chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A patient received an Adacel which had been frozen and thawed/No AE; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from non health care professional (office staff).  This case is linked to cases 2019SA196353, 2019SA224138, 2019SA224143, 2019SA224145, 2019SA224142, 2019SA224139, 2019SA224140, 2019SA224136, 2019SA224076, 2019SA224137 and 2019SA224141 same reporter.  This case involves patient of an unknown demographics who received 0.5 mL dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Lot- C55608AA, expiry date-25-01-21; Lot- C5585AA, expiry date-10-03-21) via intramuscular route in unknown administration site (received between the date 26-Mar-2019 - 24-Jun-2019) which had been frozen and thawed.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to incorrect product storage.  There were no side effects.  Caller stares that her facility was using the Adacel vaccine and she was going through the fridge log and realized that she was not being informed when the vaccines were out of the 2 to 8 Celsius range. Caller states that there are 2 situations. Caller states that she looked at July and the vaccines dropped to 1.4 C and 1.5 C. Caller states she consulted with a scientist and was told that their thermometer was not the appropriate one for the vaccines and that it was only monitoring the air temperature and not the vaccines. Caller states that the same vaccines have gotten down to -4 C a month before this current excursion occurred. Caller states that a new thermometer with fluid was ordered so that the readings can be more accurate now. Caller would like to know what are the next steps that she needs to take in ensuring that her patients are properly vaccinated.  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.  Documents held by sender: none.
Dizziness; extreme fatigue (unable to drive and doze off during conversations); headache; muscle aches; vomiting still after 8 days.; This is a spontaneous report from a contactable healthcare professional (patient herself). A 40-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date not reported), via an unspecified route of administration in the right arm on 12Jan2021 09:00 at single dose for COVID-19 immunisation. Medical history included bipolar disorder and ovarian cyst. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has been tested for COVID-19. Concomitant medications included trazodone, desvenlafaxine succinate (PRISTIQ), and oxcarbazepine (TRILEPTAL). The patient previously took morphine sulfate and experienced allergies. On 12Jan2021 19:00, the patient experienced dizziness, extreme fatigue (unable to drive and doze off during conversations), headache, muscle aches and vomiting still after 8 days. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 12Jan2021. No treatment was received for the adverse events. Clinical outcome of the events was not recovered.
Mom called regarding patient's arms - both arms red, warm to touch, swollen, itchy, "hard ball" where shots were given. Advised massing area, ice packs, BENADRYL, TYLENOL/MOTRIN for pain, arm movement.
Information has been received from a physician concerning a 24 year old female with endometriosis and a history of acne who on 13-SEP-2007 was vaccinated with her first dose of GARDASIL (lot # and route not provided). On 13-NOV-2007, the patient was vaccinated with her second dose of GARDASIL (lot # and route not provided). On about 13-DEC-2007 (about one month after the second vaccination), the patient developed joint pain and muscle aches. A mild elevation of liver enzymes AST and ALT were noted during laboratory test (dated and results unspecified) following the joint pain and muscle aches. The patient underwent various blood test (not further specified and results not reported). On 13-Mar-2008, the patient was vaccinated with her third dose of GARDASIL (lot # and route not provided). Concomitant therapy included AYGESTIN, minocycline (unspecified) and RETIN-A. The patient underwent a number of blood tests and liver function tests to rule out hepatitis by her primary physician (tests, results and primary physician not specified). The patient sought unspecified medical attention. The joint pain and muscle aches are continuing, but have improved at the time of this report. No other information was reported. Additional information has been requested.
fingertips went numb, purple, painful; fingertips went numb, purple, painful; fingertips went numb, purple, painful; This is a spontaneous report from a contactable consumer reported for herself. This 63-year-old female patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729) via an unspecified route of administration in the left arm on 14Apr2021 16: 00 as 0.3 ml single for COVID-19 immunization. Medical history was unknown. The patient had no known allergies. Concomitant medications included meloxicam, bupropion hydrochloride (WELLBUTRIN), carbidopa/levodopa (SINEMET), atorvastatin, pantoprazole (reported as "Pant"). The patient previously received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730) via an unspecified route of administration in the left arm on 25Mar2021 at 04:00 PM for COVID-19 immunization. The patient previously received ranitidine hydrochloride (ZANTAC) and omeprazole magnesium (PRILOSEC), both experiencing allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 10 days after the2nd vaccine, the patient experienced fingertips went numb, purple, painful on 26Apr2021 at 16:00.  The patient was hospitalized for 4 days and put on blood thinners. The Cardiologist, vascular surgeon, and Rheumatologist were not sure why this was happening.  This had continued for 2 weeks without any improvement.  The patient had had lots of tests and they were still trying to figure it out.  It may have nothing to do with the vaccine, but the patient thought you should be aware and have this information. The patient had covid test post vaccination on 03May2021 via Nasal Swab with negative result. Prior to vaccination, the patient was not diagnosed with COVID-19. The events resulted in: Emergency room/department or urgent care. Treatment received for the events with Heparin Drip in hospital, Eliquis at home. Outcome of the events was not recovered.   Information about lot number/batch number has been requested.
She got her vaccine, the next morning at 5:30 she woke up feverish and body aches all over.  She took her temp it was 100.4,  and that lasted about half a day and took Tylenol for the fever and body aches, which helped.  Her fever broke about 6:30 yesterday evening, and is feeling better now.  She called in and missed work yesterday.
Time 3:07 of SX T= 97.8 qx. Local redness of Rt thigh. Rt is red and area is warm. 10 cm x 4 cm = redness only - no significant swelling. Child given diphenhydramine and local ice pack.
Several hours my left arm sore-that was expected. Started to fee a bit feverish in the evening. Woke up the next morning with a remaining fever and joint pain throughout my body. Stayed in bed all day. Sunday woke up and still continue with the joint pain. Its worrysome. I am a healthy 68 yr. old woman, do not take any medications. I hope this is a temporary setback. This was my 2nd shot. Did not feel like this after my 1st shot.  Have these symptoms been reported before?  Are these symptoms temporary???? I can't feel like this everyday. I am happy that I am safe from covid but at what cost??
Prolonged pain in arm where vaccine was administered for almost 7 weeks since getting the second dose.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 09:45 (Lot number: ER8730) at the age of 25 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LAMICTAL; GABAPENTIN; ALEVE; PROPRANOLOL; TYLENOL. Vaccination history included: Covid-19 vaccine (Lot number:ER8727, Administration time: 07:00 PM, Dose number: 1, Vaccine location:Left arm), administration date: 20Mar2021, when the patient was 25 years old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Apr2021, outcome "not recovered", described as "Prolonged pain in arm where vaccine was administered for almost 7 weeks since getting the second dose.". Therapeutic measures were not taken as a result of vaccination site pain.  Follow-up attempts are completed. No further information is expected.
46 year old female was fine this AM and developed nausea and vomiting after first covid sho this morning No fever, abdomen pain, shortness of breath, cough ,rash  or dysuria She is not sick Not pregnant.  Orders Placed This Encounter ? Ondansetron (ZOFRAN) 4 mg Oral Tab
hoarness /voice was really raspy; pain at the injection site; FATIGUE; weakness; loss of appetite; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHONIA (hoarness /voice was really raspy), VACCINATION SITE PAIN (pain at the injection site), FATIGUE (FATIGUE), ASTHENIA (weakness) and DECREASED APPETITE (loss of appetite) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concurrent medical conditions included Hypertension and Arthritis. Concomitant products included GABAPENTIN, LOSARTAN, MELOXICAM and CALCIUM CARBONATE, ERGOCALCIFEROL (CALCIUM AND VITAMIN D) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DYSPHONIA (hoarness /voice was really raspy), VACCINATION SITE PAIN (pain at the injection site), FATIGUE (FATIGUE), ASTHENIA (weakness) and DECREASED APPETITE (loss of appetite). At the time of the report, DYSPHONIA (hoarness /voice was really raspy), VACCINATION SITE PAIN (pain at the injection site), FATIGUE (FATIGUE), ASTHENIA (weakness) and DECREASED APPETITE (loss of appetite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Swelling of injection arm starting at armpit and ending at elbow. Redness and itching. Swelling subsided significantly when the patient came in on 11/25 to talk to pharmacist about it. Recommended Benadryl if itching continued. Patient said that it had improved a lot in 24 hours and didn't really itch too much anymore.
This case was considered medically important (OMIC). Information was regarding Hib Titer vaccine was received from a consumer regarding her son male who experienced diarrhea episodes, autism and developmental delay. At 7 months of age, the pt received the third dose of Hib titer vaccine on 7/20/00, along with the third dose of Infanrix. Relevant medical history was not provided. Indication for Hib Titer vaccine was immunisation. Product was administered on 7/20/00. Dose regimen was 1 dose 1 time per day IM. Additional suspect medication included Infanrix and Engerix B. Pt was not taking concomitant therapy. The boys mother states that in approx April or May 2000, her son seemed quieter, had difficulty taking the bottle and had frequent bouts of diarrhea. At 9 months of age, her son was not developing as he should. At 4 years of age, he began to speak. On an unspecified date, he was diagnosed with autism by a neurologist. No additional information was available at the time of this report.
12 days after vaccine  - site of injection started to hurt, approximately 2 inch of raised red rash at site and small nodule size of ping pong on top of shoulder area.
Mild redness and mild itchiness at injection site. Also, slight feeling of swelling/firmness compared to contra-lateral side.
Developed red patches on both his arms and shoulders; Developed red patches on both his knees; Still very fatigued; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ERYTHEMA (Developed red patches on both his arms and shoulders), ERYTHEMA (Developed red patches on both his knees) and FATIGUE (Still very fatigued) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included Brain injury (brain injury about 6 years ago). Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Developed red patches on both his arms and shoulders), ERYTHEMA (Developed red patches on both his knees) and FATIGUE (Still very fatigued). At the time of the report, ERYTHEMA (Developed red patches on both his arms and shoulders) and ERYTHEMA (Developed red patches on both his knees) outcome was unknown and FATIGUE (Still very fatigued) had not resolved.            No treatment medication were provided by the reporter
Information has been received from a nurse concerning a 13 year old female with a history of methicillin-resistant staphylococcal aureus infection who on 02-FEB-2008 at 9:30 am was vaccinated IM with the first (0.5 ml) dose of GARDASIL (Lot # 657617/0384U).  Concomitant therapy included the second dose of HAVRIX.  On 02-FEB-2008 at 9:30 pm the patient experienced fainting episode.  The next several days the patient had several fainting spells, one per day.  The patient also experienced dizziness, rapid heartbeat and low blood pressure.  The patient sought medical attention in the office on 04, 05, and 07-Feb-2008.  The patient was sent to the ER on 05-FEB-2008.  The patient is being referred to an unspecified pediatric cardiologist.  The patient is getting better.  No product quality complaint was involved.  Additional information has been requested.
numbness in half of my body/starting by facial nerve then upper limb going back to face and eyes area/felt numbness in different areas including chest; numbness in half of my body/starting by facial nerve then upper limb going back to face and eyes area; felt numbness in different areas including chest and throat (it was itchy); felt numbness in different areas including chest and throat (it was itchy); felt numbness in different areas including chest and throat (it was itchy), by lips as well were itchy.; felt numbness in different areas including chest and throat (it was itchy), by lips as well were itchy.; This is a spontaneous report from a contactable physician (patient) reported that a patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got numbness in half of his/her body, starting by facial nerve then upper limb going back to face and eyes area, which decreased over one hour, then he/she felt numbness in different areas including chest and throat (it was itchy), by lips as well were itchy. Numbness stayed for two days. The patient asked what he/she should do to take his/her second dose. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Very stressful/great anxiety; Annoying; Tinnitus; This spontaneous case was received on 19-Oct-2023 from other non-health care professional (consumer) via Company (reference number: SEQW23-03559) and concerned a female patient of unreported age.  The patient's medical history and concomitant medications were not reported.  On an unspecified day in Dec-2022, the patient was vaccinated with influenza vaccine (brand not specified; dose, route of administration, anatomical location: not reported) for influenza immunization. The batch number was not reported.  On an unspecified day in Dec-2022, ever since receiving influenza vaccine, the patient had tinnitus.  On an unspecified date, the patient felt terrible, very stressful and annoying. As reported, it was causing her great anxiety and the great fear to get anymore vaccines.  At the time of initial reporting, the patient had not recovered from the event of tinnitus.  The outcome of the events of 'anxiety', and 'feeling irritated' was not reported.  The reporter did not provide a causality assessment.  This case was assessed as non-serious.  Company comment: A patient of unspecified age experienced tinnitus, anxiety, and irritability an unknown amount of time after receiving the suspect product influenza vaccine. The patient's medical history, concomitant drugs, and diagnostic findings were not provided. Due to lack of information and unclear temporal relationship, causality for the reported events is unassessable.; Sender's Comments: A patient of unspecified age experienced tinnitus, anxiety, and irritability an unknown amount of time after receiving the suspect product influenza vaccine. The patient's medical history, concomitant drugs, and diagnostic findings were not provided. Due to lack of information and unclear temporal relationship, causality for the reported events is unassessable.
Swelling @ site 29AMR91 called MD stated knot @ inject site on rt thight; To Hlth ctr 3APR91 area on rt thigh 1 1/2 x 1 1/2 hard to touch; Some peeling of skin in center; Mom stated had been draining;
"Orange" size redness, warm area around injection site. Low grade fever. "Achy" all over.
Horrible headache, extreme joint pain, chills, fever 101.4 for 12 hours, extreme left arm pain that is spreading (Still occuring) nausea, fatigue dizziness
Tingling/numbness in my mouth and ears started today 3/29/21 around 4pm
Exactly 4 to 5 days after my vaccination I was waking up with headache, brain fog and confusion and memory issues, I thought I was experiencing COVID-19 symptoms. I went to the ER and was tested and sent home. I was told to follow-up with my Neurologist. When I did, he found not issues with my symptoms and sent me home with no answers. I was diagnosed with new onset of seizures for not any reasons. It is listed as unknown. I started having seizures in my sleep 4 to 5 days after receiving vaccines. I have bilateral temporal seizures now. I am now taking LAMICTAL. I have been missed diagnosed three times from the ER and my Neurologist. I had awakened up to the symptoms again on 11/27/2022. I went to the ER, and they performed the same test and sent me back to my Neurologist and he gave me no results or answers. He said he believed I had sleep apnea and recommended a sleep study test. Instead of the test I went to visit my daughter. There I had awaken in my rental with no visual memory of how the building I was staying in looked or where the rooms where. I was confused and had no idea of how to get to the place. This lasted about 4 hours. I contacted my cousin who is neurologist and had me carry an ambulatory EEG machine to record my brain patterns. I was diagnosed with having seizures in my sleep. I have never had this issue before; I was being misdiagnosed.
Information has been received from a pharmacist referring to male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (subcutaneous, once; lot #, strength, dosage and frequency unspecified) (extra dose administered). Then the patient's wife told the patient that he already had vaccine a few years ago. No adverse effects were reported. Additional information is not expected as there was no consent to contact the physician.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with improperly stored doses of PNEUMOVAX 23 injection (strength, dose, route of administration, indication, lot# and expiry date unspecified). No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to a 11 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 08-MAR-2016, the patient received improperly stored GARDASIL 9 (lot number L037339 and expiration date 09-FEB-2018, dose, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion. The call was because of a data logger. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
29Mar2021 Approx. 5pm = slight pain at injection site (left upper arm) when I lift my arm 30Mar2021 Approx. 1pm = Nasty persistent headache with fatigue 30Mar2021 Approx. 8:30pm = Tiredness + chills. I went to bed. 31Mar2021 Approx. 11am = Felt good except for slight pain in left armpit when I move my arm. 01Apr2021 woke up at 6:30am feeling like I have a golf ball in my left armpit which look swollen compare to my right armpit (no problem here). Additionally, itching, readness on left arm skin 2 inches below vaccine injection site spreading towards my armpit. 02Apr2021 Left armpit still swollen but the golf ball feeling less prominent than the day before.
Received Moderna  Dose 1  12/29/20 Dose 2  1/26/21 Tested + for Covid on 4/9/21.  Partner identified as sorce
the day following vaccination she described worsening of chronic fatigue, headache, chest/rib cage discomfort, swelling of left arm and left face, hives under eyes and left face