chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Event was as followed; expired vaccination was administered three days after expiration date to child. Called company stated we should call patient to administer another dose of vaccine in 4 weeks. Patient's mother will be called and will bring patient in for another dose.
Felt a little bit sluggish; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Felt a little bit sluggish) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SLUGGISHNESS (Felt a little bit sluggish). On 26-Feb-2021, SLUGGISHNESS (Felt a little bit sluggish) had resolved.            After second dose, friend's husband of reporter felt a little bit sluggish, and then felt fine the next day. Caller also reports for her friend who had the same symptoms   This case was linked to MOD-2021-030380 (Patient Link).
This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (felt uncomfortable), MALAISE (felt not well), HEART RATE INCREASED (heart rate is fast (95 to almost 100, his usual is in the 80s, it is on and off)), CHEST DISCOMFORT (chest discomfort) and PALPITATIONS (palpitations) in a 43-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.                No relevant concomitant medications were reported.   Patient had the bivalent Moderna booster dose, 21-Nov-2022 at around 6:00pm and 2 hours after that, they felt uncomfortable and not well. 22-Nov-2022, he has a fever (37.5C) and his heart rate is fast (95 to almost 100, his usual is in the 80s, it is on and off). He checks his O2 sats and it has been 96-98. He states that it was not that bad.  Adverse event caused patient to seek medical care.  The patient did not experienced a similar event in the past.  No treatment information was provided.
ulcerative colitis flare up; This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (ulcerative colitis flare up) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis (Moderate to severe).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. On an unknown date, the patient experienced COLITIS ULCERATIVE (ulcerative colitis flare up) (seriousness criterion medically significant). At the time of the report, COLITIS ULCERATIVE (ulcerative colitis flare up) had resolved.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was provided. Treatment medication was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of ulcerative colitis flare up with humira(adalimumab) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment:  This is a spontaneous case, reported by a consumer concerning an elderly male patient with relevant medical condition of moderate to severe Ulcerative colitis, who experienced the unexpected serious (medically significant) adverse event of special interest Colitis ulcerative, reported as ulcerative colitis flare up, in the context of the a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. It was reported that the event had resolved. The medical condition of moderate to severe Ulcerative colitis remains as a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case, reported by a consumer concerning an elderly male patient with relevant medical condition of moderate to severe Ulcerative colitis, who experienced the unexpected serious (medically significant) adverse event of special interest Colitis ulcerative, reported as ulcerative colitis flare up, in the context of the a dose of mRNA-1273 vaccine. Latency cannot be properly assessed since vaccination date nor event onset date were provided. No further details about the clinical course, diagnostic procedures and treatments were provided. It was reported that the event had resolved. The medical condition of moderate to severe Ulcerative colitis remains as a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
This spontaneous report was received from a nurse concerning a patient of unknown gender and age. On 16-MAY-2015 the patient ws vaccinated with an improperly stored dose of GARDASIL (lot # K006960; expiration date: 19-FEB-2017) (dose and route not provided). No adverse effects were reported.  This is one of several reports received from the same source. Additional information has been requested.
Administered 2 days past the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered 2 days past the beyond use date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered 2 days past the beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered 2 days past the beyond use date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Beyond Use date was reported as 25 May 2022. It was reported that the product did not experienced any other temperature excursions and no particulates or discoloration noted. Suspect product was transported and maintained between 36-46F. No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-581911 (Patient Link).
Acute onset of cough, rhinorrhea, congestion, sore throat, sore neck, and ear pain. Patient had pharyngitis with early right sided ear infection. Treated with Zithromax antibiotic.
04/14/2021, experienced leg cramps, fatigue, body aches. Visited ER on 04/15/2021 05/10/2021, experienced chest pain, rapid heart beat, exhaustion Visited ER 5/11/2021
dermographism, when any pressure is apply on their body it turns red.; broke out with hives all over their body; lip swelling; eyelid swelling; very itchy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of URTICARIA (broke out with hives all over their body), LIP SWELLING (lip swelling), SWELLING OF EYELID (eyelid swelling), PRURITUS (very itchy) and MECHANICAL URTICARIA (dermographism, when any pressure is apply on their body it turns red.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A, 049C21A and 025B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 28-Dec-2021, the patient experienced URTICARIA (broke out with hives all over their body), LIP SWELLING (lip swelling), SWELLING OF EYELID (eyelid swelling) and PRURITUS (very itchy). On an unknown date, the patient experienced MECHANICAL URTICARIA (dermographism, when any pressure is apply on their body it turns red.). The patient was treated with CORTISONE on 31-Dec-2021 for Adverse event, at an unspecified dose and frequency; PREDNISONE on 31-Dec-2021 for Adverse event, at an unspecified dose and frequency and BETAHISTINE HYDROCHLORIDE (VERTEX [BETAHISTINE HYDROCHLORIDE]) for Antihistamine therapy, at an unspecified dose and frequency. At the time of the report, URTICARIA (broke out with hives all over their body) and PRURITUS (very itchy) had not resolved, LIP SWELLING (lip swelling) and SWELLING OF EYELID (eyelid swelling) had resolved and MECHANICAL URTICARIA (dermographism, when any pressure is apply on their body it turns red.) outcome was unknown.            No Concomitant medications were reported.  Patient stated that she experienced hives every day and very itchy, which come and go throughout the day, spread on the stomach and appeared in various parts of the body at different times. Patient stated that she have been taking Vertex, an antihistaminic and also visited urgent care on Friday 31-Dec-2021 where she got a cortisone shot and a prednisone course for 5 days. Patient also stated that she do not take any medication regularly and she was pregnant back when she received the first two shots of vaccine
Stated the first shot hurt but that was it; This is a spontaneous report from a non-contactable female consumer (the patient) from a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her first dose and was supposed to get her second dose tomorrow; she wanted to know if she should make an appointment. She stated the first shot hurt, but that was it. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Vertigo, room spinning, nausea. Has suffered off and on ever since, with symptoms lasting over two months at a time.
Information has been received from a pharmacist concerning a 64 year old male patient who was inadvertently vaccinated with a dose of Varivax instead of Zostavax. There was no product quality complaint involved. Additional information indicated that Zostavax was ordered however Varivax was given on 26-JUL-2006. The pharmacist indicated that it was a "med sound alike error." No further information was available.
After the second dose iIstarted getting hive s and burning of my skin . I got eczema all over my face and neck it has been going on for about a month and a half now after second vaccine. I also get itchy like ant feelings on skin. I have never got this before at all . I am not an itchy person at all.
Patient was accidentally given second dose of Pfizer 1 week earlier than recommended dose.  Patient did not report any side effects/symptoms.
This spontaneous report was received from a nurse refers to a unspecified patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (dose, frequency, route of administration and indication were not reported, lot # K025760 with expiration date: 08-JUN-2016). No adverse event was reported. This is one of the several reports received from the same source. Additional information has been requested.
Soreness in left arm; vomiting; nausea; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Dec2020 09:45 (Lot number: EKS730) at the age of 51 years 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: NAUSEA (non-serious) with onset 31Dec2020 16:00, outcome "unknown", described as "nausea"; VOMITING (non-serious) with onset 31Dec2020 18:00, outcome "unknown", described as "vomiting"; VACCINATION SITE PAIN (non-serious) with onset 02Jan2021, outcome "unknown", described as "Soreness in left arm". The events "nausea", "vomiting" and "soreness in left arm" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of nausea, vomiting.  Additional information: The patient took ondansetron (ZOFRAN) for nausea and vomiting.   No follow-up attempts are possible. No further information is expected.
It was basically tapering off and then like it kind of continue to taper off for 2 more days and then it kind of took break; My shot hurt a little bit for the first day and maybe like second day; I had my arm really really hurt; Joint pain/my hip and my knee hurt; This a spontaneous report received from contactable consumer (patient) or other non HCP   A 46-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0171), via an unspecified route on 30Apr2021 in the right arm (at the age of 46-years) as 1st dose, single dose for covid-19 immunisation. The patient medical history included allergies. Concomitant medications included diphenhydramine hydrochloride (BENADRYL), multi Vitamins. The patient did not receive any other vaccines within four weeks prior to the vaccination. On unspecified date, the patient experienced basically tapering off and then like it kind of continue to taper off for 2 more days and then it kind of took break and almost felt like it restarted cycle all over again; it is like super crazy heavy; it is still continuing to be really heavy flow, joint pain, her shot hurt a little bit for the first day and maybe like second day; patient had arm really hurt and had hip and knee hurt. Patient feel like how much blood loss it is. Patient stated that she wasn't really fully tracking or aware of it after the first dose but something did happen where she remember it being a little heavier and a little longer but not as extreme as it has been after the second dose. Patient stated that from the past 2 days, like she said it's like very heavy flow and also like major cramping, so she took Tylenol 500 milligrams. The outcome of the events was unknown.  Follow up needed, further information has been requested.
Patient reports on 11/01/2021 that she started having tingling and numbness in my feet that move up my legs from my toes to my knees along with lower back pain. This continued all day and through the night and still this morning. It's worse when sitting or laying down less noticeable when walking or standing. Medical record notes indicate that she will see a neurologist to rule out Guillan Barre'. She reports being prescribed steroids during urgent care visit.
This spontaneous report as received from a vaccine coordinator refers to a 6 month old patient of unknown gender. On 19-FEB-2016, the patient was vaccinated with a second dose of PEDVAXHIB (Lot # L038501 exp date 16-AUG-2018) (dosage and route unknown) following a temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Hives, swelling of face and throat. Went to emergency room multiple times to treat continued problems with swelling and hives. Over a course of more than a month he was given epinephrine shot, treated with antihistamines and steroids. Eventually led to problems with constipation that led to bleeding in colon, so much so that he became anemic. Still having problems with that.
This solicited report was received from a consumer (mother), via Market Research Agency. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On unknown date (reported as this morning), the patient was vaccinated with GARDASIL (strength, dosage schedule, route, lot number and expiration date were not reported). The reporter said that the patient mentioned that it hurts a lot and therefore she wasn't very keen on getting the shot. He said that you have to sit there for 10 minutes after to make sure you don't pass out. This scared the crap out of her (reporter). The reporter said that she had never heard of this before so why would she want to get a shot that could hurt her child (daughter). This made the reporter not want to get the shot now. The reporter kept going back and forth in her mind. Action taken was not applicable. The outcome of the event was unknown. The reporter's causality was unknown. Additional information is not expected because the reporter refused to be contacted.
A lawyer reported the occurrence of mercury poisoning in a female child of unspecified age who was vaccinated with hep B vaccine recombinant (manuf unk) and diphtheria and tetanus toxoids and acellular pertussis vaccine (manuf unk) at approximately 2 weeks of age. She also received injections of hep B vaccine 2/14/95 and 8/9/95; combination diphtheria and tetanus toxoids and pertussis/Haemophilus influenzae type B conjugate vaccine (DTP+ActHIB 2/14/95, 4/10/95, 8/9/95); diphtheria and tetanus toxoids and acelluar pertussis vaccine (manuf unk; 3/31/96); Orimune 2/14/95, 4/10/95, 8/9/95; and MMR II 3/5/97. She also received a tuberculin tine test 8/9/95. The subject's attorney alleged that "as a result of mercury in thimerosal-adulterated infant injection that the subject received as an infant, she now suffers, and in the future will continue to suffer from the toxic neurological effects of mercury poisoning." The mercury poisoning in this report is consider medically serious (OMIC).
had cold sores; This is a spontaneous report from a contactable nurse reporting different events under the same suspect product for 5 patients. This is one of the 5 reports (for the 1st of 2 additional people).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had cold sores after getting the COVID-19 vaccine. The clinical outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021541866 Same reporter/ drug/ event for different patients
Pt recv vax on 2/1/99; post vax pt exp headache, achy joints &burning knees; dx=allergic rxn to vax
Reports that she felt fine until 3 days after receiving the Tdap. Reports that she has developed serve pain in that arm. States it wakes her from sleep. Is taking Ibuprofen product for pain relief. Referred to PCP.
Injection sight of vaccination swollen, hard, red, and tender in an area about 6 inches in diameter. Severe fatigue lasting 2 weeks or so. Nausea for 2 weeks, off and on.
patient pulled back arm when administering and had to repeat administration of needle, same arm, no adverse effects acknowledged
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: tingling and numbness in arm started at night on 10/27/22
Vaccine > PREVNAR  / VARIVAX administered 2-25-2009, Lt Leg induration and erythema started 3-06-2009.
Her blood number are not the best and a little low lately; This spontaneous case was reported by a consumer and describes the occurrence of FULL BLOOD COUNT DECREASED (Her blood number are not the best and a little low lately) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy. Concurrent medical conditions included Immunocompromised.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FULL BLOOD COUNT DECREASED (Her blood number are not the best and a little low lately). At the time of the report, FULL BLOOD COUNT DECREASED (Her blood number are not the best and a little low lately) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Full blood count: low (Low) blood number are not the best and a little low lately.         No concomitant medication was reported.  No Treatment information was reported.
Joint pain; Muscle pain; Chills; Vomiting; Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), CHILLS (Chills), VOMITING (Vomiting) and PYREXIA (Fever) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), CHILLS (Chills), VOMITING (Vomiting), PYREXIA (Fever) and NAUSEA (Nausea). At the time of the report, ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), CHILLS (Chills), VOMITING (Vomiting), PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This was my 2nd dose. DAY 1 8:45 am Similar to the first shot almost immediately my tongue went numb and swelled up a bit. DIFFERENT from my first dose, on Day 1 the 2nd dose my upper lip also swelled up and went numb. The gums around my top teeth also went numb. There was an usual taste in my mouth as well. The numbness etc. subsided after a few hours. Then at 10pm my tongue and upper lip swelled and went numb all over again. This lasted 20min or so. This intermittent swelling and numbing continued off and on for the first 10 days after the shot. At no point did I need to use the EpiPen. Was not life threatening. Just weird feeling.   Also on day 2 only I ran a low grade fever and had a mild case of vertigo [which I had never experienced in my life before]. That went away after that day but the numbness and swelling continued intermittently for 10 days. Some days it wouldn't happen then the next day it would. Seemed random.  Worth noting though I had an allergic reaction to both doses, I have never in my life had an allergic reaction to any vaccine prior.