chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My lips started to tingle (same reaction as cobalt allergy before my lips swell).  I asked if I could take benadryl (which I brought with me).  The person watching us texted someone and they came in and looked at me, asked me what was happening, took my blood pressure and said to take 2 benadryl.  I told the nurse I only take one benedryl when this happens.  She said take 2 benadryl.  I did take 2 benadryl 12 minutes after my  vaccine.  My blood pressure went up.  They called an ambulance and I went to the Hospital.  My blood pressure was 176/105 at 11:50 am.  While I was in the ER, I took a selfie and noticed that I had a rash.  No one mentioned that earlier so I am guessing that is why they had me take 2 benadryl.  At the ER I was put on an IV - NS .09% 1000ML at 12:27 pm.  Then at 13:04 I was given Pepcid 40 MG/NS 250 ML IV at 500 ml/hr intravenous.  At 1:12 pm my blood pressure was 138/96 and at 2:31 pm it was 135/70.  My rash went away then.  Up until last week I have been taking benadryl and/or pepcid everyday since the vaccine.   I would still get a rash.  I have not had the rash for about 5 days.
Allergies: Amoxicillin, Aspirin, Metformin, Pneumococcal vaccine; Allergies: Amoxicillin, Aspirin, Metformin, Pneumococcal vaccine; This is a spontaneous report from a contactable Physician. An 81-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (manufacturer unknown), via an unspecified route of administration on an unspecified date at single dose for immunization; co-suspect drug included amoxicillin (manufacturer unknown), acetylsalicylic acid (ASPIRIN), and metformin (manufacturer unknown), with route of administration, therapy date, dose and indication unspecified. The patient's medical history and concomitant medications were not reported. The patient experienced allergies to amoxicillin, acetylsalicylic acid, metformin, pneumococcal vaccine on an unspecified date.  The action taken in response to the event for amoxicillin, acetylsalicylic acid and metformin was unknown. The outcome of the event was unknown.   Pfizer is a Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) and was a Marketing Authorization Holder of amoxicillin in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) and amoxicillin has submitted the same report to the regulatory authorities.  No follow-up attempts are needed. No further information is expected.
Fever (100) and severe swelling at the injection side-raised swelling covering half of the upper arm and hot to the touch-deep red in color.  Applied ice 09/10/2013 and 09/11/2013  Returned to the MC Pediatrics clinic for evaluation and to report reaction-swelling resolved 09/13/2013.
itchy erythematous maculopapular rash on torso and face. no swelling or discharge x 1 week. Rash erupted 9 days after vaccines were administered
Information was received 15-AUG-2017 from a lawyer regarding a case in litigation concerning a female plaintiff of unspecified age. It was claimed the plaintiff was inoculated with ZOSTAVAX on or about 06-OCT-2009 and again on 06-DEC-2012 at the same pharmacy in her residing state, as recommended for routine adult health maintenance and for the prevention of shingles. It was claimed the vaccine did not prevent shingles as intended, but rather caused her to contract a persistent strain of herpes zoster. On or about 04-SEP-2015, the plaintiff was treated in the emergency department of a hospital for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 07-SEP-2015 the plaintiff was treated by a physician for ongoing and worsening symptoms of shingles. She was prescribed acyclovir (ZORIVAX), oxycodone (+) acetaminophen and prednisone for management of her painful symptoms.  It was claimed that as a direct and proximate result of these malfunctions, the plaintiff suffered painful injuries and damages and required extensive medical care and treatment.  As a further proximate result, the plaintiff suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information was requested.
Client was inadvertently given second booster, client is only 31 years of age and not immunocompromised.  Client was notified of the error and observed for 15 minutes after.  No adverse reaction occurred. Client denied any questions after observation.
fever; patient is very nervous because of her auto immune; muscular discomfort; her daughter had a temperature of 100.2 but was okay by Sunday; This is a spontaneous report from a contactable consumer (parent). A 43-year-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 19Mar2021 as dose 2, single for COVID-19 immunisation. Medical history included pemphigus vulgaris (autoimmune disease). The patient's concomitant medications were not reported. The patient previously received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as dose 1, single for COVID-19 immunisation. The patient reported that her daughter had a temperature of 100.2 but was okay by Sunday (body temperature increased) on 20Mar2021, muscular discomfort on 22Mar2021, had fever and patient was very nervous because of her auto immune on an unspecified date. Seriousness of the events was reported as non-serious. The patient underwent lab tests and procedures which included body temperature increased: 100.2 on 20Mar2021. The patient received Tylenol as treatment for adverse events body temperature increased, myalgia and pyrexia. The event outcome for body temperature increased was reported as recovering, myalgia as not recovered, pyrexia as not recovered and nervousness as unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 14Mar2021 as dose 2, single (Lot number: EP7534), in left arm and on 02Oct2021 as dose 3 (booster), single (Lot number: PFRERFE3F90) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing), notes: High Blood Pressure. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Follow-up attempts are completed. No further information is expected.
pt recv vax in 1985 & whole body became paralyzed;the reporter stated that the pt was dx w/GBS;hosp is presumed, although not documented;
Random severe muscle joint tendon pain. Extreme fatigue. Brain fog. Episodes of serious chills despite ambient temp in the 90s.  Fine one day, next day can barely walk. Attempt to exercise beyond easiest levels will result in the 1 or more of above 1-2 days later.   Depression. No problem with lungs, breathing.  Times of elevated heart rate and / or low oxymeter readings (89-90 where 92-94 is expected) I want to think I'm getting better, but then this morning another chills and fatigue episode motivated this report.   Ps as a longtime serious cyclist, I know how to suffer all kinds of setbacks. I know how my body responds to various exercise loads.
25 y/o female c/o sore throat, fever, chills, nausea, vomiting, lightheadness and dizziness. 101.1 temp. At this time pt on ward for hydration for past two days.
bleeding since receiving the Pfizer covid vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right (reported as Right shoulder), administration date Jun2021 (Batch/Lot number: unknown) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "menopause" (unspecified if ongoing), notes: have been through menopause for over 10 years. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1; Right shoulder), for COVID-19 Immunization, reaction(s): "did not have any problem". The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset Jun2021, outcome "unknown", described as "bleeding since receiving the Pfizer covid vaccine". Additional informaiton: Caller had not taken the Pfizer covid vaccine but calling for her friend who was bleeding since receiving the Pfizer covid vaccine. Caller wanted to know about any information on this side effect of bleeding after the vaccination. The caller was an older withheld and the caller had some friends, all about age 60 and had been through menopause for over 10 years. The caller had friends received the Adult Pfizer Covid 19 Vaccine and were bleeding. The caller knew the friends were not lying, the friends were withheld women. It was really scary. The caller had not received the any dose of Adult Pfizer Covid 19 Vaccine and was scared to receive the Adult Pfizer Covid 19 Vaccine. The caller knew the bleeding had been reported and was being covered up. The caller would like to know why the bleeding happened and when the bleeding would stop. The caller was scared to take the Adult Pfizer Covid 19 Vaccine, the caller did not want to get period. The caller stated the patient began bleeding a week after receiving the Adult Pfizer Covid 19 Vaccine. The patient received the Adult Pfizer Covid 19 Vaccine back in Jun2021. The caller clarified the patient received the Adult Pfizer Covid 19 Vaccine in Jun2021, it was in the summer. The caller clarified the bleeding began a week after the patient received the second dose Adult Pfizer Covid 19 Vaccine. The caller did not know if the patient was still bleeding or if the bleeding had stopped. The patient was basically pretty healthy. There were no Additional Vaccines Administered on Same Date of the Pfizer suspect vaccine. The caller knew the patient did not receive the booster dose Adult Pfizer Covid 19 Vaccine. The event did not require a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks), there were no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. There were no events following prior vaccinations. The caller clarified there was more than one friend that was bleeding after receiving the Adult Pfizer Covid 19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever 6 days after immunization (104.5) severe neutropenia diagnosed 9 days after immunization (10/27/08) mildly elevated LFT (10/27/08).
The patient was seen for a clinic visit with the provider. She experienced the following symptoms within 1 minute post administration of vaccinations (Tdap, MCV4 and HPV): blurry vision, light-headedness, near-syncope and diaphoresis. She was sitting at the time symptoms developed. Blood pressure = 60/30 mmHg, pulse = 61 bpm. Provider notified and returned to the room to examine patient. The patient stated that she had not consumed breakfast this morning, nor had drank a lot of fluids prior to coming to the appointment.  Patient consumed approximately 8 ounces of apple juice and laid down with her lower extremities elevated; applied ice pack to forehead/lower back/neck. BP = 83/54, pulse = 84 bpm. The patient consumed water and graham crackers while sitting back up. Vision back to normal and feeling less faint. Warm to touch, but no more diaphoresis. BP = 95/61, pulse = 73 bpm & 94/63, pulse = 71 bpm. The patient stated she felt better and stood up with father and nurse at her sides. She stated she felt no abnormal symptoms and therefore walked around the room noting she continued to feel well. The provider stated the patient may leave as long as her blood pressure was back to normal, her abnormal symptoms were no longer and she felt well. She recommended that the patient consumed adequate amounts of fluid and eat sometime of substance. The patient and her father expressed understanding. The patient left the clinic by foot after meeting all provider requirements (BP, symptoms, feeling well). She was given more apple juice and graham crackers to take with her. The patient's father will continue to monitor the patient and will drive her home.
Sudden onset sciatic pain, no prior pain experience, further study and MRI revealed herniated dusc pressing on right leg nerve trunk. Active lifestyle including yoga curtailed, pain still moderate to sever 6 months later.
REDNESS OF LEFT ARM, SWELLING EXTENDING TO THE ELBOW, PAIN, WARMTH, DIAGNOSED AS CELLULITIS BY ER PHYSICIAN.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. In 2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 12-MAR-2015, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient got into poison ivy; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS CONTACT (Patient got into poison ivy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022m20a) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE and FINASTERIDE for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced DERMATITIS CONTACT (Patient got into poison ivy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DERMATITIS CONTACT (Patient got into poison ivy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Fever; Sore throat; Cough; Body aches; Weakness; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness). At the time of the report, PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment information was provided.   Company Comment: This case concerns a 76-year-old female who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: .; Sender's Comments: This case concerns a 76-year-old female who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt has a 4"x4" round, red area on side of thigh that feels warm to touch.
45 minutes following injection I noticed numbness/tingling on the left side of face and my tongue tingling on the left side.  At one hour following injection, both the face and tongue numbness/ tingling was subsiding.  At  2-1/2 hours following injection there was only slight sensation on the face and tongue, akin to sensation following novocaine injection at the dentist.  At 5 hours following injection, no further symptoms.
Patient presented with bright red rash that covered from shoulder to elbow. Rash starting to go below elbow.
It was just like muscles and joints aches that lasted for two and a half days. It felt like I had the flu or it was coming on.
No adverse effects; Inappropriate schedule of vaccine administered; This spontaneous report has been received from a registered nurse concerning to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 22-AUG-2006, the patient was administered a unspecified dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose number, dose, anatomical location, lot# and expiration date were not reported) subcutaneously for prophylaxis and on 01-SEP-2006, the patient received 1 dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose number, anatomical location, lot# and expiration date were not reported) subcutaneously for prophylaxis (inappropriate schedule of product administration). No adverse effects were reported.
Patient was given Tdap in error as this has only been studied to age 64 and recommended for ages 11-64. Patient having no adverse symptoms per phone call to her.
This spontaneous report was received from a nurse regarding a patient of unknown age and gender. There was no information abut the patient's pertinent medical history, drug reaction or allergies and concomitant therapies provided. On 23-MAY-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (orally, dose was not reported, lot # L037574, expiration date 01-JUL-2017). There was no adverse effect reported. The administration dose of vaccine experienced the temperature excursion of 34.5 degrees Fahrenheit for 75 minutes. A data logger was involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.
Info has been received from a hospital pharmacy employee and a licensed practical nurse concerning a 33 year old female with an allergy to penicillin and type II diabetes mellitus who on 11/13/2002 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #642720/0172M) subcutaneously in her right arm. That same day, the pt had a reaction that involved her "left arm" becoming "swollen and red." The nurse reported that diagnostic and laboratory tests were not performed. On 11/15/2002, the pt had recovered. The hospital pharmacy employee also provided info regarding other pts' experiences (WAES #0212UA01104). The pt sought unspecified medical attention. Additional info is not expected.
positive for COVID-19 (PCR test). His symptoms are mild (headache, sore throat, fatigue); positive for COVID-19 (PCR test). His symptoms are mild (headache, sore throat, fatigue); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A "15 (units not provided)" male patient received bnt162b2 (COMIRNATY), administration date Jun2021 (Batch/Lot number: unknown) as dose 2, single and (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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jan2022, outcome "unknown" and all described as "positive for COVID-19 (PCR test). His symptoms are mild (headache, sore throat, fatigue)". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient described the actual injection of the vaccine as painful, and pain at the injection site has continued since vaccination. Two days after vaccination (8/7/18) patient developed redness around the injection site, which was still present at time of reporting. Two days after that (8/9/18), patient developed severe itching around injection site which has not resolved as of time of reporting.
Approximately 3.5 inch in diameter injection site reaction that began approximately 72 hours after receiving vaccine.  The area is swollen, hot to touch and red in color. The area itches and is very painful when touched. Occasional sharp pains occur and entire left arm is sore after use even for simple tasks such as typing or driving.
Severe violent vomiting every 1/2 hour x 2 then each hour for 4 hours.
Next day patient had fever, nausea, tiredness. Injection site was red, swollen, hard, itchy and warm.
Severe, severe leg pain in both legs and especially hips. Nearly unable to walk. Felt like bone pain. Lasted 7+ days after shot, but decreased in intensity after 4. Also, fever, shaking, body aches. The intensity and how long it lingered was actually frightening.    Feet still tingle pins/needles.
Resident was given  Covid vaccine around 1:30 pm and was fine following the administration.  Around 2:25 pm resident was observed on the floor next to her bed with no pulse or respirations present.  Resident was a DNR so no attempts were made at resuscitation.
Case number PHEH2014US025351, is an initial spontaneous report received from a consumer on 15 Dec 2014. This report refers to a 12 year old male patient. His medical history and concomitant medication were not reported. The patient was vaccinated FLUVIRIN (batch number: not reported) intramuscularly in Sep 2014. Despite vaccination with FLUVIRIN, she developed influenza (vaccination failure) on 12 Dec 2014. The outcome of the event influenza was unknown. Seriousness was not reported. Seriousness assessment of influenza and vaccination failure was upgraded to serious (medically significant) based on NV-key event list. Causality was not reported.
Severe pain on the side of the body the vaccine was administered (starting with the arm and bicep and shooting down to the leg). Chills, sweats and presumed fever starting 4 hours after administration Unable to move from bed, incontinent due to inability to move Stayed in bed until the morning, symptoms have been improving since waking this morning