIC (itchy rash) and RASH (Rash on legs,feet,arm,face and back). At the time of the report, RASH PRURITIC (itchy rash) and RASH (Rash on legs,feet,arm,face and back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment include  Benadryl and OTC lotion to keep itchy calm down. Concomitant medication include blood pressure medication and potassium supplement.   This case was linked to MOD-2021-039859 (Patient Link).
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 78 year-old male patient received bnt162b2 (BNT162B2), administration date 21Dec2021 (Batch/Lot number: unknown) at the age of 78  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 (DOSE-1, The first and second doses of the vaccine he and his wife had no problems), for Covid-19 immunization, reaction(s): "no problems"; Bnt162b2 (DOSE-2, The first and second doses of the vaccine he and his wife had no problems), for Covid-19 immunization, reaction(s): "no problems". The following information was reported: IMMUNISATION (non-serious) with onset 21Dec2021, outcome "unknown", described as "booster"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; DISORIENTATION (non-serious), outcome "unknown", described as "Disoriented"; PRODUCTIVE COUGH (non-serious), COUGH (non-serious), outcome "unknown" and all described as "Coughing up Phlegm". Additional information: It was reported that patient and his wife, began feeling dizzy, disoriented and coughing up phlegm since being administered the Pfizer booster dose and want to know has this been reported by other. After the first and second doses of the vaccine he and his wife had no problems but began to experience symptoms after receiving the booster dose. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202101878726 different patient, same drug and event.
Called on 8/10/17 to say that area/arm was sore and swollen in neck.
Heavy period. Currently has lasted twice as long as normal. (Still ongoing); Severe cramping; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the left arm on 17Jun2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On 20Jun2021, the patient experienced heavy period, currently had lasted twice as long as normal (still ongoing) and severe cramping. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events heavy period, currently had lasted twice as long as normal (still ongoing) and severe cramping were not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Fatigue; Really low grade fever between 99.1-99.7; body aches; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), PYREXIA (Really low grade fever between 99.1-99.7), MYALGIA (body aches), PYREXIA (Fever) and HEADACHE (Headache) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced MYALGIA (body aches), PYREXIA (Fever) and HEADACHE (Headache). On 19-Apr-2021, the patient experienced FATIGUE (Fatigue) and PYREXIA (Really low grade fever between 99.1-99.7). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. On 18-Apr-2021, MYALGIA (body aches), PYREXIA (Fever) and HEADACHE (Headache) had resolved. At the time of the report, FATIGUE (Fatigue) and PYREXIA (Really low grade fever between 99.1-99.7) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, Body temperature: 99.1-99.7 (High) Low grade fever.         No relevant concomitant medications were reported.
Patient received just the DTap/IPV part of the Pentacel and the Acthib portion was not mixed/NO AE; Initial information received on 04-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 15 months old male patient who received just the DTap/IPV part of the vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot U66113AA via intramuscular route in the right thigh on 01-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and INFLUENZA VACCINE INACT SPLIT VIRION 3V (FLUARIX) for Immunisation.  It was a case of actual medication error due to Inappropriate reconstitution technique. The doctors gave the DTAP/IPV part and did not know that the Acthib portion was not mixed.  At the time of report no adverse event was reported.  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.
Prior to Covid, I only got very rare exercise induced asthma, requiring an inhaler maybe once a year.    After getting Covid in March 2020, I needed to use an inhaler frequently and had moderate asthma persisting 3 months after recovering from Covid as part of my long Covid symptoms.   After each Covid vaccine, the asthma I experienced post Covid came back, with it coming back to a greater degree with each shot, but by the time I got the 3rd shot, my asthma had resolved and I was back to doing one hour of heavy boxing five days a week.   In a particularly good place health wise then and feeling like switching to Moderna might prevent the asthma side effects I was getting from Pfizer, I got a 3rd booster in December and went from exercising daily, to being unable to exercise, having severe asthma, going to urgent care due to asthma multiple times, having a battery of tests, and eventually being put on Breztri.   I'm still suffering ill and debilitating effects to this day, with improvement since December but pretty severe issues.    By the way, I'm still pro-Vaccine, I'm just suspecting I'm part of a 1-2% of people out there with some autoimmune issue history and prior covid that this sort of auto-immune asthma could happen to.
BP 10:05 89/52, Pulse 112 10:15 151/104 Pulse 98 10:25 163/105 Pulse 120 10:30 174/114 Pulse 124 10:40 am 137/95 Pulse 118 Patient received influenza vaccine at around 9:55am. Started feeling nauseous BP & pulse rate taken & monitored as listed above. Paramedic called, pt refused to go to hospital, continue to monitor.
Patient got vaccinated, by the time she sat in the area of observation, she refers having head pain, blurry vision, nausea and immediately vomits. We proceed to take her vitals BP 120/70, P:115, and sat.o2 99 and we call the ambulance and she is taken to the hospital area.
11:33 AM: Reported generalized pruritis, worst to face/head/neck. Severe dizziness/lightheadedness reported. Patient reported similar sensation of itching, feeling of impending doom/"about to pass out" previously with shellfish allergy. Exam notable for: Alert but drowsy appearing, seated slouched in chair. +Erythema and edema to ears bilaterally; macular erythema to face over cheeks. Tongue WNL. Lungs CTA= bilaterally.   11:34 AM-- Epipen 0.3 mg administered R vastus lateralis. Well tolerated. 911 called  Post administration 11:35 AM: , BP 146/86, HR 88/minute. Lungs CTA= bilaterally. Continue reports of lightheadedness.   11:40 AM tranferredcare to EMS; patient transported to closest emergency department
On June 17, 2022 I thought a sinus infection was starting. On June 19, 2022 I had more sinus congestion and a sore throat. By June 20, 2022 there was more congestion and sinus problems. On June 21, 2022 I went and saw a doctor and was given medication for my sinuses. It was Amoxicillin, Albuterol and Prednisone. I was also given COVID-19 test at the doctor's office and after two days the results came back positive. The next day after starting the Amoxicillin I started to feel better but still had congestion. That Friday I began to feel better and by Sunday I was 90% better. On Monday I was given another COVID-19 test and it was positive. I kept feeling incrementally better. On Friday July 1, 2022 I took another COVID- 19 test and it was negative. On July 7, 2022 I went back to the doctor and was feeling better but just a little congestion. I currently feel really good, pretty much back to normal.
Tdap inadvertently given in place of Dtap by mistake. Patient should have received Dtap vaccine on immunization date.
Patient had a cough and sore throat, generalized fatigue, dizziness, body ache, and nausea on admission. She also complained of left ear pain. Left ear canal is completely occluded so no dampening membrane is visible. Doxycycline was started empirically. For COVID-19 patient was also placed on vitamin-C, vitamin-D, and zinc supplements. She have no respiratory distress, she did not require any supplemental oxygen. Remdesivir was started but patient was improving sooner than expected so remdesivir was discontinued. She was subsequently discharged.
Hyporesponsive, pale, febrile - onset 30-45 min after vax.  Seen in ER.
redness at the site of application; swelling at the site of application; itching at the site of application; nausea; fatigue after administration.; fever; joint pain; This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 63-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number YR7AA, expiry date 14th April 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st September 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 21st September 2022, less than a day after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced injection site erythema, injection site swelling, injection site itching, nausea, fatigue, fever and joint pain. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site itching, nausea, fatigue, fever and joint pain were recovering/resolving.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site itching, nausea, fatigue, fever and joint pain to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-SEP-2022 Reporter's Comments:  The reporter stated adverse reaction that the patient suffered after administration of Boostrix.  The reporter mentioned that since the day of administration the patient showed redness, swelling, and itching at the site of application. Moreover, patient suffered from nausea, fatigue, fever and joint pain after receiving Boostrix dose. Finally, the reporter mentioned that the patient was getting better but had not fully recovered. The Vaccine Administration Facility is the same as Primary Reporter. The reporter gave consent to follow up.
Patient had appointment to receive 3 vaccines (COVID, flu, and Tdap). Patient received the flu and COVID vaccines, and reported to have started feeling dizzy right away. Elevated patient's legs in the vaccination room, then patient says started feeling better. I escorted the patient out the vaccination room to the waiting area and had the patient rest with legs elevated for 30 minutes. After that the patient said felt much better and both of us agreed to reschedule the Tdap vaccine for another day.  Patient states that this is the first time this has ever happened with vaccines, and only occurred seldom with blood draws. Recommended that patient follow up with primary care.
Muscle aches, headache, fatigue, fever (100-101), soreness at site (arm). Started with fatigue and flight body aches on same day. Worse in AM with fever and headache and more body aches.
Started at twice the size of a quarter red spot. Then next day spot elongated to twice that size. Next day 06/27 now 5" long going down my arm and raised.
One week after I got the vaccine, on Saturday, I developed a fever over 100 degrees and felt lousy for a couple of days. It went away, and I returned to work.  The following Thursday, Feb 3, the fever returned. I had a fever of over 101 or 102 every day for 10 days (from Feb 3-12) accompanied by a terrible headache. I took Tylenol and ibuprofen every day to control the fever and headaches. The headache went away when the fever subsided.  Sometime during the week I developed a burning sensation in my leg muscles (like lactic acid?) On the morning of Feb 12, I broke out in a rash on my feet, ankles and lower legs, so I stopped taking the ibuprofen. I also stopped taking Tylenol due to my liver enzymes being high (see below re lab tests). From Feb 13, I have had no fever or a low-grade fever (not over 100), but I still feel extremely fatigued.  I have been unable to work since Feb 3.
Spouse reported severe swelling of right arm near injection site & hot to touch. Also fever, etc. & required an emergency room/or doctor visit & Rx filled next day.
I had contact with tested someone who tested positive, so I went ahead and got tested and the test was positive on 5/3/2022.
Phlebitis ONE WEEK POST VACCINE INJECTION SITE HOT, SWOLLEN, ITCHY. WENT TO PCP, PRESCRIBED MEDROL DOSEPACK 4 MG Narrative: PRESCRIBED MEDROL DOSEPACK 4 MG FOR INJECTION SITE RED, WARM, SWOLLEN, ITCHY. SXS RESOLVED.
Urgent care, CovID test positive, Aches and temp 100.3, fatigue, weakness, Cough with clear drainage. Son and daughter had the same symptoms but did not take a vaccination at that time. Went to see the doctor early because of health conditions. Zpak 5day supply and fluids. D3, C, Zinc, Antihistamine.
patient felt dizzy and lightheaded within a few minutes of receiving the vaccine.   She also claimed she had trouble with her vision.  She stayed seated in a cool room for about 10 minutes and the symptoms passed.
Left arm hurt at injection site for a few days; Metal taste in mouth for a couple of weeks; pains; felt kind of like he had a cold; asthma was real bad; Aches; Bronchitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 13:00 (Lot number: ER8727) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Verbatim: Asthma" (unspecified if ongoing), notes: Verbatim: Asthma, 11-12 years ago; "Verbatim: HIV positive", start date: 24Jan2001 (unspecified if ongoing), notes: Verbatim: HIV positive; "Verbatim: COPD" (unspecified if ongoing), notes: Verbatim: COPD. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 31Mar2021, outcome "recovering", described as "Aches"; BRONCHITIS (non-serious) with onset 31Mar2021, outcome "recovering", described as "Bronchitis"; VACCINATION SITE PAIN (non-serious) with onset 01Apr2021, outcome "recovered" (2021), described as "Left arm hurt at injection site for a few days"; DYSGEUSIA (non-serious) with onset 31Mar2021, outcome "recovered" (2021), described as "Metal taste in mouth for a couple of weeks"; PAIN (non-serious) with onset 31Mar2021, outcome "recovering", described as "pains"; NASOPHARYNGITIS (non-serious) with onset 31Mar2021, outcome "recovering", described as "felt kind of like he had a cold"; ASTHMA (non-serious) with onset 31Mar2021, outcome "recovering", described as "asthma was real bad". The events "bronchitis" and "asthma was real bad" were evaluated at the physician office visit. Therapeutic measures were taken as a result of bronchitis, asthma.  Additional details: Emergency Room? Yes Throwing up. 10Nov2021 went to (name). Placed IV and gave medication. One was to keep him from throwing up. He was more half asleep than he was awake. Treated and released. Physician Office?No. If the patient was hospitalized, how many days was the hospital stay? No. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): none. AE(s) following prior vaccinations: None. Patient's Medical History (including any illness at time of vaccination)? None or Unknown Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic/chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity. COPD 4-5 years ago. Family Medical History Relevant to AE(s): Family is diabetic. Relevant Tests: Pancreas levels 600-700.  No follow-up attempts are possible. No further information is expected.
Patient's CDC card did not have second COVID-19 vaccine information filled out. Patient was believed to be receiving the second dose. However, it was determined that patient previously completed the series and ended up receiving a third dose.
Mom reports she noticed swelling around the injection site approximately 30 minutes post vaccination.  No redness, heat or pain.  Swelling continued into the evening and Benadryl was given. Area continued to demonstrate swelling and erythema and patient followed up with pediatrician on 12/31/2020.  Pediatrician  advised continued Benadryl as needed for allergic reaction.
24 hrs after vaccination with Dtap #4 and Hib #3 in L thigh pt developed pain, redness and swelling.
After 8 days of my shot (today), I noticed I was pretty itchy on my arm at the injection site. When I finally got a good look at it, it was red and had, what seems to be, little hives around it. It?s also a little tiny bit swollen at that area. Very warm to the touch and I can now feel this continuous, residual heat around it now that it?s later on in the day.   Since it?s only the first day I noticed it, the size of the area is still rather small. I don?t know if it will progress to be any bigger than it is now or if its appearance will change in the future.