chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ventricular tachycardia, it actually hit her heart; never had heart trouble before; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 71 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), administered in arm right, administration date 18Feb2021 (Lot number: EL9266) at the age of 70 years as dose 2, single for COVID-19 immunization. The patient had no relevant medical history. The patient took concomitant medications, which included unspecified multivitamins. Vaccination history included: BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (dose 1, single, Batch/Lot number: EN5318), administration date: 28Jan2021, for COVID-19 immunization. The patient had no prior vaccinations (within 4 weeks). The following information was reported: VENTRICULAR TACHYCARDIA (medically significant) with onset 2021, outcome "not recovered," described as "ventricular tachycardia, it actually hit her heart; never had heart trouble before." The event was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: echocardiogram (Echo): (2021) unknown results; holter monitor: (2021) unknown results; and test: (2021) unknown results. It was further reported that the patient was just curious; she had a reaction to the shot, to the point where, it was not that she had a fever or anything like that; she ended up without maybe six weeks after the first two shots, okay; the second shot, she ended up with ventricular tachycardia, it actually hit her heart of course when she went to the cardiologist and had test taking and everything out, the only thing that doctors could say was "yes it was, no it was not," but she never had heart trouble before and after taking this shot, she got ventricular tachycardia. She was just curious about how many people had called and said that there was some sort of heart-related or other incidents, because she knew she was probably not the first. The patient did take the booster; they did tell everybody to take this booster and so far, she had tachycardia and that was something that was not going to go away unfortunately, but down it was what it was. But, she was just curious to find out why it hit certain people in certain spots. When asked regarding treatment for the event, the patient stated that except getting an echo and wearing a monitor, a holter, they did want to put her on a beta blocker, but she refused the beta blocker; she did not like medication and she was going to live with what she had.  Follow-up attempts are completed. No further information is expected.
2MAR93 w/in 4 hrs devel t104; not relieved by APAP; shrill screaming seen on PVH-called MD on following Saturday for rash involved;
5 weeks pregnant By 6 extremely tired and head ache Next day still no energy and very nauseous  Took Tylenol to help with the headache 3rd day still very little energy
Covid arm, headache severe, hallucinations, heart pain for weeks prob inflammation. Felt like I was dying multiple times
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 12:23 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 12:23 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 48 No concomitant medications were reported. On 27-Oct-2021 at 09:00 A.M., the temperature recorded was 29 degree Fahrenheit and vial was initially moved to the fridge on 29-Sep-2021 and beyond use date was 29-Oct-2021. Product moved to clinic on 27-Oct-2021, and at 10:00 Am the temperature recorded was 32 degree Fahrenheit and vial was initially moved to the fridge on 05-Oct-2021 and beyond use date was 04-Nov-2021. Product moved to clinic on 27-Oct-2021.  Vial was stored on cooler 1, on 27-Oct-2021, Excursion duration At 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 AM: 43, 1PM: 43, 2 PM : 46, 3 PM: 46, 4 PM: 46 and 5 PM : 45.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a  traceable temperature monitor at every hour. No treatment medications were reported.
Diarrhea, headache, upper back pain starting from right going left, swelling and soreness at injection site, bruised leg and clotted on inside of right leg outside. Diarrhea left yesterday.
Awoke with abdominal cramps and sharp pain, had diarrhea; later on in the morning had chills and malaise.
Pain and large (3 inches diameter), hard, red circle on arm lasting for two days so far.
The health event presented with the beginnings of a frozen shoulder in my left sub deltoid. I have a limited range of motion. Specifically we're talking about anterior deltoid. Range of motion is limited when I start with my left arm extended and I try to reach back, I can really feel it in that deltoid. The pain is acute and sharp, then immediately goes away when I stop making that  motion. There's still about 10-15% residual pain. With my hand extended or elbow bent, if I try to reach back, it hurts. The pain lingers for a second then goes away within a minute. I take ADVIL for my back, and that doesn't help with the shoulder much. When I subluxed my right shoulder, my left shoulder was okay. My doctor put me on a prescription called diclofenac 75mg twice daily for a week then I was on that for once a day for a week after that, then as needed. I didn't start taking that until my right shoulder was really bothering me. Stretching seems to help the right shoulder. When I came off the diclofenac, my left shoulder started bothering me. After my right shoulder was okay, my left shoulder was hurting more in January/February and it's been trending in discomfort up until now. I did finally get massage therapy which was on my left shoulder. That was 3 days ago. It definitely took the edge off. This is a standard Swedish massage. It seemed to have loosened up a little bit. The pain is not as sharp. I have scheduled for another massage therapy in about 2 to 3 weeks. If it really starts to come back, then I may have another appointment with an orthopedist. I could also continue to do the stretches for my subluxed shoulder on my left shoulder. It's so painful that I recently made the decision to get a Shingles vaccine in my right shoulder because of the left shoulder pain.
A lesion developed on right wrist about 2 weeks after shots..  round sore 8-9mm.  Grew  to 20mm and ulcerated..  Shave biopsy determined it was Acantholytic Squamous Cell Carcinoma.  After booster, numerous more lesions showed up.  All were removed by surgical excision.  Since then, any new new "growths" are removed using liq. N2.
rash spread to spread to different parts all over the body; rash in injection site; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection site), VACCINATION SITE RASH (rash in injection site) and RASH (rash spread to spread to different parts all over the body) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B219) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site). On 26-Mar-2021, the patient experienced VACCINATION SITE RASH (rash in injection site). On 03-Apr-2021, the patient experienced RASH (rash spread to spread to different parts all over the body). At the time of the report, VACCINATION SITE PAIN (pain at injection site), VACCINATION SITE RASH (rash in injection site) and RASH (rash spread to spread to different parts all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Raised bumpy red rash on forehead that was noticed about an hour ago and is spreading since time noticed.
Patient given 4th dose of 0.5mL when it should have been 0.25mL. Patient developed a 102 degree fever and felt very sick but appears to be recovering.
On 10/7/09 pt came to the clinic to receive a H1N1 nasal spray. I administered this vaccine to the patient. The H1N1 spray is only recommended for patients between the age of 2 years up to 50 years, so this patient was too old to receive this vaccine.
I had a bad cold, a lot of breathlessness, feeling like I would faint often; coughing; head congestion. I took PAXLOVID. The symptoms lasted about 2 weeks and were mild to medium. I continued with my daily activities. After I tested negative for COVID-19 I was breathless, my heart was pounding and I was fatigued. My daughter is a physician and she felt my pulse and sent me to urgent care. They sent me to the ER and then they sent me home. Later that night I couldn't breathe and went back to the ER. I was very faint, breathing was hard and I felt as if I would faint. They did tests and found fluid on my lungs, and told me I had Afib. Since diagnosed I went back to the ER 3 times after this because I couldn't breathe.
on the third week I got positive with the COVID-19; on the third week I got positive with the COVID-19; Flu symptoms; runny nose; sneezing nonstop; getting this cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Oct2021 (Lot number: FE3590) at the age of 49 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, Lot no: 301358A), administration date: 20Sep2021, when the patient was 49 years old, for Covid-19 Immunization. Patient had no problem and no issue. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "on the third week I got positive with the COVID-19"; INFLUENZA (non-serious) with onset 2021, outcome "unknown", described as "Flu symptoms"; RHINORRHOEA (non-serious) with onset 2021, outcome "not recovered", described as "runny nose"; SNEEZING (non-serious) with onset 2021, outcome "not recovered", described as "sneezing nonstop"; NASOPHARYNGITIS (non-serious) with onset 2021, outcome "unknown", described as "getting this cold". Patient took the second shot on 14Oct2021 so 'getting' second shot two week later. Patient was feeling flu symptoms so for two weeks patient had almost like the flu and on the third week she got positive with the COVID-19 and she 'was taking' this same safety since last year nothing changes. So patient did not know how she was okay until she took the second shot of Pfizer vaccine and all of the sudden she was not that 100 percent that she used to. She was still suffering as of now, she was still having runny nose and was still sneezing nonstop, something was not right what was this way something was not right. Patient had been getting this cold this running nose. Two weeks after second vaccination, patient experienced flu symptoms had started and had tested positive, Positive for COVID. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive.  No follow-up attempts are possible. No further information is expected.
11/16/2022 I felt like I had congestion that felt like allergies and post nasal drip. I tested positive with a home COVID test on 11/17/22 which was positive. I did a tele health with my physician. Since I was over 50 she recommended PAXLOVID and cough medicine. I did not take the PAXLOVID or the cough medicine. My symptoms are very mild cold symptoms. My only symptom is mild congestion.
Child was seen by primary care provider for hives.  Parent reported that hives began 48 hours after vaccinations were given at the health department.  Primary care provider reported multiple hives from head to toe on infant.
On 2/3/21 a 71y/o Male arrived to the library to recieve a CoVID Vaccine from County Fire. Pt recieved Vaccine and during 30minute observation period pt began to have symptoms of SOB and Eye irritation. Pt was evaluated by FIre/EMS Staff.Pt c/c was SOB. Pt was evaluated by on site paramedic with no treatment. Pt was offered transport to local hospital but pt refused. Pt Signed AMA after hospital contact.  For Further record of pt viitals, information, and care reference EMS PCR HCFA2021-00007716 Incident #HCFA2021-00007716
received both doses of the Moderna Covid-19 vaccine 2 weeks apart not 1 month.; A spontaneous report was received from a consumer concerning a patient of unknown age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced receiving both doses 2 weeks apart/inappropriate schedule of vaccine administration.   The patient's medical history is not provided by the reporter. Concomitant medications were not reported.   The patient received their first and second of two planned dose of mRNA-1273 on an unknown date (Lot number: unknown). Per the patient, a second dose was received 2 weeks after the first, not 1 month.   Action taken with mRNA-1273 in response to the events was not reported.    The outcome of event is unknown.; Reporter's Comments: This case concerns a patient of unknown gender and age who received their second of two planned doses of mRNA-1273 (Lot unknown), reporting Inappropriate schedule of product administration without any associated adverse events.
Covid-19; Covid-19; 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 (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 11Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 18Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 28Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing); "heart disease" (unspecified if ongoing). Concomitant medication(s) included: MESALAMINE, start date: 01Jan2013; REMICADE, start date: 01Jul2017; METOPROLOL, start date: 01Jul2020; ROSUVASTATIN, start date: 01Jul2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Jul2022, outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jul2022) Positive, notes: tested positive for Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The doctor told the patient to get his shingles shot and 3 weeks later, had shingles. The follow-up would not possible as no contact details were available.
Information has been received from a Physician's Assistant (P.A.) concerning a female patient who roughly on 29-DEC-2006 was vaccinated with a first dose of Gardasil and on an unknown day was vaccinated with a second dose of Gardasil and on 19-JUN-2007 was vaccinated with a third dose of Gardasil. Concomitant therapy included hormonal contraceptives (unspecified). The reporter reported that the patient developed "breakthrough bleeding and spotting" after both the first and second injection. The patient mentioned this information on 19-JUN-2007 when she came to the office. Unspecified medical attention was sought by the patient. The patient recovered. Additional information has been requested.
aches/pains shooting down my right leg; severe lower back pain; This is a spontaneous report from a contactable nurse. This 54- year-old female patient (reported for herself) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: lot EK5730), via an Intramuscular route of administration, on 06Jan2021 at 09:00 AM (at the age of 54-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the right arm. The patient reported allergies to food. The patient does not have any medical history. Concomitant medication included omeprazole ((MANUFACTURER UNKNOWN) 20 mg QD, diclofenac (MANUFACTURER UNKNOWN) 75 mg EC tablet QD. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jan2021 3:00AM, 18 hours after 1st dose, she experienced severe lower back pain with aches/pains shooting down my right leg. Nine hours, after the injection I took 1 gm of Tylenol. At 3 am, I took another 1 gm of Tylenol with some relief. At 8 am took 400 mg of Motrin with some relief-aches/pain still there. No paralysis or weakness. The patient received Tylenol and Motrin as treatment for the events. The clinical outcome of the events aches/pains shooting down my right leg and severe lower back pain was not recovered. Patient was not tested for COVID-19 since having the vaccine.  No follow-up attempts are possible. No further information is expected.
Redness, swelling, heat, and itching  left upper arm. within 24 hrs of injection.  Symptoms are still present to date.
side effects; A spontaneous report was received from a consumer concerning a 90-years-old female elder patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events side effects.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.   side effects.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown  The outcome of event(s), side effects,  was unknown.
Feeling listless on Saturday and about 14:00, I ran a fever of 102F, had chills and could not get warm, even after putting on 2 quilts on my bed. Monday morning, about 05:00, the fever broke and the chills went away. Felt like a dish rag for a couple of days.
Lightheadedness/felt like passing-out, hand tremors, trouble walking, trouble focusing vision and  numbness in face.
This spontaneous report as received from a pharmacist refers to a patient (id# 488) of unknown age. The patient was vaccinated with improperly stored PNEUMOVAX23 on 29-AUG-2012. Lot# was reported as 0217AE, expiration date: 22-AUG-2013. Route was unspecified. No adverse events reported. The vaccine storage information was reported as "From 04-AUG-2012 to 09-AUG-2012, lowest temp excursion exposed to -1.7C for 65 minutes and exposed to 0C to 2C for total of 80 minutes. High temp excursion exposed to 11.1C for total of 322 minutes (5.4 hrs). From 12-AUG-2012 to 14-AUG-2012, lowest temp excursions at -1.9C for 153 minutes, -0.5C for 90 minutes, 30 minutes and 60 minutes and exposed to 0C to 2C for total time of 407 minutes. From 14-AUG-2012 to 28-AUG-2012, lowest temp excursions at -8.3C for total of 9 hours (2 excursions), -3.6C for total of 19 hours (2 excursions), -4.8C for total of 12 hours (4 excursions) and -5.7C for total of 9.5 hours (2 excursions). High temp excursion exposed to 18.4C for 1 hour and 10 minutes." This is one of several reported received from same source. 1209USA007525, 1209USA008597, 1209USA008598, 1209USA008599, 1209USA008600, 1209USA008601, 1209USA008602, 1209USA008604, 1209USA008605, 1209USA008606, 1209USA008607, 1209USA008608, 1209USA008609, 1209USA008610, 1209USA008611, 1209USA008612, 1209USA008613, 1209USA008614. Additional information has been requested.
Site: Pain at Injection Site-Mild, Systemic: patient semed ok prior to leaving-Mild
Information has been received from a certified medical assistant concerning a 62 yr old white female registered nurse with a codeine allergy, bronchitis, and no medical history, who on 17Feb06 was vaccinated IM into the left deltoid with a 0.5ml first dose of pneumococcal 23v polysaccharide vaccine (lot 651328/1046P). There was no concomitant medication. On 17Feb06, the pt developed a fever of 103F. On 20Feb06, the pt developed swelling, redness and local heat at the injection site and a knot. Unspecified medical attention was sought. Subsequently, the pt recovered from swelling, redness and local heat at the injection site and a knot. The pt was recovering from a fever. No product quality complaint was involved. Additional information is not expected.