chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer via Pfizer sales representative. A male patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient had bad reaction and was very sick for a week, right after vaccination on an unspecified date with outcome of unknown.
BOTH LOWER EAR LOBES BRUISED; This spontaneous report received from a patient concerned a 44 year old female. 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: 043A21A and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-APR-2021, the subject experienced both lower ear lobes bruised. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from both lower ear lobes bruised. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
Patients received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported.On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patients received an expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported by reporterNo treatment medications provided by the reporter.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EL3247), in left arm and on 16Mar2021 as dose 2, single (Lot number: EL3247) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication=Treatment of COVID-19; Positive, notes: covid testwas positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient received other medication in 2 weeks were Unknown. 11 days after initial infection covid test was positive again with same symptoms "bad disease".   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information, there is reasonable possibility of causal association between the events  and the suspect drug  BNT162b2
Patient received vaccine @ approximately 2pm 10/22/19. Developed subjective fever approximately 5pm. Noticed fever blister on lower lip that evening + worsened the next day. Sought treatment 10/24/19
booster; contracted the Omicron variant of SARS-COV-2; contracted the Omicron variant of SARS-COV-2; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (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: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "contracted the Omicron variant of SARS-COV-2".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200058493 same reporter/drug/event, different patient
Heavy menstrual bleeding for 9 days accompanied by very painful cramps beginning 3 days  after vaccination.  For previous 2 years, menstruation had been very light with no painful cramps.
Pt recvd 1st dose of Engerix-B on 08MAY91; 24 hrs post vax pt exp fever, sweating & urticaria; sx resolved w/no tx;
Sore throat & runny nose first 3 days, Headache off and on through 11/9/11, Lots of mucus production continuously until now. Small rash started to develop on face within 4 days of getting Flu Mist.  Within a week it was a severe rash on face, chest, back, fingers, neck, thighs.  Large white patches still on neck. Still has slight rough patches on back. Actually had large sore on chin. Put steroid lotion on face one application before realizing it was not the seborrheic dermatitis.  When rash got severe started oral tablets of Benadryl for 3 days. Rubbed up with aloe vera and jojoba oil, because rash started to get dry and white.
The previous 2 vaccines I had were Pfizer and I had no reaction to them. I got these vaccines 6 months before the Moderna booster. 11 days after the booster I noticed some soreness on the right side of my neck. It was tender to the touch. It was like a little bump. For the most part it was mobile. Since then it has gotten less tender over time. I still can feel it. The week after I discovered it, I made a video appointment with my PCP just because I thought it was the booster but I am aware that enlarged lymph nodes can mean cancer. We agreed it was nothing to concern about. My PCP still wanted me to come into the office and I am going next week. She did schedule an ultrasound just to be safe.
gradual increase redness, swelling and itching since immunization administration. relieved by ice and hydrocortisone cream 10 over 4 days fever and cold sx 1-20-02
Shortly after vaccine, just like with 1st dose, I experienced right arm numbness and tingling.  This did resolve by evening.  On the morning of 2/12/21 I awoke with vertigo, emesis and headache.  I'm not prone to frontal headache which progessed to migraine symptoms - i.e.  sensitivity to noise, light and motion.  The vertigo and headache lasted into the following morning.  This resulted in a absence from work on 2/12/21.
No adverse effects; The patient was vaccinated with an improperly stored and expired dose of GARDASIL on 24-APR-2019; The patient was vaccinated with an improperly stored and expired dose of GARDASIL on 24-APR-2019; This spontaneous report was received from a Nurse referring to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies, or concomitants medications were not reported.  On 24-APR-2019, the patient was vaccinated for prophylaxis with an improperly stored and expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dosage regimen and route of administration were not provided) lot number: M017983 and expiration date: 30-MAY-2018.   The improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) experienced a temperature above 47 Fahrenheit Degrees / 9 Celsius Degrees (66 Fahrenheit Degrees) for 5 hours. The vaccine did not experience any previous temperature excursion and the digital data logger was not involved. No adverse effects were reported.
Did not receive 2nd dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Did not receive 2nd dose of Moderna COVID-19 vaccine) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Did not receive 2nd dose of Moderna COVID-19 vaccine). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Did not receive 2nd dose of Moderna COVID-19 vaccine) had resolved.            The patient stated that she failed to get the 2nd dose of the vaccine because being busy with children and their virtual school. And the clinic where she received the vaccine is only open on Monday. No concomitant medication was reported. No treatment medication was reported.
Patient called and reported she had a blood clot in her leg confirmed by doctor on 4/14/21. Leg pain started 4/13/21. Patient reported her doctor informed her the clot was due to the COVID vaccine she received.  Doctor put her on Elliquis and instructed her to elevate leg. She follows up with doctor once a week.
tightness in throat 30 mins after vax-went to er, skin peeling at vax site, twitching in rt arm
Prior to receiving the vaccine I was feeling well, history of asthma, seasonal and environmental allergies, and no history of significant symptoms after previous vaccinations.  Shortly after administration of the COVID-19 vaccine I began to feel nauseous which lasted in duration for approximately 3 days.  On the vaccine administration day,  several hours after administration I developed retrobulbar pain, bilateral eyelid edema, erythema of the right eyelid, this was one of the most significant symptoms that persisted for several days.  In addition, on 12/20 I experienced a several hour episode of  tinnitus and diminished auditory acuity in my right ear, this has also resolved.  From day 2 until current I have experienced decreasing myalgias and arthralgias, the most significant has been lower back midline pain which has been improving.  I developed a temperature of 99.7 Fahrenheit, with administration of acetaminophen.  Although the symptoms have improved this is certainly the most significant constellation of symptoms I have experienced after any vaccination.
Kinrix was administered to a 9 month old. This combination vaccine is only indicated for children between the ages of 4-6 years of age.   Mother notified  of the error. Child reports no adverse symptoms. Denies fever, chills, nausea/vomiting.   Health department notified.
7 DAYS AFTER VACCINATION PATIENT FELT NUMBNESS AND LOSS OF TASTE IN HER TONGUE.  THE FOLLOWING MORNING SHE WOKE AND ONE SIDE OF THE FACE WAS DROOPING.  PATIENT RECEIVED CARE AT AN URGENT CARE FACILITY.  A CT SCAN WAS PERFORMED TO RULE OUT BLOOD CLOT.  PATIENT WAS DIAGNOSED WITH BELL'S PALSY
Painful swelling at injection site on outer aspect of thigh (Left) 2x3 cm tense swollen area warm-non-tender-no discharge. Ice to leg. Pt given BENADRYL elixir 5 mL Q HS.
Patient called 10/11/2007 complaining of red arm swelling, pain & high grade temperature. Patient did not have thermometer to take temp, but presumed it has high. Advised her to make appointment with doctor.
Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04713211A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period). On 13-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given beyound 30 days of refrigeration period) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medication was provided. No treatment  was provided.   This case was linked to MOD-2021-313106 (Patient Link).
Initial report received from the patient's parent on 10 January 2011. This case is not medically confirmed. A 10 year-old male patient (also reported as a 17 year-old) with unknown medical history had received on an unknown date a dose of MENOMUNE (lot not reported), and a dose of Cholera, and Tetanus Diphtheria vaccines (trade names, manufacturer names and lot numbers also not reported) in preparation for travel out of the country. Two months after receiving the vaccines while the patient was overseas, he developed bloody diarrhea and was treated with antibiotics. The patient returned home (date not reported), and a year after his return he again experienced bloody diarrhea and had wheezing and shortness of breath. It was reported that about a year after receiving the vaccinations the patient was diagnosed with Crohn's disease. Recovery status for the wheezing, shortness of breath and bloody diarrhea were unknown. The patient has not recovered from the Crohn's disease. Documents held by sender: None.
pt felt weak & nauseous;vision became blurred;eyes were bloodshot;BP went up to 200/110 (although it may have already been elevated pt on BP med);
Starting 12/19/2022, I developed a sore throat. It progressed to body aches, headache and congestion. I did have some gastrointestinal issues as well. I ended up testing positive for COVID-19 (12/20/2022). After about 3 days, the symptoms improved but the congestion lingered. I continued to test positive for a total of 8 days. About a week after testing positive, I had a miscarriage. I am feeling fine today.
Administration error: bivalent vaccine administered instead of 1st dose of the primary series; No adverse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (Administration error: bivalent vaccine administered instead of 1st dose of the primary series) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Administration error: bivalent vaccine administered instead of 1st dose of the primary series) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Administration error: bivalent vaccine administered instead of 1st dose of the primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were provided.  It was unknown if patient experienced any AEs or if any treatment was given.   Reporter did not allow further contact
Fast heartbeat; Stomach pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 6 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Dec2021 11:00 (Lot number: FK5618) at the age of 6 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Innocent Heart murmur/abnormality as baby" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (non-serious) with onset 05Dec2021 18:15, outcome "unknown", described as "Fast heartbeat"; ABDOMINAL PAIN UPPER (non-serious) with onset 05Dec2021 18:15, outcome "unknown", described as "Stomach pain". Therapeutic measures were not taken as a result of heart rate increased, abdominal pain upper. No follow-up attempts are possible. No further information is expected.  Additional Information:  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination, was the patient diagnosed with COVID-1.Since the vaccination, the patient has not been tested for COVID-19.
As soon as the vaccine was given, I was lightheaded ,dizzy and difficulty walking.  My left hand went numb and I felt the vaccine travel through my system.  I had to be helped to the 15 minute waiting area where I grew nauseous and continued to feel dizzy and light headed.  The paramedics were called but my vital signs were normal.  I came home and slept for 12 hours.  By Saturday ( 4 days ) after the vaccine, I felt like I was in a fog, couldn't think straight, and my speech become slow.  Once I got to the ER, I was having delusions and was convinced my deceased dog was sitting on my lap.
pt recv vax 7APR97 & started feeling faint, instructed to sit down for the 2nd time;pt fell & hit rt side of occipital as per mom rt occipital inspected, no swelling or redness noted to area;VS taken 5min & 15min p/incident;
pt recv vax 5/96 & in 2/98 pt exp chickenpox
None - Patient received vaccine in Feb 06 2013 and then again on 5-9-2013. No adverse effect noted. NO allergic reaction. Patient felt fine.
Extreme fatigue; Extreme chills; Extreme muscle aches; Fever 102; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 03May2021 at 15:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included Penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 11Apr2021 at 16:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 03May2021 at 18:30, the patient experienced extreme fatigue, extreme chills, extreme muscle aches, fever 102 (unspecified units). on the same day(03May2021) the patient checked body temperature and the result was found to be 102 (unspecified units). Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme fatigue, extreme chills, extreme muscle aches and fever 102 was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
A report has been received from a Pharmacist concerning a 55 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The patient experienced administered FLUMIST QUADRIVALENT to a 55 year old patient which started on 29-Nov-2014. The outcome of the event of administered FLUMIST QUADRIVALENT to a 55 year old patient is unknown. The report was considered to be non-serious.
Clinical staff mixed the powder portion of the menveo vaccine with a sterile diluent instead of the liquid portion of the menveo vaccine.
RASH ALL OVER.  SPOTTED AND ITCHES. WHELPS. BEGAN 12/21/2009.  METHLTREN 4MG (MEDROL) STARTED 12/22/2009 MEDS.
Administered with the vaccine from vial which has been punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from vial which has been punctured for more than 12 hours) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from vial which has been punctured for more than 12 hours). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered with the vaccine from vial which has been punctured for more than 12 hours) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The booster dose was given on 11-Nov-2021 between 09:00 AM to 11:00 AM. The pharmacist reported there were no reported adverse reaction.  Treatment information was not reported.
Pt received Pneumococcal vaccine at 8:50AM on 1/3/19. Pt called in at 9:30am on 1/4/19 experiencing swelling in arm, shoulder, ear and back of neck. Inj site is warm to touch Pt going to urgent care to rule out cellulitis.
Patient was given the incorrect dose of Pfizer, she was given a regular 12+ dose instead of the 5-11 year dose.   Time: 09:09 am No symptoms reported.
After administration pharmacist noticed an almost immediate lump forming at injection site.  Patient also bleed more than usual, but that was not a surprise as her shirt was very tight from being rolled up.  Howevever, the onset of the lump seemed typical than would expect.  Patient checked back 2 weeks later to say that lump persisted for several days, but has no resolved, and that there was still a bruise.  Patient did report that she sometimes bruise easily.  Pharmacist recommend to continue to monitor and bring up with primary care physician,  as full physical examination is outside pharmacist scope of practice.
warm and itchy at injection site; warm and itchy at injection site; rash 3 days after 2nd dose; 3 days after 2nd dose redness on arm of the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm and itchy at injection site), VACCINATION SITE PRURITUS (warm and itchy at injection site), VACCINATION SITE RASH (rash 3 days after 2nd dose) and VACCINATION SITE ERYTHEMA (3 days after 2nd dose redness on arm of the shot) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 04SB21A) for COVID-19 vaccination.     Concomitant products included LORAZEPAM for an unknown indication.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced VACCINATION SITE WARMTH (warm and itchy at injection site), VACCINATION SITE PRURITUS (warm and itchy at injection site), VACCINATION SITE RASH (rash 3 days after 2nd dose) and VACCINATION SITE ERYTHEMA (3 days after 2nd dose redness on arm of the shot). At the time of the report, VACCINATION SITE WARMTH (warm and itchy at injection site), VACCINATION SITE PRURITUS (warm and itchy at injection site), VACCINATION SITE RASH (rash 3 days after 2nd dose) and VACCINATION SITE ERYTHEMA (3 days after 2nd dose redness on arm of the shot) outcome was unknown.