chrisvoncsefalvay/vaers-outcomes huggingface dataset:
prescribing menactra with 2-doses for primary vaccination of a 17-year old male going to college with no reported adverse event; Initial information received on 01-May-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves 17 years old male patient for whom meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] was prescribed with 2-doses for primary vaccination going to college with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-May-2023, the patient received a dose of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine Solution for injection (lot number, dosage, strength, expiry date- not reported) via unknown route in unknown administration site for Prophylactic vaccination.  On 01-MAY-2023 , (latency- same day), the patient developed a non-serious event of prescribing menactra with 2-doses for primary vaccination for a patient going to college with no reported adverse event (off label use).  Reportedly, A Father calling on behalf of his son for whom college is prescribing off-label use to take 2-doses of MENACTRA prior to starting college wanting to know how many doses a 17-year-old should receive who is unvaccinated to Meningococcal (Groups A, C, Y and W-135). The father reported that the consumer just received their initial dose of MENACTRA today   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event
So Afraid; just feel horrible; Fatigue; Headache; joint pain; muscle pain; Fever 99 degrees; Chills; A spontaneous report was received from a consumer concerning a 74-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events fatigue, headache, muscle pain/myalgia, joint pain/arthralgia, chills, fever 99 degrees, just feel horrible/feeling abnormal, so afraid/fear.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 015M20A) via unknown route for prophylaxis of COVID-19 infection.  On 10 Feb 2021, at 7.00 pm approximately eight hours after receiving the vaccine the patient experienced the events fatigue, headache, muscle pain, joint pain, chills, fever 99 degrees, just feel horrible, so afraid.  Treatment details included paracetamol, naproxen, baby aspirin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events fatigue, headache, muscle pain, joint pain, chills, fever 99 degrees, just feel horrible, so afraid was unknown.
blanching macular rash progressing from head distally w/koplik spots; hands & feet spared pos fever;
It is stated she had her second dose on Monday and ever since then she has not had night sweats or hot flashes/after getting her 2nd dose she had no night sweats or hot flashes; It is stated she had her second dose on Monday and ever since then she has not had night sweats or hot flashes/after getting her 2nd dose she had no night sweats or hot flashes; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer reported that a 53-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot Number: EL3302; Expiration Date: May2021), dose 2 via an unspecified route of administration on left shoulder 01Feb2021as 2nd dose single for covid-19 Immunization.  Medical history and concomitant medications were reported as none. Patient Previously took, first dose of vaccine on 11Jan2021 with a Lot number: EJ1685 and Expiry: 30Mar2021.It was reported that, caller stated she had her second dose on Monday and ever since then she has not had night sweats or hot flashes. She wanted to go online and report this, but it kept asking about adverse effects and this is not a bad effect. It is explained that after the second shot, that night. When she woke on the 20Feb2021 she realized that she was not soaking wet and didn't get up in the middle of the night for water. This week she couldn't remember using desk fan for when she gets hot, at work. Caller clarifies these were experiences prior to taking the vaccine and related to menopause. There has been no new medications started, she has not been exercising, there has been nothing that has changed in what she doing. Both shots were given in the left shoulder area. The outcome of the events was not recovered.  Follow-up (05Feb2021): This is a follow-up spontaneous report from a contactable consumer. added lot number, patient details, onset dates, outcome, first dose details.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a medical assistant concerning multiple unspecified patients (demographics unknown). The patient's pertinent medical history and concurrent conditions were not provided. On multiple unspecified dates, the patients were administered improperly stored doses of GARDASIL 9 (Lot # L024993 expiration date: 17-OCT-2017) (route not provided). The patient's concomitant medications were not provided. No adverse effects were reported. It was reported the following temperature excursion for the administered vaccines: 34/2 degrees F for 9 days (216 hours). No previous temperature excursion was reported. This is one of several reports received from the same source. Additional information has been requested.
heat at the injection site; redness at the injection site; fever; red spot at the injection site; bleeding at the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE WARMTH (heat at the injection site), VACCINATION SITE HAEMORRHAGE (bleeding at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), PYREXIA (fever) and VACCINATION SITE RASH (red spot at the injection site) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-May-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (bleeding at the injection site). On an unknown date, the patient experienced VACCINATION SITE WARMTH (heat at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), PYREXIA (fever) and VACCINATION SITE RASH (red spot at the injection site). At the time of the report, VACCINATION SITE WARMTH (heat at the injection site), VACCINATION SITE HAEMORRHAGE (bleeding at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), PYREXIA (fever) and VACCINATION SITE RASH (red spot at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not reported.
In the evening I had a headache, nasal congestion, and sore throat. I went in to the doctor the next day and I was prescribed an antibiotic because they thought I had a sinus infection. A few days later, I was fatigued and slept for 10 hours. I took an at home test and it came back positive for COVID-19 on 4/30/2022. I went into a walk in clinic on 5/1/22 and was given Paxlovid to lessen the symptoms of COVID-19 to take for 5 days.
Injection site swelling, extreme tenderness and soreness, fatigues, muscle pain, joint pain, chills then  FEVER 102.2,
woke up at 3 am with itching to her chest and arms; This is a spontaneous report from a contactable other health professional.  A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (lot number: EK9231), via an unspecified route of administration in the left arm on 18Jan2021 17:45 at SINGLE DOSE for COVID-19 immunization. Medical history included "hypothyroid", HTN (hypertension) and allergy to contrast dyes.  The patient has been diagnosed with COVID-19 on an unspecified date prior vaccination. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included thyroid (ARMOUR THYROID), silybum marianum (MILK THISTLE), magnesium chloride and unspecified BP medications. The patient previously took tetanus toxoid and experienced allergies.  On 19Jan2021, the patient woke up at 3 am with itching to her chest and arms. Patient took generic Zyrtec as treatment to the event. Outcome of event was recovering. The events were considered as non-serious.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
2 days p/receiving vax pt had 4 afebrile seizures; nl LP; while hospitalized devel fever & CXR suggestive of poss pneumonia;
Vaccine given 10/20 afternoon. Flu-like symptoms started 10/21 afternoon. Chills, aches, fever, extreme fatigue. Worse on 10/22 and 10/23 woke with rash that attacked all scar tissue area on body, old scars and any area that had ever had blood drawn or IV started. Raised, red, painful. Seen at ER and was given IV fluids, blood and urine drawn. C-reactive protein was only elevated lab at 145. Medrol dose pack given. Symptoms improved with meds and rest.
Patient incorrectly received Covid-19 monovalent vaccine. Patient should have received Covid-19 bivalent booster. Patient had previously completed initial Covid-19 series on: 3/24/21, 4/14/21 and initial booster on 10/27/21.
One week following my 1st vaccination, on Monday January 11, I developed small red bumps at the injection site, which turned into one big, itchy welt by the end of that same day. I visited my PCP the next afternoon, on Tuesday, January 12th. He said it was not a systemic reaction but a localized reaction to the vaccine and prescribed a 5-day Medrol pack and Hydroxyzine. I was also experiencing episodes of anxiety beginning 2 days following my injection, on Wednesday, January 6 th. The redness is subsiding at this time - approximately 50% improvement; some itchiness persists if I don't take the hydroxyzine regularly (I don't because I have to work and it makes me very sleepy). Anxiety is improved, as well.
Pt. states that after receiving the 3rd Booster of Phizer 10/13/2021, started experiencing symptoms 10/14/2021 of pain at the injection site, inflammation of heart wall (self-diagnosed), fatigue, muscle pain, nausea, joint pain, loose stool, and headache. Symptoms have subsided.
Redness and swelling at site left arm. Fever 103. Hives on face and arm. Right eyelid swelling with drainage.
Bilateral arm and feet paresthesias without numbness or muscular weakness that started several days after initial vaccine. Patient also started taking Xyzal at the same time. We are stopping Xyzal. His neurological and musculoskeletal exam is normal.
after 6-7 days of receiving the shot  I have a sore arm and a rash from the point of the shot  running down my arm about 3 inches, the concern is the reaction occurred 6-7 days after receiving  the shot ,Will I be able to take the second shot on 2/17/21 . Have not gone to a doctor , realize this is a normal reaction  ,but  wonder way  it occurred 6-7 days later,  concerned about taking the second shot on 2/17/21
On January 28, 2020 at 6:00 AM I got up and noticed that on the left arm where I had received the vaccine on January 15, 2021, there was a red patch which was I felt a little hot when I touched and it hurts a little. It felt like I had the vaccine the day before. I called the hospital around 11 AM and spoke with a doctor. I explained what was happening to me. Doctor asked me if I felt short of breath and I answered that no, that the only thing I am experiencing was only the reaction on the arm. Doctor said yes, reactions were being reported but the most serious ones occur on the same day or the day after the vaccine is applied. He recommended applying cold to the site and take Tylenol for the discomfort. Doctor told me that I definitely have to apply the second dose of the vaccine.
Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ABIRATERONE ACETATE (ZYTIGA) and PREDNISONE for an unknown indication.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On 22-Apr-2021, VACCINATION SITE PAIN (Pain at the injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided by the reporter.
"Normal" strong arm pain for 4 or 5 days, then horrible shoulder pain for 6 weeks so far, including tingling, weakness, pain in the left arm. Chiropractic treatment, physical therapy, X-rays, MRI, appt. with orthopedic surgeon and still horrible pain.
I received my first dose of the vaccine on Wen. By Thursday afternoon I started to experience a tingling/numbness in my big toe on my left foot that evening I started to get the same feeling in my big toe on my right foot (left foot was still experiencing it as well) By Saturday the numbness and tingling started to migrate up my foot and by Sunday I could feel it in my lower calves. On Monday it went away for the most part and today I just feel a slight tingling along the toes and bottoms of my feet but it isn't painful. Along with this I did feel pain at the injection site and noticed that it was lightly red and swollen by Friday the pain was gone in the injection site and by Saturday the swelling was gone from the injection site.
Had a herpes outbreak; This is a spontaneous report from a contactable other healthcare professional (the patient). A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN9581) via an unspecified route of administration in the arm right on 05Feb2021 at 12:45 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included low thyroid and depression postmenopausal.  Concomitant medications included levothyroxine sodium (SYNTHROID), HRT (MANUFACTURER UNKNOWN), duloxetine hydrochloride (CYMBALTA) and aluminium hydroxide, magnesium trisilicate, sodium alginate (PEPCID) for unknown indication from an unknown date. The patient previously received tetracycline (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Mar2021 at 22:00, the patient had a herpes outbreak. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Therapeutic measures were taken as a result of the event which included treatment with acyclovir (MANUFACTURER UNKNOWN). The clinical outcome of the event herpes outbreak was recovered on unknown date in 2021. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration on 16Mar2021 as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
Thirteen minutes after receiving 2nd dose of  COVID vaccination; pt c/o of itchy and scratchy throat.  Pt denied respiratory difficulty and not in immediate distress.  25 mg of diphenhydramine IM administered at 9:15 am in opposite arm of vaccination. 5 minutes later at 9:20 am patient stated she felt her throat as constricting.  Immediately at that time RN administered 0.3ml of epinephrine IM in opposite arm of vaccine and EMS called by staff at facility.  No urticaria, no wheezing, no angioedema noticeable from RN.   Pt declined EMS transport to ER and after consultation with her PCP office was transported by private vehicle to ER for further evaluation/monitoring.  Pt w/o respiratory distress at time of private transport and able to ambulate independently.  Independed transport arrived at 9;33 am.  Pt vitals taken every 5-10 min with BP ranging from 138/102 to 152/96.  O2 ranging between 93 - 99% and HR between 88 -123.
This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 11-APR-2021 for prophylactic vaccination. Concomitant medications included vitamin B12 NOS. On 11-APR-2021, the patient experienced very long, could not move body, sweating like came out of a pool, suddenly started feeling very ill, and numbness of both legs and both hands for 8 weeks (2 months). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suddenly started feeling very ill, sweating like came out of a pool, and very long, could not move body, and the outcome of numbness of both legs and both hands for 8 weeks (2 months) was not reported. This report was non-serious.
Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: tingling in left hand and fingers
Missed the correct interval inter doses; Contracted covid-19 after the 1st dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the correct interval inter doses) and COVID-19 (Contracted covid-19 after the 1st dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Treated with monoclonal antibodies.).    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 PRODUCT DOSE OMISSION ISSUE (Missed the correct interval inter doses) and COVID-19 (Contracted covid-19 after the 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the correct interval inter doses) and COVID-19 (Contracted covid-19 after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication and treatment information were not reported.  It was reported that the first patient, on December got covid-19 and got a treatment with monoclonal antibodies. Two patients got the 1st dose of the moderna covid-19 vaccine on 25 Feb-2021 and the other got the 1st on 4-Mar-2021 and got covid-19 vaccine and did not get yet the 2nd.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up document contains no new information
That night, post vax, she woke up 3 times with numbness and pain in left arm from fingertips to elbow. Right arm was also affected on the 3rd awakening. Continues to have soreness at site.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE SLEEP APNEA OBSTRUCTIVE SLEEP APNEA ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN ACUTE DVT OF LEFT CALF, UNSPECIFIED VEIN
Patient had previously been feeling short of breath for about a month. She received the 2nd Pfizer covid vaccine dose on 6/9 and felt nauseous the next two days. She came to the ED on 6/10 with nausea, vomiting, and lethargy. Found to be hypotensive, bradycardic, and in 3rd degree heart block. Suspect patient was already in heart failure and might have developed myocarditis after receiving the vaccine which could have exacerbated her heart failure.
started feeling something weird on my upper lip, the left one; feeling something like it was, the lips is something wrong; I am been swollen from the lip, the upper left lip; This is a spontaneous report from a contactable consumer. This 67-years-old female consumer (patient) reported for herself.  A 66-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20Mar2021 10:40 (at the age of 66-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 20Mar2021 20:30, the patient experienced started feeling something weird on my upper lip, the left one, feeling something like it was, the lips is something wrong and i am been swollen from the lip, the upper left lip. The patient reported regarding COVID vaccine reaction. After the vaccine it is been 15 minutes everything was okay but the on 20Mar2021 about 8:30 she started feeling something weird on my upper lip, the left one and I was feeling something like it was, the lips is something wrong. It looks like swollen but I am been swollen from the lip, the upper left lip." The patient not received any treatment (No, because I do not know what to take). The outcome of events was unknown.  Information on the lot/ batch number has been requested.  Follow-up attempts completed. No further information expected.
Drooping of face, double vision and loss of balance representing stroke like symptoms.   Symptoms began 4 days after receiving the Pfizer vaccine on the same side as vaccine was administered.
24 hours post vaccine: swelling, itching at site. 36 hours post vaccine: swelling 5 inch diameter at site injection, severe itching at site, mild fever, severe body aches, 10/10 pain, chills quivering. 48 hours post vaccine: symptoms are improving.
Chest pain briefly at 6am on 4/23/21. Chest pain returned at 9am and was more severe. I went to the emergency room. I was given aspirin and ibuprofen and was admitted to the hospital because of elevated troponin. I was given heparin on 4/24/21. Diagnosis - presumed mild myocarditis.
Rash on middle of back spaced out red spots about 5 appeared 1 wk after injection painful.
3 days after Dtap/IPV/Prevnar/Comvax developed confluent erythematous rash which dermatologist described as urticaria.