chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Filing of a complaint with FDA concerning the use of Trulicity and the Pfizer vaccine. My age is 88. At the beginning of January 2022, my endocrinologist suggested trying a product called Trulicity. It replaced two pills - Glimepiride and Tradjenta. I used the Trulicity until April 18, 2022 when I voluntarily went back on the pills. My health began to decline from January 2022 until May 2022. Most notable decline was my weight - went from 186 pounds in December to 145 pounds mid May 2022. All of this affected my overall functional ability, decreased endurance during physical skills, poor sleep due to discomfort, fatigue during he day, and just an overall depression. Also notable was increased joint pain - shoulders, wrists, fingers, hips, knees, ankles. Orthopedists tried injecting cortisone even tho there was no evidence of arthritis - left hip, left knee, and right knee. Did provide some temporary relief. Right after the right knee injection I developed an edema and cellulitis below right knee down to the right ankle. My infectious disease doctor immediately put me in hospital. Was there from May 6, 2022, some 12 days before being transferred to a rehab facility for another 18 days and there did receive some PT and OT. After getting out of there a rehab company came to the house for several weeks, I am still battling joint pains, fingers that don't work anymore loss of about 80% of my power in my right hand and about 50% of my power in my left hand. Motor skills are totally limited. Prior to all this, I was fully functional. I was and am my wife's caregiver, (she is 86 and is afflicted with fibromyalgia for the past 5 years and arthritis). I have managed the household needs and was involved in numerous community activities. Was able to drive all around the neighborhood. Need help now just to go shopping for food and supplies. Now what? Did anyone think to test the combination of these products? Were the Pfizer products really that proven? I am at my wits end as to how this can be resolved. I now use a 4 wheel rollator in the house and also have a spare one in the car. Also need a cane to help navigate because of unsure navigation. Someone, please help. This change in medication has ruined a once viable person. I do not know what test date you might want but can provide what I have. The hospital and rehab facility probably can provide additional. What is truly discouraging is the fact that none of my doctors have tried to find the cause, just treating the symptoms.
pt c/o pain in lt arm one day p/receiving DTP inject; area devel redness & swelling as well w/o fever; 2 days p/inject area less painful, improved ROM, pink, swollen area 4-5cm diameter;
My taste changed.  Now when I eat anything that has chocolate, peanut butter, bread, anything breaded or fried, I get an awful taste in my mouth.  I describe it like you are eating a wet, burnt house. I had Covid 19 the last week of December 2020 and lost my taste and smell.  I could taste sweet, sour, bitter, and salty foods, but I could not taste any flavors.   After the vaccination, my taste changed.  I had heard on the news that the vaccine, for some people, had reversed some of the long term symptoms, so I thought that maybe my taste and smell were returning and this was just temporary.  I was wrong.  I still am experiencing the awful tastes described above.
Arm soreness; fatigue; Rapid Heart Beat; Hot Flush over body; dizziness; This is a spontaneous report from a contactable other health professional. This consumer (patient) reported that a 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 39-years, via an unspecified route of administration in left arm on 15May2021 at 11:15 at single dose for COVID-19 immunization, in hospital. Medical history included penicillin allergy, epidural caused severe hypotension/allergic reaction, demoral adverse reaction (as reported). Patient was not pregnant at time of vaccination. Concomitant medications included ibuprofen, cetirizine hydrochloride (ZYRTEC) and multi vitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15May2021 12:00, rapid heart beat, hot flush over body, dizziness. Started 40 minutes after vaccination. EMS called since she was driving at the time. Arrived 10 minutes later. Oxygen stable entire time. Blood pressure normalized and heart rate lowered to normal by the time they left 20 minutes later and diphenhydramine hydrochloride (BENADRYL) administered. Arm soreness and fatigue next day on 16May2021. BENADRYL taken again 6 hours later. Back to normal 2 full days later. The events result in emergency room/department or urgent care. Outcome of the events was recovered/resolved. Since the vaccination, the patient has not been tested for COVID-19.   Information on lot/batch number has been requested.; Sender's Comments: There is a reasonable possibility that the events arm soreness and fatigue were related to BNT162b2 based on known drug safety profile Based on the close temporal relationship, the association between the events rapid heart beat, hot flush over body, and dizziness can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
On April 20, 2021, two days after I received my second dose of Pfizer, I felt that my lymph nodes in my left armpit were swollen. I received the dose in my left arm. This symptom was observed in the morning and other than that, I had no other symptoms. Later, around seven in the evening, I noticed that my throat felt very sore and my chest began to hurt. My temperature was in the mid- 99's and I felt tired. The following day, my symptoms increased and my head began to ache, my lower back ached, my chest felt heavy, and my sinuses felt full and pressurized. My temp went above 100 and I then scheduled for a rapid covid screen. I tested positive and my symptoms lasted through Friday, April 30, 2021. My chest held a lot of congestion and this took several days to break up.
24 hours post vaccine develoved T 100.1, headache, light sensitivity, reports headache worsened, blurred vision - went to Emergency Services at Hospital, admitted.  Reports diagnosis of CVA.  Reports headache has improved, continues with blurred vision
Mother states pt had a temperature of 105.  Vaccine administered the previous day.  Pt taken to ER that evening.  Mother states pt had similar reaction to hep b vaccine.
Fever following vaccine administration sweats, chills, aches. Pain at site and constipation.
Received DTaP at 2:30 pm. Per call to On call doctor at 10:30 pm - vomited several times since 12 with possible mild temp. Asked to eat but not keeping anything down. 1/22/09 10 AM no more vomiting but diarrhea x 3; no fever, seems happy. 1/23 seen in ER- Ketonic breath per mom
After 30 minutes of receiving the flu vaccine, she became dizzy, lightheaded, had trouble swallowing and breathing. Her face and neck started turning red. She was seen in the ED within 1 hour of receiving the flu vaccine. She received BENADRYL IV and then sent home.
Patient had a vasovagal reaction due to receiving both the YF and Typhoid vaccines. Patient had described having similar issues previously when she received vaccinations and gave blood. Patient displayed syncope, sweating, cool clammy skin. Orthostatic Vital signs following the reaction were in normal parameters.
half dollar size, erythematous, tender lump on the injection site; sand papery type of skin rash on the neck; Half dollar size, erythematous, tender lump on the injection site; Half dollar size, erythematous, tender lump on the injection site; Erythematous swelling at the injection site; A spontaneous report was received from a nurse concerning a 44-year- old, female patient who who received Moderna's COVID-19 vaccine and experienced erythematous swelling at the injection site (R. deltoid) and later, a half dollar size, erythematous tender lump on the injection site. This was associated with sand papery type of skin rash on the neck.  The patient's medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 (LOT # 039K20A) on 23-Dec-2020 intramuscularly in the right deltoid for prophylaxis of COVID-19 infection.   A healthcare provider (HCP) reported that the patient received the Moderna vaccine at their facility on 23-Dec-2020.  Following vaccine administration, the patient initially developed erythematous swelling at the injection site which she did not treat and per HCP report, resolved without treatment the same day.  However, on 30-Dec-2020, the patient was seen by the HCP and had developed a half dollar-sized, erythematous, tender lump at the injection site.  Additionally, the patient had developed a sand-papery type of skin rash on her neck.  The patient was prescribed prednisone for 10 days.    Treatment for the event included Prednisone for 10 days.    Action taken with mRNA-1273 in response to the events, erythematous swelling at the injection site (R. deltoid) and a half dollar size, erythematous tender lump on the injection site associated with a sand papery type of skin rash on the neck was not provided.   The events, erythematous swelling at the injection site (R. deltoid), were considered resolved. The events, a half dollar size, erythematous tender lump on the injection site associated with a sand papery type of skin rash on the neck was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
administered high on several patient's arm almost interarticular; shoulder soreness; This case was reported by a pharmacist via call center representative and described the occurrence of shoulder soreness in an unspecified number of patients who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   On 28th September 2020, the patient received FluLaval Tetra 2020-2021 season (intraarticular). In September 2020, less than a week after receiving FluLaval Tetra 2020-2021 season, the patient experienced shoulder soreness. On 28th September 2020, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the shoulder soreness and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the shoulder soreness to be related to FluLaval Tetra 2020-2021 season.  Additional details were reported as follows: The age at vaccination was not reported. The FluLaval was inadvertently administered high on several patient's arm almost intraarticularly instead of intramuscularly and as a result caused sore shoulders. The reporter consented to follow up.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient received vaccine 04//30/2019 and called in 05/07/2019 stating that  05/06/2019 she had noticed a sore bump at injection site the size of a quarter.
Low fever; Swollen lymph nodes under left arm and left clavicle; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 10May2021 at 12:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. It was unknown whether the patient had any known allergies to medications, food or other products. Concomitant medications included hydroxyzine (MANUFACTURER UNKNOWN), unspecified medication for birth control (MANUFACTURER UNKNOWN), vitamins (MANUFACTURER UNKNOWN) and probiotics (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 19Apr2021 at 12:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11May2021 at 20:00, the patient experienced low fever and swollen lymph nodes under left arm and left clavicle. 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 events. The clinical outcome of the events low fever and swollen lymph nodes under left arm and left clavicle were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Two brief seizures about 12 hours after vaccine administration.  EEG: NL, neuro consultation pending.
Patient collapsed a few minutes after vaccine. He hit his head and had a clonic jerk as he collapsed. Pharmacy staff put his legs up and gave him water, he continued to be a little disoriented and when he tried to get up , started to look like he would pass out again so we kept him down.  Staff called 911, BP was low when taken at 9:50am.  He started to regain color but again looked pale when he attempted to raise himself.  EMS took over when they arrived and they decided he needed to be transported to ER.
The patient developed hives over her entire body starting from her feet and spreading upwards around 5:30 pm, 11/03/2001.
pretty severe hives/acute urticaria; skin rash over his body seem to follow the lymphatic system (groin, creases, neck); This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (pretty severe hives/acute urticaria) and RASH (skin rash over his body seem to follow the lymphatic system (groin, creases, neck)) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034F21A, 039B21A and 011A21A) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    The patient's past medical history included Surgery. Concurrent medical conditions included Drug allergy (Had given Morphine during a surgery in the past and patient had vomiting, nausea and he felt like he was catching his breath).   On 18-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 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, the patient received dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced URTICARIA (pretty severe hives/acute urticaria) and RASH (skin rash over his body seem to follow the lymphatic system (groin, creases, neck)). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Hives and Rash, at an unspecified dose and frequency; FAMOTIDINE (PEPCID AC) for Hives and Rash, at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]) for Hives and Rash, at an unspecified dose and frequency. At the time of the report, URTICARIA (pretty severe hives/acute urticaria) and RASH (skin rash over his body seem to follow the lymphatic system (groin, creases, neck)) had not resolved.            Patient noticed that the symptoms were aggravated by touch and friction.The patient stated that he is going to see an allergist immunologist on 14 December 2021. No concomitant medications were reported.  Other treatment medications included steroids.
This is a spontaneous report from a contactable nurse via Pfizer sales representative. This nurse reported for an 18-years-old male patient receive the second dose of TRUMENBA, via an unspecified route of administration on an unspecified date at 0.5ml single for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient complained of headache, fatigue, chills, weakness, vomiting and went to ER. He was sent home from ER to follow up with office. It was reported that he was fine. No follow-up attempts are possible. No further information is expected.
Sciatica, muscle pain, back pain. Difficulty walking, sleeping, due to pain. 2 weeks duration (so far).
Weekness; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration in the right arm on 02Mar2021 12:00 AM (at the age of 82-years-old) as second dose, single dose for COVID-19 immunisation at a hospital. Patient's medical history was not reported. Concomitant medications included antihistamines taken for an unspecified indication, start and stop dates were not reported. The patient was not pregnant at the time of vaccination. No other vaccine was received by the patient in four weeks. The patient had no COVID prior vaccination. On 02Mar2021 12:00 AM, the patient experienced weekness. No treatment was taken for the events. The patient underwent lab test and procedure which included SARS-CoV-2 test (nasal swab, PCR test): negative on 03Mar2021. The outcome of the events was not recovered.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Patient called pharmacy stated that she felt dizzy and both arms pain and leg pain when she wake up at 6 am 4/19/19. She has to go to doctor for cancer treatment appointment and doctor looked injection site. No rash. No redness.
Burning red at injection site immediately after. Sore arm the rest of the day. Started headache and fatigue 6 hours later. 24 hours later more extreme fatigue, headache, and full body aches.
Initial complaints were weeping left eye, shot administered in left arm.  Over the course of the coming days I began to experience night sweats, malaise and fatigue.  1 week after the shot was administered I developed a couple small bumps on my left cheek, and was diagnosed with shingles 11/27/09
Headaches came, then chills. I felt like I had the flu. I didn't go to the doctor at that time. A few weeks later I went to an urgent care and they told me pleurisy. They told me to rest. I had prednisone on hand and started to use that. I still hear myself wheezing when I'm resting and sleeping. A high pitched wheezing noise is what I hear when I exhale.
Anterior cervical lymphadenopathy on the ipsilateral side of the vaccination. It seemed to begin on the third day but was most pronounced and painful on the fourth day.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 11-FEB-2013, the patient was vaccinated with VARIVAX (merck) injection (Lot #, dose and route were not reported) instead of ZOSTAVAX, due to a human error. No adverse effect was reported. At the time of the report, patient's outcome was unknown. Additional information has been requested.
The nurse forgot the draw the pfizer solution into the syringe, and injected the empty needle to her arm.  The patient bled alot and her face got pale.  Her face color came back to normal after 5 min. and she still wanted to get the actual vaccine, so she did get her 4th booster shot for pfizer bivalent.
Received vaccine on 9/28/2006.  On 10/2/2006 Patient reported through a third party that he developed a 'rash' two days later. Asked him (through third party) to go to his doctor.  Doctor stated he had 'hives'.
Vaccine given outside recommended dosing interval, second dose was administered 15 days following the first dose which was given on 5/20/2021
person reported being 5 months pregnant. no previous known allergies to foods or medications. received her 1st covid vaccine; in obs area and within 15 min she reported feeling flushed and having trouble breathing.  No hives or airway swelling;  diaphoretic, bp 80/40, dizzy, nauseous complaining of throat closing.  Transported to ED by 911. Reportedly released from ED.
Experienced a head to toe rash and hives. Joint pain in fingers, wrists, and jaw with slight swelling in the fingers.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "prone to migraines/ "ocular" migraine" (unspecified if ongoing), notes: prone to migraines/ "ocular" migraine, this is not an "ocular" migraine as she usually. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jul2022, outcome "unknown", COVID-19 (medically significant) with onset Jul2022, outcome "recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Caller wants to know if she can take Aspirin if she finished her last day of treatment with Paxlovid today. She stated that Paxlovid is a fantastic medication that has eliminated all the COVID symptoms and her husband has started taking it because he also got infected with COVID. Caller started experiencing a migraine starting in the past 15 minutes, she took her last dose of Paxlovid today in at 9 am. She has also received Pfizer COVID-19 vaccines. Caller mentioned that she is prone to migraines and does not want the "reputation of the product to be damaged". She stated that this is not an "ocular" migraine as she usually sees flashes of light that give her time to prevent the migraines, once they have started they can last 4 days. Her current migraine feels like a pressure across the forehead and it feels intense. Caller declined to make a safety report as she was experiencing her migraine.  Caller stated that Paxlovid is a "miracle" that has taken out all of her COVID symptoms, she is very grateful that the product exists and that she was able to get it. She also took the COVID vaccines manufactured by Pfizer which she described as a "wonderful" company.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a  physician concerning a female who was vaccinated with a first dose of HPV vaccine (yeast). Subsequently the patient complained of pain and then fainted within minutes of administration. Subsequently, the patient recovered without any additional treatment.  Additional information has been requested.