chrisvoncsefalvay/vaers-outcomes huggingface dataset:
large red area at the injection site; small vesicles at the injection site; welt at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site wheal in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number JC453, expiry date 15th February 2022) for prophylaxis.   On 24th January 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 27th January 2020, 3 days after receiving Shingrix, the patient experienced injection site wheal. On 31st January 2020, the patient experienced injection site erythema and injection site vesicles. On an unknown date, the outcome of the injection site wheal was recovered/resolved and the outcome of the injection site erythema and injection site vesicles were not recovered/not resolved.   It was unknown if the reporter considered the injection site wheal, injection site erythema and injection site vesicles to be related to Shingrix.   Additional details were reported as follows: The patient received a dose of Shingrix on the left arm. On Monday, the patient devloped a welt at the injection site. At the time of reporting, the patient came into the pharmacy and she had a large red area at the injection site and small vesicles at the injection site. The area containing the vesicles is approximately 2 inches in diameter.
chills; very dry mouth; 104 fever; sleepy The temperature came down to 100 but got improved after taking Tylenol 3-4 times
Death.   It's not known if pt. died on March 31 or soon thereafter.  His body was found on April 7, but he was incommunicado before that when I tried to contact him over the Easter weekend.   He was found on the floor of his bedroom as if he were getting ready for bed and keeled over.
About 10 minutes after pt received the vaccine, she started to feel dizzy. After that, she developed a racing heart and dry mouth. She has a history of palpitations. EMS was called to evaluate her
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Systemic: Weakness-Mild
pt recvd vax; onset of sneezing, watery blood shot eyes; chills; fever & breathing difficulty;
Started experiencing extreme  hair loss on 4/14/2022 about 2 days after the vaccine . My hair was falling out in clumps and has continued for the past 3  months. Contacted my Dermatologist and she recommended a medical shampoo. The shampoo has not worked to date. MD recommended  taking iron and vitamin C due to anemia. And have been diagnosed with Hair Loss due to a Traumatic Event. I have a  follow up  appointment on  7/25/2022.
shortness of breath; chest tightness; lightheaded and dizzy; This is a spontaneous report from a contactable consumer. This Consumer reported for a 16-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, patient received her first dose of the COVID vaccine. A few minutes after receiving her shot, on an unspecified date she began to feel lightheaded and dizzy. She sat down and continued to complain of chest tightness and shortness of breath. The pharmacist that administered the vaccine called 911 and medics arrived. By this point, she started to feel better and her symptoms went away. She did not receive any treatment and she was doing fine. The outcome of all events was recovered on an unspecified date.  Follow-up (25Jun2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Widespread, itchy rash that comes and goes. Has lasted 5 days so far.
Large local rxn 4" in size characterized by pain, swelling, inc warmth, induration.
MUSCLES OF UPPER BODY (NECK, SHOULDERS, ARMS AND BACK, NOT SO MUCH LEGS) GETTING VERY HOT/WARM, PERIODICALLY AND SPORADICALLY; STIFF MUSCLES OF UPPER BODY (NECK, SHOULDERS, ARMS AND BACK, NOT SO MUCH LEGS); HANDS (SPECIFICALLY IN JOINTS) FELT SWOLLEN AND VERY DIFFICULT TO MAKE A FIST; STIFF UPPER BODY JOINTS; LIMITING BOTH SIDES OF THE UPPER BODY; UPPER BODY JOINTS VERY ACHY; ACHY MUSCLES OF UPPER BODY (NECK, SHOULDERS, ARMS AND BACK, NOT SO MUCH LEGS), PERIODICALLY AND SPORADICALLY; FEELING WEAKER; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was a very active person. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 17-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On OCT-2021, the patient experienced muscles of upper body (neck, shoulders, arms and back, not so much legs) getting very hot/warm, periodically and sporadically, stiff muscles of upper body (neck, shoulders, arms and back, not so much legs), hands (specifically in joints) felt swollen and very difficult to make a fist, stiff upper body joints, limiting both sides of the upper body, upper body joints very achy, achy muscles of upper body (neck, shoulders, arms and back, not so much legs), periodically and sporadically, and feeling weaker. Laboratory data (dates unspecified) included: Blood test (NR: not provided) all normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stiff muscles of upper body (neck, shoulders, arms and back, not so much legs), upper body joints very achy, achy muscles of upper body (neck, shoulders, arms and back, not so much legs), periodically and sporadically, muscles of upper body (neck, shoulders, arms and back, not so much legs) getting very hot/warm, periodically and sporadically, hands (specifically in joints) felt swollen and very difficult to make a fist, feeling weaker, stiff upper body joints, and limiting both sides of the upper body. This report was non-serious.
Approx 25 minutes following administration of 2nd dose of Pfizer COVID vaccine, patient reported feeling dizzy and increased work of breathing, as well as swelling of the back of her tongue. Rep. Rate 22-24, O2 sat 98% on Room Air. Denied hoarseness or cough at that time, but Epi 0.3 given and Rapid Response called due to patient reporting continued swelling of back of tongue in the 5 minutes I was with her.
Sensation in my arm like when I first got the shot and it was bleeding; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Sensation in my arm like when I first got the shot and it was bleeding) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Sensation in my arm like when I first got the shot and it was bleeding). At the time of the report, VACCINATION SITE HAEMORRHAGE (Sensation in my arm like when I first got the shot and it was bleeding) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant product is not provided. Treatment is not provided.
This is a spontaneous report received from a contactable consumer or other non-HCP (patient's parent) for a Pfizer sponsored program (005570). A 26-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), Apr 2021, single dose, for COVID-19 immunisation. Medical history included autoimmune disorder (unspecified if ongoing). The patient's concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), single dose, for COVID-19 immunization. The following patient experienced urticaria/she broke-out in head-to-toe hives (hospitalization) onset Apr 2021, with outcome of recovered. Therapeutic measures taken as a result of urticaria  included Benadryl. Additional information: Her neurologist was also made aware but had no recommendations. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
vision loss; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient (pt) of unknown age. No information regarding the pt's pertinent medical history, drug reactions or allergies, and concomitant medications was provided. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, dose number, route of administration, anatomical site of vaccination, lot number and expiration date were not provided), for routine health maintenance and for the vaccine intended purpose: prevention of shingles (herpes zoster). On an unknown date, shortly after receiving the zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered from vision loss. As a result of these symptoms, the pt was seen and treated by medical providers, and at the time of the report, the pt was still under their care. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using the zoster vaccine live (ZOSTAVAX). The pt also experienced mental and emotional distress due to physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of the zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the zoster vaccine live (ZOSTAVAX) use, 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. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) use, the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered as not recovered. The reporter assessed that the event was related to the zoster vaccine live (ZOSTAVAX).  The reporter considered the event of vision loss to be disabling. Upon internal review, the vision loss was considered to be medically significant.
PARALYSIS; This spontaneous report received from a consumer via social media  through a company representative concerned a female of an unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and and expiry were not reported) dose, start therapy date were not reported, 1 total for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced paralysis. Reporter stated that "I personally know of 7 cases of paralysis of which one is my neighbors daughter in law". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of paralysis was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220548149, 20220548194 and 20220548524.; Sender's Comments: V0: 20220547591-covid-19 vaccine ad26.cov2.s- paralysis . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Severe joint pain in left arm/elbow, have lost 90% of strength in that arm, unable to lift with it any longer -12 days after injection
Appx 8-10 minutes after vaccine administration, a medical provider witnessed patient become unconscious and then experience 15-20 seconds of seizure activity. Patient did become coherent, EMSA was called, and patient was transferred to the ER for further work up.
Pt began feeling "tingling" on her back within 24 hrs. Got much worse and definite rash appeared in a square on lower back. Very painful by 4/29/14. On 4/30 went to MD and diagnosed shingles. Began VALTREX 1g three times daily x 1 week. Pt using ice/heat for pain. Rash appeared 4/28.
10/16 Immediately or with 5 minutes after getting shot had neck pain, nausea. Approximately neck pain continued off & on worse in the night - nauseated in the night no emesis. Pain at injection site and kinda the upper arm. Felt good on Wed 10/17. Took ADVIL. Night of 10/17-18 felt tenderness in my Rt armpit. In AM noted 8cm soft lump in the Rt axilla. Has happened with previous flu shots. No other time.
Mononucleosis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the parent.  A 18 year-old female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Batch/Lot number: unknown) at the age of 18 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFECTIOUS MONONUCLEOSIS (non-serious) with onset Mar2021, outcome "unknown", described as "Mononucleosis".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Immediate histamine response with this one just like the first 2 doses. This time I got a very bad cough that interrupted my sleep and was causing a bad mucus to build up. I did go to the doctor for this one as well but there was nothing they could do. I also had horrible leg pain like someone had taken a meat tenderizer and banged up my lower back all the way to the bottom of my legs. The headache and not being able to stay awake was much worse than the first 2.
Got 2nd dose past 42 days; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got 2nd dose past 42 days) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 026A21A) 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 11-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got 2nd dose past 42 days). On 11-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got 2nd dose past 42 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication details not  reported. Inappropriate schedule of vaccine administered.   Reporter did not allow further contact
Patient received flu shot-9-26-16-In left arm. Day after shot, started having pain in left arm and proceeded to shoulder joint. Two days later developed numbness in left side of neck and numb spots in head. Symptoms stopped in neck and back of head and proceeded to other spots of head with headaches in forehead and still numb spots in head and then became lightheaded and confused and real nervous  (jitters) and unable to think clearly. Followed by irritable and been very very tired. Had to lay down several hrs. everyday, feeling very very bad. Consulted Physicians-10-7-16-For aches and pains. Received medications for six days. After six days-retuned to Physicians again-10-12-16,medications for six more days. Symptoms still there. Contacted Physician by phone and was instructed to take TYLENOL and rest. Symptoms are still continuing. We are concerned about our health and long term effects.
Itchy rash and hives starting 4 days after vaccination. Rash/ hives from neck to groin and down the upper extremities , but effects the scalp and neck.  Pt was seen on 10-13-05, the 3rd day of the hives.  Treated with Claritin 10 mg during the day or Clarinex 5 mg. Benadryl 25-50 mg at night for sleep and to reduce itching.
Patient jerked away during IM administration of FLUZONE HIGH DOSE vaccine.  Stated it felt like I "hit a nerve" and felt immediate jaw pain that quickly subsided.
Received FLUZONE U3176FA on 9/29/2009. Developed itch rash on abdomen, 10/2 which spread 10/3 and 10/4 to back, arms, chest.
Pt developed urticaria and pruritus after vaccine of IPV and MMR. No Resp Distress. Did vomit multiple times.
Pt died 1/29/22 Septic shock with Proteus  mirabilis bacteremia/pneumonia versus line infection/ on Neo/Vaso/Levo/Epi drips/Metabolic acidosis.   Acute liver failure with  Worsening encephalopathy and coagulopathy and Thrombocytopenia   Severe volume overload/anasarca Severe liver dysfunction due to TPN  Severe anemia  Prognosis was dismal. Family made pt a DNR
This spontaneous report as received from a Registered Pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with an improperly stored ZOSTAVAX. No adverse effects were reported. Additional information has been requested.
patients received FLUZONE QIV NP from pre-filled syringes after a temperature excursion with no reported adverse event; temperature excursion involved a low temperature of 29F with no reported adverse event; Initial information received on 26-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2022SA408679, 2022SA410140, 2022SA409520, 2022SA409928, 2022SA410163, 2022SA410177, 2022SA410116, 2022SA409707 and 2022SA409694.  This case involves an unknown age and unknown gender patient who received  INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] from pre-filled syringes after a temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Sep-2022, temperature excursion occurred and involved a low temperature of 29.0 F (Fahrenheit) and the total excursion time was for 45 minutes with no reported adverse event (product storage error). The cause of the temperature excursion is unknown and doctor states that the alarm usually sounds but did not in this case.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE, Suspension for injection from pre-filled syringes (dose, strength, expiry date: unknown) lot UT7689LA via unknown route in unknown administration site for prophylactic vaccination after a temperature excursion with no reported adverse event (poor quality product administered) (latency: same day)   Doctor states that 12 patients received FLUZONE QIV NP from pre-filled syringes after a temperature excursion occurred on 23-Sep-2022, including 4 pediatric patients and 8 adults.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.   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 the guidelines. 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.
Soreness; Fever; Right elbow swelled up like a sac of fluid is in my elbow; It is quite a large lump and and size is more closer to a tennis ball; It is three-quarter of size of a tennis ball and it is full of fluid; This is a spontaneous report from a contactable consumer. An 87-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose via an unspecified route of administration, administered in Arm Left on an unspecified date,single dose for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included atenolol, other medicines were itch medicine, thinks it is 'Hydrocortisone', patient doesn't remember the name of it (consumer was not sure) and patient uses inhaler, it is 'Dulera', twice a day and  'Hydroxyzine' or whatever it is , it is also twice a day (not clarified). Patient had soreness and fever or whatever and all of a sudden, patient thinks on March 6th (not clarified), patient's right elbow swelled up like a sac of fluid is in my elbow. Patient doesn't know if it is related. After two days, patient started getting swelling in my right elbow. Patient got the shot in left arm but the swelling is in my right elbow. It is just unusual patient never had anything like this. It is almost like I don't know like there is  water inside or whatever it is, it is quite a large lump and and size is more closer to a tennis ball but it is not that large. It is like the size of a tennis ball and it is on my right elbow. Patient tried to see doctor today but patient never experienced anything like so patient doesn't know what is going to happen. It is persisting, it just swelled up like its not large as of tennis ball but it is three-quarter of size of a tennis ball and it is full of fluid. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Malaise, nausea, headache, flu like symptoms, chills, hot, pain at site
At time of injection she didn't even feel the vaccine given.  States she got a bit dizzy at 0830 when she left, but has had dizzy spells in the past and was going to push through it and decided to leave. At 0845 at work she had what she described as "wave of dizzieness and feeling like I'm going to pass out." She tried to sit and drink some water, go outside for fresh air, but was unsuccessful in feeling better. She called her significant other to drive her back into the vaccination clinc and arrived at 0900. Was brought into a room, and given some water an told to sit and rest. Frequent checks on pt. States every 4-5 minutes the waves of dizzieness hit, but not getting worse and did not have a syncopal episode.
Approximately 1 hour after getting my second vaccine I began feeling tingling and numbness on the right side of my face. The next morning my right eye was irritated. I thought I had some allergy irritant affecting it. My eye continued to get worse through the week as the eye swelling got worse, the eye was itching/burning and was developing small spots on the eyelid. I contacted Dr's office and was told it was a shingles like virus. She put me on an antiviral medication for 2 weeks. The eye cleared up to a point, but I have had ongoing issues with it. I have repeated the antiviral medication again recently with some of the same symptoms. However, this week, I am having new issues with my right eye. It is having pain constantly, pressure behind my eye, burning, itching and pain in my temple and below my eye. I went back to Dr. 8-11-21 at which time she preformed eye scans, vision test and blood work. I was informed by her this morning I could possibly have Giant Cell Arteritis. More tests to follow next week to recheck. She also said my cataract has grown that she did not see before.