chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Raised red bumps; Full body rash; DOSE 4 17Oct2022 and Dose 5 17Oct2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 63 years, in left arm and on 17Oct2022 at 18:30 as dose 5 (booster), single (Lot number: GH9702), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies Penicillin" (unspecified if ongoing), notes: Known allergies Penicillin. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation, on 16Sep2022 as dose number unknown, single. Past drug history included: Amoxicillin, reaction(s): "Known allergies Amoxicillin", notes: Known allergies Amoxicillin. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: OVERDOSE (non-serious) with onset 17Oct2022, outcome "unknown", described as "DOSE 4 17Oct2022 and Dose 5 17Oct2022"; RASH (non-serious) with onset 18Oct2022 at 14:00, outcome "not recovered", described as "Full body rash"; RASH PAPULAR (non-serious) with onset 18Oct2022 at 14:00, outcome "not recovered", described as "Raised red bumps". Therapeutic measures were not taken as a result of rash papular, rash.  Additional Information: The events did not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
A patient received improperly stored PROQUAD; No adverse effect; This spontaneous report was received from a medical assistant, referring to a 9 year old patient of unknown gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 05-SEP-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant Human albumin) (PROQUAD) lot# S002494, expiration date 23-JUL-2020, for prophylaxis (strength, dose, route and frequency were not reported). Measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD)was reconstituted with a properly sterile diluent (MERCK STERILE DILUENT).   The temperature excursion was of 6 fahrenheit degrees (°F) to 14 °F (102°F), during 50 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported.
ill; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (ill) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (ill). At the time of the report, ILLNESS (ill) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
So, I got the vaccine on Sunday about 03:30PM, I was okay, I went to bed and was okay. I got up at 05:00 AM in the morning, I felt the need to use the bathroom, I felt very nauseous. I did not go back to bed, I laid on the floor in the bathroom in case I threw up. Just very nauseous but never threw up. I started to get chills and body aches where I felt I could not get up. I had my husband cover me up with robes and blankets on the floor. I had my husband get me some water. My lips were really dried out so I got some chap stick. I laid on the floor until about 08:00 AM, then my husband helped me to bed. I had chills and fever. At about 11:00AM when I woke up, I realized I was not well. The nurse I called suggested I stay hydrated and take Motrin. We did not have Motrin, but I took Ibuprofen. My fever was high at 102.8 at 05:00PM on Monday. My husband put a cool cloth on my forehead and the temp came down to 101.4 at 06:00PM. I basically had noodle soup and Jello. I was still nauseous. I had some toast and white rice, that BRAT Diet.  Monday night I was having a hard time breathing.  I have a CPAP and decided to use it to get more oxygen.  I moved to the recliner in the front room and brought the CPAP with me.  Just as it started at 05:00 AM on Monday, I began to feel better at 05:00AM on Tuesday. I still feel phewy, I am taking it easy and have not gone outside. Still eating the BRAT diet and I cancelled all of my appointments I had on Monday & Tuesday. I have nothing today so I am just taking it easy. Today id Wednesday. I am better, but certainly not back to where I was before this, I do not feel like doing any strenuous exercise. I feel walking is what will be best. I typically go to the gym and work out with a trainer, but I do not have the desire to do that. I feel that I am only able to do some walking.
Couldn't eat all day, hot and cold flashes; Hot flash; cold flashes; barely slept last night.; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (Couldn't eat all day, hot and cold flashes), HOT FLUSH (Hot flash), FEELING COLD (cold flashes) and INSOMNIA (barely slept last night.) 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 FEEDING DISORDER (Couldn't eat all day, hot and cold flashes), HOT FLUSH (Hot flash), FEELING COLD (cold flashes) and INSOMNIA (barely slept last night.). At the time of the report, FEEDING DISORDER (Couldn't eat all day, hot and cold flashes), HOT FLUSH (Hot flash), FEELING COLD (cold flashes) and INSOMNIA (barely slept last night.) 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 provided.
PALENESS; WEAKNESS; FATIGUE; This spontaneous report received from a consumer concerned a male of unspecified age. 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 10-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced paleness. On 11-MAR-2021, the subject experienced weakness. On 11-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from paleness, weakness, and fatigue on 14-MAR-2021. This report was non-serious.
At 11:40am this morning patient received her Pfizer booster vaccine by pharmacist. Pharmacist worked through the patient's immunization questionnaire form, noting no contraindication to the vaccine nor any past history of adverse effects to prior immunizations. The report form was provided to patient and it was explained that patient was welcomed to wait 15 minutes post immunization at our designated observation area, which she agreed to do. Two to three minutes after Patient began her 15-minute post immunization observation patient fainted, falling to the floor from her seated position. Patient's husband was with her during this time. A pharmacy customer who witnessed the incident immediately notified myself of the situation and I immediately went out to assist. My initial observation of the situation was the patient already lying on the floor unconscious, cyanotic, and had a slight lip cut on her lower lip. Patient's husband began raising the patient legs up while he began explaining to me that the patient had indeed had previous fainting incidents in past immunizations and that this was not her first time. Within a few seconds the patient regained consciousness and the husband began trying to have her sit up. I explained to the husband that it was best that the patient remained on the floor lying down till she was stable. Patient became unconscious again and seemed as though she was about to seize so I positioned her on her side. No seizure was actually observed and patient regained consciousness again after about 10 seconds. I instructed that the patient remain on her side till she was stable. At this time store management was onsite taking notes and offering that we call an ambulance, for which both patient and husband declined. An ice pack was placed on the patients back and she remained laying down for another 10 minutes till stabilized. Patient was alert and orientated to person, place, and time and showed proper neurological and muscular function by being able to squeeze both of my hands. I sat her up and provided an orange juice for her to sip on while I had her wait in the observation area for another 30 minutes to ensure she was okay. After 30 minutes, Patient indicated she felt much better and left the store with her husband and children. I followed up with the patient this afternoon at 7:45pm to check in on her. Patient confirmed that she felt fine and was very appreciative for all that we did for her.
CHRONIC HYPOTENSION 12/16/2022 ATHEROSCLEROSIS OF AORTA  CHRONIC HYPOTENSION 12/16/2022 CKD STAGE 3B (GFR 30-44)
Patient lowered to floor by staff after feeling faint. Put in trendelenburger with feet up until less faint. Remained in seated position for approx 20 min w/observation.
Lesion/rash on scalp with formication on left to center forehead.  Tenderness behind left ear in two spots.
This spontaneous case reported by a consumer, describes the occurrence of feeling abnormal (right arm was inarticulate really bad), headache (severe headache), myalgia (body aches) and nausea in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced feeling abnormal (right arm was inarticulate really bad), headache (severe headache), myalgia (body aches) and nausea. At the time of the report, feeling abnormal (right arm was inarticulate really bad), headache (severe headache), myalgia (body aches) and nausea outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant product use and treatment information not provided. Reporter did not allow further contact.
Patient received 3 vaccines listed above at PCP office on 10/1/18. Patient was seen at an Employer clinic for evaluation on 10/13/18 with complaint of persistent nausea. Patient states shortly after being vaccinated (that afternoon/evening), she experienced nausea with decreased appetite. States nausea is worse in the mornings and evenings. Patient states she had one emesis that occurred 2-3 days after the vaccination, but has not vomited since. Patient states she had loose stools for a few days after vaccination, but has been having regular/normal bowel movements since then. Patient also states she had increased fatigue directly post vaccination, but that has since resolved. Denies chance of pregnancy.
Went PCP late February/early March for trouble breathing.  Dr. listened to lungs but nothing else.  Returned to clinic 3/28/2022 for complaints of trouble breathing/shortness of breath.  Imaging tests showed DVT from mid-calf to mid-thigh and saddle PE.  Received IV warfarin and oral coumadin.
Headache C/O MIGRAINES PRIOR TO INJECTION BUT THINKS THAT THEY ARE AGRIVATED Narrative:
Severe head pressure Came on night of vaccine 4/2, took ibuprofen before bed. Awoke next morning with it really severe. Took more ibuprofen (3-4)and applied ice packs. Remained upright in seated position. Subsided by noon.
HCW w/i hours fatigue, debility and diffuse arthralgias, chills and T <100.  Day 1 persistent fatigue; L supraclavicular fullness and tenderness, erythema; L axillary tenderness on same side L arm of vaccination. Day 3 day of visit milder fatigue; arthralgias better; persistent tenderness fullness L supraclavicular area and L axillary tenderness but no discrete palpable adenopathy on exam.  Likely post vaccination syndrome steadily improving.
Patient got Bexsero instead of Tdap; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 13-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB59AA, expiry date unknown) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd February 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 22nd February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that, at their clinic, they normally immunize against Meningococcal B starting at age 16 years.  The patient was given Bexsero in error, at the age of 13 years, which led to wrong vaccine administered. The patient was supposed to get Tdap instead of Bexsero.  The reporter stated that, Bexsero was ordered in error in place of TDap vaccine. The reporter enquired, since Bexsero was approved for the patient's age group, could she just give the series now or wait until she was 16 and repeat the series. The reporter wanted to be able to do what was best for her, if she could get the series nor that was fine by her, just unsure if immunity waned and she should get it closer to 16. The reporter was in the process of checking for expiry date but disconnected before providing additional information or follow permission.  Contact information was provided in case of follow up.
COVID arm 3/27/2021 at 10:30pm noticed multiple he?d swollen hives in circular form around injection site  3/28/2021 6:00am hives were gone replaced by solid red raised mass about 3? by 3? in a circular shape.  Resembled a spider bite. Extremely itchy, red, hot to touch, and the raised bump was hard. Hard lump has remained all day. Applied ice and spot remained hot to the touch.
Pt not normally given adult dose Hep B until 19. Pt is only 18. No adverse reaction.
Because of all of my allergies I took 25 milligrams of benadryl   30 minutes prior to the vaccine injection.  Just a few minutes less than an hour after vaccine injection, my face turned beet red and got flaming hot.  After 40 minutes of a red, hot face I took another 25 milligrams of benadryl.  Now two hours and 40 minutes later my face is much less red and much less hot.
Shock-like appearance, reporting swelling of tongue, and some tingling. Administration of 50mg diphenhydramine and 20 min. of rest, seemed to help. Color improved and speech was back to normal.
immediately after, pt reports felt lightheaded, anxiety, jittery, and fatigue, reports increased dizziness/jittery/fatigue 2nd day, and continued sxs  including development of headache day 5, felt like "I had low blood sugar"
I'm not sure of the exact type of flu vaccine used, I just chose the first one on the list above. I developed a small discoloration/rough spot within 2 inches of the injection site. It looks like a birth mark (more visible after a hot shower). Also, I have sensitivity in my right hip and upper thigh near the surface of the skin, hard to describe, no visible change, just a pain when I touch that area, feels almost like a cut. It hasn't worsened, I noticed this after the patch on my arm. It's still present at 2/3/2018. I have an old injury in my right inner hip from a bike accident that had been bothering me prior to the shot, but did not feel anything like this.
headache; This is a spontaneous report from a contactable consumer (patient). A 52-year-old patient of unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8732) intramuscularly, administered in Left Deltoid on 26Mar2021 at 14:30 at single dose for COVID-19 immunization in Hospital. Medical history included Eczema flare up on 03Mar2021 and ongoing, Menstruation fatigue from 03Mar2021, Soretonil from 03Mar2021. Family Medical History: Relevant to AEs included dad had stomach cancer died of complication after 1year, Mom had thyroid cancer remission over 40years. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6199, expiration date: 30Jun2021) intramuscularly, administered in Left Deltoid on 05Mar2021 at 14:30 (at the age of 52-year-old) at single dose for COVID-19 immunization and experienced fatigue exhaustion; swelling, with a pain full lump; pain and swelling along the left side of the neck/inflamed Lymph node. It was reported that after the second vaccine, experienced throeung HEADACHE for two days thus consumed eight acetometyston in the two days in Mar2021, stayed home than worked on the these day. No other symptoms. The patient underwent lab test which included COVID Test: Negative (Pre-colonoscopy test COVID required) on 28May2020. Therapeutic measures were taken as a result of the event. The outcome of the event was recovered in 2021 for duration of 2 days.  No follow-up attempts are needed. No further information is expected.
Fever 101, chills, tiredness, urinary incontinence    Went to ER early morning of 3rd day 3/6, ,given 1000 mg. ascetaminaphen, urine culture taken, blood work done, CT scan.  Stayed there only about 2 hrs. and released 3/6
pt was accompanied by her grandmother. Pt felt a little dizzy after the vaccine, but she said she always feels a little dizzy like this after any vaccine she has gotten in the past.  We provided bottled water.  Pt said she didn't need ice pack. Pt sat in place for about 5 minutes, accompanied by her grandmother, and closely observed by me. Pt said she felt much better and felt normal.  I asked the pt and grandmother to stay for extra 30 minutes just in case, even though pt was feeling normal now.  Pt felt normal after 3 minutes, and had no other adverse effects at all after that.  Pt and grandmother left after 30 minutes without incidence.
Worst case of flu ever-when I got my flu shot; Initial information received on 16-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced worst case of flu ever-when i got my flu shot while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine (strength, formulation, dose, frequency: unknown) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for Prophylactic vaccination.   On an unknown date the patient developed a non-serious worst case of flu ever-when i got my flu shot (influenza) (unknown latency) following the administration of Influenza Vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (Worst case of flu ever-when I got my flu shot).  At time of reporting, the outcome was Unknown for the event worst case of flu ever-when i got my flu shot.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. On an unknown date, the patient did not receive a full dose of RECOMBIVAX HB (dose, frequency, lot number and route not provided) because the prefilled syringe leaked. Some of the medication got on the patient's skin. No adverse event was reported. Product quality complaint (PQC) reported because the syringe leaked. Additional information has been requested.
Incredible pain in arm that is still present 7 weeks later. Mobility is increasing, but still do not have full range of motion. In treatment and extreme inflammation has been noted. In first weeks, pain extended up neck and left side of head. Slight tingling on left side of tongue that has resolved. Inflammation currently in shoulder muscles, scapula, neck, and upper arm.
Headache, Myalgia, Arthralgia, Fever, chills, metal taste Narrative:
One week after second Moderna covid vaccination patient developed tinnitus and hearing loss in both ears, right worse than left.  I saw him in clinic on 3/31 about 13 days after onset of symptoms.  Normal ear examination.  His hearing is reduced even with hearing amplification.  Sense of ear pressure is lessening but the tinnitus and hearing loss are still present to the same extent.
Pt. developed an itchy diffuse rash to torso, face and genital region but was also started on antibiotics following vaccine administration.
her second dose of the Pfizer COVID-19 vaccine on 11 FEB 2021 and is battling with COVID; her second dose of the Pfizer COVID-19 vaccine on 11 FEB 2021 and is battling with COVID; This is a spontaneous report from a contactable other hcp (nurse) (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3246, Expiry Date: not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9262, Expiry Date: not reported) via an unspecified route of administration on 11Feb2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included casirivimab, imdevimab (REGEN COV) on 15Sep2021 for unspecified indication. The patient had her second dose of the pfizer covid-19 vaccine on 11feb2021 and was battling with COVID on an unspecified date. Patient stated that she was not feeling well when she went to get the regeneron shot that she was battling with covid. Patient was asking when she can get her booster dose of the pfizer COVID-19 after getting regeneron. she got covid seven months after she got her pfizer covid vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date in Sep2021. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.