chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving flu vaccine on 10/4/13 began "breaking out" with generalized wheals and itching the night of 10/08/13, "all over except palms of hands and soles of feet". Taken to local ED by husband. Received steroid inj, BENADRYL while in ED, stayed for 4 hours. Discharged home with steroid dose pk/BENADRYL. Wheals/itching lessened but not go away. Went to PCP 10/10/13; sent to dermatologist same day. Biopsy of wheal in arm performed. On 10/24/13 was informed by dermatologist "allergic to flu vaccine". The pt. also reported, "on 10/16/13 and 10/17/13 started vomiting repeatedly". Pt. presented to her PCP, on 10/18/13, subsequently hospitalized with diagnoses of "dehydration and kidney failure". Was transferred by ambulance on 10/20/13 to another hospital, remained hospitalized there until 10/22/13, where upon she was discharged home. While talking via telephone to pt today, 11/14/13, day the pt. reported adverse event to Health Dept., pt reports she is continuing to experience "itching" on her back. Continues to take BENADRYL daily.
55 yr old arrived to medical room escorted by employee, pt was a/ox4 and c/o of tingling in tongue and lower lip. Pt had received her 2 dose of the moderna vaccine in her RT arm. Pt was brought into the medical room and sat on stretcher. Pt vs were taken and bp was 166/95, hr was 73, resp 18, spo2 was 97% ra. Pt rested in room for 15 mins and her last set of vs improved. Bp was 143/99, resp 18, hr was 72, spo2 was 96% ra.  Pt felt better and signed a refusal to be transported to er. Pt was released by provider to observation area and pt checked out.
developed urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (developed urinary tract infection) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included Chronic kidney infection. Concurrent medical conditions included UTI. Concomitant products included AMIODARONE, ESCITALOPRAM OXALATE (LEXAPRO), snythroid, RIVAROXABAN (XARELTO), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12), cranberry pill and TRANEXAMIC ACID (XANEXTRA) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced URINARY TRACT INFECTION (developed urinary tract infection). The patient was treated with CEFALEXIN (CEPHALEXINE) at an unspecified dose and frequency. At the time of the report, URINARY TRACT INFECTION (developed urinary tract infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Additional clarification about UTI and medical history
shingles; Information has been received from a lawyer and the patient regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided.   In 2016, the patient (pt) was vaccinated by a pharmacist with zoster vaccine live (ZOSTAVAX), (lot# and route unknown) for long-term prevention of shingles and zoster-related conditions.  Subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt experienced shingles (date unspecified) and was treated by a health care professional, and was hospitalized due to the event (date unspecified).  As a direct and proximate result of pt use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was considered as not resolved.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
received the first dose of the Moderna vaccine they got COVID; had to wait 90 days until they received the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (received the first dose of the Moderna vaccine they got COVID) and PRODUCT DOSE OMISSION ISSUE (had to wait 90 days until they received the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (received the first dose of the Moderna vaccine they got COVID) and PRODUCT DOSE OMISSION ISSUE (had to wait 90 days until they received the second dose). At the time of the report, COVID-19 (received the first dose of the Moderna vaccine they got COVID) and PRODUCT DOSE OMISSION ISSUE (had to wait 90 days until they received the second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were reported.
Approximately one month after receiving COVID vaccine I started having pain in my back and across my buttocks area. After seeing doctor I have had X-ray and MRI of back to find arthritis. I never had pain in my back before this. Also feeling shortness of breath at times. Am still suffering with back pain.
This spontaneous report as received from a physician via a field representative referred to a male patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot#, dose/frequency, route and duration were unspecified) for shingles vaccination. Then the patient experienced irritation, swelling, redness and tenderness at the injection site on an unknown date. The outcome of irritation, swelling, redness and tenderness at the injection site were unknown. The relatedness of irritation, swelling, redness and tenderness at the injection site were unknown for ZOSTAVAX. This was one of several reports that received from the same source. Additional information is not expected.
The official diagnosis was cellulitis imposed on Shingles. I was hospitalized for 3 days with antibiotics given and acyclovir for Shingles.
pt recvd vax & devel elevated liver enzymes following vax w/Hep B; No further details were provided;
9/20/12 at 11:15am Tdap and influenza vaccines administered to patient. Patient began c/o feeling "jerky", throat tight, feeling as though she was going to "pass out". Assessment revealed: flushed face, no swelling of throat; no loss of consciousness. BP 103/78, P 62, R 24. EMS 911 notified and patient was transported via ambulance at 11:28am to ER.
Chills, fever, body ache, headache, sweating, teeth/gums sore and sensitive.
Pt with Hx radiation to skin years ago for mycosis fungoides, was given ZOSTAVAX in right arm -sq- 7/24/2009. Two days later she complained of pain at the site and had a warm raised slightly tender area that was 6 1/2 cm x 4 cm. Pt treated it with oral BENADRYL. Five or six days after the vaccination she noticed one blister and by 8 days pt had 6-7 blisters noted in that area.
The patient has a shingles rash underneath the right side of his chest wrapping around to his spine.  The rash is blistered but he has not complained about itching.  PAtient still has injection site pain on his left arm after 4 days from getting the shot.  Current the patient will be seeing Dr tomorrow on 05/10 for treatment
feels crappy; fatigue; nausea; pain at the injection site; headache; fever of 102; slept 18 hours; light-headed; arm swelling,swelling on arm bigger than silver dollar; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept 18 hours), DIZZINESS (light-headed), PERIPHERAL SWELLING (arm swelling,swelling on arm bigger than silver dollar), FEELING ABNORMAL (feels crappy) and PYREXIA (fever of 102) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hysterectomy. Concurrent medical conditions included Lymphoma.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced SOMNOLENCE (slept 18 hours), DIZZINESS (light-headed), PERIPHERAL SWELLING (arm swelling,swelling on arm bigger than silver dollar), PYREXIA (fever of 102), NAUSEA (nausea), VACCINATION SITE PAIN (pain at the injection site) and HEADACHE (headache). On an unknown date, the patient experienced FEELING ABNORMAL (feels crappy) and FATIGUE (fatigue). At the time of the report, SOMNOLENCE (slept 18 hours), DIZZINESS (light-headed), PERIPHERAL SWELLING (arm swelling,swelling on arm bigger than silver dollar), FEELING ABNORMAL (feels crappy), PYREXIA (fever of 102), FATIGUE (fatigue), NAUSEA (nausea), VACCINATION SITE PAIN (pain at the injection site) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient states that she is on a lot of psychological medicines. Treatment information was not provided.   This case was linked to MOD21-075908 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: No specific follow-up information recorded.; Sender's Comments:  MOD21-075908:follow up
Upper respiratory: Cough/Phlegm producing General feeling of malaise Swollen (L) Lymph node (Submandibular) All symptoms coming to a  head ~ (2) weeks post second shot
On 02/14/01, the mother noticed the patient was really sluggish with fever. On 02/15/01, the patient began bruising by just touching things. On 02/16/01, the patient saw the MD. the patient was admitted to the hospital diagnosed with severe ITP crisis. The patient had severe petechiae all over his body. The patient was given 2 rounds of gamaglobin. Discharged on 02/19/01, from the hospital. The MD said he was unsure if S/P vaccines or maybe vaccine overload. He will be followed up in 1 year. The 60 day follow-up states the mother says that the child still has bruising and feeling sluggish. Lab was done 1 week ago (platelet count 70,000). Has appointment in Aug. with pediatric oncologist. If platlet count is still low will do bone marrow aspiration. The follow up received on 6/2/01 states "our first OV with pt was 2/16/0. Pt has not been given any vaccinations in this office."
Pain when movement and pressure on arm. Much more intense upon wakening. The pain level has not subsided since onset.
Woke up with soreness in muscle where shot was given, felt like was working out all day yesterday. Feeling feverish, very lightheaded and dizzy with headaches behind the eyes. Felt like a bad cold or flu.
Patient received the influenza vaccination on 10/24/2005.  She work up that evening with red welts and burning and itching on her left arm around the site of the injection.  The next day she developed welts and generatlized itching in the groin, anal area, back and bilateral arms.  Had three episodes of shortness of breath which prompted breathing treatments which helped the symptoms resolve.
Child c/o headache approx 2 hrs after immunizations. H/A worsened throughout the day and became excruciating by 6pm (8 hrs post shots). Child was crying and holding head. Given liquid Advil with slight relief. Child c/o HA until she fell asleep at 2am. Awoke the next am with slight HA and nausea which went away by mid morning.
Stye in her eye; Case reference number MOD-2021-012942 is a report which refers to a 66 Years old Female patient.  The patient experienced Stye in her eye.  This occurred while participating in Protocol mRNA-1273 Moderna COVID-19 vaccine   .  The patients started Moderna COVID-19 Vaccine on  .  Some     later, the patient developed Stye.'  Relevant laboratory results were not reported  and relevant physical signs were <LIST PHYSICAL SYMPTOMS>. The patient experienced the following serious criteria:   The eventual diagnosis made was Hordeolum .  The patient was treated for the event with  antibiotic.The action taken for Moderna COVID-19 Vaccine was  Unknown on  . The event(s) were:  Stye in her eye - Unknown.  The investigator considered the Stye in her eye  not related to the drug/placebo.
The patient developed paresthesias and weakness in the legs  approximately 2 weeks after the vaccine. After the thorough work-up he was diagnosed with Guillain-Barré syndrome. He was treated with IVIG and has had some improvement.
Information has been received from a nurse referring to multiple unspecified patients of unknown ages and gender. On unknown dates the patients were vaccinated with doses of improperly stored PEDVAXHIB (Lot# L014428, expiry 12-MAR-2018; L042835, expiry 19-AUG-2018; strength, dosage, frequency and route unspecified). The vaccines were exposed -2.6 degree C for 1 hours and 45 minutes. No previous excursions. Data logger was unspecified. No adverse effects were reported. No product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.
Mother called to report that on April 9 pt developed a "bad cold" on April 10 "welts & a rash" very itchy all over including hands & soles of feet. Took her to an osteopathic physician dx as allergic reaction to hep A vaccine given 4/7 no tx given.
HEAD FELT HEAVY; BODY ACHE; COUGHING; HEART RACED; SLEPT MOST OF THE TIME; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 26-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case requested for this case. No concomitant medications were reported. On APR-2021, the subject experienced head felt heavy. On APR-2021, the subject experienced body ache. On APR-2021, the subject experienced coughing. On APR-2021, the subject experienced heart raced. On APR-2021, the subject experienced slept most of the time. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from head felt heavy, body ache, coughing, heart raced, slept most of the time, and fever on APR-2021. This report was non-serious.
DIABETES (SUGAR); WEIGHT FLUCTUATIONS (GAINS WEIGHT, THEN LOSES AGAIN); This spontaneous report received from a consumer concerned a 58 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had nothing like that before receiving vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered on APR-2021 (maybe 2 years ago, but reporter was not sure) for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, shortly after received the vaccine patient started losing weight and was treated for sugar diabetes. Still had weight fluctuations (gains weight, then loses again) and being treated for diabetes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from diabetes (sugar) and weight fluctuations (gains weight, then loses again). This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220242399-COVID-19 VACCINE AD26.COV2.S- Diabetes (sugar) ,Weight fluctuations (gains weight, then loses again).. 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). Therefore, this event(s) is considered unassessable.
Severe body pains, loss of feelings in hands, feet and legs. Extreme continued pain and weakness. Body burning with heat sensations with horrible pain, along with vision changes, etc.
This spontaneous report was received from a licensed practical nurse and refers to a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 31-AUG-2015, the patient was vaccinated with a dose of GARDASIL (lot # L010596; dose and route were not provided) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient became hot, nauseous, and blotchy five minutes after vaccine administered (09430). Clinic nurses and a physician in the clinic area responded immediately: history, comfort, pulse, BP, comfortable/safe position in chair. Approximately 8-9 minutes later (0938-9), patient asked that her personally-owned Epinephrine Auto-Injector (EpiPen) be administered, as she was unable to do so. Her symptoms were worsening and she had developed a lump in her throat.  At 0940 a clinic nurse (RN) administered the EpiPen in the patient's right anterolateral thigh. Symptoms improved. 911 was called. Paramedics arrived quickly, and transported patient to Hospital Emergency Department, less than one minute away.
On 12/5/21, I began to experience a rapid heart rate and palpitations. My heart rate before going to the emergency department was over 200 bpm. I had to go to the emergency room and was given metoprolol succinate to decrease my blood pressure and heart rate. It was diagnosed as supra-ventricular tachycardia. I am now currently taking metoprolol every day to prevent another episode.
Systemic: Allergic: Difficulty Breathing-Mild, Additional Details: Paitent states she had difficulty breathing, I did advise patient to go to urgent care or ER, but she said she slept it off and was fine next day.
I awoke on 12/19/2019 with a headache and facial pain on the left side of my face and head. After 24 hours I felt like I had the flu and spent 3 days in bed with a swollen arm I had to ice as it was very red. Headache continued and I was hospitalized the week of 1/13/2020 late in the evening until my release around 6:20 pm on 1/17 2020. I was treated with a lot of migraine medication and drip bags of Valporic Acid which helped my headache some but my facial pain has continued and does even as I write this report. The headache comes and goes.
4/12/21 Achiness and chills came on and lasted about 12 hours.  4/13/21 overnight for two nights severe shoulder and breast pain on left side which was side of injection.  4/14/21 diarrhea started and lasted about 2 weeks, this was not extreme just anytime I had a bowel movement it was loose.  Also about this time started feeling dehydrated and still do.  4/24/21 right lymph node swollen and painful axillary near armpit this is side opposite shot. Still swollen today 5/8/21, but seems to have gone down a bit and is no longer tender.  4/25/21 Tongue seems dry and swollen a little on right side has improved mostly.  4/30/21 hives at injection site upper left arm and lower right ankle.  5/1/21 Period two days late and only lasted two days.  Normal for me is 6 days.
LD phone interview conducted with 52 y/o who reports change in size and appearance of SPV scar on rt deltoid over the 6-9 months since returning from assignment. Phone f/u voicemail. Returned call to Employee, who followed HC recommendation and has seen Dermatologist. Dermatologist not initially concerned re malignant transformation. Injected SPV scar with steroid. Employee with send me the Dermatologist's report. Emailed patient HC mailing address / fax. "Turned out to be skin cancer" (local) at SPV site Dermatologist removed AUG 2012.
Patient suffered a heart attack 18 hours later, and died less than 50 hours after 2nd vaccine injection.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 01/28/2021, 02/25/2021, and 07/12/2022. They also received the Pfizer Bivalent product on 10/11/2022. They tested positive for COVID-19 on 09/15/2022. They received home care from a hospital system from 10/14/2022 until their death on 10/20/2022. Also note this person received their last booster about 8 days before their death. COVID-19 disease is on the death certificate.
8 year old patient was given Pfizer 12+ as his 1st covid vaccine.
This spontaneous report was received from a pharmacist, and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 06-MAY-2016, the patient was vaccinated with a dose of ZOSTAVAX, lot # L032403 with expiration date of 26-NOV-2016, (dose and frequency were not reported), which was prepared using an expired STERILE DILUENT with lot # reported as L010588 and expiration date of 18-MAR-2016 (dose, frequency and indication were not reported). No concomitant medications, no adverse effects and no product quality complaints were involved. Additional information has been requested.
3/31- went to  ER- diagnosed with UTI Keflex 500 bid x 7days
severe lower abdominal pain more on the right hand side, somewhere around the ovary area It was like having had abdominal surgery, again, which I had years ago, couldn't move easily, hard time getting in and out of bed which lasted about three days decreasing in severity with each day Headaches, still, that are unusual and I find it hard to wear a straw hat this week! Which is also unusual as I am a gardener and wear one all summer. More than usual fatigue, still happening. Dry heaves and felt  like I had a hang over for two days too! I have never had a problem with my gall bladder or liver which I know are on the right had side also.
I don't take them they make me sick; Initial information received on 14-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a patient.  This case involves Adult and unknown gender patient who while receiving vaccine INFLUENZA VACCINE reported that he/she don't take them, they make him/her sick.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE (with an unknown formulation and strength) produced by unknown manufacturer lot number not reported in unknown administration site.  On an unknown date the patient developed a non-serious event "i don't take them they make me sick" (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (I don't take them they make me sick).  At time of reporting, the outcome was Unknown for the event i don't take them they make me sick.