chrisvoncsefalvay/vaers-outcomes huggingface dataset:
my ears started ringing; felt like my head has been under water; extremely sensitive to all loud sounds; extremely sensitive to all loud sounds and it fells like my ears and glands are swollen.; extremely sensitive to all loud sounds and it fells like my ears and glands are swollen.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 14:00 (Lot number: ER8736) at the age of 35 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CLARITINE. The following information was reported: TINNITUS (non-serious) with onset 22Apr2021 22:00, outcome "not recovered", described as "my ears started ringing"; HEAD DISCOMFORT (non-serious) with onset 22Apr2021 22:00, outcome "not recovered", described as "felt like my head has been under water"; HYPERACUSIS (non-serious) with onset 22Apr2021 22:00, outcome "not recovered", described as "extremely sensitive to all loud sounds"; LYMPHADENOPATHY (non-serious), EAR SWELLING (non-serious) all with onset 22Apr2021 22:00, outcome "not recovered" and all described as "extremely sensitive to all loud sounds and it fells like my ears and glands are swollen.". Therapeutic measures were not taken as a result of tinnitus, head discomfort, hyperacusis, lymphadenopathy, ear swelling.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. His ears started ringing and felt like my head had been under water 8 hours after my first Pfizer shot on 22Apr. I am extremely sensitive to all loud sounds and it fells like my ears and glands are swollen.  No follow-up attempts are possible. No further information is expected.
Henoch-Schönlein purpura flare up in arms and legs. Haven?t had a previous flare up in years. Seeking in joints and feet.
Patient received J & J vaccine in the clinic and approximately 3 mins after administration of vaccine, patient fell to the floor from a sitting position and was unresponsive. Smelling salt was used, patient then became alert but stated "Im dizzy". Patient was clammy, pale and diaphoretic. VS obtained at 1459 BP-122/92, HR-56, SPO2-RA 98%, Left patient on the floor for approximately 20 mins until he was in no acute distress. VS obtained at 1505 BP 130/92, HR-64, SP02- RA 99%, VS obtained  AT 1515 BP-136/92, HR-56. When patient fell to the floor he was twisted to the left of his body. Bump noted to left temple region approximately 15mins after fall. Face mask was on patient and staff.
This case was reported by a pharmacist via other manufacturer and described the occurrence of anaphylactic reaction in a patient who received DTPa vaccine. On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, an unknown time after receiving DTPa vaccine, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown. It was unknown if the reporter considered the anaphylactic reaction to be related to DTPa vaccine. Additional details were provided as follows: This case was received via Merck National Service Center. The age at vaccination was not reported. An unspecified patient experienced an anaphylactic reaction to an unspecified TDaP vaccine. No additional information was available.
Information has been received from a health professional for the pregnancy registry for GARDASIL concerning a female with a history of atrial septal defect repair at age seven, who on 07-OCT-2007 was vaccinated with GARDASIL (lot # 656371/0181U). On 7-Jan-2008 the patient was vaccinated with her second dose of GARDASIL (lot # 655322/0092U). On 06-May-2008 the patient received her third dose of GARDASIL (lot # 655322/0092U). It was reported that the patient was found to be pregnant later the same day the last vaccination was given. A laboratory report was received in the office of a positive pregnancy test from the hospital the same day the last dose of vaccine was administered. Patient did not report the pregnancy. No problems were reported. Follow-up information has been received from a certified medical assistant who said that the patient was actually not pregnant at the time of the shot. She was not specific about which dose she was talking about. She reported that they found out that the patient lost the pregnancy a few days before her shot and very early in the pregnancy. She was not sure if it was an elective termination or a spontaneous abortion (SAB). Upon internal review, elective termination or a spontaneous abortion (SAB) was determined to be an other important medical event.
Pt states that he has had a headache for 2 months since his 2nd dose of the Moderna vaccine. He has seen his doctor about this, who has prescribed amitriptyline & ibuprofen. He has had an MRI done & pt states the prescriber did not find anything. Pt stated that he used to take heart medications but he stopped them...I advised following up w/ the doc who prescribed the heart medications as having uncontrolled blood pressure can cause headache. He however states that his blood pressure is not currently high.
Pt reported to clinic with immunization reaction concern. Pt had a fluid filled blister to left deltoid area with some bruising and redness and area warm to touch. Medical officer notified. No tx done.
Patient described tingling sensation to left upper arm (injection site) soon after receiving vaccine then reported mild facial swelling and throat constriction within 45 minutes of receiving vaccine.
Initial unsolicited report received from a consumer on 26 December 2016. This case involves a 65-year-old patient (gender not reported) who was vaccinated with a dose of FLUZONE (batch number, expiry date, dose, route and site of administration were not reported) on 28 November 2016 (reported as Nov 28TH). Patient's medical history and concomitant medications were not reported. On unspecified date, two to three weeks following the vaccination, shoulder muscle of patient was decriped, imobile and patient felt like hit with a baseball bat. On specified date (reported as a week or so later from previous event), following the vaccination patient felt that it moved accross patient's back and in the other shoulder muscle with sore and imobile feeling in entire muscle system , legs,hands, every where and patient also felt like beaten with baseball bats. On unspecified date, following the vaccination the patient couldn't sleep. Lab data was not reported. Patient received corrective treatment with ibuprophen and acetaminophen. The outcome of the events was not reported. Upon internal review the case was considered as serious because of important medical event: Immobile. List of documents held by sender: none.; Sender's Comments: This case concerns 65 year old patient who received INFLUENZA QUADRIVAL A-B VACCINE and developed muscle pain immobile feeling, muscle wasting and cant sleep. Time to onset was not compatible with the role of vaccination. Further information regarding etiological work up, concurrent condition at the time of vaccination, concomitant medication, and more investigation results to rule out the alternative cause are needed for complete assessment of the case. Based upon available information role of vaccine cannot be judged.
mom reports pt fussy & won't quit crying >4hr despite advil, APAP w/codeine;no fever;discussed over phone advil dose rxn s/sx;
patient get sick if patient take the flu shot; Initial information received on 17-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case is linked to case 2020SA328836.  This case involves a unknown demographics female patient who get sick (illness), while she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient who get sick (illness) (Unknown latency) following the administration of INFLUENZA VACCINE.  Final diagnosis was patient was illness.   Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  There will be no information available on the batch number for this case.
I was positive for COVID-19 on 22FEB2023, my brother came home positive for COVID and I was exposed but he thought it was just a cold, days later I was feeling sick and coughing a lot of flam and I had the chills. I took test and it came back positive.
Approximately 10 hours after vaccination (Pfizer-BioNTech Covid-19), developed severe arm pain, fever of 101.5F followed by shaking chills,, then fever again. Experienced myalgia  and severe migraine-like headache with light sensitivity. The arm pain from shoulder to mid-palm was so severe that I couldn?t lift my arm. This resolved by approximately noon on 02/10/2021. The other symptoms largely resolved by midday 02/11/2021 wit residual low-grade headache, dizziness, and unsteadiness on my feet.  I woke up on 02/11/2021 around 7AM with left axillary lymphadenopathy approximately the size of a tennis ball cut in half with associated moderate discomfort. The discomfort resolved by 02/14/2021, but the lymphadenopathy remains at about half the mass noticed originally.
This spontaneous report as received from a medical assistant refers to a multiple unspecified patients of unknown age and gender. The patients; medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ orally (lot number: M019690, expiry date: 02-NOV-2017 and lot number: M038724 and expiry date: 24-APR-2018) (dose not reported). No adverse effect was reported. Temperature excursion was 47 degree of Fahrenheit to 77 degree of Fahrenheit. Time frame was reported as 50 minutes. There was previous temperature excursion for ROTATEQ: 47 degree of Fahrenheit to 77 degree of Fahrenheit for 3 hours. Data logger was involved. This is one of several reports from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1705USA012563: US-009507513-1705USA012564: US-009507513-1705USA008387:
Pain from neck, shoulder and upper arm. Shot was given in shoulder. I have used ice, heat and Tylenol. I am still having problems.
Extreme pain in right arm, worst in arm pit.  Lymph nodes area.  Started 25hrs after injection.  Including fever.  Fever gone in 12 hours. Lymph node pain and swelling continues including bruising under right arm.  Left arm swelling very minimal but right nodes continue to get worse 3 days in.  Today
Tremors of her left hand starting about 2 days after vaccination.  Lasted for 2 days then resolved for 3 days then started again on left hand then involving right hand.  10/24/08 Reviewed PCP medical records of 8/18-10/09/2008. FINAL DX: tremor NOS Records reveal patient experienceced good overall health.  On 10/6 visit noted to have left arm twitching & aching x 2 days & then resolved in 3 days. Hand shakes when in use.  Had rec hpv vax 4 days prior & started new acne med 5 days prior.  RTC 10/9 w/recurrence of right hand tremor & left fingers.  Referred to neuro & counselor.  Seen by dermatologist 9/08 due to very fair skin, acne, benign nevi & inflammed skin tag which was removed.
Swollen lymph nodes and pain in neck, nausea and vomiting  12/01/2012 to present (12/04/2012).
Upper respiratory congestion; Productive cough white phlegm.; This is a spontaneous report from a non-contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 10Mar2021 at 14:00(at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included chest heaviness and peanut allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included paracetamol (TYLENOL), gliclazide (CLARITIN) and multivitamin(MANUFACTURER UNKNOWN). On 10Mar2021, the patient experienced upper respiratory congestion, productive cough white phlegm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events upper respiratory congestion, productive cough white phlegm were unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I woke up the day after my second vaccine with very loud ringing in my ears.  The loud ringing, high pich noise caused hearing, focus issues and anxiety My heart was acing casuing me to feel like I was falling after the heart beat slowed back to a normal pace.  AFter my heart stopped racing it caused me to cough.
Hospitalization for COVID +, hypoxia 1/6/22-1/11/22. Treated with Remdesivir, baricitinib 4 mg PO daily, dexamethasone, zinc 50 mg daily, vitamin D3 50 mcg daily and vitamin C 1,000 mg daily
bruising @ shot site;some pain radiating down arm & across neck;sluggish feeling;
Patient was given 0.5ml instead of 0.25ml, patient called on 1/19/2022 and denies any problems since getting vaccine. Letter also sent notifying of dosage given.
Mild sore shoulder; This is a spontaneous report from a contactable consumer (patient). This 56-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution of injection, Lot Number: EP7534), via an unspecified route of administration, administered in right arm on 09Apr2021 at 10:15, as dose 1, single for COVID-19 immunization at Hospital. The patient medical and concomitant medications reported as none. The patient had no known allergies. Patient not diagnosed with covid-19 prior to vaccination. List of any other medications the patient received within 2 weeks of vaccination reported as none. The patient had not received any other vaccinations within 4 weeks prior to the COVID vaccine. The patient received other vaccine same date vaccine date (09Apr2021). On an unspecified date in Apr2021 the patient experienced Mild sore shoulder. Since vaccination patient not tested for covid-19. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution of injection, Lot Number: EP7533), via an unspecified route of administration, administered in right arm on 14Apr2021 at 11:15 (at the age of 56 years old) as dose 2, single for COVID-19 immunization at Hospital and experienced the events Tinnitus, mild sore shoulder, fatigue and dizziness. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021481505 Same patient, same product in different dose, partial same event
gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) and PRODUCT STORAGE ERROR (Product storage error) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) and PRODUCT STORAGE ERROR (Product storage error). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (gave 11 patients Moderna Covid-19 Vaccine doses  on 6Oct2021 from a vial that had been moved from frozen to refrigerated storage when they received them on 30Aug2021) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported.
Dizziness, Myalgia, Fever, Tachypnea, CoughWheeze, NauseaVomiting, Syncope,  pneumonia, chills, fatigue, and pain/redness/warmth/swelling at injection site Narrative:  Syncope and diagnosis of pneumonia occurred on Jan 8. Other symptoms noted above occurred/began on Jan 6 and Jan 7.
got her first dose of the vaccine last March 29, 2021. She got tested for Covid-19 last Thursday and results came positive for Covid-19 on Friday.; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: ER8733), via an unspecified route of administration, on 29Mar2021 as a single dose for COVID-19 vaccination. The medical history and concomitant medications were not reported. The patient received first dose of the vaccine last 29Mar2021. She got tested for Covid-19 last Thursday and results came positive for Covid-19 on Friday. She is due to have her second dose on 19Apr2021. The clinical outcome of the event positive for Covid-19 was unknown.   Information on the lot/batch number has been requested.
Sore throat, swollen lymph nodes, voice hoarse, no fever or cough ,started on third day after injection. Treated with Tylenol. Swollen glands improved today and throat improving but voice still hoarse.
just seems like she gets weaker; more run down some days; Bone pain got worse; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Bone pain got worse), ASTHENIA (just seems like she gets weaker) and FATIGUE (more run down some days) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included Emphysema. Concurrent medical conditions included COPD. Concomitant products included LATANOPROSTENE BUNOD (VYZULTA) for Glaucoma, ROFLUMILAST (DALIRESP), GABAPENTIN, LORAZEPAM, LOSARTAN, PENTOXIFYLLINE, SIMVASTATIN, METHIMAZOLE, OMEPRAZOLE, CYANOCOBALAMIN, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE (FOLBIC), SALBUTAMOL SULFATE (PROAIR HFA), OXYGEN, BUDESONIDE, SALBUTAMOL (ALBUTEROL HFA) and VITAMINS NOS for an unknown indication, IPRATROPIUM BROMIDE.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced BONE PAIN (Bone pain got worse). On an unknown date, the patient experienced ASTHENIA (just seems like she gets weaker) and FATIGUE (more run down some days). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, BONE PAIN (Bone pain got worse) had not resolved and ASTHENIA (just seems like she gets weaker) and FATIGUE (more run down some days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       .   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: FU received on 21-MAY-2021 Contains new events was updated.
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 doses of improperly stored GARDASIL injection (lot # K010215, expiry date: 05-MAY-2017; strength, dose, site and route of administration were unspecified). No concomitant medications were reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
15JUN93 rash all over; 16JUN93 t101 ax 17JUN93 t104.3 R w/throat inf-had sz a/going to ER; has yeast inf & t101.7;
I had a bad headache begin a couple hours after receiving the vaccine, and muscle soreness. I woke up and could barely move my arm, and throughout the day I got progressively more fatigued. By the next night, I had a low-grade fever and had extreme all-over body soreness. It felt like I had the flu. By morning, I was feeling a bit better and got progressively better. The next day (2.5 days after the vaccine), I was feeling better other than some soreness in my injection site.
Mom describes shaking of extremities with sudden sitting up and talking gibberish as well as very scared. Fell asleep then awoke an hour later screaming about things on his skin and other scare things. Taken to ER all labs and scans negative. No fever or other infectious symptoms.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 25-JUN-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a clinic, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 26-FEB-2016, the patient was treated at the clinic for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the 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. Additional information has been requested.
Pt is a 14-month-old male with a past medical history of reflux who is no longer on Pepcid for the past month, no seizure history who presents emergency. Department today with concerns for a febrile seizure. History obtained from mom at the bedside. Mom states that patient was in normal state of health until this morning. Mom states that she dropped off patient at grandma's while she was at work. He did record a low-grade fever of 99.1 and the patient when he felt warm this morning. He took a nap and woke up at approximately 10 AM, shortly after which he had his eyes rolled to the back of his head, became limp, and had full body twitching. Mom states that grandma said this lasted approximately 1 to 2 minutes. He is a little lethargic after this event however was quickly back to baseline shortly afterwards. No seizure history. Simple febrile seizure  Emergency room evaluation No testing.
After receiving the Moderna vaccine and about 5 minutes later, the customer became dizzy and blacked out for a few seconds and fell.  She was then transported to the hospital.