chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed 2 nodules 11DEC2022 to the marionette lines  approximately 2 cm and palpable; Inflamed; This spontaneous case was reported by a health care professional and describes the occurrence of NODULE (Developed 2 nodules 11DEC2022 to the marionette lines  approximately 2 cm and palpable) and INFLAMMATION (Inflamed) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product POLY-L-LACTIC ACID (SCULPTRA) injection for an unknown indication.    No Medical History information was reported.   On 04-Nov-2022, the patient started POLY-L-LACTIC ACID (SCULPTRA) (unknown route) at an unspecified dose. On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form, third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2022, the patient experienced NODULE (Developed 2 nodules 11DEC2022 to the marionette lines  approximately 2 cm and palpable) and INFLAMMATION (Inflamed). The patient was treated with DOXYCYCLINE at an unspecified dose and frequency. At the time of the report, NODULE (Developed 2 nodules 11DEC2022 to the marionette lines  approximately 2 cm and palpable) and INFLAMMATION (Inflamed) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant medications were not reported. On 14-MAR-2016, the patient received improperly stored VARIVAX (Merck) lot # L035128, expiration date: 14-SEP-2017 (exact dose, route of administration and anatomical location were not provided). There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 9 degrees Fahrenheit for 1 hour. There was no previous temperature excursion. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to a 66 year old female patient. No medical history or drug reactions were reported. On 25-SEP-2013, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX, subcutaneously as it was recommended by 3 physicians. On 26-SEP-2013, the patient experienced injection site redness, warmth, swelling and itchiness. The redness and itchiness had spread. Laboratory diagnostics studies performed were none. Patient sought medical attention: patient visited the pharmacist. The outcome of injection site redness, warmth, swelling and itchiness was reported as not recovered. Additional information has been requested.
This case was reported by a physician via sales rep and described the occurrence of fatigue in a 53-year-old female patient who received SHINGRIX. On 2nd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 3rd April 2018, 1 days after receiving SHINGRIX, the patient experienced fatigue, sore throat and sneezing. On 8th April 2018, the patient experienced generalized rash, rash urticaria-like and raised rash. On an unknown date, the outcome of the fatigue, sore throat, sneezing, generalized rash, rash urticaria-like and raised rash were unknown. it was unknown if the reporter considered the fatigue, sore throat, sneezing, generalized rash, rash urticaria-like and raised rash to be related to SHINGRIX. Additional details were reported as follows: Six day after vaccination, the patient experienced rash which was described as full-body, hive-like and raised.
Fever,  nausea, dizziness, muscle aches; Fever,  nausea, dizziness, muscle aches; Fever,  nausea, dizziness, muscle aches; Fever,  nausea, dizziness, muscle aches; This is a spontaneous report from a contactable other hcp, the patient. This 49-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EL3302), second dose, via an unspecified route of administration in the right arm on 23Jan2021 at 18:30 (at the age of 49-years-old) as a single dose for COVID-19 vaccination. Medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing, penicillin allergy from an unknown date and unknown if ongoing (Penicillin type antibiotics) and a shellfish allergy from an unknown date and unknown if ongoing. Concomitant medications included omeprazole (OMEPRAZOLE), montelukast sodium (SINGULAIR), fluticasone propionate, salmeterol xinafoate (ADVAIR), cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), calcium (CALCIUM) and probiotics (PROBIOTICS). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: EK9231), dose #1, intramuscularly on 02Jan2021 at 0830 in the left arm as a single dose for COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. On 23Jan2021 at 11:00, the patient experienced fever, nausea, dizziness and muscle aches. No therapeutic measures were taken as a result of the events. The clinical outcome of the fever, nausea, dizziness and muscle aches was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Soreness transitioned from top/outside of shoulder to the upper bicep in 24 hrs. It is continuing to transition down the bicep. Minor soreness and discoloration at lower bicep at 48 hrs. Skin is flushed and sensitive to heat Bicep turned yellow once dissipated Recovered by 9/29/20
Rash to face, daughter called with information, stated she was going to give her benedryl
Abscess; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of ABSCESS (Abscess) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 02-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 an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free (1 in 2 wk), Solution for injection in pre-filled pen. On an unknown date, the patient experienced ABSCESS (Abscess) (seriousness criterion medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with Surgery (Drainage of abscesses) for Abscess. At the time of the report, ABSCESS (Abscess) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            No concomitant medication was reported.   The patient had to drain abscesses. Physician was testing to see if Humira was doing anything for her. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No treatment information was provided.  Company comment: This is a spontaneous case concerning a 21-year-old female patient with Crohn´s disease on treatment with Adalimumab, who experienced the serious (medically significant) unexpected event abscess, on an unknown date after the second dose of mRNA-1273. Clinical findings, abscess location and diagnostic tests details were not provided. It was reported that the patient had to drain abscesses. Events seriousness captured as per IME list. Humira (Adalimumab) was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.  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.; Sender's Comments: Company comment: This is a spontaneous case concerning a 21-year-old female patient with Crohn´s disease on treatment with Adalimumab, who experienced the serious (medically significant) unexpected event abscess, on an unknown date after the second dose of mRNA-1273. Clinical findings, abscess location and diagnostic tests details were not provided. It was reported that the patient had to drain abscesses. Events seriousness captured as per IME list. Humira (Adalimumab) was reported as a co-suspect product. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Patient received the H1N1 vax on 1/27/2010 at about 9:15am. Around 11:15am, that same day patient had a headache, and back and neck pain. He also had severe diarrhea. This symptoms have all subsided except for the back pain as of 2/3/2010.
This is a hospice patient.  She died on 2/13/2021 from her underlying medical conditions.  I just received notification of the death 3/11/2021 and am reporting this immediately.
pt with remote history of bells palsy who developed another episode of bells palsy 1/20/21 PRIOR to getting covid vaccine. however, that was resolving, when on 3/16/21 she developed ANOTHER episode of bells palsy, this one following her second dose of the pfizer covid vaccine which was on 2/25/21. MRI brain revealed marked CN VII inflammation c/w bells palsy. treated with pred/valtrex.
7 days of diarrhea, golf ball sized  swollen lymph node in armpit, weakness,joint pain,dizziness, palpitations, elevated heart rate (120-140's)
pt recv vax 5APR96 & 10APR96 pt exp intense itching on the palms of hands & soles of feet;also exp redness & warmth of feet & devel small lesions on head & nose;tx meds;pt unable to sleep > 2-3 hr w/o waking u p to scratch;
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Relevant medical history and concomitant medication were not provided. On 28-MAR-2013 the patient was vaccinated with M-M-R II. Dose, route and frequency were not provided. Lot number was not provided. On 29-MAR-2013, the patient had a TUBERSOL (tuberculin skin test) test administered. No adverse event was reported. Additional information is not expected.
3 inch diameter redness vaccination site; Nausea; Fever; Fatigue; Headache; Bruised vaccination site; Swollen vaccination site; Hard vaccination site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), PYREXIA (Fever), FATIGUE (Fatigue), HEADACHE (Headache) and VACCINATION SITE BRUISING (Bruised vaccination site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, the patient experienced VACCINATION SITE BRUISING (Bruised vaccination site), VACCINATION SITE SWELLING (Swollen vaccination site) and VACCINATION SITE INDURATION (Hard vaccination site). On 27-May-2021, the patient experienced NAUSEA (Nausea), PYREXIA (Fever), FATIGUE (Fatigue) and HEADACHE (Headache). On 31-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (3 inch diameter redness vaccination site). On 27-May-2021, NAUSEA (Nausea), PYREXIA (Fever), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown. At the time of the report, VACCINATION SITE BRUISING (Bruised vaccination site), VACCINATION SITE SWELLING (Swollen vaccination site), VACCINATION SITE INDURATION (Hard vaccination site) and VACCINATION SITE ERYTHEMA (3 inch diameter redness vaccination site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
pt complaints of eye feeling dry to the right corner of eye, onset after observation, started feeling dry when he got in car, no visual disturbances, changes or swelling, pt requested to have reported "just in case"
Erythema (4 x 8 cm), induration (3 x 3 cm) surrounding injection site.
COVID-19 TEST POSITIVE; RESPIRATORY SYNCYTIAL VIRUS TEST POSITIVE; This spontaneous report received from a consumer and 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced covid-19 test positive, and respiratory syncytial virus test positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) positive, and Respiratory syncytial virus infection (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 test positive and respiratory syncytial virus test positive was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard operating procedure as the case assessed as non-serious.
One week after receipt developed pain at the injection site, followed by progression to her shoulder to her elbow and wrist, with edema distal to her mid elbow. She reports the second injection seemed less careful and the site was too high. She has normal strength and reports her baseline is very strong as she has played tennis for 40 years. The pain has continued to increase and went to community ER 14 APR 21. EKG, U/S were normal. She is trialed Tylenol and NSAID and they have helped. Symptoms mostly resolved on f/u 06 May 2021.  She occasionally gets a small amount of burning pain in her deltoid, but it is not significant. She is otherwise well.
initially sore arm that went away; few days later headache, rash on face which developed gradually.  could be reaction to mask or vaccine not sure.  been very noticeable the last 2 days.  bright red by nose and mouth not really on forehead or anywhere else, does not itch
8 days after my shot I had chills and was very cold for 8 hrs.   Later that day  my arm above the injection site  had a red, itchy rash  the size of a softball.
patient was given the  2nd Moderna vaccine at 21 days from the 1st vaccine
granuloma annulare; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Oct2021 (Lot number: FF2690) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (Dose 2, Single, Lot No: EN6 200, Location of injection: Arm Left), administration date: 19Feb2021, when the patient was 58 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, Single, Lot No: EL8982, Location of injection: Arm Left), administration date: 20Jan2021, when the patient was 58 years old, for COVID-19 immunization. The following information was reported: GRANULOMA ANNULARE (non-serious) with onset 24Oct2021, outcome "recovering", described as "granuloma annulare". The event "granuloma annulare" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of granuloma annulare.  Additional information: No other vaccine in four weeks. Other medications in two weeks: Only multi vitamins and Zyrtec antihistamine. No Covid prior vaccination. Covid tested post vaccination. No Known allergies. Ae treatment: Skin lesion biopsy and then high dosage cortisone.  No follow-up attempts are possible. No further information is expected.
10FEB93 445PM pt recvd vax & exp fever 103 ax & APAP given; c/o sore leg; but slept fine thru noc; 11FEB93 could not move legs; given APAP 730AM & again 1130PM; 530PM 103 ax; listless, cranky; sz/convuls;
Sleep for the whole day; Lose control of emotions/cry and laugh; Cry and laugh; Cry and laugh; Chest tightness; Breathing difficult; Feel cold and hot at first night; Bedridden; Feel chilly (for 4-5 hrs); Fever (38.5 degrees; treatment received)/Fever (around 38 degrees; treatment received); Sleepy/Feel sleepy; Sore arm (can not lift); Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 03Jan2022 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 08Dec2021, for COVID-19 immunization, reaction(s): "No side effects experienced". The following information was reported: AFFECT LABILITY (non-serious) with onset 04Jan2022, outcome "recovering", described as "Lose control of emotions/cry and laugh"; CRYING (non-serious), STRESS URINARY INCONTINENCE (non-serious) all with onset 04Jan2022, outcome "recovering" and all described as "Cry and laugh"; CHEST DISCOMFORT (non-serious) with onset 04Jan2022, outcome "recovering", described as "Chest tightness"; DYSPNOEA (non-serious) with onset 04Jan2022, outcome "recovering", described as "Breathing difficult"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 04Jan2022, outcome "recovering", described as "Feel cold and hot at first night"; BEDRIDDEN (non-serious) with onset 04Jan2022, outcome "recovering", described as "Bedridden"; FEELING COLD (non-serious) with onset 04Jan2022, outcome "recovering", described as "Feel chilly (for 4-5 hrs)"; PYREXIA (non-serious) with onset 04Jan2022, outcome "recovered" (07Jan2022), described as "Fever (38.5 degrees; treatment received)/Fever (around 38 degrees; treatment received)"; SOMNOLENCE (non-serious) with onset 04Jan2022, outcome "recovering", described as "Sleepy/Feel sleepy"; SOMNOLENCE (non-serious) with onset 05Jan2022, outcome "recovering", described as "Sleep for the whole day"; PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "unknown", described as "Sore arm (can not lift)"; HEADACHE (non-serious) with onset Jan2022, outcome "unknown", described as "Headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: Fourth day after vaccination: Feeling well and temperature became normal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a mother concerning her 15 month old daughter with no pertinent past medical history who on 05/05/03 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy that day included a dose of MMRII, poliovirus vaccine (manufacturer unknown), DTP vaccine, Hib conj vaccine (manufacturer unknown) and one other vaccine that the "caller is not sure of name".  On 05/05/03 the pt developed a fever that lasted for 3 days. On 05/08/03 the pt developed a rash on her arm. No lab diagnostic studies were performed. No medical attention was sought. There was no product quality complaint. Follow up information from the mother indicated that "the adverse reaction ended up to be from the MMR".  Additional information has been requested.
Information has been received from a physician concerning a 20 year old female patient with IgA deficiency and no known drug reactions/allergies who on 29-JUN-2010 was vaccinated IM with a first 0.5 ml dose of PNEUMOVAX 23 (lot# 667136/0499Z), in her right deltoid. Concomitant therapy included unspecified allergy medication. On 30-JUN-2010 the patient developed redness and swelling at the injection site of her right deltoid. She was traveling and was admitted to the hospital. The patient was being treated for cellulitis, presumed to be due to methicillin resistant staphylococcus aureus, with unspecified intravenous antibiotic therapy. It was also reported that the patient had developed an abscess at the site. A culture of the abscess had been performed but the results were not available. It was unknown if the patient had been discharged from the hospital. At the time of the report, the patient was recovering. The reporting physician considered "abscess at the site", "presumed to be methicillin resistant staph. aureus" and "cellulitis" to be other important medical events due to IV antibiotic therapy. Additional information has been requested.
Mother reported to nurse that patient broke out in full body hives 30 minutes after administration of vaccines, after having left clinic. No other new exposures in time frame. Denies breathing difficulties or swelling. Resolved in 3 hours w/o intervention. No reinsurance of symptoms.
red blotches all over w/little red bumps; exp itch; ankle on rt side seemed swollen; around the area where got shots was a red blotch; almost blister like has gone down the sides of the legs; rt thigh area red & discolored;
Patient came into the fire station for another reason. Upon exiting  he mentioned he would like to take a test "just to check."  I replied, "no problem." While Patient was waiting for his test results we began with small. He started to tell me that he had a terrible reaction to the bivalent booster he received from the clinic. His symptoms started the morning after receiving the vaccines. Patient mentioned his heart was racing and reported a maximum heart rate of 170, BP 90/60 and a 10/10 headache. He proceeded to tell me he had a similar but milder reaction with his very first moderna vaccine of his primary series. He has since received other doses of the moderna monovalent vaccine with only mild flu-like symptoms as a reaction after those doses.  He felt he should  have gone to the hospital but chose not to.
Patient came to a first dose Pfizer Vaccine Clinic on May 7, 2021 and was given his first dose of the two dose series. On the consent form, it was noted that the patient has not received a vaccine in the past 2 weeks and has never received a COVID vaccine. Upon processing his vaccination, an insurance rejection showed that the patient has received the Janssen vaccine on April 8, 2021. When contacting the patient, he initially denied receiving the Janssen vaccine, but called back after to say that he has received this vaccine on April 8. Patient is currently not experiencing any side effects or allergic reactions but is concerned on if he should receive his second Pfizer vaccine dose.