chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had a rashes on her neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:  The reporter is the patient.  A 78-year-old female patient received BNT162b2 (BNT162B2), as dose 1, 0.3 ml single (Lot number: 301308A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu (Caller stated she was able to get a flu, pneumonia, shingles shot); Pneumonia (Caller stated she was able to get a flu, pneumonia, shingles shot); Shingles (Caller stated she was able to get a flu, pneumonia, shingles shot). The following information was reported: RASH (non-serious), outcome "unknown", described as "had a rashes on her neck".  Additional information: It was reported that, the reporter confirmed, her rashes didn't happen right away and didn't notice it the next day. She had no primary care physician and don't take any medication. She tried today and get her booster her pharmacist seemed very reluctant to administer the vaccine and advised to call Pfizer. She never had an allergy to anything and had no primary care physician/allergist. She was able to get a flu, pneumonia, shingles shot and never had a reaction until she took the Covid-vaccine. The reporter was seeking recommendation on what to do going forward. The reporter stated she and her husband were doing the best they could to be healthy. She exercises and walks 2 miles everyday and she was as healthy as she could be. She already got first and second Pfizer COVID-19 vaccine. She didn't actually notice after getting the first shot of the vaccine she had a rashes on her neck she already. She also got the booster shot, the first one and the same thing happened to her. When she got the first shot she did know anything happened. With the second shot, the next day, she had a light pink rash on the neck. Went to patient first, got steroids and it went away in couple days. With the first booster dose, she literally forgot about the previous rash, she went and got the booster dose and the rash came back. It was deeper pink and more widespread. Went to patient first, got steroids again and it went away in couple days.
2 weeks after vaccine, I noticed a 6-7" oval area around the point of the vaccination with a light red rash on the periphery lighter red in center, warm to touch.
Pt developed  8 cm X 10 cm erythematous, warm reaction at injection site on right anterior thigh.
One day post vax, the pt experienced blotchy skin, lips, hands and feet were bluish, she vomited once. She was seen in the MD's office and had a few urticaria.
1st day golf ball size lump with redness and purple with warmth around area. 2nd day lump grew to soft ball size w/redness, purple and swelling. Felt Warm to touch. 2nd started on Augmentin day 3 lump size going down.
Day after injection (Oct 20), itching back of head, top of ears itchy & warm like on fire.  Persisted 4 days.  Then noticed swollen glands Tuesday (Oct 23rd) after injection.  10/26-Noticed rash on chest that itched.  Took Benadryl 50 mg q hrs x3 nights.  10/29-At 22OD, rash on arms & trunk noticed with urticaria.  Went to ECC.  Taken out of work 30th & 31st.  Own MD started patient on Prednisone pack with declining doses & XYZ.  Recovered by Nov 5th & returned to work 11/6.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 15-MAR-2018 the patient was vaccinated with a dose of M-M-R II, (lot number and expiry date unknown) (dosing regimen and frequency unknown) intramuscularly in error for prophylaxis. No adverse events were reported. No product quality complaint was reported.
pains in her upper back; headache, 3 to 4 days later she started experiencing headaches again; tiredness; shingles pain has gone away since she received the booster shot; she has not been feeling well since she received the booster shot; chills running down her back; sweating/ sweating so much at night that she had to take her top off to sleep; legs burning; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating/ sweating so much at night that she had to take her top off to sleep), BURNING SENSATION (legs burning), MALAISE (she has not been feeling well since she received the booster shot), BACK PAIN (pains in her upper back) and HEADACHE (headache, 3 to 4 days later she started experiencing headaches again) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Shingles (which was misdiagnosed) since 2018 and Post herpetic neuralgia (from the back of her shoulder down to her waist due to Shingles).    On 26-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced HYPERHIDROSIS (sweating/ sweating so much at night that she had to take her top off to sleep), BURNING SENSATION (legs burning) and CHILLS (chills running down her back). On 26-Nov-2021, the patient experienced MALAISE (she has not been feeling well since she received the booster shot) and THERAPEUTIC RESPONSE UNEXPECTED (shingles pain has gone away since she received the booster shot). On 27-Nov-2021, the patient experienced BACK PAIN (pains in her upper back), HEADACHE (headache, 3 to 4 days later she started experiencing headaches again) and FATIGUE (tiredness). On 26-Nov-2021, THERAPEUTIC RESPONSE UNEXPECTED (shingles pain has gone away since she received the booster shot) had resolved. On 29-Nov-2021, BACK PAIN (pains in her upper back) and FATIGUE (tiredness) had resolved. At the time of the report, HYPERHIDROSIS (sweating/ sweating so much at night that she had to take her top off to sleep), HEADACHE (headache, 3 to 4 days later she started experiencing headaches again) and CHILLS (chills running down her back) had not resolved and BURNING SENSATION (legs burning) and MALAISE (she has not been feeling well since she received the booster shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient stated that she does not know if this was due to her age or the vaccination.  No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-038136 (Patient Link).
Idiopathic thrombocytopenia, vesical scotamate-papilledema bilaterally or papillite bilaterally also received a PPD on same day as Menactra. 6/20/07-records received for DOS-05/02-05/04/07-DC DX:Idiopathic Thrombocytopenia Purpura. Presented to ER with hsitory of bruising of the lower extremities with petechial type rash, rash of lower extremities particularly of ankles and mid calf. C/O aches and pain prior to presentation of rash. Treated with IVIG and after second dose complained of headache. Seen after discharge by neurologist. Complained of headaches and vomiting and low grade fevers which persisted for couple of weeks. Experienced visual scotomata in form of green spots and saw an ophthalmologist who diagnosed bilateral papilledema.  Visual symptoms resolved and on revisit to ophth. diagnosed papillitis as opped to papilledema. PE: spontaneous venous pulsations were minimally present bilaterally. No overt features of increased intracranial pressure.
Constant pain in left armpit (arm where shot was received).  Intermittently worse at times. A small cyst developed in left shoulder/neck area.  Painful with pressure.
15 minutes after booster injection, patient verbalized bilateral hand swelling and hot sensation over entire body. Skin color became red and flushed. Patient took a po 25mg Benadryl. Symptoms did not resolve. Rapid Response called and patient transported to ED for evaluation. BP 120/68. No respiratory distress or airway compromise noted.
Very severe flu like symptoms. All my joints were very sore for about 2days. Sinus problems.very tired. Sore and very swollen arm at injections site.
The following day post vax, the pt experienced double vision. On 11/2/98, the pt was seen by an ophthalmologist and was dx with left VI nerve palsy.
Chest tightness; Burning sensation; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team.  A 32 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) 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: CHEST DISCOMFORT (non-serious), outcome "unknown", described as "Chest tightness"; BURNING SENSATION (non-serious), outcome "unknown", described as "Burning sensation". Therapeutic measures were taken as a result of chest discomfort, burning sensation.  Additional information: The reporter inquired about side effects of the Pfizer Covid-19 vaccine and reported that he and his wife received their first dose of the vaccine 9 days and was wondering about an adverse effect that had been lasting a few days. It was reported that his wife was experiencing chest tightness and a burning sensation and that his wife had never really had heart burn, but they tried heart burn medicine and that did not help at all. Reporter was looking for information regarding other reports of the occurring and what might be causing it.   The lot number for bnt162b2 was not provided and will be requested during follow up.
13Dec03 (9:30 pm) Fever, chills, severe joint and musclar pain continued on and off thru out the nite. Soreness in left arm where influenza vaccine was administered.  14Dec03 (10:00am) Temperature 100.5, moderate aches thru out body. Neck felt very tender and swollen.  Breathing uncomfortable.  *Could not take a normal to deep breath without my neck and chest hurting.  3:00 pm  Felt tired and had aches in shoulder,rib, and mid back areas.  Temp. 98 2:30am - Pain in my neck and chest from breathing, woke me up from sleeping  15Dec2003  (5:30 am) Headache, Temperature 99.6, breathing again uncomfortable.  Sides of my neck really hurt along with breathing.  Tightness in chest/lower throat area when inhaling.
17 year old son received vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old son received vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old son received vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old son received vaccine) had resolved.            No concomitant medications reported. No Treatment medications reported.
Left thigh redness, swelling, knot very irritable at DTAP vaccine site only, Resolved 2-3 days,  Still with knot but not tender.
Developed fever to 103 F and vomiting approximately 5 hours after immunization. Also had faint rash in scalp. Left deltoid was sore the following day at the site of immunization. Symptoms resolved within 24 hours.
Patient received vaccine, came out to the waiting area, and lost consciousness for a very short period of time.  He came to and threw up several times.  He sat for  a while longer said he felt better and under the guidance of his wife left the store.  I tried to call him several hours later to see how he was doing but only got an answering machine
Fever and diarrhea. Used Tylenol for fever and highest was 103 and diarrhea lasted 2 weeks and was treated by giving probiotics.
This spontaneous case, initially received on 30-Mar-2017 was reported by a Other non-health professional (consumer) and concerns a 8 years old female patient. Administration of Company suspect drug: On 04-Oct-2016, FLUVIRIN was administered (dosage: 0.5ml, frequency, duration and batch number: not reported, route of administration: intramuscular). Adverse reactions/events and outcomes: Patient received FLUVIRIN on 04-Oct-2016 at pharmacy and was diagnosed with influenza on 08 March 2017. On 08Mar2017 Influenza was diagnosed. Patient was treated with TAMIFLU. On 24-Mar-2017 the events was reported as recovered and the event vaccination failure was updated to unknown. Reporter's Assessment: The other non Healthcare Professional assessed the causality as related. This report was serious (medically significant). Follow-up report received on 24-Apr-2017: It was confirmed that patient had no any medical history. Patient was healthy at the time of vaccination (immunological status). It was reported that patient has been previously immunised and first flu vaccine was of two doses. Nasopharyngeal swab,  blood culture and serology were performed, but diagnosis of influenza was confirmed with nasal swab. Follow up received on 09-May-2017: Batch review report (reference number [1021187] received from quality assurance department on [09-May-2017]: Based on the document review, it was stated that the concerned [FLUVIRIN]  was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements.
Patient stated that 45 minutes after receiving the vaccine he became dizzy and foggy, requiring the individual to sit down for a period of time as they felt unsteady on their feet.  No treatment was given, patient decided to have spouse pick them up and go home.
c/o pain at injection site and redness day after injection. The next day it was warm to touch with a 4cm x 4.6cm area of redness, was placed on Benadryl 25mg and Pandel cream 0.1%. The next day the redness had decreased and was not as painful.
Initial, I had 3 days of left arm soreness. About 1 week later, I noticed moderately severe neck pain. I was not able to sleep on my pillow and thought it was a muscle strain. Took Ibuprofen sparingly with good relief. One week later, I noticed tender right armpit (at the region of lymph node). The following week, I noticed right occipital lymph node enlargement, right supraclavicular lymph node tenderness, and moderately severe left occipital headache. I took Ibuprofen with good relief of left occipital headache. Seasonal allergies symptoms including runny nose, sneezing, itchy red eyes, eye discharge, tearing, nasal congestion, and dry throat coincided with these symptoms for 2 weeks.  I took loratadine 10 mg and applied Alaway eye drops on several occasions. I began applying ofloxacin eye drops with resolution of eye discharge and treatment coincided with second Covid 19 vaccine on 5/1/2021. I also began taking MitoQ supplement. I had discontinued loratadine 10 mg and Alaway eye drops one day prior to second dose. Lymphadenopathy also resolved except right occipital lymph node is still enlarged. A mild headache, chills, and bodyaches began on 5/1. It worsened the following day. It was on the left frontal and maxillary sinus regions and left occipital region. Mild left knee itching, redness, and warmth began. On the following day, left knee itching, redness, and warmth slightly worsened and right and left sides of right and left hind feet began itching and maculopapular rash began. On 5/5, skin is hypersensitive. Maculopapular rash began on left ventral aspect of hand and resolved with application of hydrocortisone 1% cream. Bilateral arms also began itching and resolved on its own. Bilateral knee itching, redness, and warmth and hindfoot itching comes and goes. I began noticing bilateral cheek redness and warmth (flushed) that continues today on 5/6.
Dizziness, motion sickness, tinnitus, loss of hearing, increased susceptibility to abscesses
A pregnant female received a dose of Adacel vaccine, no AE; Initial information was received on 29-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to case 2020SA269365 (same reporter).  This case involves a female patient who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] while she was pregnant.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The date of last menstrual period was not reported.  The estimated due date was not reported.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5665AA, expiry date: 24-Sep-2021) via unknown route in unknown administration site for prophylactic vaccinations (between 07-Aug-2020 to 03-Sep-2020, exact date of vaccination was not reported).  It was case of vaccine exposure during pregnancy.   It was unknown whether patient experienced any adverse reaction after the injection.  Pregnancy outcome was unknown at the time of report.
1. Pain at vaccine site (severe) within 15 minutes 2. Nausea 3. Loss of appetite that evening 4. Stomach ache all night 5. Nausea and light-headedness 6:00AM waking up 6. Nausea and VOMIT and headache at school 7. Sent home early from school by nurse 2PM 8. Severe painful abdominal cramps all day
Chief complaint: dizziness. Vital signs BP 136/82, RR 16, spO2 97%, HR 72. Patient felt sweaty. Vital within normal limits, patient able to go home.
Patient experienced dizziness about 40 minutes after dose. Then significant arm swelling at injection site, patient described as "a deltoid on top of his deltoid" started by the same evening. Pain subsequently occurred described as severe that radiated into shoulder and all the way down the patient's arm  that also felt like burning.  The patient is still experiencing this 15 days later, although admitting it is finally starting to improve. Patient admitted to not being able to do much for the first 1-2 weeks and requiring opioid pain medication relieve the pain enough to sleep at all. Patient contacted primary care as well as drug manufacturer, Janssen.
About 30 minutes after receiving Janssen vaccine patient stated that she felt like her heart was racing. When vitals were taken patients HR ranged from 85-81 bpm. Blood pressure was 134/86. Patient was given water to drink. After approximately 20 minutes of observation patient stated she was feeling better and was taken by wheelchair out to her car. Patient's mother was in the drivers seat and drove patient home.
her thinking has been off. Sometimes she cannot think of the word and then it finally comes to her went; Out of sorts in her head; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9269), via an unspecified route of administration, administrated in Arm Left on 13Feb2021 (age at the time of vaccination 66-years-old), as a single dose for COVID-19 immunization. Patient medical history included Medication allergies, Outpatient surgery from Dec2020, Cholesterol, Anxiety, Thyroid, Acid reflux, Hormones, Allergy to Sulfa, and Keflex, reaction to Keflex. Patient concomitant medications included levothyroxine as 0.25mg for Thyroid medication, Simvastatin as 5mg tablet for Cholesterol, Alprazolam (generic Xanax) as 0.25mg for Anxiety, Famotidine (Generic product) as 40mg tablet for Acid reflux, Estradiol as 0.5mg for Hormones, Progesterone as 100mg capsule for Hormones, Centrum Silver Multivitamin as Over the counter, Calcium with Magnesium and Zinc as Over the counter, Vitamin d, Vitamin C as Over the counter, Zinc as Over the counter, and Osteo Bi-Flex as Over the counter. On 13Feb2021, the patient experienced Out of sorts in her head, and on 14Feb2021 her thinking has been off. Sometimes she cannot think of the word and then it finally comes to her went. Patient neither visit to Emergency Room or Physician Office nor not hospitalized. The outcome of the event Out of sorts in her head was unknown, and her thinking has been off. Sometimes she cannot think of the word and then it finally comes to her went not recovered.  No follow-up attempts are possible. No further information is expected.
Extreme abdominal pain, pressure, nausea. Sharp, stabbing pain in back, and headaches.
Uncontrolled head movement; Facial twitch/ Uncontrolled eye twitches; Headache; it feels weird. She got an unusual 'sensation'. Her head feels weird; intermittent exotropia; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the parent.  A 5-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Nov2021 (Lot number: FK5127) at the age of 5 years as dose 1, single for covid-19 immunisation. Relevant medical history and concomitant medications were not reported. The following information was reported: DYSKINESIA (medically significant), outcome "not recovered", described as "Uncontrolled head movement"; MUSCLE TWITCHING (medically significant), outcome "not recovered", described as "Facial twitch/ Uncontrolled eye twitches"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "it feels weird. She got an unusual 'sensation'. Her head feels weird"; STRABISMUS (non-serious), outcome "unknown", described as "intermittent exotropia". The reporter stated, "the most serious one that keeps continuing she (patient) has uncontrolled head movement, twitches (voice incomprehensive) she has facial twitch and she is having some uncontrolled eye twitches." The patient underwent the following laboratory tests and procedures: blood magnesium, blood phosphorus, blood urine, notes: Reporter stated, "Yes right at the hospital she had blood urine and a (voice incomprehensive)."; c-reactive protein, drug abuse, full blood count, metabolic function test, red blood cell sedimentation rate, toxicologic test, troponin, and urinalysis: all on (23Nov2021) results unknown. The reporter stated that the second dose was scheduled on 04Dec2021.  Follow-up attempts are completed. No further information is expected.
Patient reports feeling unwell, collapsed on floor, skin tone became grey, 911 called, epinephrine 0.3 mg IM autoinjector  administered, patient put in recovery position, BP monitored, vomitted X 3 or 4, EMT's arrived and transported patient to Hospital.  Call from MD at hospital confirming anaphylaxis and patient recovery. Spoke with patient at 15:50 and confirmed recovery.