chrisvoncsefalvay/vaers-outcomes huggingface dataset:
discoid lupus; This case was reported by a consumer via call center representative and described the occurrence of discoid lupus erythematosus in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included discoid lupus erythematosus (Family History) (father), pruritus and hair loss. Previously administered products included Shingrix (received 1st dose on 14th January 2021) and Clobetasol cream with an associated reaction of drug ineffective.   On 14th July 2021, the patient received the 1st dose of Shingrix (intramuscular). In July 2021, less than a month after receiving Shingrix, the patient experienced discoid lupus erythematosus (serious criteria GSK medically significant). The patient was treated with fluocinonide cream and steroids nos (Steroid (Not Specified)). On an unknown date, the outcome of the discoid lupus erythematosus was unknown.   It was unknown if the reporter considered the discoid lupus erythematosus to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient received Shingrix in the left arm.  After receiving Shingrix, the patient was diagnosed with discoid lupus. Prior to 2021, he was told he had a genetic marker for lupus and his father had discoid lupus.  In April 2021, his head was itchy, and he was losing his hair. In July, healthcare professional told him, he had discoid lupus and it was causing bald spots.  The patient reported his healthcare professional initially gave him Clobesterol cream for the itching, in April 2021, and that did not work. Next the healthcare professional gave him Fluocinamide Cream, in July 2021, and that did not work.  Next the healthcare professional injected him with steroids in his head on 14th October 2021 and he went to see the healthcare professional this Thursday on 29th October 2021 to check progress. The reporter did not consent to follow up. The reporter did not give permission to contact healthcare professional.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR224156:Same Patient
LARGES BUMPS, HIVES, SORENESS, RASH AT INJECTION SITE
Itchy, red and slightly swollen area around injection site. Didn?t show up until 6 days after the first shot.  Not painful but definitely a reaction.
The next day after vaccine chills, vomiting and swollen lymph nodes of left armpit
About 5/2/07 Headache, sensory deficit below T4 Level. Urinary retention. Abnormal MRI brain. CSF with lymphocytic plecytosis. Clinical Diagnosis of ADEM (microbiology negative). Paraparesis. 7/25/07-records received for DOS 5/11-5/22/07- and 5/25-6/08/07. DC DX Acute demyelinating encephalomyelitis resolving. Began complaining about ten days of headaches, progressive lower extremity and trunk weakness with decreased senation and urinary retention for 2 days prior to admission. Twelve days ago vacationed in Hawaii, swan in several freshwater pools and took scuba diving lessons. Did a dive of 30ft for 35 minutes. On last day of vacaion woke up with headache that increased in intensity. Relieved by lying down. Developed photphobia with headaches and developed progressive lower extremity weakness and dizziness. Los consciousness about 7 days ago while showering. Lethary. Difficult to arouse.
It was reported that a 4 year old pt (2 of 3) received a Tripedia vaccination and reportedly, sometime after the vaccination, the pt developed a 3" local reaction at the injection site. Further information is requested. From additional correspondence received on 4/26/01, it was reported that the pt received the Tripedia as well as an IPOL and a MMR vaccination on 2/23/01. Reportedly, the pt recovered. This case is closed.
Approximately one day after receiving the second dose of the regular Moderna COVID-19 vaccine, I developed right axillary lymphadenopathy. The area under my right arm became swollen, red, hard, and hot. It was also painful to the touch, as well as feeling painful in general even when nothing was touching it. After about a day, the pain and redness spread down my right tricep and stopped before my elbow. This event last 3-4 days before it began to diminish spontaneously without medical intervention. Even though I received the vaccine in my left arm, I attribute this adverse event to the fact that I underwent a right axillary lymphadenectomy I. August 2010 to rule out Lymphoma (the pathology of this lymph node was negative).
Only side effect I had was pain in my left arm. Just a dull ache after the first and second shot that went away inn 24 hours or less.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202100999129 (Same patient, different drug, same event (split)).  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Aug2021 14:00 (Lot number: FC3183) at the age of 57 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Administration time: 02:00 PM, Lot no: FA7485, Anatomical location: Left arm), administration date: 03Aug2021, when the patient was 57 years old, for COVID-19 immunization.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01Sep2021 08:30, outcome "recovered" (Sep2021), described as "Only side effect I had was pain in my left arm. Just a dull ache after the first and second shot that went away inn 24 hours or less.". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Pharmacy or Drug Store. If other vaccine in four weeks= No. Only side effect I had was pain in my left arm. Just a dull ache after the first and second shot that went away inn 24 hours or less. Since the vaccination, has the patient been tested for COVID-19:No   Follow-up attempts are completed. No further information is expected.
2 weeks after ZOSTAVAX was given patient experienced redness at site, felt swelling, arthralgia, shooting pain in hand.
This initial spontaneous report was received from a physician referring to a 9 week-old female infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 10-SEP-2015, the patient was vaccinated with a dose of improperly stored oral, ROTATEQ (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence was received.
At 2 a.m.the following morning after the vaccine , my father got up to use the bathroom and realized his legs were so weak he could not stand from the bed. This happened  again at 5 a.m.and 7 a.m. when he awakened to urinate. He called his doctor that morning who advised him to go to the ER to rule out a stroke. He was admitted overnight for observation. A CT scan of the head was negative for stroke. He had a follow up MRI head which was also negative for stroke. He will follow up with his neurologist.
I have like muscle pain; I am having like chest pain, pain in my chest; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, lot number EJ1685) on 21Dec2020 for COVID-19 immunization. The patient's medical history included high blood pressure and asthma. Concomitant medications were not reported. On 21Dec2020, the patient reported that she had like muscle pain, and had like chest pain/ pain in her chest. The outcome of the events was unknown.
pt recv vax 15SEP98 & devel small pinpoint red raised areas 17SEP98 in  afternoon, rash disappeared by 19SEP98;no itching, no medications to react, no fever;
Night sweat; Headache; Hidradenitis suppurativa; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweat), HIDRADENITIS (Hidradenitis suppurativa) and HEADACHE (Headache) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2020, the patient experienced HIDRADENITIS (Hidradenitis suppurativa). On an unknown date, the patient experienced NIGHT SWEATS (Night sweat) and HEADACHE (Headache). At the time of the report, NIGHT SWEATS (Night sweat) and HEADACHE (Headache) was resolving and HIDRADENITIS (Hidradenitis suppurativa) had not resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Concomitant Drugs Not Reported.  The reporter's causality for the event(s) of night sweat and headaches after booster injection unknown onset, hidradenitis suppurativa breakouts and night sweat and headaches after booster injection unknown onset with Humira(adalimumab) was no reasonable possibility.  Treatment Drugs Not Reported.  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.   Reporter did not allow further contact
Patient's arm & chest got sore, red the night of pneumonia shot. Talked with patient to go to see doctor. Nurse advised her take TYLENOL & would be fine.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Oct2021 at 18:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 24Dec2020 at 18:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 22Jan2021 at 17:30 as dose 2, single (Batch/Lot number: unknown), in left arm and on 15Apr2022 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "penicillin" (unspecified if ongoing); "sulfa antibiotics" (unspecified if ongoing). Concomitant medication(s) included: CETIRIZINE taken for antiallergic therapy, start date: 01Apr2022; INDAPAMIDE taken for hypertension, start date: 01Jul2016.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication: Covid-19 treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Other medication in 2weeks included antihypertensive medication( Indapamide) and antihistamine (cetirizine). Known allergies included penicillin and sulfa antibiotics and other medical history inclyded HTN. Adverse event reported as rebound in symptoms 5 days after stopping medication, nasal congestion, sneezing and sore throat.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between LOE events and suspect drug BNT162B2 cannot be excluded.
Rph from Walgreens, was the immunizer that administered Covid vaccine for the  facility. He was incorrectly given a list of patients that needed to receive a second dose of the Covid vaccine . Unfortunately, the patients had already received their second dose on 2/2/2021 and received a third dose. The patients  were not able to communicate the receipt of the second dose earlier.  The dose had not been updated in the patient's chart correctly. Once the error had been discovered, vaccinations were stopped until a correct patient list could be produced. Facility was instructed to watch and monitor the patients for adverse effects and report them through the VAERS reporting system.
rash located on upper torso, face, and hands. no pain, but is itchy, if she itches it starts to burn. no respiratory issues in ER. Patient was given NS, methylprednisolone, and diphenhydramine in the ER. This improved her symptoms. Patient was sent home with benadryl
Patient states approx 14 hrs after receiving Tdap started running temp of 103. Has been taking Motrin for fever. No localized reaction
within 20 of the injection I strted to salivate and feeling nauseated.  returned to clinic and was monitor there.  my blood pressure was noted to be low at 115/41. HR 74. reepat BP was 121/48 which is much lower than my usal BP.  i was observed for about 1 hrs. the sx's did not go away but the BP improved a little to 130/64 standing.  I went home develop injection site pain, fatigue, headache and the pesistent salivation did not go away. after 1 wk it decreased in frequency but still present today.  I can not do my normal activity as this worsen the symptom. and my blood pressure has not normalized. still run in 110's/60's.  the headaches and fatigue are becoming a burden.
Arm is still real tender; Hurting all over; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm is still real tender) and MYALGIA (Hurting all over) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced MYALGIA (Hurting all over). On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm is still real tender). On 07-Sep-2021, MYALGIA (Hurting all over) had resolved. At the time of the report, VACCINATION SITE PAIN (Arm is still real tender) had not resolved.       Concomitant medication were not reported Treatment medication were not reported
Usual ache and pain at first; chest is tight; can't breathe; Little bit of coughing; Headache; This is a spontaneous report received from a contactable consumer (patient). This 37-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0153) via an unspecified route of administration on 07May2021 at 08:45 (at the age of 37-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included Ehlers-Danlos syndrome. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications were not reported. The patient previously received sulfas and morphine from unknown dates for unknown indications and experienced allergy. The patient previously received dose 1 of BNT162B2 (lot number EW0158) on 10Apr2021 at 10:00 as a single dose in the left arm for COVID-19 immunization. On 09May2021 the patient experienced usual ache and pain at first. Now (10May2021) her chest was tight and she could not breathe. She had a little bit of coughing and a headache. The patient visited a doctor or other healthcare professional office/clinic as a result of the events. It was unknown if the patient received any treatment for the events. The outcomes of ache, pain, chest tight, could not breathe, coughing, and headache were unknown. It was also reported that since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
No additional AE reported.; A nurse reported V ARlV AX was improperly stored and administered.; This spontaneous report was received from the  licensed practical nurseregarding a 4 year old male patient. Her concomitant therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II). The patient's concurrent conditions and medical history were not provided.   Since 02-DEC-2020, the varicella virus vaccine live (oka/merck)(VARIVAX) experienced temperature excursions with a total of 29.5h.    On 04-JAN-2021, the patient was vaccinated with her first dose of this improperly stored varicella virus vaccine live (oka/merck)(VARIVAX)  lot# T017686, expiration date 21-MAY-2022, subcutaneously in the left arm, for prophylaxis, on a private doctor's office/hospital with public funds.  This is one of several reports from the same reporter (US-009507513-2101USA011364).; Sender's Comments:  US-009507513-2101USA011364:Original Case : 2101USA011364
Bell's Palsy  left facial paralysis (mild) starting 1 day after vaccine.  Asymmetry of smile and closing Left eye
LIKE A GLAND WAS SWOLLEN ON THE FRONT OF NECK, LIKE A BUMP AND IT WAS TENDER TO TOUCH; TENDERNESS IN THROAT; TENDERNESS UNDER CHIN; SLEEP ALL DAY; SORE ARM; SO FATIGUED; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient experienced drug allergy when treated with macrogol.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A and expiry: 14-DEC-2021) dose was not reported, administered on 01-OCT-2021 15:00 for prophylactic vaccination. No concomitant medications were reported.  On 03-OCT-2021, the patient experienced sleep all day. On 03-OCT-2021, the patient experienced sore arm. On 03-OCT-2021, the patient experienced so fatigued. On 04-OCT-2021, the patient experienced tenderness under chin. On 05-OCT-2021, the patient experienced tenderness in throat. Treatment medications included: paracetamol. On 07-OCT-2021, the patient experienced like a gland was swollen on the front of neck, like a bump and it was tender to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleep all day, sore arm, and so fatigued on 06-OCT-2021, and had not recovered from tenderness under chin, tenderness in throat, and like a gland was swollen on the front of neck, like a bump and it was tender to touch. This report was non-serious.
Severe diarrhoea; I still experience hives on my back, on right shoulder; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Severe diarrhoea), URTICARIA (I still experience hives on my back, on right shoulder) and NAUSEA (Nausea) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     The patient's past medical history included Cancer (The patient was cancer survivor.).    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Severe diarrhoea), URTICARIA (I still experience hives on my back, on right shoulder) and NAUSEA (Nausea). At the time of the report, DIARRHOEA (Severe diarrhoea) and NAUSEA (Nausea) had resolved and URTICARIA (I still experience hives on my back, on right shoulder) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs was provided.  No treatment drugs was provided.  The patient stated she had poor immune system.  And the patient also stated that she  was vaccinated with 2nd dose and was still experiencing hives on her back  which was the  event after  first dose.
severe vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (severe vomiting) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced VOMITING (severe vomiting). At the time of the report, VOMITING (severe vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Local swelling and erythema 2 days after injection with Tdap (ADACEL) and HPV4 at same site.
Information has been received from a physician concerning a 21 year old female who in approximately September 2006 was vaccinated with the first dose of GARDASIL (lot # not provided). On an unspecified date in approximately September the patient developed swelling in her lymph nodes and groin. Unspecified medical attention was sought. At the time of this report it was unknown if the patient had recovered. Additional information has been requested. 01/05/2007: This is in follow-up to report (s) previously submitted on 11/14/2006. Information has been received from a physician concerning a 21 year old female with seasonal asthma and no known drug allergies who on 04-SEP-2006, was vaccinated with an intramuscular injection in the onterolateral right thigh of the first dose of GARDASIL (Lot # 0689F). On 06-SEP-2006 the patient developed swelling in her lymph nodes and groin. The patient was seen in her physicians office and a large (7.3 cm), soft, tender femoral lymph node was noted near the injection site. There was no evidence of cellulitis or drainage. THe patient was diagnosed with lymphadenitis and was given asthma precautions. THe patient was seen in the office on 09-SEP-2006 and the area was still tender and the swelling was noted to have decreased slightly. The patient was seen again in the office on 10-NOV-2006 and the lymphadenitis had not yet fully resolved. The doctor noted that the second vaccination would be delayed until the lymphadenitis had completely resolved. Additional information has been requested.
Headache, Arthralgia, Fatigue, chills, injection site pain and swelling, tenderness and swellingo f the local lymph nodes on the injection side Narrative:
S/P DAPTACEL -> "cried all night" (parents) no fever cranky next day - told of this on 2/24/15.
SHORTNESS OF BREATH; LIVER SPOTS; RASH LEFT THIGH; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included copd. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included oxygen for copd. On 11-APR-2021, the subject experienced shortness of breath. On 11-APR-2021, the subject experienced liver spots. On 11-APR-2021, the subject experienced rash left thigh. Laboratory data included: O2 saturation (NR: not provided) 97 %. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shortness of breath, had not recovered from rash left thigh, and the outcome of liver spots was not reported. This report was non-serious.