chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"Patient is a 94 YO female patient with a history of mild mitral stenosis, macular degeneration, arthritis, peripheral neuropathy, and severe AS. She is a patient of a Dr. and has known severe AS for a couple of years, but without symptoms and at her advanced age, she had elected to not undergo further testing/intervention. Recent TTE demonstrates critical AS - AVA 0.5cm2, mean gradient 71mmHg, peak velocity 5.4m/s.  She was seen initially in the valve clinic on 6/15/23 and agreed to complete the CTA.  She then developed acute on chronic systolic heart failure with the HA class IV symptoms of DOE and leg swelling, leading her to a hospitalization.  A shared decision making model was used with the Heart Team and it was agreed upon that the patient would undergo urgent inpatient TAVR after CHF optimization.  She required bilateral thoracentesis with pigtail placement.  On 7/26/23, she underwent successful TAVR (Medtronic Evolut FX 26 mm) via right percutaneous approach with MAC anesthesia.  Coronary angiography performed prior to TAVR confirmed no CAD.  The patient tolerated the procedure well and was transported to a HCF then another facility in stable condition.  .  The patient's post procedure EKG was compared to the pre procedure EKG and demonstrated no significant changes at time of discharge but she did have new onset atrial fibrillation that was treated with Amiodarone and Metoprolol.  She converted to NSR prior to discharge - continue Metoprolol 12.5mg BID.  Decision against anticoagulation at this time as it was a singular episode in close proximity to her valve procedure and increased risk due to age/frailty.  She ambulated without difficulty with a walker and will continue PT/OT at a SNF.  Her bilateral groin access sites are clean, dry, and intact, without hematoma.  The patient will remain on Plavix for 1 month and then transition to ASA 81mg.  All other home medications were resumed appropriately.  Continue Lasix 20mg QD for CHF.  Follow up in 2 weeks.  Discharged to a SNF with PT/OT on 7/30/23.  Referral to cardiac rehab."
Rash up right arm and a little on the left arm, jaw line and cheek; was; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash up right arm and a little on the left arm, jaw line and cheek; was) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 031B21A) for COVID-19 vaccination.     No Medical history were provided.  Concomitant products included LINACLOTIDE (LINZESS) for an unknown indication.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Rash up right arm and a little on the left arm, jaw line and cheek; was). The patient was treated with PREDNISONE for Rash, at a dose of 1 dosage form. At the time of the report, RASH (Rash up right arm and a little on the left arm, jaw line and cheek; was) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-264211 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up information received and contains No new information
Information has been received from a physician concerning a female patient who was vaccinated with varicella virus vaccine live. It was reported the patient later developed chicken pox and required treatment with acyclovir. It was noted no other information was provided. Additional information has been requestsed.
Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single, in left arm and on 07Apr2021 as dose 2, single at the age of 44 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Statin. The following information was reported: COVID-19 (medically significant) with onset Apr2023, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Apr2023, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient took Paxlovid for treatment of COVID-19 from 17Apr2023 to 22Apr2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300175926 same patient, different event/ drug;
On 10/30 the pt experienced a cough, headache, fever. On 10/31 the pt experienced general aches to the right leg. On 11/1, the pt felt better with a decrease in back and leg aches. 11/2, the pt developed a sore throat.
12/7/2009 1940 hours-Nurse called to patient's room. Patient's roommate witnessed seizure type activity lasting 2-3 minutes. Nurse stated grand-mal activity. Nonresponsive with labored respirations BP 176/100, P143, R26, Pulse OX 99%. Patient transferred to Emergency Department for evaluation. Patient reported to have bitten tongue and was incontinent (type not specified). Symptoms: 1. Seizures 2. Tachypnea; 3 Hypertension; 4. Tachycardia.
Right arm redness and swelling since yesterday. Dx right arm swelling and erythema, cellulitis. Given KEFLEX x10 days.  Will follow up. Seen today in ER.
Patient received flu shot 10-29-07.  On 2-6-08 patient called me to complain her arm was still sore.  She has noticed loss of strength.  She said she tried both IBU and APAP.  She said she does not have PCP to follow up with, even though I referred her to her MD.
Patient developed pain in (L) shoulder after receiving flu shot-and now has persistent with movement of her (L) shoulder.
One month after vaccine, diagnosed with Pseudo Tumor Cerebri.  Major symptoms: headache, loss of vision, vomiting, neck pain, balance off.  Lumbar shunt was put from spine to abdomen to drain spinal fluid.
Hives; Rash; She has a lot of itching and is very uncomfortable; very uncomfortable; This is a spontaneous report from contactable consumer (patient). A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0153) (age at time of vaccination was 54 years) via unspecified route of administration, administered in arm left on 13Apr2021 16:30 as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included ongoing penicillin allergy (told by her Mother it started when she was a baby) and she broke out in hives with Tylenol. She found out she was allergic to it in middle school. She was accidentally given it in the hospital. Concomitant medications were not reported. Historical vaccine included the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: ER2613) (age at time of vaccination was 54 years) via unspecified route of administration, administered in arm left on 23Mar2021 11:30 as DOSE 1, SINGLE for COVID-19 immunisation. No additional vaccines administered on same date of the Pfizer suspect. Prior vaccinations (within 4 weeks) was none. It was reported that the patient received her 2nd dose last Tuesday. Yesterday morning (21Apr2021), she woke up with hives. It was reported that the patient was 54 years old when she broke out in a rash. She stated the rash was spreading. She has a lot of itching and was very uncomfortable. She has no other allergies, other than spraying airborne allergies, but she has not been tested for that. Caller has not eaten anything that she was aware of that could have caused this. It was reported that the patient was not sure if this was the vaccine causing the hives or something else. The patient had not visited her physician for this but she left a message with the doctor's nurse. She has not heard back. AEs does not require a visit to emergency room/Physician Office. AEs following prior vaccinations was none. The outcome of the events hives and rash was not recovered/not resolved and unknown for other events.   No follow-up attempts are needed. No further information was expected.
Initial report received from a health care professional on 13 August 2010. A 38-year-old female patient received the following injections on 24 July 2010: a left deltoid intramuscular injection of ADACEL (sanofi pasteur Inc. lot number U3052BA and sanofi pasteur Ltd. lot number C3311), a right deltoid injection (route not reported) of TYPHIM VI (lot number not reported) and a right deltoid injection of TWINRIX (lot number not reported). Since 24 July 2010, she complained of muscle pain and weakness in the left deltoid. She also stated that the left arm was sore 3 inches around injection site. The patient has been seen by a physician who reported the reaction started soon after the injection (same day) and pain and discomfort continued for three weeks. She did not have a history of Ttox-containing vaccination within the past 10 years so Arthus reaction could probably be ruled out. Treatment was not reported. The outcome was reported as not recovered. Further information was declined. Follow-up information was received on 15 September 2010 from a healthcare professional. The patient had no concomitant medication. No treatment has been given. Per reporter, no additional information was available. Documents held by sender: None.
My husband caught Covid in the beginning of July 2022.; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (My husband caught Covid in the beginning of July 2022.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065421A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2022, the patient experienced COVID-19 (My husband caught Covid in the beginning of July 2022.). At the time of the report, COVID-19 (My husband caught Covid in the beginning of July 2022.) outcome was unknown.            No concomitant medications were reported. Patient received the second booster dose on 3-Apr-2022. No treatment medications were reported.
syncope 10 minutes after pfizer vaccine.  pt was fine after about 15 minutes. called a medic to come and evaluate patient.  they determined she was fine and she went home with her parents
Developed tenderness / lump in armpit of shot arm  5 days post vaccination and noticed COVID arm 7  days post vaccine with increased tenderness of armpit lump.  Used cortisone cream at site and took a Tylenol PM (contains Benadryl) last night. Saw doctor today. I?ve been tired today and resting.  Will continue rest, cortisone and  plenty of water.
Pt. had a high fever of 102.7 for 12 hrs. uncontrolled with TYLENOL. Fever has since resolved. Pt's mother states that baby has been sleepy.
L deltoid region (where Tdap given) with swelling, redness, induration, and warmth x 5 days after vaccine administration.  Flu-like symptoms x 3 days following vaccine administration.
Generalized pruritus, flushing, cough, bronchospasm within 3-4 minutes after admin of 0.5cc Influenza vaccine. Epi Pen Jr, Benadryl 24mg PO, Albuterol by neb led to improvement over 1 hour.
administrated with an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 28-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number bm9zy, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th July 2022, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 29th July 2022, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was 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: 05-AUG-2022 Reporter's Comments: The pharmacist reported that a female patient was administrated with an expired dose of Fluarix on 29th July 2022.  The vaccine expired on 30th Jun 2022. No adverse event was reported. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Fluarix, which led to expired vaccine used.
fever, chills, cold sweats, headache, body aches -- Tylenol and Avil
During vaccination of Men B patient collapse started seizing, regained consciousness briefly them starting having another seizure. O2 given as he started becoming pale. Sats >99, vs stable. Was transported to ER by ambulance. VSS 162/94 P 74 @ 1158, @ 1200 hrs VSS 121/78 P 63 sats 99% patient conscious alert and oriented to person and place. Patient sats remained > 99% on P/A @ 1204 EMS arrived transferred to stretcher and transported to hospital @1215 approx. has a hx of seizures was last seen by neurologist in 2015 was not put on any meds at that time as the EEG was normal.
On 5/5/2023, I felt fine until the evening. I went downhill very fast at that point. I had flu-like symptoms that included body aches, brain fog, fatigue, and runny nose. The postnasal drip caused me to have a cough. I had a fever of 100.6. That night, I didn't sleep well, because my symptoms caused me to be uncomfortable and restless. On 5/6/2023, the symptoms continued. At about 2 PM that day, I took a home antigen test and got a positive result. I called my PCP's office and arranged to have a telehealth visit on 5/7/2023 at about 9:40 AM. I had the telehealth visit, during which I was prescribed a light dose of Paxlovid. which I began taking that day. The symptoms continued the same as before. At about 8 PM, I took my second dose of the Paxlovid. By bedtime, my head felt clear, and the brain fog was gone. I slept well that night. I remained in isolation, but I felt fine all the way up until the afternoon of 5/11/2023, which is when I tested negative.
A large red splotchy spot on my arm just below the injection site. It radiates heat and is harder than the rest of my arm. Article on ??COVID? arm? aligns with the symptoms. The symptoms occurred the day after the second dose. Similar symptoms occurred about a week after the first dose and went away after about a week.  (Dose 1 was 3/31/21, Lot 082A21A).
first dose of our vaccine in DEC2020 and then second dose MAY2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of our vaccine in DEC2020 and then second dose MAY2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of our vaccine in DEC2020 and then second dose MAY2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose of our vaccine in DEC2020 and then second dose MAY2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.   Reporter did not allow further contact
Report a side effect; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (Report a side effect) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (Report a side effect). At the time of the report, ADVERSE DRUG REACTION (Report a side effect) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications and treatment information were reported.
Headache, Arthralgia, NauseaVomiting, FATIGUE, HA, PAIN/SWELLING INJ SITE, Narrative:
Information has been received from a physician concerning a 30 year old female with a history of frequent infections who was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 646712/1179N). The physician reported that, two days after being vaccinated, the pt was seen because her injection site was swollen, red and tender. At the time of this report, the outcome was unknown. The physician also reported that 2 other pt's developed adverse events after being vaccinated with pneumococcal 23v polysaccharide vaccine (WAES # 0405USA00961 & 0405USA01171).  Additional information has been requested.
Paralyzed feet, started about a week after receiving vaccines, stated from Dr that it was Guillian Barre syndrome. Received transfusion while in the hospital and in the ICU for 2 weeks. In a long term care facility now
Mom stated child's left arm was red and swollen with some itching. She gave the child Tylenol and put ice pack on arm, also applied Benadryl. Mom stated child was afebrile, which she was told to bring the child in if she felt that her arm needed to be looked at. Mom called back on 01/08/2002 and said that the child is doing much better.
pt recv vax & devel an inj site rxn characterized by redness, pain, & swelling;also exp numbness from the inj site to fingers;
Mild fatigue; felt different; This is a spontaneous report received from a contactable reporter(s) (Other HCP), Program ID:  A female patient received BNT162b2 (COMIRNATY), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Batch/Lot number: Unknown), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "Mild fatigue"; FEELING ABNORMAL (non-serious), outcome "recovered", described as "felt different". Additional information: Patient had a mild reaction (mild fatigue, felt "different") to the second dose of Comirnaty vaccine. It resolved quickly. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is a spontaneous report from a contactable Pfizer Sales Representative who reported on behalf of a physician. A 3-year-old male patient received the first dose of PREVNAR 13 on 25Apr2011. Past product vaccine history includes the first dose of PREVENAR 7 on 10Jun2008, the second dose on 14Aug2008, the third dose on 10Oct2008, and fourth dose on 22Oct2009. Relevant medical history included therapy regimen changed. Concomitant medications were unknown. On 25Apr2011, the patient experienced mild pain and soreness at the site of injection. It was elaborated that the patient refused to walk for 2 hrs. No laboratory tests were provided. Therapeutic measures taken for the reported events included ice application at the site of injection and acetaminophen as needed for pain. The patient recovered after two days. The physician believes it is unknown if there is a reasonable possibility that the event is related to suspect product. Follow-up attempts completed. No further information expected. Follow-up (08Jun2011): New information reported from a contactable physician includes past vaccine history, treatment, outcome causality assessment.
Patient passed out after receiving vaccines. His eyes rolled to the back of his head several times before regaining consciousness. His face appeared very pale. After several minutes he sat up in a chair for 5 minutes and was given water and a Kitkat. He then left with his mother.
Two days post vaccination, pt developed  7 X4 1/2 cm red, raised, warm lesion.
This case was reported by a consumer via call center representative and described the occurrence of incorrect storage of drug in a unk patient who received ENGERIX B. Co-suspect products included HAVRIX and TWINRIX. On an unknown date, the patient received ENGERIX B at an unknown dose, HAVRIX at an unknown dose and TWINRIX at an unknown dose. On an unknown date, an unknown time after receiving ENGERIX B, HAVRIX and TWINRIX, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. Reporter is a representative from distributor. He reported that some of the HAVRIX, ENGERIX and TWINRIX product have been recalled because they were not kept at the right temperature range by the time the customer received the order. However, some of his customers have already given some of these vaccines to their patients. Reporter did not clarify whether some or all three brands of vaccines were given to different patients. Reporter did not mention any symptoms.
This spontaneous report was received from a healthcare professional (medical assistant) refers to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported. On 22-JUN-2017, the patient was vaccinated with GARDASIL 9 dose 1 (strength, lot#, expiry date, dose, frequency, route of administration, anatomical location were unknown) for prophylaxis and On 19-NOV-2018, the patient was vaccinated with GARDASIL 9 dose 2 (strength, lot#, expiry date, dose, frequency, route of administration, anatomical location were unknown) for prophylaxis (inappropriate schedule of product administration). No adverse effects were reported. The outcome of inappropriate schedule of product administration was unknown. No product quality complaint (PQC) reported for this case.
pain in her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 13Oct2021 as dose 1, single (Lot number: 30135BA) at the age of 68 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in her arm".  Additional information: The patient got her original vaccines back in 2021. With the original series, she had pain in her arm. No investigations were done.