chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient is a 42 y.o. male presents to the emergency department with a worsening petechial rash. The patient noticed a dark-colored sore on his lip yesterday (10/08). This morning (10/09) he woke up and the rash had spread to inside his mouth, on his legs, arms, waistband, and chest. He noted that when he tried to brush his teeth this morning his gums started to bleed and he was tasting blood.
Within 15-minutes of vaccination with second dose, the patient reported SOB/DIB, chest tightness, and sensation of throat closing . EMS administered 1mg Epinephrine and patient developed stridor. Patient became hypertensive (189/85). EMS administered another 1mg Epi and 50mg Benadryl IV. ETCO2 waveform was normal. EMS placed patient 15Lpm oxygen via non-rebreather mask. EKG showed NSR, rate 80 bpm, no ST elevation, and no signs of ectopy. Patient was transported to Emergency Department. In the ED, patient was hypertensive (204/91), but felt improved after EMS administration of epinephrine. Patient refused admission.
A report has been received from a Health Professional concerning a subject of unknown gender, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 16-Dec-2014. The patient experienced expired FLUMIST quadrivalent administered which started on 16-Dec-2014. The following products were considered to be interacting: FLUMIST quadrivalent. The outcome of the event of expired FLUMIST quadrivalent administered was unknown. The reprot was considered to be non-serious.
Initial information was received from a registered nurse and follow up information received from a physician concerning the registered nurse's currently 6 year old son with seasonal allergies and a history of sinusitis, pneumonia, recurrent otitis media and a perforated tympanic membrane, who was vaccinated at 15 months of age with a dose of MMR (second generation) (lot not reported). Concomitant therapy included budesonide. At 15 months of age the patient had cellulitis localized at the injection site after vaccination with MMR (second generation) and this was treated with acetaminophen. The mother, a registered nurse, reported that at age 2 the patient developed symptoms of pervasive development disorder and the patient had difficulty with speech and was hyperactive. She reported that at 3 years of age the patient was diagnosed with autism and ADHD. The patient has received speech and occupational therapy, behavior modification and has been on a special diet of gluten free and casein free food. Follow up information from the physician reported that due to the recurrent otitis media and perforated tympanic membrane noted in past medical history, the child subsequently had placement of tubes on 3/5/99. The physician reported that on 4/19/99 the patient was noted to have a speech delay. In April 2001, the child was seen by a psychologist and was diagnosed with Pervasive Developmental Disorder (PPD) and ADHD. The physician reported that the child was not diagnosed with autism. The mother reported that the patient was diagnosed with a severe diary allergy at 4 years of age. It was also reported that at 4 years of age on 7/3/01, after Streptococcus pneumoniae vaccine the patient had cellulitis of his deltoid which was inflamed, red, and hot. This was treated with amoxicillin (+) clavulanate potassium, diphenhydramine and hydrochloride, acetaminophen or ibuprofen. It was reported that the cellulitis had resolved. The physician saw the patient in June 2003 and reported that at that time the child was in first grade in a life skills program. The physician noted that the child was only mainstreamed for subjects like music. The physician felt that the child had PPD and sensory integration problems. The patient was not being treated with any medications. The mother reported that the patient was now cognitively up to his grade level, but with difficulty processing sensory stimuli. A recent titer was negative for mumps. Unspecified medical attention was sought. Upon internal review, autism, pervasive developmental disorder and ADHD were determined to be other important medical events (OMIC). The registered nurse also reported that she had been vaccinated with MMR (second generation) and had a negative titer for mumps. No further information is expected.
This case was reported by a physician and described the occurrence of hives in a 43-year-old female subject who was vaccinated with Fluarix (GlaxoSmithKline). In early November 2007 the subject received unspecified dose of Fluarix at 0.5 ml. At an unspecified time after vaccination with Fluarix, the subject experienced hives with itching to the point of producing blood. This has occurred three times since receiving Fluarix. In addition, the subject underwent a spirometry test for respirator use and she did not pass. At the time of reporting the events of hives, itching and the abnormal spirometry test were unresolved. The outcome of bleeding skin was not specified. Follow-up received on 25 January 2008 via the physician. Relevant history included an allergy to walnuts. She reported that on 10 November 2007 the subject experienced hives, itching, abnormal spirometry and skin bleeding. The subject was diagnosed with an allergic reaction of unknown etiology. On 05 December 2007, results of a CBC, chemistry screen and sedimentation rate were all normal. On 13 December 2007, all the hives, itching, abnormal spirometry, skin bleeding and the allergic reaction of unknown etiology had improved. The physician considered that the events were not serious and possibly related to the use of Fluarix. A separate summary for the events was provided by the physician which included the following information. 04 December 2007. It was noted that the influenza injection was received and a week or so after that itching which got to the point that the subject would scratch herself to the point of bleeding. Symptoms were noted to include perfuse itching especially at night, no shortness of breath or feeling of throat closing. Subject did not increased nasal congestion and post nasal drip. On 04 December 2007, the subject was without symptoms. Blood work was ordered and subject advised to see physician and an allergies. 05 December 2007: Blood work was performed. CBC with differential, chemistry screen and sedimentation rate were all normal. 06 December 2007: subject seen by another physician. Subject was noted to have had a "wheal and flare" reaction of upper arm and back without shortness of breath, hypotension or other signs and symptoms of anaphylaxis. Diagnosed with an allergic reaction of unknown etiology. Treated with 40 mg Kenalog intramuscular, Synalar cream 0.025 percent to pruritic areas and Medrol dose pack. Referred to allergist. 22 January 2008: Physician contacted the subject via phone. Subject noted that she feels well. Noted that she does experienced rare episodes of pruritus which she usually can bring on herself by just scratching her skin. Occurs in small areas is of short duration responding almost immediately to the Synalar cream Denies any other symptoms and did not see an allergist.
Felt immediately pain in left upper arm after receiving annual Flu Vaccine.  Continue to have pain and difficulty getting dressed, raising my arm and not able to sleep through the night for past 7 months . Saw /spoke to PCP approximately 4 times .  Saw 2 different  Neurologist s .  Saw an Orthopedic Surgeon who ordered a MRI Having Physical Therapy x 2 every week for past 3 weeks with no relief of pain .
skin reaction of circles on forearm and trunk; This is a spontaneous report from a contactable nurse (patient). A 46-year-old male patient received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on 22Dec2020 09:15 at a single dose for COVID-19 immunization. He is fair skinned. There were no medical history or concomitant medications. The patient experienced skin reaction of circles on forearm and trunk on 23Dec2020. The outcome of event was unknown. This case is reported as non-serious by reporter.     The causality between event skin reaction of circles on forearm and trunk and BNT162B2 is related by Primary Source Reporter per Global Introspection.   Information on the lot/batch number has been requested.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (no adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.).    It was reported that 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion.  This case is for 28th patient out of 77 patients reported.  No concomitant medication information provided.  No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122: case
Client was vaccinated with Pfizer vaccines for Covid in May and on April 22, 2021.  Symptoms started 10/1 - nasal congestion, sore throat, vomiting x 1 day.  Tested positive PCR for Covid on 10/3.  Reported as a case of breakthrough Covid illness in a previously vaccinated person
Reported to a satellite clinic on 10/13/17 with complaint of 2 day history increased bruising. Labs were drawn that day. Critical lab value of low platelet count (3,000) was called to clinic. Patient was referred to Hospital where critical labs were confirmed. Hematology was consulted. IVIG X 1 given in hospital on 10/14/2017. Patient has followed with Hematology weekly for lab work and monitoring of platelet count.
Fever up to 101 started on 8/22/17 and last through 8/24/17; Rash started on face, torso and back on 8/26/17 and still currently has rash.
in a few days-stroke like sx;both arms contracted against chest-fingers not aligned;no control over movement;pain in arms for a short time-unable to ambulate-drug self could not wipe self;worsened till 2 wk-w/pain able to move-paresthesia
skin was very warm at injection site and 2 days later site started to itch and continues to itch as of today although not as bad.
Extremely sore arm with a large swollen mass in upper arm muscle that lasted for 5-6 days. Severe headache, fever up to 104.2 by 5:30 am Saturday, chills, body ache, nausea, loss of appetite. Acetaminophen only dropped temp somewhat but did not alleviate the fever. Sunday  I only had low grade fever up to 100.5 and other symptoms were not as bad. By Monday the fever was gone. It took several days for the ache and swelling in my arm to go down.
Patient received Varivax 0.5ml subcutaneous left arm 07/31/2007. Returned 8/2/2007 c/o itching at site, 3inch X 4 inch red raised area @ injection site with 3/4 inch center covered in multiple "blistery papules" of clear fluid. Patient reports that he first noted the itching around 1200 8/1/2007 then noticed the redness and swelling last night.
Once injection given, felt like Electric shock immediately afterwards, bleed a little, area swelled, painful and turned a purple /black.  The next day my neck, shoulder and area where injected swelled and painful. Muscles aches all over.  After about 3-4 days leg muscles stopped hurting but muscles in left arm continue to be bothersome, from my shoulder down to my thumb muscle spasms throughout the day. To this day 3/29/21 I continue to have muscle spasms from my shoulder down my left arm.
Raised, reddened vaccine site with wheal and severe itching approximately 24 hours post injection.
Absence of antibodies to the virus in her blood; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (Absence of antibodies to the virus in her blood) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-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 SARS-COV-2 ANTIBODY TEST NEGATIVE (Absence of antibodies to the virus in her blood). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (Absence of antibodies to the virus in her blood) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No lab data was provided. No concomitant medication was provided. A patient who received both doses of the Moderna Covid-19 vaccine on 17-Mar-2021 the first one and on 12-Apr-2021 the second one called to report that after having a blood work last week to determine the presence of antibodies in her blood, the result showed that she did not have any anti-virus antibodies in her blood She consulted with her physician, and she suggested that both doses of the Moderna Covid-19 vaccine should be repeated. The patient was asking if a third and a fourth dose of the Moderna Covid-19 was describe in the Moderna guidelines. Best method of contact is by her email. Expiration date of both vaccines was not provided.
Dose administered to patient after improper storage and handling; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling). On 26-Aug-2021, PRODUCT STORAGE ERROR (Dose administered to patient after improper storage and handling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No Treatment medication was reported.   This case was linked to MOD-2021-299914 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up contains changed patient initials, gender, route of administration and dose details.
Patient is a participant in a study. On 12/06/17, patient completed a routine plasma donation during which 880 mL plasma was collected and 500 mL saline was administered. Donation was followed by a dose of Td Adsorbed (MassBiologics). This was her 5th dose of Td vaccine over the course of 1 year. She had received all doses at an interval of not more often than every 90 days. Following vaccination, Patient remained in the center for 30 minutes to be observed for adverse events. Approx 30 minutes post-dose, she complained of lightheadedness and subsequently had a loss of consciousness > 60 seconds during which time she had a loss of bladder control. Upon regaining consciousness, she complained of abdominal pain and vomited x 2. She was provided with comfort care (including assistance to lie down, water, and a snack) per our SOP and monitored throughout. Patient recovered fully approx. 30 minutes after the onset of symptoms. Patient was assisted to the floor by staff when she lost consciousness, so no head injury occurred. Patient contacted the center after arriving home and notified the staff she had vomited once more, but was able to retain fluids and was resting. The site nurse reached out to patient on 12/07/17. At this time, patient reports all symptoms have completely subsided. She took a shower, rested, and has been feeling well. She has eaten a meal and not had a return of symptoms.
This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (experienced rash and hives all day after the booster shot that are itchy and red), ERYTHEMA (experienced rash and hives all day after the booster shot that are itchy and red), PRURITUS (experienced rash and hives all day after the booster shot that are itchy and red) and RASH (experienced rash and hives all day after the booster shot that are itchy and red) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In December 2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced URTICARIA (experienced rash and hives all day after the booster shot that are itchy and red), ERYTHEMA (experienced rash and hives all day after the booster shot that are itchy and red), PRURITUS (experienced rash and hives all day after the booster shot that are itchy and red) and RASH (experienced rash and hives all day after the booster shot that are itchy and red). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of UNK, as necessary. At the time of the report, URTICARIA (experienced rash and hives all day after the booster shot that are itchy and red), ERYTHEMA (experienced rash and hives all day after the booster shot that are itchy and red), PRURITUS (experienced rash and hives all day after the booster shot that are itchy and red) and RASH (experienced rash and hives all day after the booster shot that are itchy and red) had not resolved. Patient experienced the symptoms all day after the booster shot and the symptoms had flared up recently only in the evening. No concomitant medication were reported.
Dehydration despite drinking the usual amount of water. The person that went with me and also got vaccinated mentioned the same observation and his grandmother got a pretty severe urinary tract infection after receiving the first dose of the Moderna vaccine. It may be a coincidence, but it seems odd that several of us noticed it. It isn't something that would be incredibly harmful to most people, but it probably should be mentioned anyway, so I figured I'd report it regardless.
Red rash like on surface of left arm between elbow and wrist.   When I rub my hand across the area, I feel 5 bumps just below the skin.  the pain is very mild.  One bump is larger than the others about the size of a pea. that one is a mild pain.
She had her vaccine late evening on September 11th.  The next morning when she woke up she said her leg hurt and it hurt to walk. I just told her she would be fine.  Then I looked at her leg  when I got her dressed. It was a little swollen (which I expected) a little red and warm to the touch. She had a slight fever of 99.8.  She went to school and I picked her up at 11:30.  Her leg looked much worse. I called the dr office and they told me to put cold compress on the site and give her motrin.  I went back to work and an hour later I received a call that my daughter is really hurting. She is saying her head hurts and is not herself at all.  I called back the dr and got an apt to go in.  I saw a nurse for about 2 mins max. She looked at her leg and just said it was normal. No vitals were taken.  On the way home I stopped to pick up motrin from the store and gave it to her in the parking lot.  I picked up my son and we went home. When I got home I took her temp again (after I gave her motrin).  It was almost 103.  By that evening (5:00pm) Her whole upper thigh was huge.  Over the size of a baseball.  It was very red and very hot to the touch.  The next morning 9/13 there was no change in her leg.  Her fever was down to the upper 100's with no Motrin given.  She still said her leg hurt to walk.  On 9/14 the swelling went down slightly but was still very red and hot to the touch.  She no longer had a fever.  That evening she developed diarrhea.  9/15 she still had diarrhea that morning. Her leg was still red and  hot to the touch.  The swelling did go down a little more.  9/16 No diarrhea. The swelling continues to go down along with the redness.  It is no longer hot to the touch.
This spontaneous report has been received from a physician, concerning a 5 year old male patient. The patient's medical history and concurrent conditions were not provided. Concomitant therapies included M-M-R II and sterile diluent. On 20-JUL-2018, the patient was inadvertently vaccinated with ZOSTAVAX lot # M041086, intramuscular in the left deltoid (dose and frequency were not provided) (discrepant information also reported that lot # N021172 with expiration date was administered subcutaneously 0.65 ml once on an unknown date) for prophylaxis instead of VARIVAX (dose, frequency, route, lot number and expiration date were not provided). The reporter stated that the patient was seen 2 weeks later and no issues noted. Additionally, on the same date the patient was also vaccinated with QUADRACEL dose 4, intramuscularly in the left deltoid arm, lot number CS325BA. The patient experienced pain in arm that lasted 3 or 4 days where ZOSTAVAX and QUADRACEL were administered. The outcome of pain in arm was reported as recovered. The causal relationship between pain in arm and the therapies was not assessed.
06Mar and 10Apr90 pt vax w/ hepta B. Jun90 pt devel unspecified neurologic sx. dx of Guillain Barre Syndrome was made.