chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from the published literature article referring to a 44 year old male with allergy to penicillin class medications. His medical history included allergic rhinitis. On an unknown date, the patient was vaccinated with a dose of hepatitis A vaccine, inactivated (manufacturer unknown) (dose, route and lot# were unknown). Two hours after vaccination, the patient experienced generalized pruritus and rash, swelling (throat), chest pain, vomiting and disorientation. The initial evaluation was performed in the emergency department and the doctor in emergency department provided the diagnosis as vaccine-triggered anaphylaxis with Brighton level was 1. The patient was treated with oral and parenteral antihistamine, parenteral steroid, intravenous therapy, ketorolac and ibuprofen. Then on an unknown date, the patient recovered. Upon internal review, the event "vaccine-triggered anaphylaxis" was considered to be medically significant. This is one of several reports from the same source (1211USA007452, 0911USA01970, 1207USA012332, 1606USA012239, 1002USA01291, 1606USA012686, 1606USA012687, 1606USA012688, 1606USA012689, 1606USA012690, 1606USA012692, 1606USA012693). Additional information has been requested.
sore arm; my energy is low; feeling dizzy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Jun-2021 and was forwarded to Moderna on 10-Jun-2021.    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 VACCINATION SITE PAIN (sore arm), ASTHENIA (my energy is low) and DIZZINESS (feeling dizzy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     N Medical History was reported.  Concomitant products included ESTRADIOL (ESTROGEN) for an unknown indication.    On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced VACCINATION SITE PAIN (sore arm), ASTHENIA (my energy is low) and DIZZINESS (feeling dizzy). At the time of the report, VACCINATION SITE PAIN (sore arm), ASTHENIA (my energy is low) and DIZZINESS (feeling dizzy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment Medicines were reported
pt recvd vax 1JUL93 & 6JUL coughing; 8 & 9JUL93 taken to ER w/pertussis;
back muscles felt really tight; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21D, 031M20A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MUSCLE TIGHTNESS. The patient was treated with TYLENOL for Adverse event, at a dose of 1 dosage form. At the time of the report, MUSCLE TIGHTNESS had not resolved.            Concomitant medications were not provided.  The muscle tightness had not bothered the patient.
Employee felt aches and malaise on 7/17. On 7/18, he noticed a few fluid filled vesicles. On 7/19, he states he had many vesicles on face, neck and trunk. Was seen by private MD on 7/22 and was diagnosed with varicella.
so sick the next day; patient couldn't hardly move; Initial information received on 19-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a Patient.  This case involves an unknown age and unknown gender patient who was so sick the next day and patient couldn't hardly move after receiving Influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, 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, formulation, strength and expiration date: not provided) for Immunisation.  On an unknown date the patient was so sick the next day (illness) and patient couldn't hardly move (mobility decreased) (unknown latency) following the administration of influenza vaccine.  Flu shot for over 60 peeps, covid and pneumonia....I was so sick the next day .couldn't hardly.move!  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for both the events.
Redness, warmth, swelling, induration at varicella vaccination site.  Treated on 3/21/11 with oral antibiotics.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2013, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine "did" [considered an error] function as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. Later in 2015, he was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
24-48 hours post vax, the pt developed right arm redness and swelling down to the elbow; hot and tender.
Lightheadedness; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheadedness) and HEADACHE (Headaches) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced DIZZINESS (Lightheadedness) and HEADACHE (Headaches). At the time of the report, DIZZINESS (Lightheadedness) and HEADACHE (Headaches) had not resolved.            On 12 Mar 2021 post receiving the second dose of mRNA-1273 vaccine, the patient experienced some adverse events and wanted to know if they can take Tylenol.  Action taken with mRNA-1273 in response to the event was not applicable.  No Concomitant product use was reported.  No treatment information was provided.   Reporter did not allow further contact
Pt recvd Engerix-B, pt had a "blood test" & was determined that had a neg titer; Pt was exposed to Hep; The final dose of Engerix-B was administered about 1 month ago;
Very itchy rash all over body,especially on left side (same side that shot was given on) large swollen gland under left armpit (same arm that shot was given in).
This spontaneous report was received from a Nurse refers to a 12 month old infant. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 23-MAY-2016, the patient inadvertently received concomitant first doses of VARIVAX lot # L048466 (expiry date: 02-DEC-2017) and PROQUAD therapy type: rHA, lot # L046510 (expiry date: 19-MAY-2017) in opposite legs. No adverse effects reported. No PQC (Product Quality Complaint) reported, PROQUAD was inadvertently pulled from freezer where M-M-R II was stored. Additional information has been requested.
Information has been received from a healthcare worker referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates the patients were vaccinated with improperly stored ROTATEQ (Lot# K002921, exp. 25-FEB-2016; Lot# K009901, exp. 08-MAY-2016) (oral, dose and dose number were unspecified). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected because there was no consent to contact physician.
Pt recv vax on 3/9/99; on 3/11/99 pt exp eyes rolled back, extremities shaking x 40 sec
Pulmonary embolism. Catheterization to break the clot. Now on blood thinners.
Initial report received from a healthcare professional on 13 September 2012. A 49-year-old female patient, whose medical history and concomitant medication were not reported, had received FLUZONE intradermal vaccine (Lot number UT4470BA, anatomical site of administration not reported) on 10 September 2012. On an unspecified date, the patient had large swelling, bruising- redness looked like the size of an egg and arm pain. On 13 September 2012, all of these symptoms still persisted. Corrective treatment was not reported. The patient's outcome was not recovered. List of documents held by the sender: None.
DONOR REPORTED AT CENTER FEELING PAIN AND SORENESS TO RIGHT SHOULDER BLADE OPPOSITE OF INJECTION ARM.
Rt upper arm from axilla to just below bicep had red, raised areas. Upper arm swollen in areas and hot to touch. Pt reports area is extremely sore. Pt given Rx for AUGMENTIN x 7 days, ice and BENADRYL.
patient reports mole/papule on forehead/scalp tripled in size after 2nd covid dose.
exhaustion; after first and second vaccine; headaches; after first and second vaccine; sore arm; after first vaccine/ Sore arm: she had a sore arm from the first vaccine after 2 days.  This is worse.  Caller confirms the sore arm was only after the first vaccine and lasted 2 days.; This is a spontaneous report from a contactable consumer (Mother). A 17-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0164), Solution for injection, via an unspecified route of administration, administered in Arm Left on 10Jun2021 (at the age of 17-year-old) as single dose for covid-19 immunisation. The patient medical history was reported as none. Family medical history Relevant to AE was reported as none. Concomitant medications were not reported. On an unspecified date in 2021, the patient experienced exhaustion; after first and second vaccine, headaches; after first and second vaccine and sore arm; after first vaccine/ sore arm: she had a sore arm from the first vaccine after 2 days, this was worse. It was reported that she had headaches both times the next day when she woke up, for both of them. She had a sore arm from the first vaccine after 2 days. This was worse. Caller confirmed the sore arm was only after the first vaccine and lasted 2 days. Caller confirms the sore arm was only after the first vaccine and lasted 2 days. No test was performed. After the first vaccine, she got her meningitis vaccine. She got it 5 days after the first Pfizer Covid-19 Vaccine. Patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0164), Solution for injection, via an unspecified route of administration, administered in Arm right on 12Jul2021 as single dose for covid-19 immunisation. The outcome of events was unknown.
(R) upper extremity redness and swelling, low grade fever. Was seen at Urgent care. Pt was given an injection - possibly ceftriaxone (no records available. Pt will start BACTRIM today 4/17/17.
dose of PENTACEL was administered last week, only the Dtap/Ipv portion was administered with no AE; Initial information received on 11-Jan-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 months old male patient who received an dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: UJ319AA, expiry date: 04-Jun-2021) via intramuscular route in the left thigh on 04-Jan-2021 for prophylactic vaccination (Product preparation issue).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).  It was an actual medication error due to Product preparation issue(latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient reports that she has a history of near syncope following immunization's.  Patient was walked to recovery as per protocol, when she suffered a period of near syncope.  Patient was moved to wheelchair and placed in fowlers position, Cardiac Monitor applied, BG was 133 at time of reaction.  Patient is closely monitored in clinic with improving conditions after about 10 minutes of care.  Patient reports that she now feel well and was advised to seek further medical treatment as needed and to advise Clinic of any change in condition.
Nausea, fatigue, red swollen injection site, light headedness  lasting 4 days
Fever; sweat; felt very tired; This non-serious case was reported by a consumer and described the occurrence of fever in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included anxiety, diabetes, hot flush and heart rate. Concomitant products included metoprolol, venlafaxine hydrochloride (Effexor), omeprazole (Prilosec), semaglutide (Ozempic) and metformin.   On 26-JUN-2023 08:30, the patient received Shingrix (left arm). On 26-JUN-2023, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: Fever), sweating (Verbatim: sweat) and tiredness (Verbatim: felt very tired). On 27-JUN-2023, the outcome of the fever was resolved (duration 1 day). The outcome of the sweating and tiredness were resolved.   The reporter considered the fever to be related to Shingrix. It was unknown if the reporter considered the sweating and tiredness to be related to Shingrix.     The company considered the fever to be related to Shingrix. It was unknown if the company considered the sweating and tiredness to be related to Shingrix.   Additional Information: GSK receipt date: 26-JUN-2023 This report was submitted via the online direct entry reporting system. The patient got the Shingrix Vaccine on Monday and ran a low grade fever until 2 am on 27th June 2023.  The highest was documented with forehead thermometer was 100 Fahrenheit.   However patient did sweat through all the bedding while sleeping so it was possible that it ran higher at some point.   The patient also felt very tired and slept for about 16 hours waking up only to go to the bathroom and had a few short conversations with family.  The patient had to take a sick day for half day on Monday and half day on Tuesday to recover. The reporter consented to follow up
4 days after vax, pt started having fever 102f, chills, loss of appetite,dizziness, left foot pain. admitted next day for treatment of osteomyelitis left foot
This spontaneous report as received from a mother's consumer refers to a female patient of unknown age. Medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose of M-M-R !! (dose, route, lot number and expiry date were not reported). There was no concomitant medication provided. On an unknown date and for the past 5 days, the patient experienced pain her right thigh after receiving the M-M-R II. The outcome of pain in her right thigh was reported as not recovered at the time of the report. Relatedness between the therapy with M-M-R II and the pain in her right thigh was not reported. Additional information is not expected because no reporter details were provided.
MILD SIDE EFFECTS; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Non-company suspect drugs included: naproxen sodium ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On MAR-2021, the subject experienced mild side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild side effects was not reported. This report was non-serious.
Patient stated that her throat felt tingly . She said she thought she was having the same reaction as a previous patient.  She was given 25 mg of Benadryl and symptoms resolved.
Fatigue, chills, body aches, excruciating mid back pain,  muscle aches, small papule rashes
Pt fainted shortly after receiving vaccine, 911 called immediately, BP fluctuating rapidly, pt was mostly awake but not alert.  Paramedics took out in ambulance with Dad
I started to get horrible tinnitus (loud high pitched ringing in my ears) in Dec 2021 - Jan 2022. Began getting debilitating migraines after my first Covid vaccine in April 2021.
Slight ringing/buzzing sound in ears, has been slightly decreasing in the last day but still present
she has a red rush; a little sore on the injection site of her left non dominant arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (she has a red rush) and VACCINATION SITE PAIN (a little sore on the injection site of her left non dominant arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016b21a and 025a21a) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, the patient experienced RASH ERYTHEMATOUS (she has a red rush) and VACCINATION SITE PAIN (a little sore on the injection site of her left non dominant arm). At the time of the report, RASH ERYTHEMATOUS (she has a red rush) and VACCINATION SITE PAIN (a little sore on the injection site of her left non dominant arm) outcome was unknown.            No  treatment medications were reported. Concomitant medication takes high blood pressure (unspecified). The patient had a red rush, and a little sore on the injection site of her left.
Headache, Myalgia, Arthralgia, Nausea Vomiting, c/o chills,fatigue. Told to see primary care physician if no improvement  Narrative:
8 days after vaccine administered, the vaccination site became red, raised, inflamed, and itchy.  2" long by 2" wide raised area.  Used cold compresses and within four days it was back to normal.  Really strange.
whole body flushing; light headed; This is a Spontaneous report from a Contactable Pharmacist. This 67-year-old female pharmacist reported that she received bnt162b2 (BNT162B2, solution for injection), dose 2 intramuscular, administered in Arm Left on 10Feb2021 10:00 (Batch/Lot Number: EM9810) as SINGLE DOSE for covid-19 immunisation. Medical history included hypertension, blood cholesterol increased, asthma, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included losartan (LOSARTAN); fluoxetine hydrochloride (PROZAC); cyanocobalamin (B12 [CYANOCOBALAMIN]); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE; magnesium (MAGNESIUM); atorvastatin (LIPITOR [ATORVASTATIN]) and colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. On 10Feb2021 the patient experienced whole body flushing and light headed. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the event was reported as unknown.
Initial misuse report received from a nurse on 03 October 2013. The child had received FLUZONE HD. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Ten minutes after received the vaccine, patient felt lightheaded, weak, diaphoretic, dizzy, nauseous, and experiencing palpitations.  At that time BP 112/78 mmHg, pulse Ox 99%, HR 102.  Patient was transferred to the Emergency Department for monitoring.  Patient was discharged without any further sequalae.
Face became numb 25 minutes after vaccine administered.  Relief came the next morning 12/22/2020, 0700.