chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 2011, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about October 2015, the patient was treated by a physician for herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Pressure in head; pain in head; vertigo; blurry vision; dizzy. Pain did not go away with medication.
Around March, 2021, I began developing very dry lips with furrows.  This has become a chronic condition.  I have been to see 4 dermatologists and have had 3 biopsies.  No one is able to cure the dry lips.
Numbness in hand; tingling in hand; shooting pain; This is a spontaneous report from a Pfizer-sponsored program a contactable pharmacist reported that a patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (dipht crm197 protein) (PREVNAR 13, lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for immunization.  The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced numbness and tingling in hand like shooting pain. The patient outcome of the events was unknown.    No follow-up attempts are possible, information about batch number cannot be obtained.
sugar level is high at 225; arm is hurting; feeling drowsy; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (sugar level is high at 225), PAIN IN EXTREMITY (arm is hurting) and SOMNOLENCE (feeling drowsy) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic and Bladder disorder NOS. Concomitant products included LISINOPRIL, DULOXETINE and OMEPRAZOLE for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced BLOOD GLUCOSE INCREASED (sugar level is high at 225), PAIN IN EXTREMITY (arm is hurting) and SOMNOLENCE (feeling drowsy). At the time of the report, BLOOD GLUCOSE INCREASED (sugar level is high at 225), PAIN IN EXTREMITY (arm is hurting) and SOMNOLENCE (feeling drowsy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: 225 (High) sugar level is high at 225.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
I received my shot at 3:30 pm on Friday 3/5/21. Around 9 pm I started experiencing extreme body aches all over that felt like my body was "fighting" against itself. I also experienced chills. I had a hard time sleeping from the pain. The next morning a headache started and progressed into a migraine. I could not get up or open my eyes from how bad the migraine was. I took extra strength Tylenol for the pain with little relief. On Saturday evening the symptoms started to get better and turned more into a headache. I still had the headache on Sunday but it was better after taking the Tylenol. On Monday my arm is now sore (it wasn't sore prior).
Red rash around injection site, swelling and low grade fever. IV fluids. Cellulitis IM injection of Rocephin.
pt w/4 pox noted on lip, body, genital area;pt recv vax 11MAR98;noted 1st pox 5 days ago;
Information has been received from a pharmacist concerning a female patient who on 05-JUN-2007 was vaccinated with a dose of Gardasil. On 12-JUN-2007 one week after the injection the patient developed mononucleosis. Unspecified medical attention was sought by the patient. The outcome was unknown. 2/19/2010 In followup information the pharmacist called back on 01-OCT-2007 and stated that the physician determined that the mononucleosis was not associated with th GARDISIL vaccine. No further information reported. Additional information is not expected.
21OCT96 red rash clustered pinpoint covering;face neck & hands stiff joint generally especially elbows wrists & fingers;mild fever;swelling cheeks, neck eye area;
Left arm deltoid 3 cm area redness.  Slight swelling beginning 07/11/2003 AM. Slight respiratory congestion after injection.  07/09/2003.  History of asthma.
Approx 6 hrs post Prevnar injection unable to bear wt L leg, limp, refused to bend leg no redness or swelling. Fever to 102F, hiccups; violent x 3 - 6/8/01 continue fever child to be seen is wt bearing.
COVID-19  12/23/2021  1 of 2  Comirnaty-PFR t-s 10mcg  Full      COVID-19  01/14/2022  2 of 2  Comirnaty-PFR t-s 10mcg  Full      Hospitalized with COVID symptoms 6/25/22
I tested positive for COVID-19 On 07/22/ mild heartburn I was taking TUMS for it and it subsided, and a little bit of dizziness, and coughing, I also had a bitter, acid taste in my mouth. About the 07/31/2021, all the COVID-19 symptoms subsided. My heartburn became manageable. On 08/11/2021- I had the Pfizer Dose 1-Within that hour of getting the vaccine. I had a strong taste in my mouth. I accepted that as maybe the heartburn coming back. I woke up the middle of the night, like I was choking.  About the 3rd day, I was heavy on Tums, Pepcid and Prilosec and I was drinking a lot of water and chewing a lot of gum. Chewing a lot of gum gave me comfort. The Acid reflux got so bad I was sleeping up on the bed, I loaded up on Pepcid and started taking Prilosec, after 14 days it didn't do anything for me. On 08/22/2021, I went to ER, because I was not getting any relief from the heartburn with everything I was taking. They checked me as if I was having something wrong with my heart. I had pressure in my chest. I am treating it like it was heartburn and my chest was tight. Treatment at the hospital: A GI cocktail and Mylanta and Pepcid, it's supposed to numbing effect so I wouldn't have the tightness in my chest. I felt a little relief because it numbed it. Once it wore out, I still had the tightness in my chest. The Pepcid, TUMS, and Prilosec caused my heart pressure to go high. I'm trying to stick to the TUMs and chew gum and drink plenty of water. This weekend will be a month that I have really, really bad heartburn. I am still having the heartburn 1st thing in the morning. I try to prop myself up at night and try not to sleep flat. At this point, when I started adding in the Mylanta and Pepcid, the heartburn has gotten better. I am 56 years old and I have never had heartburn before. I had mild heartburn after COVID-19 and it went away. It came 2 or 3 times worse with the Pfizer Dose 1  vaccine. I will be following up with my doctor and try to get a referral to a GI Doctor within the next week or so, because I am concerned about taking the Mylanta, TUMS and Pepcid and the whole mix for too long and it causes my blood pressure to rise.
I am a teacher. When I was at school one day I started to feel feverish with a runny nose and cough. I went to the school nurse and got my temperature checked. The nurse said I had a little bit of a fever. She did a rapid COVID-19 test at school, and it was negative. She said that I could go home. Yesterday my symptoms started to get worse and worse. My temperature was at 101.7 degrees. I had bad coughing, congestion, feeling very weak, achy, horrible diarrhea, and a loss of appetite. I took some OTC Tylenol and Imodium. The Imodium seems to be working. I've been drinking a lot of ginger ale. The fever is gone now. I still have some weakness and muscles aches, but the coughing, congestion, and diarrhea is better now. I do plan on possibly taking the rest of the school week off.
Severe Headache/Migraine lasting for over 2 weeks; Severe Headache/Migraine lasting for over 2 weeks; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on 30Dec2020 10:00 at a single dose on left arm for COVID-19 immunization. Medical history included spinal stenosis and allergies to cephalosporin. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior to vaccination. Concomitant medication included gabapentin. On 30Dec2020 19:00, the patient experienced severe headache/migraine which lasted for over 2 weeks, required prescription medication to make them bearable but even then, they didn't go away and were very bad. The patient spent the good part of two weeks in bed or at least not doing her regular level of activity. She went to Urgent Care twice and to the Emergency Room once. The patient was given prescription medication and IV pain medication as treatment for the events. The patient underwent lab tests and procedures which included nasal swab test (COVID-19 virus test) on 11Jan2021: negative result; and the same test on 14Jan2021 with negative result. The patient was recovering from the events.   Information on the lot/batch number has been requested.
BRIEF OVERVIEW: Admission Date: 9/3/2023 Discharge Date: 09/08/2023 Discharge Disposition:  home or self care  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Sepsis [A41.9] Multiple falls [R29.6] Pneumonia due to COVID-19 virus [U07.1, J12.82]   HOSPITAL COURSE: Patient is an 81-year-old male with history of T2DM, CKD and gastric B-cell lymphoma s/p radiation and now on alkylating chemotherapy presenting following a witnessed fall from home and found to have vital sign derangements concerning for sepsis secondary to COVID-19.   Patient reported several months of functional decline with worsening generalized weakness (worse in lower extremities), balance issues, and fatigue. He has fallen several times in the last few weeks, never with loss of consciousness or severe head trauma. Timeline of symptoms is consistent with his chemotherapy regimen, which was initiated in March 2023. He has received 5 cycles of Bendamustine and Rituxan but had brief hiatus in August due to persistently low ANCs. Last cycle was two weeks ago.    On 9/3, the patient had a fall and hit the back of his head against the bathroom wall. He did not lose consciousness. Wife encouraged him to be seen in the ED. His vital signs were mildly deranged, including tachycardia around 110 and tachypnea around 23, along with one-time fever of 39.5C. blood gas demonstrating partially compensated respiratory alkalosis with pH of 7.53, CO2 of 31 calculated bicarbonate of 26. Covid-19 PCR was positive. Chemistry was remarkable for elevated BUN and creatinine, though his renal labs have been variable lately, as well as an elevated alkaline phosphatase of 189. Complete blood count demonstrated stable normocytic anemia and normal white cell count with some neutrophilic predominance by differential; however, in the setting of very low ANC last month, this was seen as an acute leukocytosis (should be noted that the patient did receive peg-filgrastim in August 2023 for leukopenia that was holding up his chemotherapy). Because of the concern for sepsis in the setting of SIRS positivity, LA was obtained and was WNL. He was admitted to the hospital for further evaluation by his oncology providers and supportive management for his COVID-19 infection.    In the inpatient setting, the patient's vitals normalized shortly after time of admission. He was stable throughout his stay, with no desaturations or oxygen requirement and minimal symptoms limited to a dry cough and persistent chronic feeling of weakness. He was evaluated by PT and OT, who recommended inpatient rehab facility transfer at time of discharge. He was also seen by Hematology/Oncology, who recommended trending CBC during admission and outpatient follow-up to discuss feasibility of continuing chemotherapy. He was discharged home in stable condition on 9/8 after finishing his course of IV remdesivir.
I had a recurrence of covid symptoms and positive test results five days after completing paxlovid therapy; I had a recurrence of covid symptoms and positive test results five days after completing paxlovid therapy; Moderna full dose/Moderna booster dose; Moderna full dose/Moderna booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 15Feb2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm and on 08Mar2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Jul2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 25Jan2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PRAVASTATIN, start date: 01Dec2020, stop date: 27Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had a recurrence of covid symptoms and positive test results five days after completing paxlovid therapy"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "Moderna full dose/Moderna booster dose".  Adverse event: I had a recurrence of Covid symptoms and positive test results five days after Completing paxlovid therapy and ten days after my first covid symptoms had resolved.  Follow-up (28Apr2022): This is a follow-up report from product quality group providing investigation results. This report included that:  Additional Information: This is a notification generated from the system. New/updated information pertaining to an AE was reported to PQC. You are receiving this notification because you have been identified as a Recipient for this record. A brief summary of this Agency/ Complaint Contact is listed below: Pfizer Receipt Date (PRD): 28Apr2022 Responsible Person: (name withheld) AE Reference Number: 202200633715; 202200635294 Status: Initial Processing Please use the following link to log into the system and view the full details of this Agency/ Complaint Contact:   Reporter Information: Is Reporter Anonymous? No Please use the following link to log into the system and view the full details of the Reporter:  Addit'l Information: 28Apr2022 02:17 PM (GMT-4:00) added by Agent: Duplicate received, attached supporting document. Added AER#  Product Description: Paxlovid co-package tablets 100 mg 5 blister cards EA with 4 x pf07321332 + 2 x RTV Product Description: compound BNT162 covid-19 vaccine suspension for intramuscular 2ml multiple dose vial x 1  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
My husband came home from a Christmas party and had started coughing at night, he tested positive for COVID-19 on 12/20/22. By 12/22/22 I started feeling tired like I was coming down with a cold, a little bit of a cough, stuffed up. I took a home COVID-19 test, it came back positive, I called my doctor's office to let them know I had also tested positive. I was prescribed PAXLOVID, I started taking the medication on 12/23/22. I think I must have gotten every single side effect.
Developed a brief 100 degree fever, felt tired & weak, headache the day after the injection. Now developed a some on/off itching on the left side area underneath my left arm pit to my waist.
1 dose was given past 30 day use by date; 1 dose was given past 30 day use by date; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose was given past 30 day use by date) and PRODUCT STORAGE ERROR (1 dose was given past 30 day use by date) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 056M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose was given past 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (1 dose was given past 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose was given past 30 day use by date) and PRODUCT STORAGE ERROR (1 dose was given past 30 day use by date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. On 19Apr2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. No treatment medications were reported.
Initial information received on 14-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an 18 years old female patient who was vaccinated with a 0.5 ml expired dose of MENACTRA lot U5751AA and expiry date: 12-Nov-2018 in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included TDAP for Immunization. It was a case of actual medication error due to expired vaccine used. It was not reported whether the patient experienced any adverse events after the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207), intramuscular, administered in the right arm on 16Mar2021 15:00 (at the age of 79 years old) as second dose at a single dose for COVID-19 immunization. Medical history included Essential thrombocythaemia from 2013 and ongoing, ongoing Acid reflux (esophageal) which was diagnosed at least 10 years ago. No other vaccinations was given within four weeks prior to the first administration date of the suspect vaccine. Concomitant medications included hydroxycarbamide (HYDREA) for Essential thrombocythaemia from 2013 and ongoing; ongoing omeprazole (PROTONIX) for Acid reflux (esophageal). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6200) intramuscular in the right arm on 23Feb2021 (at the age of 79 years old) for COVID-19 immunization. The patient experienced extreme heart palpitations on 16May2021 23:00. The patient reported that she wanted to call and report an adverse event with the COVID-19 vaccine. When she used the website, it was not working correctly. When she get 95 percent done, it would not accept. She would hit submit and it would not do anything and the email would show up in red. She said that it was the second vaccine. She experienced extreme heart palpitations. She had the vaccine at 3pm and the heart palpitations started that night around 11 and continued for hours. She almost went to the ER. She said that it continued for a good week and into the second week. In the meantime, she had a surgery. She noticed the heart palpitations a little bit then. She said that she is still having it now. She is on medication for it now to try and take care of it and it has only been 3 days though. No further details provided about the surgery. She never had any heart palpitations. She stated that the heart palpitations have subsided and when she has them they are pounding palpitations, but they do not last as long. This was the only thing that happened to her. It was all after the second vaccine. She had no other side effects. Treatment was metoprolol tartrate 25 mg 1/2, twice daily and it has not helped so far. The event required a visit to phyisician office for which they gave her a halter monitor about a month ago on 10May2021. The outcome of the event was recovering.
Patient received GARDASIL 9 that underwent an unevaluated temperture excursion; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.  On 03-MAR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), at a dose of 0.5 milliliter (ml) (lot number S028738, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 03-APR-2022) (frequency, route of administration, anatomical location and vaccination scheme were not reported), as prophylaxis. The administered dose underwent an unevaluated temperature excursion of 35.8 Fahrenheit (F) during a time frame of 14 hours and 0 minutes, as recorded by data logger (product storage error).  "This is one of several reports received from the same reporter." combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: S028738; expirationdate: 03-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA002153:
9-10-10 got TDAP RA - arm red, swollen on 9-11-10 - went to employee health - they told her it was a normal reaction - now it still has a knot size of a pea in it - no pain.