chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bitten by a stray cat, once again; The patient was bitten by a stray cat again and asked if previous vaccination with RabAvert was still good; Case reference number US-BN-2022-001170 is a spontaneous case report initially received on 01-Jun-2022 from a consumer (reference number: USBAV22-0259) and concerns an adult female patient.  The patient's relevant medical history and concomitant medications were not reported.  On an unspecified date in Oct-2021, the patient was vaccinated with RabAvert vaccine (Rabies Virus (Inactivated, Strain Flury LEP); batch number: not reported) at an unknown dose, route of administration or anatomical location, for post-exposure immunization against rabies due to a stray cat bite. The patient was not sure how many doses were administered.  On an unspecified date, an unknown amount of time after the last dose of RabAvert, the patient was bitten by a stray cat again and the patient was wondering if previous vaccination with RabAvert was still good for protection (explicitly coded as 'Inappropriate schedule of vaccine administered').  The outcome for the event of 'cat bite' was not provided.  The reporter did not provide seriousness and causality assessment.  Additional information received on 03-Jun-2022 included local case ID.; Reporter's Comments: An adult female patient was bitten by a stray cat and was wondering if previous vaccination with RabAvert was still good for protection which is considered as inappropriate schedule of vaccine administered. Animal bite is unlisted according to insert for Rabies, Inactivated, Whole Virus Vaccine while inappropriate schedule of vaccine administered is considered listed as per convention. Animal bite is assessed as not related to suspect vaccine. Inappropriate schedule of vaccine administered is also assessed as not related to suspect vaccine but to human factor. The case is considered as non-serious.; Sender's Comments: An adult female patient was bitten by a stray cat  and was wondering if previous vaccinations with RabAvert was still good for protection which is considered as inappropriate schedule of vaccine administered. Animal bite is unlisted according to insert for Rabies, Inactivated, Whole Virus Vaccine while inappropriate schedule of vaccine administered is considered listed as per convention. Animal bite is assessed as not related to suspect vaccine. Inappropriate schedule of vaccine administered is also assessed as not related to suspect vaccine but to human factor. The case is considered as non-serious.
full of anxiety; sleep deprived; unsure of herself; This is a spontaneous report from a contactable consumer or other non hcp and from a Pfizer sponsored program Pfizer . A 16-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on Apr2021 as dose number unknown, single (age at vaccination 16-year-old) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced full of anxiety, sleep deprived, unsure of herself on an unspecified date. It was reported that, reporters 16-year-old daughter got the Pfizer vaccine in Apr2021 and ended up in the psyche ward for two weeks. Before the vaccine, she was a normal healthy teen. Now she is full of anxiety, sleep deprived and unsure of herself. Please look into the effects of the vaccine on teenagers and help us deal with this crisis. The clinical outcome for all events was unknown.   Information on the lot/batch number has been requested.
1123 Patient received vaccine 1132 Patient complained of shortness of breath and throat closing, 0.3 MG Epinephrine administered and MOVE/SWAT notified, Vital Signs taken and within normal limits 1135 50 MG IM Benadryl given, SWAT arrived and report given. Patient reports feeling better 1140 Patient transferred to ER by wheelchair
Anaphylactic reaction; A spontaneous report was received from consumer (patient), concerning herself, a female patient of unknown age, unknown age and gender, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced anaphylactic reaction.  The patient's medical history was not reported. Concomitant medications were not provided.  On an unknown date in Jan 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date in Jan 2021, the patient had an anaphylactic reaction to the first dose. No treatment information was not provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the event, anaphylactic reaction was not reported.; Reporter's Comments: This case concerns a female of unknown age with a serious expected Anaphylactic reaction. Event onset with unknown latency after first dose mRNA-1273. Event outcome unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from other health care professional via phone. This case involves an unknown gender 36 months old patient who received flu qiv 0.25 ml, while he/she received vaccine FLUZONE QUADRIVALENT (Batch number, expiration date, route and site of administration was not reported) on an unknown date. The patients medical history and concomitant medications were not reported. It was an actual medication error due to underdose (three year old received FLU QIV 0.25 ml). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.
His (R) arm became swollen and painful and red. Also developed a fever. It was a few hours after the symptoms began.
A month-long, heavy menstrual cycle. Never happened before I got the vaccine. Completely abnormal.
Vaccine @ approx 2 pm, slept for 6 hours (unusual) waking once to nurse and cry @ 6 pm and then back to sleep until 8 pm. Upon waking went very pale (as white as paper) for about 15 minutes. He looked around during this time but would not smile and stayed very still. We called doc, he said possible pain reaction??? Happened again for about 2 minutes the following day.
fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and HEADACHE (headache) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced FATIGUE (fatigue) and HEADACHE (headache). At the time of the report, FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient was hospitalized with COVID-19. Upon admission to the hospital, provider reports altered mental status after fall today and decreased level of alertness. Prior to arrival to our ED, O2 saturations were in the 80s on room air. He was placed on 3L nasal cannula with improvement to the 90s. Pt reportedly had a recent cough as well. Multiple residents in his nursing home had been recently diagnosed with COVID-19.
FORGOT TO TAKE THE FOURTH DOSE; This spontaneous case (PVX2019-874) was received from a nurse on 12-Apr-2019. It describes an adult male consumer who "forgot to take the fourth dose", while being on Vivotif capsule for an unknown indication.  Case report: The consumer took three doses of Vivotif but forgot to take the fourth dose. It had been 5 days since the last dose was scheduled.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "forgot to take the fourth dose" was unknown.  Company's Comment: The causality of the event "forgot to take the fourth dose"  was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "forgot to take the fourth dose"  was considered as not applicable.
Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012C20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS, PROLIA, and ANTIHISTAMINE ALLERGY for an unknown indication.   On 05-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 06-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE REACTION. At the time of the report, VACCINATION SITE REACTION outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-089334 (E2B Linked Report). Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089334: dose 2.
left arm was so sore after the first one; This is a spontaneous report from a contactable consumer (patient). A 25-year-old male patient reported for himself that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that he received first dose of vaccine and on an unspecified date, his left arm was so sore after the first one, but the soreness went away after a few days. It was reported that the patient received his second dose on 07Jun2021. The outcome of the event was reported as resolved on an unspecified date.  Information on lot/batch number has been requested.
6-3-08 pt. received HPV #1, L delt. via biojector at 2:30 pm.  2:45 pm pt. became pale lightheaded & unable to concentrate.  Placed head between legs .  At 3 pm given juice, cool cloth to head & laid her back in chair.  Approx 3:15 diaphoretic, P 71, BP 120/76.  3:30 pm ambulated to bathroom became lightheaded again.  Laid back down cold clammy, diaphoretic, pale.  4 pm pt. states she felt better.  Color pink, skin warm to touch.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Hypertension-Severe, Systemic: Neurological Disorder (diagnosed by MD)-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Medium, Additional Details: Immunization delivered at 10:35am, patient threw up at 10:40, throat swelling/difficulty breathing 911 called and 1st epinephrine given at 10:43am, BP 243/128 at 1046am, 2nd epi given at 10:49am, EMTs arrived on scene at 10:52am and patient taken to Hospital ER.
Patients mother reported that child developed a rash all on her body including her face the day after her vaccine. It was very itchy and child wont sleep because of how itchy it is. Seen by pediatrician in office and diagnosed as having varicella. Was prescribed : Acyclovir Hydroxyzine Chlorhexidine Gluconate solution Diphenhydramine Child to be seen by pediatrician in one week
had a severe eczema respond in her body, after her second  dose of the Moderna vaccine, that she has  under control now but not 100 %; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ECZEMA (had a severe eczema respond in her body, after her second  dose of the Moderna vaccine, that she has  under control now but not 100 %) in a 47-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ECZEMA (had a severe eczema respond in her body, after her second  dose of the Moderna vaccine, that she has  under control now but not 100 %). At the time of the report, ECZEMA (had a severe eczema respond in her body, after her second  dose of the Moderna vaccine, that she has  under control now but not 100 %) was resolving.            No concomitant medication information provided.  No treatment medication information provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-614701, US-MODERNATX, INC.-MOD-2022-614693 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-614701:patient J-T US-MODERNATX, INC.-MOD-2022-614693:patient R-J
Information has been received from a consumer concerning her 14 year old female daughter who on 16-OCT-2008 was vaccinated with the first dose of GARDASIL vaccine. On 16-OCT-2008, the patient had heart problems. It is unknown if the patient sought medical attention. At the time of reporting the patient had not recovered. Therapy with human papillomavirus vaccine was discontinued. This is one of two reports from the same source. The patient's sibling experienced severe breathing problems after vaccination with GARDASIL vaccine (MSD WAES 0901USA03777). No further information is available. No further information is available.
This case was reported by a physician via sales rep and described the occurrence of injection site swelling in a 60-year-old female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In May 2018, less than a year after receiving SHINGRIX, the patient experienced fatigue, general body pain, chills and fever. On an unknown date, the patient experienced injection site swelling, injection site pain and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site pain, injection site erythema, fatigue, general body pain, chills and fever were recovering/resolving. It was unknown if the reporter considered the injection site swelling, injection site pain, injection site erythema, fatigue, general body pain, chills and fever to be related to SHINGRIX. Additional details were provided as follows: This case was also reported by a medical assistant. The patient was administered SHINGRIX in the right arm. The patient reported adverse events to physician on 4th May 2018, and sent a picture and description of the following symptoms. The patient had never had a reaction to a vaccine before so did not know if this was significant. The patient felt very tired and achy, with chills (like fever), Wednesday night and most of the day before reporting. The patient felt better so far on the day of reporting. The patient provided the photo of his arm captured on the day before reporting. The swelling had gone down some, but it was redder, whereas in photo it looked more pink. It was still very sore. Website seems to say this was a normal reaction.
COVID dx on 12/29/22, treated with 5 days of Plaxlovid.  (Completed 1/3/23. Resolve of symptoms within 36 hours.   Tested negative for COVID on January 4 and January 6, 2023 Symptoms started again  on January 9 2023.  Tested Positive for COVID and diagnosed with Rebound COVID
5cm x 7cm localized red area to (R) upper thigh - examined by doctor.
Patient reports that she had pain upon injection and continued since then for the previous 5 days. She states that she went to her physician and they diagnosed her with cellulitis.
Information has been received from a healthcare worker referring to unspecified number of patients of unknown age and gender. The patients' medical history was not reported. On an unknown date the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose, route, strength and lot# unknown). No concomitant medications was reported. No adverse effects reported. It was unknown if the patients has sought medical attention. No product quality issue (PQC) was involved. Action taken and outcome were not provided. This is one of several reports from the same source. Additional information has been requested.
I was really sick; coughing; wheezing; Very short on breath; administration date: 30Aug2021 dose number 2/administration date: 23Aug2021 dose number 1; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Aug2021 15:00 (Batch/Lot number: unknown) at the age of 67 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL/HCTZ. Vaccination history included: Bnt162b2 (lot unknown=True,, administration time=03:00 PM, dose number=1,, vaccine location=Left arm), administration date: 23Aug2021, when the patient was 67 years old, for COVID-19 Immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 30Aug2021, outcome "unknown", described as "administration date: 30Aug2021 dose number 2/administration date: 23Aug2021 dose number 1"; ILLNESS (non-serious) with onset 01Sep2021 12:00, outcome "not recovered", described as "I was really sick"; COUGH (non-serious) with onset 01Sep2021 12:00, outcome "not recovered", described as "coughing"; WHEEZING (non-serious) with onset 01Sep2021 12:00, outcome "not recovered", described as "wheezing"; DYSPNOEA (non-serious) with onset 01Sep2021 12:00, outcome "not recovered", described as "Very short on breath". The events "administration date: 30aug2021 dose number 2/administration date: 23aug2021 dose number 1", "i was really sick", "coughing", "wheezing" and "very short on breath" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of illness, cough, wheezing, dyspnoea.  Additional information: The week after last shot she was really sick - coughing and wheezing. Very short on breath. Was put nebulizer treatments. Had to take at least 4 a day just to function. 7 months later she is still taking 2 - 3 each day. The patient informed that they were Unable to locate or read the lot details, No other vaccine in four weeks. Ae treatment included Nebulizer treatments, Prednisone. No COVID prior vaccination  The lot number for bnt162b2 was not provided and will be requested during follow up.
My mother had a heart attack; two heart attacks; hives; three strokes; her cancer came back full blown; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: MYOCARDIAL INFARCTION (death), outcome "fatal", described as "My mother had a heart attack; two heart attacks"; URTICARIA (death), outcome "fatal", described as "hives"; CEREBROVASCULAR ACCIDENT (death), outcome "fatal", described as "three strokes"; NEOPLASM PROGRESSION (death), outcome "fatal", described as "her cancer came back full blown". The patient date of death was unknown. Reported cause of death: "My mother had a heart attack; two heart attacks", "hives", "three strokes", "her cancer came back full blown". It was not reported if an autopsy was performed. It was the reporter's mother had a heart attack, three strokes, two heart attacks and her cancer came back full blown and then the booster made her break out in hives and grow, it looks like men's balls under her chin. It's toxic, It's killing, It killed her.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: My mother had a heart attack; two heart attacks; hives; three strokes; her cancer came back full blown
Information has been received from a Licensed Practical Nurse referring to unspecified patients of unknown age and gender. the patients' concurrent and historical conditions were not reported. The nurse reported that doses of ROTATEQ (dose and frequency were not reported, oral, lot # K004432, expiration date 27-JAN-2016, lot # K014826, expiration date 28-MAY-2016 and lot # K017575, expiration date 01-JUN-2016) which were exposed to temperatures outside of the recommended range, had been administered to unspecified patients on unspecified dates since 18-JUN-2015. Concomitant therapies were not reported. No adverse effects had been reported. This is one of several reports from the same reporter. Additional information has been requested.
2 days after vaccine developed constant buzzing & jittering.  3 days after vaccine to ER for arm numbness & tingling.  7 days after vaccine to ER for dizziness & shortness of breath.  10 days after vaccine saw me in clinic with ongoing tremor/jitteriness.
On February 20, at 12:00 PM, I received my second dose of Moderna Covid 19 vaccine. The next morning, as I was making breakfast, I felt very dizzy and fell in the kitchen bumping my head. I visited my Doctor on February 23 to look at my injuries. He said I have bruised/broken ribs and a subcutaneous hematoma on my forehead. Before receiving the vaccine, I have never experienced dizziness. I still have dizziness many days later. Also the next morning on February 21,2021, my left arm was swollen at the injection site and red and itchy. This has gone away.
Redness and swelling at injection site. Fever of 101.2 with generalized aches. Injection site a dark reddish pink extending towards elbow, 5" in diameter.
A week after a very red swollen rash and lump vaccine site. Still have it. Today  11 days after 1st dose not have swelling and lump under my right eye and cheek and on side in chin. Also redness and itchiness.
DVT and bilateral PE.  Taking Xarelto 20 mg.  Pfizer was my booster.  My original vaccine was J&J
per phone call from MD pt had fever 104 on 2AUG96 & still remains irritable 7AUG96;pt aunt noticed pt warm & a difference in eyes; pt had temp 102;
Sore arms the following day and right arm was red from elbow to the shoulder. M.D. ordered antibiotic.
Patient had a Vasovagal reaction and became dizzy,  light headed and had calmmy skin. Pt laid on the floor and was seen by EMS, but he refused any treatment. Pt was rolled to the side in a wheelchair and given water to drink while being monitored.  Upon feeling better the  the facility being escorted out in a wheelchair by staff and accompanied by his father.