chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vertigo; Sudden idiopathic hearing loss of left ear; Sensorineural hearing loss of left ear; Tinnitus; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or around 23-SEP-2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered sudden left ear hearing loss and dizziness. Pt was diagnosed with sudden idiopathic, sensorineural hearing loss of left ear, tinnitus and vertigo. It was also specified that the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The events were considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.  Upon internal review, deafness neurosensory and sudden hearing loss were considered medically significant.
Patient received two FLUZONE HIGH DOSE vaccinations within few weeks with no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional and consumer/non-health care professional (Reference number- 00800876) and transmitted to Sanofi on 06-Oct-2021.  This case involves a 72-year-old male patient who received two vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] within few weeks one on 17-Sep-2021 and another on 06-Oct-2021 (extra dose administered).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On 17-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [via an unknown route at an unknown administration site]. On 06-Oct-2021 he also received a dose of the same vaccine [frequency: once, strength: standard, dose = 0.25 mL to 2 mL for vaccines or 0.1 mL for tuberculin test(TB) skin test 0.7ml, lot UJ716AB, expiry date: 30-Jun-2022 via an intramuscular route at an the left arm] for prophylactic vaccination.  It was an actual medication error case due to extra dose administered (latency: same day).  It was reported ''Patient received two FLUZONE HIGH DOSE vaccinations, one on 17Sep2021 and 06Oct2021. Caller states the wife called since he came to the doctor's office by himself and he didn't realize he had already had the vaccine. Caller states he has never had any side effects from the past vaccine and she didn't report any this time.''  At the time of reporting, no adverse event was reported.  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.
Shortly after pt received Prevnar, pt had febrile seizure, in the car on the way home,  and was brought to local ER with a temperature of 103F. Pt also had 2nd and 3rd febrile seizures on 4/18/01 and 4/19/01. No history of seizure disorder prior to Prevnar.
***** FIRST VACCINE DOSE 3/1/2021, SECOND DOSE 4/2/2021. SYMPTOMS BEGAN APPROXIMATELY 3/25/2021.  Severe myalgias that continue through 8/25/2021, pain started in knee, then all muscles, hurt to touch, pain when her cat walked across her lap. Pain has been moderately debilitating, just now starting to subside some (5 months of symptoms thus far). Has had complete rheumatologic workup, as noted below. no etiology found.  Also, is on OCP but missed 2 of 6 periods in the last 6 months.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021 at 4:25 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 4:25 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 52.99 on 15-Apr-2021.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021 (Batch number: 044B21A ).  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Approximately 30hrs. post vaccine I experienced hearing loss in my right ear. I could hear very little and it became worse within the next few hours. 12hrs after this began, my hearing came back and I then acquired a ringing in my right ear. This progressively lessened, and about 24 hrs after the initial hearing loss started,  all the symptoms dissapated.
Swelling in face and neck; Swelling in face and neck; Generally itching; This case was reported by a physician via call center representative and described the occurrence of facial swelling in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced facial swelling, neck swelling and pruritus. On an unknown date, the outcome of the facial swelling, neck swelling and pruritus were unknown.   It was unknown if the reporter considered the facial swelling, neck swelling and pruritus to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  The patient developed swelling in face and neck with generally itching after her first Shingrix. The chat was ended by the practitioner before further details could be clarified or obtained. No further details was provided. The reporter abruptly ended chat. The reporter did not consent to follow-up.
Patient reported her leg giving out causing her to fall on the day following her Covid-19 vaccination. She reported one leg giving out around 4pm, and then both legs giving out a few hours later causing her to sprain her ankle. She said there was no warning leading up to the event and that she experienced no other symptoms or adverse effects. She mentioned that doctors diagnosed these events as TIAs. Due to the proximity of these occurrences to her vaccination, she felt that it should be reported. Since then, she has had no other problems.
Information was received on 31-MAY-2017 from a field representative. Physician had reported to field representative that an unknown male patient (age not reported) had developed a case of shingles (on an unspecified date) after receiving the ZOSTAVAX vial 19400 PFU vaccination (on an unspecified date) (dose, lot#/expiration not reported). The physician also noted that the patient had contracted the shingles (on an unspecified date) in the past prior to the ZOSTAVAX vaccination. Outcome of shingles was unknown. No additional adverse event information provided. Additional information has been requested.
On 05/09/2002 per pt's grandmother, pt developed high temperature of 101.1 deg F., and listlessness since post vaccination. No local reaction noted. On 05/10/2002, now afebrile but complained of fussiness and not sleeping. Pt taking Ibuprofen prn. A follow up report received 5/24/2002 adds: No site reaction.
Redness at site Slight fever throughout the day Hives on stomach Bumpy injection site  Burning at injection site
BRAIN FOGGINESS; HEADACHE; SHORTNESS OF BREATH; ABDOMINAL PAIN; LEG PAIN; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to sulfa, occasionally drinks, and non-smoker. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: unknown) dose was not reported, 1 total dose, administered on 09-APR-2021 14:00 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 10-APR-2021 (Saturday morning), the patient experienced shortness of breath, headache, abdominal pain and leg pain. Later, the symptoms were significantly decrease, however he was still experiencing shortness of breath and sometimes brain fogginess. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, abdominal pain, and leg pain, and had not recovered from brain fogginess, and shortness of breath. This report was non-serious.; Sender's Comments: V0:Medical assessment comment not required as per standard operating procedures.
Breakthrough case after 4 vaccines  Pfizer 3/22/21 Lot# not given;  Pfizer 4/12/21 Lot# not given;   Pfizer 10/13/21 Lot# 30145BA;  Pfizer 5/13/22 Lot# FK9893
reports having the usual sore arm after day or two/had a sore arm, but states that was normal soreness; This is a spontaneous report from a contactable consumer (patient). The patient reported events for two doses. This case is regarding dose 1. A 73-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 05Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 05Feb2021, patient received her 1st dose of the Pfizer COVID vaccine and reported having the usual sore arm after day or two (Feb2021), but stated that was normal soreness. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I received my 3rd dose on 12/22/2021. After 1 year my adverse event started on 08/28/2022 in the morning around 8:00AM I felt pain in my neck. I couldn't swallow. I didn't think much about it. I went to a doctor who did a blood test. My thyroid level was high. My T3 and T4 was high. I had fast heartbeat. I had difficulty sleeping. I was experiencing Hyperthyroidism. I had 4 blood test and 1 ultrasound. My doctor prescribed me atenolol for about 1 week. By the 3rd blood test all of my symptoms resolved. This is the first time it happened to me.
12:30 c/o headache and stomach hurts, BP 104/70, P 84, R 16, T 99.4. 13:30 unable to contact mom. Sent to office to lay down.
Difficult breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficult breathing) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced DYSPNOEA (Difficult breathing) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (Difficult breathing) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug was not reported.  Treatment for the event was not reported.  The patient visited Emergency room on 24 Mar 2021.  Based on the current available information and temporal association between the use of the product and the start date of event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: TCR document attached Containing Non significant information. event upgraded to serious as per MR; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of event, a causal relationship cannot be excluded.
Scheduled for their second dose of the Moderna COVID-19 vaccine 8 days after their first shot; A spontaneous report  was received from a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and was scheduled for their second dose of the Moderna COVID-19 vaccine 8 days after their first shot.   The patient's medical history was not provided by the reporter. No Concomitant medications reported.  On 25 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011A21A) intramuscularly for prophylaxis of COVID-19 infection.   A patient called stating that they were scheduled for their second dose of the Moderna COVID-19 vaccine today (8 days) after their first shot.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273.
throwing up; he says his throat is bothering him; He is weak; losing weight; This is a spontaneous report from a contactable consumer (patient's daughter). A 70-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 18Apr2021, the patient experienced throwing up, oropharyngeal discomfort, weak and losing weight. The daughter stated that after he received first dose he was doing well as far as she knows, but on Sunday, April 18, he started throwing up and has not been able to keep anything down. He was weak from not eating and losing weight and he says his throat is bothering him and cannot get out of bed. She wanted to know can this be side effects of the vaccine even two weeks later. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I have had fever, chills, body aches, congestion, headaches, slight nausea, loss of appetite, almost every day since the injection.  I sleep at night, and wake up around 2am with sever chills, take 800mg Ibuprofen, and within an hour my chills break and I start feeling better.  The process repeats itself in the afternoon and then again in the evening.  I'm constantly tired and fatigued, and have been unable to exercise or work out since.   I'm still experiencing the symptoms as of today.
chest is fluttering; my whole body is on flames; rash on her entire body (hives all over body); not feeling well, doesn't feel right since then; feels like something is crawling down her skin; rash on her entire body (hives all over body) that are very painful; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest is fluttering), BURNING SENSATION (my whole body is on flames), URTICARIA (rash on her entire body (hives all over body)), MALAISE (not feeling well, doesn't feel right since then) and FEELING ABNORMAL (feels like something is crawling down her skin) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included LEVOTHYROXINE and VITAMINS NOS for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced CHEST DISCOMFORT (chest is fluttering), BURNING SENSATION (my whole body is on flames), URTICARIA (rash on her entire body (hives all over body)), MALAISE (not feeling well, doesn't feel right since then), FEELING ABNORMAL (feels like something is crawling down her skin) and RASH (rash on her entire body (hives all over body) that are very painful). At the time of the report, CHEST DISCOMFORT (chest is fluttering), BURNING SENSATION (my whole body is on flames), URTICARIA (rash on her entire body (hives all over body)), MALAISE (not feeling well, doesn't feel right since then), FEELING ABNORMAL (feels like something is crawling down her skin) and RASH (rash on her entire body (hives all over body) that are very painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitantly, patient was taking high blood pressure pills.  Treatment reported was Benadryl but patient could not take it.
Received pneumococcal vaccine left deltoid AND routine allergy shot in left and right arms on 12 Jul.  Felt well until next day when developed left arm discomfort, 4th/5th left hand parasthesias, lower lip tingling, malaise, tactile temps, 6cmx4cm area of induration/pink skin color change on bicep and chest discomfort which she attributed to left arm discomfort.  No urticarial/angioedema/GI/CNS sx.  Went to work on day of sx development and completed pushups and pullups.  Took Tylenol but became concerned b/c induration appeared to be moving distally and paresthesias above and lower lip tingling were persisting.
Unable to get out of bed. Transport to medical center via ambulance. Severe pain in lower region and unable to ambulate. 22 days inpatient stay.
WITHIN 20 MINUTES OF PFIZER VACCINE #1 SHE FELT TINGLY LIPS AND LEFT ARM NUMBNESS BELOW SHOT SITE. >4 HOURS LATER  GOT HIVES ON RIGHT THIGH
Patient came for Pfizer Vaccine Bivalent  but Moderna Bivalent was administered.  She was monitored for 15 min, stable not acute stress noted. She was advised to monitor for unusual side effects and notified MD or call 911 for any emergency.
The left deltoid, biceps and proximal forearm had edema, tenderness, induration.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates, the patients were vaccinated with doses of improperly stored ZOSTAVAX (lot # K021953 with expired date 10-FEB-2016, dose and route were unknown). No concomitant medication was reported. The reporter could not tell how many doses had been administered. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected since the reporter refused to be contacted.
I had a headache, slight sore throat, fever of 101, and metallic taste. I tested positive for COVID-19. I spoke to my doctor, and he prescribed me an antiviral. 48 hours after I stop taking the antiviral I rebounded for about a week with headache and fever of 101. I just took ibuprofen.
Fever 102F, aches, extremely painful left deltoid muscle that inhibited movement. No redness or swelling noted.
This spontaneous report as received from a nurse refers to a multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On multiple unspecified date the patients were vaccinated with improperly stored GARDASIL 9 (lot N003703 expiry date 29-OCT-2019) or (lot M041212 expiry date 21-JUN-2019) (incorrect product storage) for prophylaxis. No adverse effects reported with any patients. The vaccine was exposed to temperature of 0°C to 1°C for a time frame of 35 minutes. Previous temperature excursion was reported. The call because of a data logger. No PQC involved. No further information provided. This is one of the several reports linked via same reporter link.; Sender's Comments: US-009507513-1708USA008709: US-009507513-1708USA008409:
THREE BLOOD CLOTS ON LEG; This spontaneous report received from a consumer concerned a 40 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included occasional alcohol use, and non-smoker. The patient had no known drug allergies. The patient was healthy and regularly active. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported,1 total administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. The patient experienced pain in his leg since mid November and went to urgent care on 27-NOV-2021. They sent him to emergency room where he was diagnosed with three blood clots on his leg on the same day but was not hospitalized. They did a real time grayscale and duplex ultrasound of his right lower extremity and the results came out to be occlusive and non occlusive thrombosis in the peroneal vein of the calf and a non-occlusive thrombosis in the posterior tibial vein of the calf. Laboratory test also included bloodwork and the results seemed to be normal. The patient was put on blood thinners, Elaquis 5mg 2 tabs twice daily for 1 week then dropping down to take 1 tab twice daily for the next 3 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from three blood clots on leg. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211163804-covid-19 vaccine ad26.cov2.s- three blood clots on leg. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).