chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fell off the couch; no mental acuity/. I feel like I can't think right/don't have the clarity of mind; dizziness; headaches; weakness; I get really really sick; can hardly move; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (weakness), ILLNESS (I get really really sick), MOBILITY DECREASED (can hardly move), FALL (fell off the couch) and MEMORY IMPAIRMENT (no mental acuity/. I feel like I can't think right/don't have the clarity of mind) in a 72-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Pfizer (EN6026) on 08-Mar-2021, Pfizer (ER8727) on 29-Mar-2021, Pfizer (FE3592) on 04-Oct-2021, pfizer (FK9729) on 24-May-2022 and Pfizer bivalent (GJ9697) on 13-Oct-2022. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer, Pfizer, Pfizer bivalent and pfizer.    On 18-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On 18-Oct-2023, the patient experienced ASTHENIA (weakness), ILLNESS (I get really really sick), MOBILITY DECREASED (can hardly move), MEMORY IMPAIRMENT (no mental acuity/. I feel like I can't think right/don't have the clarity of mind), DIZZINESS (dizziness) and HEADACHE (headaches). On 19-Oct-2023, the patient experienced FALL (fell off the couch). The patient was treated with CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) at an unspecified dose and frequency. In October 2023, HEADACHE (headaches) had resolved. At the time of the report, ASTHENIA (weakness) and MEMORY IMPAIRMENT (no mental acuity/. I feel like I can't think right/don't have the clarity of mind) had not resolved and ILLNESS (I get really really sick), MOBILITY DECREASED (can hardly move), FALL (fell off the couch) and DIZZINESS (dizziness) was resolving.            No concomitant medication was reported. It was reported that every time patient gets one she get really really sick, she gets severe headaches, she can hardly move; dizziness and weakness, don't know day and time, and can't register date and time, can't remember what she did, she can't think. On 19-Oct-2023 fell off the couch, she had to have her husband assist me to get up; she had to use the bathroom and just laid there. All her symptoms started the evening that she gets her shot. Patient lose all track time, she had no mental acuity, and had weakness. She never getting the vaccine again. Patient reports that symptoms have diminished a bit, but she doesn't have the clarity of mind that that she normally has. They last 2 days of being out of it, headaches that last 2 days. She felt like she can't think right. At the time of reporting, patient had weakness and trouble thinking and will be staying in bed. While collecting case number, patient stated, she doesn't remember what a hyphen looks like.
PUI's symptoms started with a cold-like symptoms - congestion, cough, headache.The doctors at the urgent care where they tested sent PUI to Hospital for chest x-ray due to cough and smoking hx. Wife states PUI stayed 1 night in the hospital due to dehydration and low Blood pressure and was discharged the next day.
By administering the third dose of the Moderna vaccine, everything was stable until 11 p.m. My heart started to beat harder, my heart started racing, I also started feeling chest pain in part the front of my chest and the back of the chest. Also I have difficulty breathing I have to breathe up to a certain limit because if it does not give me chest pain and headache
3rd dose given 4 weeks after 2nd; 1st dose 28Sept2022, 2nd dose 30Dec2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 5-month-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Pediarix (received 0.5 ml of 1st dose in an unknown thigh intramuscularly on 28th September 2022).   On 27th January 2023, the patient received the 3rd dose of Pediarix (intramuscular) .5 ml and Pediarix Pre-Filled Syringe Device. On 30th December 2022, the patient received the 2nd dose of Pediarix (intramuscular) .5 ml and Pediarix Pre-Filled Syringe Device. On 30th December 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On 27th January 2023, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too long and drug dose administration interval too short were unknown.     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-Jan-2023 Reporter's comment: The patient's mother stated that it was given at 4 weeks from the 2nd dose versus the 6 to 8 weeks as recommended in the prescribing information.   The reporter did not had any lot numbers for the vaccine. No follow-up with health care professional. The reporter did not consent to follow-up. Additional supportive information: The patient received 2nd dose of Pediarix later than the recommended interval and 3rd dose of Pediarix earlier than the recommended interval, which led to lengthening of vaccine schedule and shortening of vaccine schedule. The 2nd dose was captured as suspect along with event drug dose administration interval too long based upon the vaccination dates.
Narrative:  Patient received full Pfizer COVID-19 vaccine series with 1st dose on 1/21/21 (lot: EL3302) and 2nd dose of 2/11/21 (lot: EN6201). On 4/29/21 patient sent to ED with shortness of breath, chest pain, weakness and headache. CT scan showed groundglass pattern consistent with COVID pneumonia. COVID test resulted as positive on 4/29/21. Patient admitted to general medicine ward. Patient oxygen saturation decreased requiring initiation of supplemental O2. Patient placed on dexamethasone 6mg oral daily x 10 days and remdesivir 200mg IV x 1 followed by 100mg daily for 5 days total duration. Local health department contacted to coordinate specimen collection and send off for further testing.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program. A female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on May 4, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for immunisation. The patient developed a vaccination site mass (a red bump over injection site), and pain in extremity (sore arm), with outcome of unknown. Additional information: The patient wondered if she should be concerned. She got her second dose of the COVID-19 shot on May 4, 2021, and it was still sore. There was a red bump over her injection site.  No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Mother brought child back to clinic to evaluate due to recent swelling to both hands and feet which began 2-3 days after vaccinations on 10/19/2005.
Cysts in pancreas and liver; Cysts in pancreas and liver; From 27Sep2021, I had various episodes of diarrea.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Apr2021 14:00 (Lot number: EP6955) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asma" (unspecified if ongoing), notes: Other medical history : Asma. Concomitant medication(s) included: MONTELUKAST; CETRIZINE. Vaccination history included: Bnt162b2 (Dose Number: 1, SINGLE, Batch/Lot No: EP7534, Location of injection: Arm Left, Administration Time: 02:00 PM), administration date: 21Mar2021, when the patient was 40 years old, for Covid-19 immunization. The following information was reported: HEPATIC CYST (non-serious) with onset 27Sep2021 12:00, outcome "not recovered", DIARRHOEA (non-serious) with onset 27Sep2021 12:00, outcome "not recovered" and all described as "From 27Sep2021, I had various episodes of diarrea."; PANCREATIC CYST (non-serious) with onset 05Oct2021 12:00, outcome "not recovered", described as "Cysts in pancreas and liver". The events "cysts in pancreas and liver", "from 27sep2021, i had various episodes of diarrea." and "cysts in pancreas and liver" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.   Additional information: The patient has not received any other vaccine in four weeks. The patient had not had covid prior to the vaccination. The patient tested covid post vaccine.    No follow-up attempts are possible. No further information is expected.
This case was reported by a consumer and described the occurrence of aphthous stomatitis in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 7 days after receiving SHINGRIX, the patient experienced aphthous stomatitis. On an unknown date, the outcome of the aphthous stomatitis was recovering/resolving. It was unknown if the reporter considered the aphthous stomatitis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had no history of canker sores. In 2018, about 7 weeks before the reporting date, the patient received first SHINGRIX shot. About 6 weeks before the reporting date, the patient experienced numerous canker sores. The patient and his dentist could not determine any other possible causes for the sores. The sores were still present but healing slowly. The patient wanted to report this possible side effect, and find out if there had been any other similar reports before he schedule his second shot.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Medium, Systemic: Nausea-Medium, Systemic: Weakness-Severe, Additional Details: HER COMPANION NOTICED SHE "STIFFENED UP" PRIOR TO FAINTING. PARAMEDICS WERE CALLED AND FOUND HER BLOOD GLUCOSE LEVEL CLOSE TO HYPOGLYCEMIC AND HYPERTENSIVE ABOUT 15 MINUTES AFTER EPISODE. PATIENT REQUIRED A LITTLE OVER AN HOUR TO RECOVER TO THE POINT SHE FELT WELL ENOUGH TO STAND UP, BUT WAS STILL WEAK. PATIENT DECLINED TO BE TAKEN TO HOSPITAL FOR OBSERVATION AND TOOK A RIDE SHARE HOME WITH HER COMPANION. PATIENT IS REQUESTING DOCUMENTATION OF INCIDENT BE AVAILABLE TO HER FOR HER RECORDS.
Large 3-5" Red welts (patches), long red lines/streaks down sides and arms,  and prickly rash all over body, scalp, head, flushed face and chest, all down body torso front and back, crotch, and down legs into toes.  Severe intense itch and pain all over.   Waves of pain and nausea.  Reduced somewhat at night but bad in afternoons.  Pictures are available via email to doctor -  Started immediate treatment by applying Calamine to mitigate itch.  Went to  Urgent Care Dr  who prescribed Benadryl pills.
3" x 4" area of redness/swelling/pain. Temp 99.7F
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 25-SEP-2013 the patient was vaccinated with M-M-R II (reported lot # H018950 corresponding with lot # 1483AA; expiration date 18-OCT-2014). The vaccine was exposed to temperature exposures of 50F for 85 minutes, 47F for 15 minutes, 48F for 35 minutes, 52 F for 95 minutes, 48F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372; 1310USA008373, 1310USA008374; 1310USA008375; 1310USA008376; 1310USA008377; 1310USA008378; 1310USA008379; 1310USA008380; 1310USA008381; 1310USA008382; 1310USA008384; 1310USA008385; 1310USA008386; 1310USA008387; 1310USA008388; 1310USA008389; 1310USA008390; 1310USA008391; 1310USA008392; 1310USA008393; 1310USA008394; 1310USA008395; 1310USA008396; 1310USA008397; 1310USA008398; 1310USA008399; 1310USA008400; 1310USA008401; 1310USA008402; 1310USA008403; 1310USA008404; 1310USA008405; 1310USA008406 and 1310USA008407 (same reporter linked). Additional information has been requested.
Covid monitoring documentation. PT admitted 12/16/21 documented to have positive covid. PT received 1st dose Pfizer 2/17/21 Lot EN6200, and 2nd dose Pfizer 3/10/21 Lot EN6204
p/vax pt seen in office for cough, sore throat, fever;dx URI symptomatic tx;7/6/99 seen for fever off & on x 2wk;no other s/s now 104 ax temp w/APAP, exam fever of unk origin;
Hives, swelling, screaming, fever, behavior change, rashes. Each time it would take longer for my son to return to normal and then finally he never did. He is now autistic. Medical records (1) states diarrhea as symptom. Information from 60 day follow-up report states: Severe learning disability, autism, food allergy (severe) colitis constant digestive and gastroeintestional problems, sleep disorder, speech delay. I am convinced my son was permanently damaged by these vaccines- we are trying to provide the best possible life for him but its becoming more difficult- even standard medical claims are being denied putting extensive financial and emotional burden on us.
Within 24 hours, the pt developed a generalized urticarial reaction described as Giant urticaria. The pt was seen by the physician on 8/15/00; the child was "not sick or not toxic". He was treated with oral diphenhydramine.
patient received a pfizer new booster today 10/13/22 at store and developed adverse reaction right after her vaccine while waiting in waiting area. she stated she felt a pressure in her throat and felt like someone is chocking her. pharmacist administer Benadryl 25mg one dose and watched her closely till she felt better. After a few minutes patient stated that the pressure started to go away. Patient felt better and went for shopping afterwards. pharmacist called her after 30 minutes to follow-up and patient made it home safe and the symptom had complete went away. Pharmacist called her PCP and reported the Adverse reaction.
Prickly sensation in the middle of the upper arm in a certain area; they had erythema, skin is like stained red; increase on the temperature of their arm which lasted about 3 days and started on day 8; it was swollen; Increasing pain; pain in the  arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (Prickly sensation in the middle of the upper arm in a certain area), ERYTHEMA (they had erythema, skin is like stained red), FEELING HOT (increase on the temperature of their arm which lasted about 3 days and started on day 8), SKIN SWELLING (it was swollen) and PAIN (Increasing pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 028L20AA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy, Drug allergy and Drug allergy. Concomitant products included LEVOTHYROXINE, VITAMIN D [VITAMIN D NOS] and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced PARAESTHESIA (Prickly sensation in the middle of the upper arm in a certain area), ERYTHEMA (they had erythema, skin is like stained red), FEELING HOT (increase on the temperature of their arm which lasted about 3 days and started on day 8), SKIN SWELLING (it was swollen), PAIN (Increasing pain) and PAIN IN EXTREMITY (pain in the  arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and DEXLANSOPRAZOLE (DEXILANT) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Prickly sensation in the middle of the upper arm in a certain area), ERYTHEMA (they had erythema, skin is like stained red) and FEELING HOT (increase on the temperature of their arm which lasted about 3 days and started on day 8) was resolving and SKIN SWELLING (it was swollen), PAIN (Increasing pain) and PAIN IN EXTREMITY (pain in the  arm) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Tenderness, swelling, with hardened lump in middle area at injection site. Day after injection, these symptoms became more severe with addition of fever (max 101 F), chills, body aches, headache, mild nausea, fatigue.
MMR given LA, SQ, immediate reaction at injection site, redness, swelling, itching observed patient for 20 minutes, patient start c/o itchiness on neck and upper body but denies SOB. SRO2 100% room air. Patient was given Benadryl 0.75 ml IM per doctor patient had local reaction. No O2 ordered.
62 y.o. female h/o RA, afib (recent ablation, on flecainide, bb, xarelto) who presented with sob. Was fully vaccinated for covid in April. Symptoms for 8 days pta with fatigue, headaches, fevers, n/v/d. Went to ED was started on prednisone and dc'ed, but continued to feel worse over 3-4 days with worse sob and spo2 63% on ambulation at home which prompted her to come in. She normally wears o2 at home, 2L at night but has wearing it throughout the day.  She received remdesivir and dexamethasone 10 mg IV.  She was discharged to home after receiving 5 days of remdesivir.  She returned to the hospital six days after discharge as she had worsening shortness of breath, dyspnea on exertion that started after her last day of dexamethasone.  She was admitted to the hospital for 2 additional days, then discharged back to home on dexamethasone to complete a total of 14 days of therapy.
Pt was 2 yrs old and adult vaccine given Tdap.  Pt has not had any issues with it. Parents were notified and are aware of situation. Poison control was contacted on same day for advise.
Perfectly fine until about 25 minutes after the injection.  Then, nausea and dizziness started, followed by burning and itching on both sides of tongue.  Then the back of the throat started hurting, and it became hard to swallow, followed by becoming very cold, chills, and dry mouth.  Finally the skin area around mouth and lips and up through the cheek/jawline became very itchy.       It was not anaphylaxis because my breathing was okay.  We drove home, and I took two Benedryl (50 mg) upon arriving home.  Within 2 hours all symptoms subsided with the exception of a nasty headache.  Today, I am fine, but just have a sore arm at the site.
This spontaneous report as received from a physician refers to her 15 months old female baby. The physician stated that her baby had been administered an additional dose of M-M-R II (Lot#, dose/frequency, route unspecified) and PROQUAD (Merck) (Lot#, dose/frequency, route unspecified) accidentally on 11-DEC-2012. Other suspect therapies included PROQUAD (Merck) on 11-DEC-2012. The patient did not seek medical attention. No treatment was given for the event. The outcome was unknown. Additional information has been requested.
Sx's started on 9/27/10. Examination revealed multiple small ulcers on left soft palate, no lesions on right side - Dx's Herpes Zoster CN x 11. Rx-Lidocaine 2% mucosal solution (swish and spit) Valacyclovir 1 gr - 1 tab tid x 7 days.
Fri Oct 01, 2021 2159 SARS CoV-2, PCR, Rapid, V(!): Detected 2202  Revision decompression L2-4.  4. Partial laminectomy L2, L4; laminectomy L3.  5. Bilateral foraminotomies L2, 3, 4.  6. Repair of incidental durotomy with 6-0 Gore-Tex muscle patch and DuraSeal.
Weeks after and continuing up to the end of July   after  receiving 1st phizer vaccine I would feel very weak and sick and with a lump on my neck right thyroid. I went to ER and found out I have Hyperthyroidism which I never had before or never had a problem with my thyroid even when I was pregnant. I know my hyperthyroidism came from my vaccine because i got it after been vaccinated when I was a very healthy person before getting vaccinated. I?m now taking medication for my hyperthyroidism
Developed a blood clot in her leg after receiving the first dose of vaccine on 23Jan2021; High blood pressure/ Blood pressure up; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 86-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 23Jan2021 11:00 (age at vaccination was 86 years) (Batch/Lot Number: EL9261) as dose 1, single for covid-19 immunization. Medical history included ongoing Difficulty sleeping since 10 to 20 years, osteoarthritis and osteoporosis probably since 20 years or more, hip arthroplasty or replacement when she was 64 years old, Hip revision when she was 83 or 84 years old, she wore out the ball in her hip. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included trazodone (TRAZODONE) taken for insomnia. The patient experienced developed a blood clot in her leg after receiving the first dose of vaccine on 23Jan2021 on an unspecified date in 2021 and taking Eliquis, she took it for 90 days. She said she was doing better, she now had high blood pressure. They first noticed the high blood pressure when she had her ultrasound for her blood clot. It was in the 170s, but now she was on blood pressure medication taking Losartan 100mg, Metoprolol 25mg. Her blood pressure reading this morning (25Jun2021) was 152/83. Her blood pressure reading in 08Sep2020 was 126/84. The events led to the emergency room. She had been seeing her doctor as well. The patient underwent lab tests and procedures which included blood pressure measurement: 126/84 on 08Sep2020, blood pressure measurement: 170s on unspecified date in 2021, blood pressure measurement: 152/83 on 25Jun2021, ultrasound doppler: blood clot in vein on an unspecified date in 2021. The patient received treatment for the events. The event blood clot in her leg was always serious and medically significant. The outcome of the event blood clot in her leg was unknown and other events was recovering.
Pt vacc. w/Engerix-B developed Petit mal seizure 5 min after inject. Treated w/smelling salts. Fine after an hour.