chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of HYPERACUSIS (Noise sensitivity), TASTE DISORDER (Could hardly taste), PHOTOPHOBIA (Light sensitivity), PALPITATIONS (Woke up with her heart racing/the heart palpitations are down) and FEELING ABNORMAL (She felt like she was dying) in a 50-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. Concurrent medical conditions included Egg allergy. On 04-Apr-2022 at 3:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING ABNORMAL (She felt like she was dying). On 04-Apr-2022, the patient experienced HYPERACUSIS (Noise sensitivity), PHOTOPHOBIA (Light sensitivity), PALPITATIONS (Woke up with her heart racing/the heart palpitations are down), PRURITUS (Started itching, itching off and on everywhere), DIZZINESS (Feeling really dizzy), FATIGUE (She was tired so she went to bed early), VOMITING (Vomited 3-5 times a lot/vomiting stopped), HEADACHE (Headache, bad headache) and NAUSEA (Nausea). On 05-Apr-2022, the patient experienced TASTE DISORDER (Could hardly taste). On 05-Apr-2022, PALPITATIONS (Woke up with her heart racing/the heart palpitations are down) and VOMITING (Vomited 3-5 times a lot/vomiting stopped) had resolved. At the time of the report, HYPERACUSIS (Noise sensitivity), TASTE DISORDER (Could hardly taste), PHOTOPHOBIA (Light sensitivity), FEELING ABNORMAL (She felt like she was dying), PRURITUS (Started itching, itching off and on everywhere), DIZZINESS (Feeling really dizzy), FATIGUE (She was tired so she went to bed early), HEADACHE (Headache, bad headache) and NAUSEA (Nausea) outcome was unknown. Concomitant product use was not provided by the reporter. On 04-Apr-2022 at 3 PM, patient received her 2nd Moderna COVID-19 booster dose in her left arm. At night, she reported she felt like she was dying. She sat for 5 minutes and started itching but not at the shot site. She reported no hives, but just itching off and on everywhere. She was tired so she went to bed early, woke up with her heart racing, it woke her up. She vomited 3-5 times a lot. Patient reported feeling really dizzy, headache, nausea, light sensitivity, noise sensitivity, bad headache. Patient reported on 05-Apr-2022, she feels a little better, the heart palpitations are down, vomiting stopped. Patient reported the first couple of shots did not affect her like this, just mild reactions: fever, headache, chills. Treatment information was not provided.
Per doctor's notes on 5/9/21: Patient was admitted on 5/9/2021 for induction of labor, first with foley bulb, then Pitocin. She had a prolonged first and second stage but progressed to NSVD of a viable male infant. Breastfeeding is going well and postpartum course has been uncomplicated other than her allergies bothering her and a rash on her hand that is itching, like her eczema.
On 10/24/10 started with temp 102.4, by Wed temp was 103.5, rash started on face on Thurs. 10/29 rash all over her body. Afebrile since Thurs. No other noted rxn at this time.
Constant headache since second shot. It?s been 9 days and the headache does not disappear. I?ve taken Paracetamol but it does not help.
Patient reported on 1-27-21 at 11:40am to Employee Health office that on 1-8-21 3:15pm received COVID dose #1 at staff COVID vaccination clinic - waited 15 minute observation then returned to workstation. About 20 minutes after vaccination began experiencing light headedness, anxiousness, agitation and heart racing. Symptoms increased over next 1-2 days then diminished over the following week. Did not report symptoms. Stated "feeling like myself now"
pt recv vax by late PM on 26OCT devel flu sx now having bad case of flu-rhinitis, fever, myalgia, usual sx;
6/9 1800 (L) arm became very painful. 1900 great earaches with pain into head - upper jaw, teeth, back of neck, bad headache and tinnitus. During night, (L) shoulder began swelling and pain from shoulder and clavicle with swelling down (L) arm to hand. Called clinic 6/10 - left msg - call back 1009 - stated swelling was going down arm and shoulder but still has some headaches, not so intense. Did not want to be seen. Would call if symptoms didn't resolve.
pt called in stating feels hot, a disoriented, light headed feeling, heavy breathing/feeling in chest (not SOB);rt arm sore;BP 180/120;red splotches non raised areas of neck;feeling hot, lightheaded & achy all over;arms sore on 4/14/97
No additional AE reported; HCP reported PROQUAD was administered to patient after a temperature excursion. Date of administration was Mar 23, 2022.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 23-MAR-2022, the patient was vaccinated with improperly stored (product storage error) dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin) (PROQUAD) lot #: U010745, expiration date: 03-OCT-2022 (exact dose, strength, site and route of administration were not provided) for prophylaxis. Temperature excursion information: -8.3 degree Celsius for 1 hour 1 minute. No previous temperature excursion. There was no additional adverse event reported.
16mins post vaccination, pt in observation in area, c/o chest tightness, SOB and heaviness. VSS. Pt AOx4. Taken to triage. Charge RN, on-site provider notified.  Vitals signs @430PM: BP 117/77, HR 70, RR 20-21, O2 97-98%. Assessed by PA, recommended extended observation.   @437PM: BP 146/86, HR 68, RR 20-22, O2 96%  @453PM: BP 106/80, HR 61, RR 18-20, O2 97-98% Pt states feel better.  Per PA, no driving. D/C to home with family member. VSS. Pt AOx4. Denies chest tightness and SOB at time of d/c.
She is scheduled to take the 2nd dose on 13MAY2021; Really cold; Shaking; Aching; Really bad headache; Really really tired; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Really cold), TREMOR (Shaking), PAIN (Aching), HEADACHE (Really bad headache) and FATIGUE (Really really tired) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced FEELING COLD (Really cold), TREMOR (Shaking), PAIN (Aching), HEADACHE (Really bad headache) and FATIGUE (Really really tired). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She is scheduled to take the 2nd dose on 13MAY2021). At the time of the report, FEELING COLD (Really cold), TREMOR (Shaking), PAIN (Aching), HEADACHE (Really bad headache), FATIGUE (Really really tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She is scheduled to take the 2nd dose on 13MAY2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient might have taken ibuprofen as treatment but it did not help. No concomitant medications were reported.  Reportedly, the patient had experienced the events about 12 hours after getting the vaccination.
Intermittent headaches for 48 hours; general malaise; chills without fever; Sore injection site; This is a spontaneous report from a contactable Physician reporting for himself. A 33-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular Right arm on 16Dec2020 10:00 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. Medical history included allergy to Shellfish. The patient's concomitant medications were none (None medication the patient received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Intermittent headaches for 48 hours, general malaise and intermittent chills without fever, Sore injection site on 16Dec2020 13:00. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the event Intermittent headaches was recovered on 18Dec2020 13:00, the outcome of the other events was recovered on an unknown date.
This case was reported by a healthcare professional and described the occurrence of arm swelling in a child subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline).  Previous and/or concurrent vaccination included live attenuated measles, mumps (strain not specified), rubella vaccine;  manufacturer unspecified given on the same unspecified date as KINRIX;  measles and varicella virus vaccine;  manufacturer unspecified given on the same unspecified dated as KINRIX.  On an unspecified date subject received 1st dose of KINRIX (unknown).  At an unspecified time after vaccination with KINRIX, the subject experienced arm swelling and arm redness.  A sales representative reported that a public health nurse stated that she gave ten doses of KINRIX and out of these doses, seven children or their parents reported significant swelling in the arm where they were injected.  All of the children were within the four to six years age range.  She stated that she had gone to one of the children's school and was able to see a large are of swelling in the upper arm with redness.  The child denied any pain.  Please see A0780868A,  A0780875A, A0780877A, A0780878A, A0780879A, and A0780880A for the six  additional cases reported by the nurse.  At the time of reporting the events were resolved.  The healthcare professional considered the events were probably related to vaccination with KINRIX.
Patient passed out after getting ADACEL vaccine (Tdap). She woke up right after and rested in waiting room for 20 min. Left after feeling well.
Pt received GARDASIL #3 and within a five minutes became pale, limp, nauseous. Pt vomited twice, after lying down for about 20 minutes, recovered fully.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 24-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
PT HAS REDNESS, ITCHING, INFLAMMATION OF LEFT ARM. STILL ITCHING AS OF 11/18/19; HAS NOT SOUGHT ADDITIONAL PHYSICIAN'S CARE.
Pt received Varicella vaccine 5/19/98. Pt developed mild case of chicken pox 1/17/01.
Pt had fever beginning 1APR91 which rose to 104.9 on 2APR91 & then had seizure; Was admitted to Hosp;
Right hand numbness and tingling present upon waking up this morning around 0645 and continues at this time. (1500)
My arm has bursitis from the Second shot. I have a lot of pain and immobility when I barely try to move it. It is affecting my daily  necessary routine like showering, dressing.  The pain started initially after the second  shot but I thought it would go away. It has only gotten worse
inadvertently given Adacel for his fourth DTaP dose in the left thigh on 30Oct2020 (with no Adverse event); Initial information received on 06-Nov-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 15 months old male patient who was inadvertently given DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] for his fourth DTaP dose in the left thigh on 30Oct2020 with no Adverse event (Wrong vaccine administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  On 30-Oct-2020, it was reported that a 15 month old patient was inadvertently given Adacel [lot no. C5JL7; expiry date 28-Nov-2021] for his fourth DTaP dose in the left thigh via an unknown route for immunization (Wrong vaccine administered).  At the time of reporting, the patient had no adverse event.  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 was brought to local Hospital 11/10/2021 for increased confusion and low blood sugar. EMS called. Paramedics came and administered glucose juice with improvement of his symptoms. A second episode which occurred when patient woke up with confusion prompted patient?s family to bring the patient to the ED for further evaluation. In the ED patient received D50 and D5 infusion with recurrent hypoglycemia to 57. Ultimately patient was started on D10 infusion with improvement in his symptoms. Patient endorses recent mechanical fall but did not hit his head. CK noted to be elevated to 2600 s. Rapid COVID was positive on admission. BNP 3600s. UA positive for leukocyte esterase, WBC 21-30, urine cultures pending. CBC shows no leukocytosis WBC 4.58, hemoglobin 9.6, platelets 190. INR 1.95. CMP shows no AKI creatinine 2.01, baseline 2.6. AST 88, ALT 37. CXR negative for acute cardiopulmonary abnormalities. Patient admitted for recurrent hypoglycemia likely due to sulfonylurea use, complicated UTI, mechanical fall with rhabdomyolysis and COVID-19 virus infection. Patient was recently vaccinated with 2nd booster. Bivalent Moderna on 11/3/2022 lot # 061F22A and flu vaccine 11/3/2022. Local County public Health department has no further information on the outcome of this patient. Please contact provider/facility for any further information.
The day after the vaccination I developed a rash on my neck, upper chest and shoulders. The rash disappeared in 2 days. Very itchy after rash disappeared.
196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) 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)) 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)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25 mL of Moderna Covid-19 Vaccine, Bivalent).    No Concomitant medications were provided.  It was reported that 196 patients had received 0.25 ml of Bivalent Moderna vaccine.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine  No treatment medications were provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689916 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow-up received, updated narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689916:Master case
Patient began to feel nauseas and light headed following vaccination.  She was given some Gatorade and the pharmacist sat with her until she began to feel better.  Symptoms resolved in a few minutes and she stayed for further observation until she was completely better.
immediately following the vaccine patient went pale and was shaking and then lost consciousness at 10:39, was unconscious for 20-30 seconds and then regained consciousness.  10:40 pt laid down on the mat, ice pack applied, elevated legs.  bp 142/90 hr 78  10:45 pt shaking/feeling cold says she normally anxious about getting vaccines  10:52 BP 149/87 hr 79 temp 96.  11am pt okay getting up sitting in chair. 11:04 patient drinking glucose drink since she didn't eat at all before the vaccine, 11:08 able to stand and answer questions walked to car.
CHIEF COMPLAINT:   Pt with weakness, poor appetite, less active x 1 week. Forgets to take meds sometimes. Found down x 4 hrs after fall last night. Reports no headstrike or LOC. Was hypotensive on ems arrival   HISTORY OF PRESENT ILLNESS:     85-year-old female past medical history of A. fib, hyperlipidemia, CKD, hypothyroidism, type 2 diabetes, hypertension, CHF?,  Morbid obesity, presented to the emergency room complaining of generalized weakness, poor appetite, and lethargy for 1 week.  As per chart patient was found on the floor after she fell last night however patient denies any falls.  Patient reports that she has been feeling somewhat forgetful lately.  She reports that she has not been feeling well for the past month and has been having decreased appetite generalized weakness and fatigue which she associated with not eating well.  Patient reports that for the past week her generalized weakness has been getting progressively worse, now having some shortness of breath since 1 week ago as well as chills and cough.  She reports that she has a friend who has been helping her lately at home.  She reports that before this month she was fully independent and was driving as well.  She denies any sick contacts.  She has been fully vaccinated against Covid.  She was supposed to get her booster soon however she ended up in the hospital today.  On my evaluation patient denied any chest pain, nausea, vomiting, diarrhea, constipation.  ED vitals noted significant for oxygen saturation 88% on 6 L via nasal cannula, heart rate 127, blood pressure 161/103, afebrile, respiratory 20.   Labs are interpreted significant for BUN 36, creatinine 1.2, AST 78, ALT 65, CK 543, BNP 124.2, Covid positive.   Chest x-ray showing: Patchy bilateral pulmonary opacities    EKG showing A. fib with RVR  In the emergency room patient received Cardizem 50 mg IV push.  Patient deferred further evaluation and treatment of COVID-19 and A. fib with RVR.
Initial report received from a health care professional also the consumer on 14 September 2012. A male patient, had received a dose of FLUZONE intradermal vaccine (site and dose no. was not reported) on an unspecified date (lot number: UT4467AA). Medical history and concomitant medications were not reported. The patient reported that after receiving FLUZONE ID vaccine he had a wheal immediately which was followed by arm swelling at the same spot. Corrective measures were not reported. At the time of this report, the patient's outcome was unknown. Documents held by sender: none.
pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain) and CHILLS (chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (pain) and CHILLS (chills). At the time of the report, PAIN (pain) and CHILLS (chills) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported.
Started having body aches and fatigue on the second day (no fever). Symptoms were gone on the fourth day.
pain at injection site and swelling; pain at injection site and swelling; chills; tiredness; headache; in addition to previous I have sore underarm; itchy vaccine site today; This is a spontaneous report from a contactable consumer (patient). This consumer reported that: A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported I had my first dose of Pfizer vaccine yesterday and I had pain at injection site and swelling, chills, tiredness and headache on an unspecified date. I am assuming those are typical in addition to pervious I have sore underarm and itchy vaccine site today (1 week after initial vaccine) on an unspecified date. The outcome of the events was reported as unknown.    No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
c/o nausea, abdominal pain, pain in arm and muscle spasms in had continuing through date of complaint 9/19/05.
Hives, itching.  Started 11/28 behind knees and under armpits, spread to under breasts, buttocks; now on arms, across stomach, and still spreading.  Intense all over the body itching (despite daily Claritin, and, prn Benadryl), and point tenderness behind knees and other joints.  Slightly swollen hands.
was given Moderna 0.5ml upper left arm by mistake. He was also given Fluarix that he was supposed to have in same arm .His father was present entire time. Follow up  will be today and again in a few days, and also by Risk Management.
Pt vaccinated with DTP 5 days later developed a lump in leg which was painful inspite of oral antibiotics became ascess which caused sepsis and was hospitalized. Twin not infected.
Case number PHEH2016US004000, is a spontaneous report initially received from a nurse on 15 Feb 2016. This report was initially reported as a multiple patient case; upon follow up information, identifiers were reported making this a valid single patient case. The report refers to a 17 year old male patient. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with FLUCELVAX (batch number: 1740874) intramuscularly on 17 Nov 2015. No adverse event was  reported following this maladministration. Upon follow up it was reported that all safety questions were answered by the reporter. No new information was received. Follow up report received from reporter on 17 Feb 2016: All safety questions answered. No new information received. Follow up information received from the nurse on 05 Apr 2016: Updated report type (other to spontaneous), patient demographics (initials, date of birth, age, gender), batch number of suspect vaccine and vaccination and event onset date.