chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm) and fatigue (tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 030A21A and 074M20A) for COVID-19 immunization. No medical history reported. Concurrent medical conditions included abnormal blood pressure. On Feb 2, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 4, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 4, 2021, patient experienced pain in extremity (sore arm) and fatigue (tired). At the time of the report, pain in extremity (sore arm) and fatigue (tired) outcome: unknown. Concomitant medication included blood pressure pills. No treatment medications provided. This case linked to MOD-2021-417532, MOD-2021-417565 (patient link).
He got his vaccine, and mother had talked to his girlfriend said that he felt fine other than a sore arm.  He called his mother and told her that he was sick to his stomach with cramps and that he was throwing up blood.  The girlfriend found him on the floor on the 21st dead on the floor in his hotel room at 8:00 AM.  The girlfriend said she had spoken with him around 10:00 PM and that he said he was going to sleep on the floor in the bathroom as he was throwing up and the floor was cool.  She subsequently found out that he was throwing up blood, and autopsy report showed that his stomach was full of blood and further testing is being done to see what has caused the bleeding.
Stated that immediately after injection had pain radiating down arm and into shoulder and remained very tender.  Stated was unable to sleep on it at night due to pain. C/o of NO redness at injection site.  Had low grade temp 99 on 8/17 at Drs office. 8/20 no redness seen at injection site but still c/o of pain in right arm.
This case was reported in a literature article and described the occurrence of anaphylaxis in an adult male subject who was vaccinated with Hepatitis B vaccine (manufacturer unspecified). Concurrent medical conditions included allergic rhinitis, allergy to DAPSONE, asthma, coronary artery disease, dermatitis and obesity. On an unspecified date, the subject received unspecified dose of Hepatitis B vaccine (unknown route, unknown lot number). 15 minutes after vaccination with Hepatitis B vaccine, the subject experienced anaphylaxis, respiratory arrest, cardiovascular collapse, loss of consciousness, shortness of breath and diaphoresis. The subject was treated with EPINEPHRINE and ATROPINE. The subject died, cause of death is not specified. It was unknown whether an autopsy was performed. The case could have been an acute coronary event. Initial case was retrieved from the scientific literature on 08 June 2011. The National Vaccine Injury Compensation Program (VICP) was established in 1986 in response to vaccine safety concerns. A unique feature is a table of compensable injuries, the Vaccine Injury Table (VIT). Anaphylaxis is a listed adverse event with an interval of 0 to 4 hours for several vaccines. In 2009, the VICP charged the Institute of Medicine with the task of completing a comprehensive review of the medical literature regarding adverse events related to vaccines so that the VIT could be updated. Concurrent with the Institute of Medicine's review, we undertook a systematic analysis of the VICP''s anaphylaxis case experience. The VICP administrative database was queried for all cases submitted to the VICP alleging "anaphylaxis or anaphylactic shock" for the 10-year period from January 1, 2000, through December 31, 2009. Cases were categorized as anaphylaxis, possibly allergic-not anaphylaxis, and not anaphylaxis or allergic. The anaphylaxis cases all met the Brighton Collaboration (BC) case definition and were further subdivided into 3 levels of diagnostic certainty using  major and minor criteria, with level 1 being the greatest level of certainty. Possibly allergic cases were defined as those for which there were signs and/or symptoms compatible with an allergic reaction occurring within 4 hours of injection but that did not meet any of the BC case definitions for anaphylaxis. All of our anaphylaxis cases met the BC diagnostic certainty and, with an interval of 0 to 4 hours, are consistent with the current VIT. This case was classified at level 1 of certainty. This review represented the first systematic approach in analyzing the VICP experience with anaphylaxis and will be useful when the VIT is updated. This was one of 9 cases reported in the same article and represented 8 different vaccines containing at least 11 different vaccine antigens.
Information has been received on 27-NOV-2018 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 16-SEP-2015, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 14-NOV-2016 and 18-NOV-2016, the patient was treated by a physician and a healthcare provider at a physician's office and an eye institute for shingles and shingles around the eyes respectively. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is unknown. The causality of the events is related. Upon internal review, shingles around the eyes was considered to be medically significant. Additional information has been requested.
This case was received from a consumer on 27 March 2008.  A 53-year-old female patient, with a history of restless legs syndrome, received a right deltoid intramuscular injection of FLUZONE (lot number U2489AA) on 08 February 2008.  On 13 February 2008, she complained of flu-like symptoms including fever, chills, and severe headache.  The patient recovered on an unknown date.  The reporter for this case also reported an event for the patient's sister following FLUZONE administration.  That report, which included the serious events of optic nerve edema, blurred vision, vision disturbance, dilated pupils, and headache, is captured in case number 2008-00893.
Pt vaccinated with FLU developed induration & erythema w/pain at injection site approx 7 days after injection. Was referred to ER by PMD for evaluation. Aspiration was attempted;no aspirant. Dx: localized reaction to vaccine.
Tinnitus, Moderate to Severe: affecting sleep, ability to hear voices of family and coworkers, other sounds were loud and abrasive. Treatment: Hearing Aids with a tinnitus program, ongoing Outcome: After 9 months of treatment, the tinnitus is decreased, but not gone.
A 60-year-old female reported that she received pneumococcal polyvalent (manufacturer unknown) and influenza virus (manufacturer unknown) vaccines on 10/04/2002.  The following day, she developed an injection site reaction characterized by swelling, redness, and soreness.  The patient also experienced chills, nausea, a headache, coughing, arm cramping, and sore throat.  She was seen in an emergency room where she was treated with an unspecified steroid and instructed to apply ice to the injection site area.  Approximately 1 week later, the patient was seen by her physician who prescribed a "cough medicine".  Results of a chest x-ray "found nothing clinically significant".  As of the date of this report, the reporter states that her "arm is still tender and will cramp occasionally" and that the nausea, sore throat, and cough have not resolved.  This is 1 of 2 patients from this facility who had an adverse experience following receipt of Pnu-Imune 23 vaccine.  See MCN HQ4898728OCT2002.
Information has been received from a medical assistant referring to a 4 month old female patient. No relevant medical history or concurrent conditions were reported. On 11-JUN-2015, the patient inadvertently vaccinated with improperly stored ROTATEQ (lot # K014826, expiration date 28-MAY-2016; dose was not reported) orally. No adverse effects were reported. This is one of several reports received from the same reporter. Original report is MARRS#1507USA011322. Additional information has been requested.
BLISTERING AND PEELING OF SKIN, LESIONS ON FACE AND NECK OOZING, DRAINING AND CRUSTING, GENERALIZED PRURITUS, BURNING SKIN, CRAWLING FEELING ON SKIN, GENERAL MALAISE, POLYARTHRALGIA, POLYMYALGIA, EXTREME FATIGUE AND DISCOMFORT, HEADACHES.
Pt. stated she had some symptoms following a flu shot 7 years ago.  Her doctor, recommended getting the covid vaccine. She saw him last week . About 10 minutes after administering the vaccine, patient exhibited specific signs of not feeling well. She stated her throat felt a bit itchy and getting hard to swallow the saliva. Vital signs were taken often (per Dr.); 5-10 minutes post vaccine:  5 minutes  to 10 minutes: 134/83 96/18/98.5; 15 minutes post vaccine: 144/85 95 19; )2 sat 100%; 30 minutes post vaccine: 145/85 95/99/19; 45 minutes post vaccine: 188/102 100 99%; manual BP 45 minutes post vaccine: 184/90 103 99% l 1 hour post vaccine: 136/78 92 18 99%
fatigue, sore arm, chills, dizziness fatigue and sore arm gone by Monday after the shot Dizziness intensified and remains,
This spontaneous report as received from a nurse refers to a female patient of unknown age. No information about medical history, concurrent conditions was reported for the patient. The reporter stated that the patient completed series of hepatitis B vaccine (manufacturer unknown) (dose strength, frequency unspecified) intramuscularly on an unknown date in 1996. On 12-JUN-2015 the patient was vaccinated with an additional dose of hepatitis B vaccine (manufacturer unknown) (dose strength unspecified) intramuscularly for nursing school although she did not have any titers drawn. No adverse effects reported. The outcome of the events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Patient received their first dose of the Pfizer COVID-19 vaccine in their left deltoid intramuscularly. Patient was advised about the 15 minute recommendation to stay at pharmacy for observation after vaccination. Approximately 20 minutes after vaccination at 5:00, patient returns to pharmacy complaining of extreme itching on her back and legs. I saw redness and raised irritation on her back. I advised patient to sit. I spoke to her and mom and got their consent to give 1 dose of 25 mg Bendadryl (diphenhydramine) by mouth to patient. EMS were called. At 5:30 patient began complaining of "trouble breathing." No wheezing was observed but patient said she could not breath. Epinephrine 0.3 mg was administered to right thigh at 5:33 pm. Immediately pt said she was feeling better however a few minutes later she again said she, "has trouble breathing." A second dose of Epinephrine 0.3 mg was administered at 5:38 pm on the left thigh, 5 minutes after her first dose. EMS arrives at 5:43 pm. All medications administered and times given were provided to EMS as well as a synopsis of situation. Patient will be taken to hospital downtown. Patient alert at time of departure. Pulse ox from EMT showed 100.
Ha ve broken out in hives starting with ears, back of neck, face, arms . torso.   legs are the only part of  my body not affected.   Have received steroid shot at doctors office, and followed by a week steroid pack, however i am still itching  BAD>
they both tested positive for COVID-19.; they both tested positive for COVID-19.; losing weight; had a slight fever of 102; both lost their sense of smell and taste; both lost their sense of smell and taste; coughing; sneezing; chills; common cold; This is a spontaneous report from a  support program. This Consumer (patient's wife) reported for male patient.  A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: EW0171), via unspecified route of administration, in left arm on 13Aug2021 (at the age of 38-year-old) as a dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication were not reported. Patient had not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Reporter stated that her husband was tested positive for COVID on 07Sep2021. The test was between 4-5 days ago though. Patient was tested negative on 31Aug2021. Reporter knew that patient had it and at home test came back positive. The reporter also stated that about a week after their first doses they both tested positive for COVID-19. They were due for their second dose on 03Sep2021. The caller queried if it was safe to receive their second dose since they tested positive for COVID-19 after receiving their first dose. The reporter also mentioned that on unspecified date her husband's weight could be less, he has been losing weight like crazy and they felt like they just had a cold. They had coughing, sneezing, and chills; her husband had a slight fever of 102. Reporter stated that they both lost their sense of smell and taste. She said that it felt like they had the common cold. She stated that she can't get rid of the cough. The caller and her husband were seen by the physician over the phone and were both prescribed a Z-Pak. Patient had not attended any emergency Room and physician Office for the events reported. The outcome for all the reported events was unknown.
Large redness at injection sight and a circling around arm. Phone call from parents at approx. 1:40pm. Asked that patient come in so we could look at presenting symptoms. Above noted what was seen.
Patient reports having deafness in left ear (unclear exact date of onset) after first Shingrix injection. Patient visited a doctor in a different network and was prescribed oral prednisone (dose and length of treatment unknown).  Patient says deafness resolved in after a total of 9 days.
Localized rash at site of injection. Covered, inform MD - caution: Avoid contact w/ infant - pregnant persons- immunosuppressed persons.
About 15 minutes after the injection employee reports her throat began feeling tight and she was having some trouble swallowing.
Pt c/o fatigue from ITP that increased after shots. She traveled to wedding which took place 8/30. She developed an itchy rash with hives at that time that continued. She went to ER facility on evening 9/5. They prescribed cephalexin for infected foot from injury. Symptoms have improved since that time. She is anticipating splenectomy in near future (that was the reason her Dr referred her here).
Patient started making growling noises. Other customers observed him become rigid, then loose consciousness and slide from chair to knees on floor. I was called. The patient seemed to be unconscious. I  lowered him to the floor, and called 911. I started talking to him. He regained consciousness and was able to speak with me after 1 minute. Patient was also incontinent of bladder. 911 arrived after approximately 5 minutes. They came and took patient to the hospital for evaluation.
got a flu shot which has 40% effective rate and paient still get the flu; got a flu shot which has 40% effective rate and paient still get the flu; Initial information was received on 07-Dec-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient of unknown age who got a flu shot which has 40% effective rate and patient still get the flu (influenza due to therapeutic product effect incomplete), while patient was treated with influenza vaccine.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient got a flu shot which has 40% effective rate and patient still get the flu (influenza due to therapeutic product effect incomplete).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the events was unknown.  There will be no information available regarding batch number in this case.
Losing her voice after receiving the second dose of Moderna COVID-19 vaccine; Chest pains; Diarrhea; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (Losing her voice after receiving the second dose of Moderna COVID-19 vaccine), CHEST PAIN (Chest pains), DIARRHOEA (Diarrhea) and ARTHRALGIA (Joint pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No historical condition was reported.).   On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced APHONIA (Losing her voice after receiving the second dose of Moderna COVID-19 vaccine), CHEST PAIN (Chest pains), DIARRHOEA (Diarrhea) and ARTHRALGIA (Joint pain). At the time of the report, APHONIA (Losing her voice after receiving the second dose of Moderna COVID-19 vaccine), CHEST PAIN (Chest pains), DIARRHOEA (Diarrhea) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter.  Treatment for the event included steroids.
I started noticing the normal symptoms after the vaccine the same day of vaccination-- swelling in my left arm, a rash that hurt, and a headache. The rash went away but the headache lasted for two months. I took migraine medicine--Tylenol, ibuprofen, I laid down, everything. The headache was so bad, it messed with my vision. The headache went away, but then body pains appeared in my neck, back and hand. I went to the doctor, and they increased my normal prescription from once to twice a day. I then started having abnormal tingling in my fingers in my left hand. As time went on, over the next month, the tingling went into both of my hands and they started swelling and hurting, I could no longer drive. It felt like glass was stabbing my hands. It began spreading to my ankles, they swelled as well. It felt like my fingers and feet had been burned and felt raw. I noticed my vision began to blur significantly, I already had astigmatism, but it progressively got worse; my memory was shot, and I couldn't speak normally anymore. I went to my PCP; I was referred to a rheumatologist, neurologist, and other specialists who one prescribed me Gabapentin 300mg 3x a day. That didn't help anything either. They ran MRI, CT scans, x-rays, arthrogram, and EMGs done to help properly diagnose me. After seeing several neurosurgeons, neurologists, and rheumatologist-- I was then diagnosed with fibromyalgia (not specifically diagnosed with what kind, but Lupus was ruled out).
Light-headed, dizzy and felt like her tongue was very swollen after her first dose. Not to the point where she was unable to breath. Then she was "exhausted" the remainder of the day. She did not say how long her tongue was swollen, but it happen 5-10 minutes after her first dose. She recieved her second dose with us and The Pharmacy. She did not have any reaction within 30 minutes of the second vaccine. She was sent home with Benadryl just in case. Second dose recieved 5/3/21.
Injection 4/23/12. AM of 4/24/12 pt reports fever, chills, mild flu like symptoms. 4/25/12 pt arrives at clinic with 5 x 6" area of redness pain, swelling and hot to the touch on (R) arm at injection site. A febrile at this time.
Patient received vaccine in exam room and then passed out in waiting room; we stabilized her, took a BP, and let her lie down for 10 minutes.
mild-to-moderate air traipping 5mm nodularity in the left lung apex is new from prior scan
Several hours after receiving the vaccine  Pneumovax the patient visited an Emergency room. She experienced severe symptoms on the right side of her body: Swelling, numbness, difficulty moving. She also recived flu vaccine from another provider on the same day. The swelling on her arm was located by the site of of Pneumococcal injection.
Body aches began 7 hours after flu shot. Dizziness and slight nausea as well. Fever began 9 hours after flu shot. Still experiencing headache following morning (now) at 10 am.
received Janssen vaccine on 3/5/21 Tested positive for COVID-19 by PCR on 6/13/21
cardiac stents; unspecified surgeries; received the first dose 12/2019 / has not yet received her second dose; This case was reported by a consumer via call center representative and described the occurrence of coronary stent placement in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced coronary stent placement, surgery and incomplete course of vaccination. On an unknown date, the outcome of the coronary stent placement, surgery and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the coronary stent placement and surgery to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient voluntarily stated about her history but dates were unknown in relation to the 1st Shingrix dose as having cardiac stents and history of unspecified surgeries. The patient had no lot and expiration date. Till the time of reporting patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
REACTION 1- Within two hours of vaccine, experienced itchy face and scalp, took 2 Benadryl pills; symptoms gone next morning  REACTION 2- Within eight hours of vaccine, experience feeling of heat on top of scalp, took 2 additional Benadryl pills; symptom gone next morning  REACTION 3- Within sixteen hours of vaccine, experienced soreness in arm at injection site; symptom lasted three days  REACTION 4- 11 days after injection, red whelp appeared at injection spot (measured 1 inch by 1 inch);  day 12, whelp was larger and hot; day 13 whelp was same size and hot (measured 2 inches wide and 4 inches long), day 14 whelping completely disappeared; no fever or other symptoms at anytime during this weekend event, did not take any Benadryl
Irregular menstrual periods (15-25 days menstrual cycles) after getting the COVID-19 vaccine. In addition, swollen lymph node for 6 months now, at the left side of the neck.