chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist concerning a patient who on 07-NOV-2007 was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck) instead of zoster vaccine live (Oka/Merck) for the prevention of shingles. This was a staff error and not product confusion. No adverse experience was reported. There was no product quality complaint involved. Additional information from the physician indicated that there was no adverse effect. No further information was provided. Additional information is not expected.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 information is not expected.
At 07:15AM I felt hot and my skin on my chest and neck were red.  I am a nurse and was in a patients room in an isolation gown.  I thought I was hot and the patient noticed I was red and said something to me.  I was in her room for about an hour noticed I was itching but igonored it given I was busy and in the ICU.  Around 08:15 I noticed hives on my chest and neck and developed a dry cough and some wheezing and I took 50 of Benadryl.  By 10am I had 2 hives on left on my neck and chest, skin continued to be red.  11:40 I went to employee health they took my vital signs Blood pressure and pulse ox.  130/80 99% and HR was 110. They told me I did not need a temperature done. (I disagreed took my own temp and it was 100F. did this outside of employee health).  My heart rate is 50-70 normally (I run and do lots of cardio) BP runs low 90-110/60's normally. Employee health told me I could not get any further flu shots without a doctors note.
About 20 Chicken pox-like papules (no pus or scab) emerging on the knuckles of 7 fingers, palm of left hand, above and below the knee on left leg, bottom of big toe on right foot.  These 3-7mm papules(?) multiplied by day 2, some white heads in middle of red, inflamed and painful to the touch 3-7mm patches. When a few were lanced (to relieve pressure and be able to use my hands), they bled minimally, but no solids, fluid or pus. It wasn't until the afternoon of day two that I determined they were a result of the vaccine.  Prior to that, I explored numerous possibilities and nothing fit.  It was a Saturday, so I couldn't call my doctor.  Throughout the evening of day 1 and all day 2 I had chills and some body aches.
1 month after receiving the vaccine, patient was admitted critically ill to ICU for the onset diabetes Type 1. Was seen 1 month prior for WCC and was asymptomatic. Date of vaccine 06/27/2018. Date of hospital admission 07/28/2018.
No adverse event yet. Patient did not think she was pregnant and a urine pregnancy test was negative at the date of service. Patient called our office on 02/04/08 stated she had a positive test.
huge welt on her arm; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. Medical history included covid-19 from end of Oct2020 to an unknown date. The patient's concomitant medications were not reported. The patient reported that she is an nurse in the ICU. She had received the 1st dose of the vaccine after she had covid the end of Oct2020. Her reaction to the vaccine was, she felt exactly how she did when she had covid. It lasted 3 days. She had a huge welt on her arm. Her pulmonologist suggested that she contact Pfizer for advice on if or when she should receive the 2nd dose, which is currently due 08Jan2021. Outcome of the event huge welt was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of giant urticaria due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
adverse outcome; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT FOLLOWING IMMUNISATION (adverse outcome) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT FOLLOWING IMMUNISATION (adverse outcome). At the time of the report, ADVERSE EVENT FOLLOWING IMMUNISATION (adverse outcome) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: No significant information was received.
got Covid after receiving Pfizer Covid-19 vaccines; got Covid after receiving Pfizer Covid-19 vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient received BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6204, Expiration Date: Jun2021), in left arm (also reported as left shoulder), on 03Apr2021 as dose 2, single (Lot number: ER8729, Expiration Date: Jul2021), in left arm and on 10Nov2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 41 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 "unknown" and all described as "got Covid after receiving Pfizer Covid-19 vaccines". Therapeutic measures were taken as a result of vaccination failure, covid-19. The report was not related to a study or programme. The patient got Covid after receiving Pfizer Covid-19 vaccines. The patient said she vaccinated and boosted and she went 3 years without Covid.  The reporter confirmed Covid was after being vaccinated. For dose 1, dose 2 and booster, given time were all  in the afternoon. The patient had not had the fourth vaccine. Additional vaccines was not administered on same date of the Pfizer suspect. No Emergency Room or Physician Office required. No relevant tests. No prior vaccinations (within 4 weeks). The patient was prescribed nirmatrelvir; ritonavir (PAXLOVID).
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 30-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.
passed out / passed out for 5 or 10 minutes; she was sweating; shivering; heart palpitations; upset stomach; felt weak for 1 whole day; This case was reported by a consumer via call center representative and described the occurrence of passed out in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 7th September 2019, 1 days after receiving Shingrix, the patient experienced upset stomach and weakness. In September 2019, the patient experienced passed out (serious criteria GSK medically significant), sweating, shivering and palpitation. On 7th September 2019, the outcome of the upset stomach and weakness were recovered/resolved. In September 2019, the outcome of the passed out, sweating, shivering and palpitation were recovered/resolved.   It was unknown if the reporter considered the passed out, sweating, shivering, palpitation, upset stomach and weakness to be related to Shingrix.  Additional details were provided as follows: 12 hours after receiving Shingrix, the patient was sweating, shivering, had heart palpitations, and then passed out.  The patient reported, she thought she was passed out for 5 or 10 minutes both times but was not sure.  The patient reported the sweating, shivering, and heart palpitations resolved after she woke up from being passed out.  The patient also had an upset stomach and felt weak for 1 whole day and then these events resolved.  The reporter consented to follow up. For the tolerance of 2nd dose, refer linked case US2020AMR253265.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR253265:same patient (2nd dose)
dad reports 19JUL96 pt had fever of 103 consistently p/vax;
Patient received a third dose of the Pfizer vaccine at a  clinic.  First dose was 12/12/2021, second dose 1/8/2022, and third dose was received on 1/13/2022.
Patient reported to pharmacy and told us that her physician told her to come get a SHINGRIX vaccine from our pharmacy. When logging into the system, it was discovered that the patient had already received 2 doses of SHINGRIX in 2018. Patient was informed and documentation was sent to prescriber.
Severe! pain in the shoulder. Great difficulty moving arm for 2 days - (still sore) 7/10/16. 9/10/16 profuse sweating for 12 hrs. Arm still sore.
Sat 7/17 6PM pain in left arm some swelling. Sunday 7/18 3AM Extreme pain in arm increased swelling, called EN. On call told pack in ice. Mon 7/19 AM saw doctor received shot antibiotic. Prescription for Cephalexin. Return to doctor Friday 7/25 had less pain and swelling reduced. Sun 7/25 pm swelling increased. Pain extreme in arm: left breast. Back and chest. Saw doctor Monday 7/26 AM received shot Cortisone and Prescription hydroxyzine Hel. Still in pain.
Vaccine was administered at 2:51pm. While patient waiting 15 mins she began to feel dizzy and clammy. At 3 pm, had patient lay down, while we elevated feet and applied a cool compress to her  forhead. After 5 mins, sat up to a sitting position. After another 5 mins, moved to a chair to sit for a while longer.  At 3:13pm patient felt dizzy again. Had patient lay down and elevate legs again. At 3:23pm patient moved back to sitting position with no additional issues.
This spontaneous report as received from a 66 year old female consumer with no pertinent medical history and no drug reactions or allergies reporting on herself. On JAN-2013, the consumer was vaccinated with a dose of ZOSTAVAX (route and lot # not reported) in the right arm, and a dose of influenza virus vaccine (route and lot # not reported). The consumer reported that "a few days after the injection", she experienced an adverse experience with ZOSTAVAX. Consumer reported that she had a dry patch that was itchy at the injection site. The patient did not receive treatment for the adverse event. There were no Lab diagnostics or studies performed. The outcome of dry itchy patch at the injection site was reported as not recovered/not resolved. Additional information has been requested.
This spontaneous report has been received from a nurse referring to a patient of unknown age. Information regarding the patient's medical history, drug reactions or allergies, concurrent conditions and concomitant medications was not reported. On 08-FEB-2019, the patient was vaccinated with PROQUAD, subcutaneous, for prophylaxis and M-M-R II (indication, strength, dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis.
Information has been received for the pregnancy registry for GARDASIL from a nurse practitioner concerning a 15 year old female patient who on 06-JUN-2008 was vaccinated with the first dose of GARDASIL IM.  The day after receiving the first dose of GARDASIL, the patient found out she was pregnant (gestation or last menstrual period of "1 month").  On 11-JUN-2008 the patient started bleeding and went to the emergency room on 17-JUN-2008, where it was determined she had a miscarriage.  Upon internal review, miscarriage was considered to be other important medical event.  Additional information has been requested.
Narrative:  Pt was a 74 YO Male with PMH of major neurocognitive disorder with possible PD/LBD (last seen in cognitive clinic 2016), COPD on home O2 2Lpm, OSA on CPAP, CKD 4, recurrent UTIs, urinary retention, DMII w/neuropathy, paroxysmal A. Fib on apixaban, and HTN who presented to ED from another location on 10/5/21 with c/o cough and SOA. Pt was COVID-19 negative on admission. After discussion with family, pt requested to pursue hospice care. Comfort measures were initiated and the patient passed peacefully on 10/26/21. Death does not appear to be related to COVID-19 vaccine.
p/vax pt devel bumps mom describes them as goose bumps same color as skin;mom noticed bump on rt wrist;mom gave child bath & noticed that child had more bump on rest of body-mostly on legs & arms;no MD visit;
Patient waited after vaccine  in store as directed, probably returned home about one hour after vaccine.  Felt general full body weakness after vaccine, some dizziness, no site reaction (no visible site reaction), no fever ever, etc. lasted about 12 days, did go to hospital, spent 6 nights in hospital. Cannot confirm this is all from vaccine - did begin that day, but patient has not had reaction to other dose (this was her 2nd) or any other vaccine. She is aware this may not all be related to vaccine, she just wanted record reported.
(L) Deltoid with swelling, erythema & warmth, 6cm x 8cm, headache, & vomit x 1.
Fever of 103.7 controlled by ibuprofen and tylenol.  Fever lasted for 48 hours after onset. Total body fatigue and acute muscular pain onset occurred with start of fever.  These lasted for 24 hours, most severe pain in lower back and neck.
Loss of taste; loss of smell; Body aches; Severe chill; headache; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Feb-2021. The most recent information was received on 27-May-2021 and was forwarded to Moderna on 27-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), CHILLS (Severe chill), HEADACHE (headache), AGEUSIA (Loss of taste) and ANOSMIA (loss of smell) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 26-Mar-2020, COVID-19 on 11-May-2020 and Pneumonia in May 2020. Concurrent medical conditions included Sarcoidosis. Concomitant products included VITAMINS NOS for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN (Body aches), CHILLS (Severe chill) and HEADACHE (headache). On an unknown date, the patient experienced AGEUSIA (Loss of taste) and ANOSMIA (loss of smell). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Body aches), CHILLS (Severe chill), HEADACHE (headache), AGEUSIA (Loss of taste) and ANOSMIA (loss of smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-091740 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Events added; Reporter's Comments: female who
ARM PAIN; FEVER; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced arm pain, fever, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fatigue, and arm pain, and the outcome of fever was not reported. This report was non-serious.
Red rash and swelling at site of vaccination 1 week following vaccine. Shortness of breath every day following vaccine for 1 week.
sick; Initial information was received on 16-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer via social media.  This case involves a patient (unknown demography) who was sick (illness), while the patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medications, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious was sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that she never had sick after that she received it 10 times.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome was unknown for the event.  There will be no information available on the batch number for this case.
This spontaneous report was received from a Registered Nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 31-MAR-2016, the patient received an improperly stored dose of (Oka/Merck) VARIVAX (lot# reported as L044525, expiration date: 31-MAR-2016, dose, route of administration and injection site were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Progress Notes Date:  4/8/2021                                                                                                 Subjective Patient is a 17 y.o. female who was seen at COVID Vaccine Clinic today for her first  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience lightheadedness and dizziness.  She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, itching and facial swelling.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , collapse, hypotension, rapid progression of symptoms and respiratory distress.   Patient accompanied by her mother.      ALLERGY REVIEW OF SYSTEMS:  Patient complains of dizziness   Patient denies chills, malaise/fatigue, facial swelling, cough, chest tightness, shortness of breath, wheezing, rash, itching of skin, vomiting, diarrhea and headaches    +Lightheadedness, +Tremors:     Previous Reactions: History of anxiety with vaccines but no previous reactions of note.     Objective    Vitals Vitals:   04/08/21 0846 04/08/21 0855 BP: 101/56 97/57 Pulse: (!) 37 70 SpO2: 100% 100%          Physical Exam Constitutional:      General: She is not in acute distress.    Appearance: Normal appearance. She is normal weight.  HENT:     Head: Normocephalic.  Cardiovascular:     Rate and Rhythm: Normal rate and regular rhythm.  Pulmonary:     Effort: Pulmonary effort is normal. Tachypnea (hyperventilating) present. No respiratory distress.     Breath sounds: Normal breath sounds. No decreased breath sounds, wheezing or rhonchi.  Skin:    General: Skin is warm and dry.     Coloration: Skin is pale.  Neurological:     Mental Status: She is alert.  Psychiatric:        Mood and Affect: Mood is anxious.        Behavior: Behavior normal.        Thought Content: Thought content normal.        Judgment: Judgment normal.         Assessment/Plan  Treatment included: water, snacks and Rest (Trendelenburg) Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Systemic reaction (headache, itching, tachycardia, hypoglycemia, hypotension, generalized rash)     Patient was resting on her mother after receiving the vaccine and felt dizzy/lightheaded without loss of consciousness. She was brought to the Med bay at 08:45 and placed in trendelenburg. After snacks, water and rest her symptoms resolved. She was able to ambulate without assistance.     Electronically Signed by APRN 4/8/2021 8:56 AM
Febrile seizure, lasted a few minutes.  No prior history of febrile seizures.
Patient should have got the 2nd shot on 04/27/21, but she came in 2 weeks and got the 2nd shot on 04/19/21 instead. No adverse event reported immediately, but not been able to get in touch with the patient.
N17.9 - Acute kidney failure, unspecified TESTICLE PAIN FEVER
When I received my 2nd covid shot on 8/27/21, I noticed the day after, 8/28/21, I developed severe itching on my stomach, feet, and ankle region. The itchiness has spread to my arms and hands region as well. I am pregnant - received 2nd covid shot when I was week 31. I had no unusual itchiness but right after I received the 2nd covid shot, my OB confirmed during a  week 32 check-in OB appointment that I have PUPPPS. Since I haven't had any issues with my pregnancy this whole time, reporting this event since it happened right after I received the 2nd covid shot. Expected date of delivery for the baby is Oct 23rd, 2021.
Jaundice; This is a spontaneous report from a contactable healthcare professional (patient). A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK5730), intramuscular in right arm on 22Dec2020 at a single dose for COVID-19 immunization. Medical history included almonds and apples allergy, Sulfa drugs allergy, and antibiotics allergy. The patient's concomitant medications were not reported. The patient previously took oxycodone hydrochloride;oxycodone terephthalate;paracetamol (PERCOCET) and VALIUM and experienced allergies. The patient experienced jaundice on 07Jan2021. Patient does not have COVID-19 prior vaccination. COVID-19 was not tested post vaccination. No treatment was received for the event. The outcome of the event was unknown.