chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (bump started to become itchy), VACCINATION SITE PAIN (Burning), VACCINATION SITE SWELLING (Little bump) and VACCINATION SITE ERYTHEMA (arm got a llittel red/red bump) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No Medical History information was reported.  On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced VACCINATION SITE PAIN (Burning), VACCINATION SITE SWELLING (Little bump) and VACCINATION SITE ERYTHEMA (arm got a llittel red/red bump). On 08-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (bump started to become itchy). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Vaccination site swelling and Vaccination site pruritus, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (bump started to become itchy) had resolved, VACCINATION SITE PAIN (Burning) outcome was unknown and VACCINATION SITE SWELLING (Little bump) and VACCINATION SITE ERYTHEMA (arm got a llittel red/red bump) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Patient syncopal episode that occurred 15 minutes post vaccination. Staff arrived, put patient recumbent position, vital signs taken. BP 80/40, pulse 68, 12 Respirations per min, O2 sat 96%. Patient arousable after 2 minutes. Complained of R jaw pain w/ radiation to R shoulder. Skin warm and dry, PERRLA. Neuro checks assessed, within normal limits. EMS called immediately., arrived to the scene at 11:55. BP 135/83, O2 sat 98%, NSR @ 78, respirations 14 per min.  ALert, oriented X3. Transported to ER.
Might administer dose after 42 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Might administer dose after 42 days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Might administer dose after 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Might administer dose after 42 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Serious upper respiratory infection, still sick 2 weeks later. Was placed on decongestion then antibiotics. Doctor said it was from the flu vaccine. 101 F temp for days, nasal discharge severe, now to cough and asthma symptoms.
death; lost consciousness; headache; This is a spontaneous report from a non-contactable consumer via a regulatory authority. A 33-year-old patient of an unspecified gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced lost consciousness, headache, and death. The event, lost consciousness, was life-threatening. The event, death, was serious for death. The clinical course was as follows: the patient was a pilot who had been vaccinated with bnt162b2. A strong headache occurred immediately after starting the flight. Two hours later, the patient almost lost consciousness and made an emergency landing. (withheld) inoculated and killed three pilots. It's been a fuss, but it doesn't stop anymore. The patient did not know when it will fall when the patient flies (as reported). The clinical outcome of the events, lost consciousness and headache, was unknown. The clinical outcome of the event, death, was fatal. The patient died on an unspecified date due to an unknown cause of death. It was not reported if an autopsy was performed.  No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death
SEVERE chills approximately 13-14 hours after receiving vaccine. Even after turning heat up in the house and wrapping myself in two comforters, I was still experiencing severe chills. These chills lasted for approximately 5-6 hours. I was unable to sleep due to them. I did not have a fever, as I checked my temperature several times during this episode. At approximately 6:00 am on the same day as experiencing the chills, I experienced abdominal pains, which lasted approximately 1 hour and resolved on their own.
dizzy; This is a spontaneous report from a contactable female consumer(patient) reported for herself.  A 78 years old female patient received 1st of BNT162B2 (Pfizer/BioNTech COVID-19 Vaccine) on 26Jan2021 13:00 at single dose for covid-19 immunization. Medical history was Allergy from dust. Concomitant drug was not reported. Mentioned had Pfizer covid vaccine but aware might not be protected because on immune suppressing drug. Dr had it wrong and pharmacy was right about following protocol of wearing mask since vaccine may not be effective. Also mentioned was dizzy from being outside and having allergies from dust. Thinks mask aren't working. The need for a booster dose of Pfizer-BioNTech COVID-19 vaccine based on duration of protection or impact of variant strains has not yet been determined. On February 25, Pfizer and BioNTech announced they have begun an evaluation of the safety and immunogenicity of a potential third dose of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) to understand the effect of a booster on immunity against COVID-19 caused by the currently circulating and potential newly emerging variants. It is important to have a vaccine technology that allows us to both provide boosting doses if needed and to address potential changes in the virus itself if a new variant emerges that the vaccine does not protect against. While we have not seen any evidence that the circulating variants result in a loss of protection provided by our vaccine in our laboratory studies, we are taking multiple steps to be ready in case a strain becomes resistant to the vaccine. Pfizer does not suggest or recommend the use of the vaccine in any manner other than as described in the company Prescribing Information / authorized product monograph Outcome of the event was unknown.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Donor received Tdap on 1/10/2018 reported no reaction after 15 minute wait. Donor reported on 4/20/18 the next day after receiving Tdap (1/11/18) she experienced shooting pain up her right arm, mostly sore in morning when waking up. Donor stated that fast movement even caused discomfort. Donor rated pain today on a scale of 1-10 a 3. Donor stated that the reason she did not report this issue sooner was that the vaccine information sheet she was provided that it was normal. Donor reports that pain to her right arm was so excruciating that she was not able to put her clothing on without crying. Donor declined outside medical treatment. When donor presented 4/20/18 she was attempting to donate plasma and reported that slight discomfort to right arm.
Arm bled; Have lost 20 Lbs. Since first shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old patient received BNT162b2 (BNT162B2), on 11Apr2021 at 09:40 as dose 1, single (Lot number: EW0151) at the age of 60 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE HAEMORRHAGE (non-serious) with onset 11Apr2021, outcome "unknown", described as "Arm bled"; WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "Have lost 20 Lbs. Since first shot". The event "have lost 20 lbs. since first shot" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: There were no prior vaccinations. Specific relevant test for thromboembolic events with thrombocytopenia was not done. It was reported that the patient had been to their PCP and dentist for weight loss.
Arms hurt really bad; red arm; swollen arm; hardened arm/it is hard to touch; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), INDURATION (hardened arm/it is hard to touch), PAIN IN EXTREMITY (Arms hurt really bad) and ERYTHEMA (red arm) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced PERIPHERAL SWELLING (swollen arm) and INDURATION (hardened arm/it is hard to touch). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arms hurt really bad) and ERYTHEMA (red arm). At the time of the report, PERIPHERAL SWELLING (swollen arm) and INDURATION (hardened arm/it is hard to touch) had not resolved and PAIN IN EXTREMITY (Arms hurt really bad) and ERYTHEMA (red arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Reporter information and additional events were provided.
Thur 11/7 pt felt achyness, chills Fri 11/8  8am pt develop  headache, did not feel good; left arm from flu vaccine was warm to touch, red & itchy.  Sun 11/10  pt's left arm still red, warm to touch & itchy Mon 11/11 pt called nurse  & possibility due to  reaction from ingredients in flu vaccine.   patient started to apply ice which helps, but was not able to sleep Tues 11/12  Redness is no longer as warm as it was before. Patient will continue icing & will take benadry tonight
nausea; chills; feeling hot; Feeling like she has a hangover; Initial information received on 04-Nov-2023 regarding an unsolicited valid non-serious case received from a Patient. This was a courtesy case received from regulatory authority.  This case involves a 48 years old female patient (86.2 kg) who experienced nausea, chills, feeling hot and feeling like she has a hangover after receiving Influenza vaccine, Pfizer biontech Covid-19 vaccine and while treated with treprostinil diolamine [Orenitram].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension.  Concomitant medications included ondansetron hydrochloride, riociguat (adempas); lidocaine; fluoxetine, furosemide, loperamide hydrochloride, simeticone (imodium multi symptom relief); famotidine (pepcid); tramadol hydrochloride (tramadol hcl); levothyroxine sodium (synthroid); fluticasone propionate (flonase allergy relief); loratadine, gabapentin, lamotrigine, calcium carbonate (tums); paracetamol (tylenol); salbutamol sulfate (albuterol sulfate); macitentan (opsumit); and diphenhydramine hydrochloride (benadryl).  On 18-Oct-2023, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (dose, route, formulation, strength and expiration date: not provided) for Immunisation.  On 03-Nov-2022, the patient started taking orenitram (treprostinil diolamine) Tablet at a dose of 10 mg TID (three times daily) oral (strength, lot/batch number and expiration date: not provided) for Secondary pulmonary arterial hypertension.  On an unknown date, the patient received a dose of suspect pfizer biontech covid-19 vaccine not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunisation.  On 18-Oct-2023 the patient developed nausea, chills, feeling hot, feeling like she has a hangover (hangover)  11 months 15 days following the administration of Influenza vaccine, Pfizer biontech Covid-19 vaccine and treprostinil diolamine.  Action taken- Unknown for treprostinil diolamine and not applicable for other suspects.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for all the events.
I began developing pain in my left leg Friday, March 19th - two days after receiving my second injection. My early Monday morning I was in so much pain that I went to the ER. I was diagnosed with acute DVT in my entire left leg from the Iliac vein in my abdomen down to the ankle. The entire leg was occluded.
Patient complained of Redness at the injection site and pain that went from her armpits down her sides.
This was my booster. I had the usual symptoms (nausea, tiredness), and then developed tinnitis  early this week.
Information has been received from a RN nurse concerning a 78 year old female physician  with hypertension, hypothyroidism, osteoporosis, spondylolisthesis, and a positive tuberculin purified protein derivative test and a history of vaginal bleeding who on 4/30/03 was in the office for a routine visut and was vaccinated in the left arm with the second dose of pneumococcal vaccine 23 polyvalent (643784/0676M), P1: in 1998. On 4/30/03, in the first 24 hrs following vaccination, the pt "felt like she had the flu." It was reported that the pt experienced pain at the injection site which lasted for 7 days. The arm was reported as being swollen, hot, and difficult to use. The reporter indicated that the reaction spread to the elbow and "this continued for 6-7 days." On 5/3/03, the third day after vaccination, the pt develped a "superimposed, blanching rash that looked like Scarlet fever but did not peel like Scarlet fever" in the area. It was also noted that on approximately 5/14/03, two weeks after vaccination, the pt was still experiencing pain with pressure. Unspecified medical attention was sought. No additional pt info was provided. There was no product quality complaint. Follow up information received from a registered nurse indicated that the injection on 4/30/03 was a painful injection. Within one hour, it became extremely painful, was deep red, swollen, and hot around 7/8th of the left arm. It was spreading almost to the elbow. For the first 24 hours after injection, the patient had flu-like symptoms. It was also reported that the patient had difficulty using her arm. On about the third day, approximately 5/2/03, there was a superimposed, blanching rash. Symptoms continued for 6-7 days. The pain remained for seven days. Two weeks after the injection, the patient still had pain with pressure and the skin was brawny. On about day 10 to 12, approximately 5/9/03 to 5/11/03, the patient was very pruritic. It was noted that the patient recovered on approximately 6/4/03. No further information is expected.
ARM HURTS LIKE HELL; MILD SHORT LIVED HEADACHE; MINOR CHEST TIGHTNESS; 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 not reported, batch number: not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 27-JUL-2021, the subject experienced minor chest tightness. On 27-JUL-2021, the subject experienced mild short lived headache. On 28-JUL-2021, the subject experienced arm hurts like hell. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the minor chest tightness, mild short lived headache and arm hurts like hell was not reported. This report was non-serious.
This is in follow-up to report(s) previously submitted on 9/14/2006.  Initial and follow-up information has been received from a physician concerning a 52 year old female with a history of a "herpes outbreak" two weeks ago.  On 17-JUL-2006.  "10 days prior" to receiving GARDASIL (yeast), the patient had taken acyclovir 200 mg.  On 27-JUL-2006, the patient was vaccinated intramuscularly with the first dose of 0.5 mL of GARDASIL (yeast).  It was reported that the patient had "2 herpes lesions on her inner labia" at the time of vaccination.  On 27-JUL-2006, the patient developed a neck ache, eyelashes fell out, "a decrease memory for people" and excessive dry eye.  On 27-AUG-2006 the patient developed a migraine with vomiting (previously reported that the patient had "burning at the injection site").  The patient sought unspecified medical attention.  At the time of this report, the patient had recovered from the events (date unknown).  Additional information has been requested.
A few hours after TD aministration, employee felt extreme soreness at site, left deltoid. on 01/17/2011 came to OHS at Hospital stating left arm hurt, bruising noted at administration site left deltoid, slight swelling. Given Iprin for discomfort and advised to continue using warm compresses, return to OHS if any further concerns. 01/19/2011 returned to OHS c/o continued pain/soreness at site, left deltoid, noted to be with bruising at injection site, warm to touch, swollen, reddened from site down to 2 inches above elbow on lateral arm. Saw nurse practioner in clinic. Motrin 400mg TID, rest, no lifting greater than 10 lbs for 3 days, if not better or worsens, call/come in to see NP
PATIENT DEVELOPED A REFRACTORY FORM OF PERICARDITIS APPROX 3 WEEKS AFTER 1ST MODERNA COVID VACCINE
warm at site of injection; the center of it looks kind of yellow; arm itching; pinkish-red arm of injection; bigger; cold symptoms; tender site of injection/soreness; feverish 99.9F; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (tender site of injection/soreness), PYREXIA (feverish 99.9F), NASOPHARYNGITIS (cold symptoms), VACCINATION SITE PRURITUS (arm itching) and VACCINATION SITE ERYTHEMA (pinkish-red arm of injection) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (anti-inflammatories), Sulfonamide allergy (sulfur), Drug allergy (codeine), Allergy to antibiotic (minocycline) and Shellfish allergy. Concomitant products included CALCIUM, VITAMIN D [VITAMIN D NOS], TOCOPHEROL (VITAMIN E [TOCOPHEROL]), PROBIOTICS NOS, ACETYLSALICYLIC ACID (BABY ASPIRIN), PROSTATINE and medicine for allergies for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (tender site of injection/soreness) and PYREXIA (feverish 99.9F). On 03-Feb-2021, the patient experienced NASOPHARYNGITIS (cold symptoms). On 09-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (arm itching), VACCINATION SITE ERYTHEMA (pinkish-red arm of injection), VACCINATION SITE WARMTH (warm at site of injection), VACCINATION SITE SWELLING (bigger) and VACCINATION SITE DISCOLOURATION (the center of it looks kind of yellow). The patient was treated with PARACETAMOL (TYLENOL) for Cold symptoms, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (tender site of injection/soreness), PYREXIA (feverish 99.9F), NASOPHARYNGITIS (cold symptoms), VACCINATION SITE PRURITUS (arm itching), VACCINATION SITE ERYTHEMA (pinkish-red arm of injection), VACCINATION SITE WARMTH (warm at site of injection), VACCINATION SITE SWELLING (bigger) and VACCINATION SITE DISCOLOURATION (the center of it looks kind of yellow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Swelling of lymph nodes in arm pit, neck and groin on right side. Fever, chills, body aches. Severe symptoms resolved after 3 days, but armpit lymph node is still tender and PM fevers (99-99.9) are still occurring.
throat pain; neck pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Sep2021 11:00 (Lot number: EW0173) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "diagnosed with COVID-19:Yes" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Augmentin, reaction(s): "known_allergies: Augmentin". The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 14Sep2021 08:00, outcome "not recovered", described as "throat pain"; NECK PAIN (non-serious) with onset 14Sep2021 08:00, outcome "not recovered", described as "neck pain". Therapeutic measures were not taken as a result of oropharyngeal pain, neck pain.  Additional information: Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not received any medication within 2 weeks of vaccination. Since the vaccination, the patient had not tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Child was suddenly and very uncharacteristically depressed, emotional and (in her words), "grumpy."  She could not give a reason why she would suddenly start crying...Also reported having a bad headache. This behavior is *extremely* unusual in this child. Given how her brother and mother reacted at the same time, I thought it was worth reporting.
My wife was given the following booster shots: COVID-19, mRNA LNP-S PF - 100mcg or 50mcg   -  01/04/2022   -  75y 2m 25d  -  COVID-19, mRNA LNP-S PF 100mcg or 50mcg    -      05/05/2022 75y 6m 25d
VACCINE GAVE HIM BOOTY WARTS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) 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 patient experienced vaccine gave him booty warts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine gave him booty warts was not reported. This report was non-serious.