chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am having brain fog, and generally feeling unwell. /haven't been feeling good - has brain fog forever; generally feeling unwell. /I'm not well /feeling sick /; thought that had COVID-19 again /like experiencing COVID-19 again; sick /illness; shoulder was hurting; headache; scared to death; very agitated; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I am having brain fog, and generally feeling unwell. /haven't been feeling good - has brain fog forever), MALAISE (generally feeling unwell. /I'm not well /feeling sick /), SUSPECTED COVID-19 (thought that had COVID-19 again /like experiencing COVID-19 again), ILLNESS (sick /illness) and ARTHRALGIA (shoulder was hurting) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2020.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-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 FEELING ABNORMAL (I am having brain fog, and generally feeling unwell. /haven't been feeling good - has brain fog forever), MALAISE (generally feeling unwell. /I'm not well /feeling sick /), SUSPECTED COVID-19 (thought that had COVID-19 again /like experiencing COVID-19 again), ILLNESS (sick /illness), ARTHRALGIA (shoulder was hurting), HEADACHE (headache), FEAR OF DEATH (scared to death) and AGITATION (very agitated). The patient was treated with PREGABALIN (LYRICA) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (I am having brain fog, and generally feeling unwell. /haven't been feeling good - has brain fog forever), MALAISE (generally feeling unwell. /I'm not well /feeling sick /), SUSPECTED COVID-19 (thought that had COVID-19 again /like experiencing COVID-19 again), ILLNESS (sick /illness), ARTHRALGIA (shoulder was hurting), HEADACHE (headache), FEAR OF DEATH (scared to death) and AGITATION (very agitated) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: significant follow up appended new events added
pt recv vax 7MAY97 & 8MAY97 pt devel a fever of 101-103 that lasted for @ least 7 days;
sore arm, headache on both shots.   after 2nd vaccine, within a week, started having brain fog/fuzzy/dizziness with thickness inside of head.  Sharp pains in the head in different spots randomly.  Still getting worse each day, affecting ability to think.
area of injection still has pain; redness; swollen; when area pressed it is painful/painful initially; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (area of injection still has pain), INJECTION SITE ERYTHEMA (redness), INJECTION SITE SWELLING (swollen) and PAIN (when area pressed it is painful/painful initially) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced INJECTION SITE PAIN (area of injection still has pain), INJECTION SITE ERYTHEMA (redness), INJECTION SITE SWELLING (swollen) and PAIN (when area pressed it is painful/painful initially). On 16-Apr-2021, INJECTION SITE ERYTHEMA (redness) and INJECTION SITE SWELLING (swollen) had resolved. At the time of the report, INJECTION SITE PAIN (area of injection still has pain) and PAIN (when area pressed it is painful/painful initially) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Treatment details were unknown.
Right deltoid moderate swelling, induration, erythema 70x80mm Tylenol, cool compress.
Seen 2 days after injections in pediatric office with temperature of 100.1 at office.  Father reported temperature as high as 105.
Expired vaccine by the time of admin. No harm done. Patient will come back for replacement dose.
very sore arm. could not lift arm higher than 90 degrees from side of body. fatigued in the afternoon. no appetite for a few hours after the shot.
dizziness; chest heaviness; could not stand well; itchy on the back of her neck; arm soreness; HA; fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Nov2021 14:00 (Lot number: FF2589) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 18Feb2021, when the patient was 61 years old, for COVID-19 Immunization, reaction(s): "no adverse effect"; Bnt162b2 (Dose 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 28Jan2021, when the patient was 60 years old, for COVID-19 Immunization, reaction(s): "no adverse effect". The following information was reported: DIZZINESS (non-serious) with onset 09Nov2021 23:00, outcome "recovered" (10Nov2021 23:00), described as "dizziness"; CHEST DISCOMFORT (non-serious) with onset 09Nov2021 23:00, outcome "recovered" (10Nov2021 23:00), described as "chest heaviness"; DYSSTASIA (non-serious) with onset 09Nov2021 23:00, outcome "recovered" (10Nov2021 23:00), described as "could not stand well"; PRURITUS (non-serious) with onset 09Nov2021 23:00, outcome "recovered" (10Nov2021 23:00), described as "itchy on the back of her neck"; PAIN IN EXTREMITY (non-serious) with onset 09Nov2021 23:00, outcome "recovered" (10Nov2021 23:00), described as "arm soreness"; HEADACHE (non-serious) with onset 09Nov2021 23:00, outcome "recovered" (10Nov2021 23:00), described as "HA"; FATIGUE (non-serious) with onset 09Nov2021 23:00, outcome "recovered" (10Nov2021 23:00), described as "fatigue". Therapeutic measures were not taken as a result of dizziness, chest discomfort, dysstasia, pruritus, pain in extremity, headache, fatigue.  Additional information: The patient reported no symptoms after the first two vaccines, but reports today at 15:00 that she had onset of arm soreness 12 hours later and then dizziness and then HA and itchy on the back of her neck and chest heaviness and "could not stand well" fatigue and that resolved about 24 hours after it started. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Administered dose FLUARIX. Patient called with question of ABR. Pt sent to hospital. Hospital called pharmacy with Dx: Anaphylaxis. Pt tx for condition with SC therapy and BENADRYL, EPINEPHRINE, Dextrosol. Shot given 14:05. Pt called approximately 1600.   11/03/2008 ER record received for 9/25/2008 with DX: Allergic Reaction-acute to Influenza vaccine. Pt presented with SOB, wheezing and feeling throat closing.  PE (+) for anxiety, angioedema of the uvula and pharynx, hoarse voice and moderate respiratory distress. Tx: Benadryl, epi, albuterol nebs, decadron and depomedrol.
Received third dose of engerix-B (AHBVB286CA) at approximately 2:30PM and it was reported that at approximately 7:30 experienced nausea and dizziness, then vomited and had some chest pain.  He was at work at the time and had taken a dinner break previously to the vomiting.  He remained at work until 10:30PM(his quit time) and rode his motorcycle home.  He is a diabetic who has maintained low and appropiate blood sugars.  He has dropped about 50lbs in the last year to help his diabetic levels.  He does exercise daily  by walking.  He was calm when he came to my office to receive the vaccine and knew what to anticipate as this was his third dose.  When hearing of this reacation today from another custodian rather than having the High School school nurse (where he works) check on him and advise him to contact his family doctor.
Case number PHEH2014US024987, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 61-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 28 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Temp on 6/6/2019 101 then rash from head to toe, loose stools, cranky
14 year old was given Pfizer 5-11 monovalent accidentally as her booster dose. It was realized at the time of the visit, so we were able to re-vaccinate with the Pfizer bivalent booster at that time.
Seizures returned within 24 hours of 4 month vaccines. Seizures previously started after 2 month vaccines but were controlled by early Dec. 2006 after ACTH. 12/22/08-records received-consultation report DOS 6/2/08-history of medical refractory infantile spasms since age 3 months. Clusters of infantile spasms on daily basis, 3-9 clusters per dasy lasting approximately one minute. Mostly the spasms involve truncal jerk but occasionally evolve to clonic seizures involving left leg. Making progress in milestones. Mild left arm weakness.
p/vax c/o neck ache becoming worse;14JUL97  very stiff, bent over, arms bent up at elbows, didn't respond to mom or dad;16JUL97 light & sound sensitive;20JUL97 stopped breathing, confused, heart rate decreased;Wolff-Parkinson-White synd;
pt recvd 2nd dose of vax & 12 hrs later exp vomiting, t101, grey eyes, redness all over body, was lethargic but alert; pt not hospitalized;
I'm 54.  Went through menopause in my 40's. Have been taking birth control (Lo-Estrogel) constantly for the estrogen and for my osteoporosis for over 10 years.  I take the Lo-Estrogel everyday without taking the placebos.  After my first Moderna vaccination, I started bleeding about 3 days after my shot and bled for a few days.  No bleeding after the second Moderna shot.  Diagnosed with Covid 19 on  November  15, 2021.  Had my booster shot on December 29, 2021.  I started bleeding about 3 days after the booster shot and bleed for about 3 days.  I started bleeding again this week starting on Feb 2nd and am continuing to bleed.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; Poor quality vaccine administered; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered).    This case contains information for the 59th of 77 patients described by the reporter.  No concomitant product was reported. It was reported that the dose was administered to patient before it was known if the vaccine was ok to use after the excursion. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
5cm. round red area R arm itchy induration. 15 X 10 cm. area with red, warm induration which includes a 4X4 cm. area of vesicles at the injection site.
Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea) and VOMITING (Vomiting) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041620A and 016M20A) for COVID-19 vaccination.     no history was reported.  Concomitant products included WARFARIN for Heart valve replacement.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 18-Jan-2021, the patient experienced NAUSEA (Nausea). On an unknown date, the patient experienced VOMITING (Vomiting). At the time of the report, NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved.            No treatment information was provided.    Patient reported about a historical procedure mechanical valve implant.  action taken with mRNA-123 is not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. The reported events are consistent with the product safety profile
Patient felt tightness and "tingly" in her throat about 15 minutes after vaccination.  Hx of tachycardia after first dose - discussed with PCP who indicated unsure if this was a reaction or not.  However, PCP felt pt should go ahead and take the second dose.  Pt's baseline HR is around 66.  HR taken - 73.  Patient said it felt like pins on her tongue.  Drank one bottle of water, denied SOB or throat issues.  HR monitored for another 30 minutes and returned to baseline.  Patient had another bottle of water and tinglyness dissipated.  Declined to go to ED for further evaluation, and said she would follow up with PCP if she noticed any further issues.
SHORTLY AFTER RECEIVING HER SECOND COVID SHOT, PATIENT STATED THAT SHE WAS FEELING ITCHY.  PATIENT TOOK 25MG OF DIPHENHYDRAMINE.  PATIENT CONTINUED TO HAVE ITCHING FOR THE FOLLOWING 15 MINUTES, BUT NO WORSENING OF THE SYMPTOMS.
Evening of vaccination developed rash on trunk.  Parent thought possible hives.  Advised BENADRYL po dose.  No other symptoms.  Rash resolved in 24 hours.  Inadvertently received GARDASIL dose.
ACTHIB portion of PENTACEL was not given, with no adverse event; Initial information received on 24-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age/gender patient to whom acthib portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] was not given, with no adverse event.   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 DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (dose, formulation, strength lot and expiry date: unknown) via unknown route in unknown administration site for prophylaxis vaccination.   On an unknown date, acthib portion of pentacel was not given to patient, with no adverse event (single component of a two-component product administered) (unknown latency).   Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable.  At time of reporting, the outcome was Unknown for the event acthib portion of pentacel was not given, with 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 the 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.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 29-JUN-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). On an unspecified dates, the GARDASIL vaccine had six temperature excursions: 80, 24, 168, 336, 1172 and 416 hours respectively. The lowest recorded temperatures were 30 (-1.111111111 Celsius degrees) and -3 (-3 Celsius degrees). The highest recorded temperatures were 48 (8.888888889 Celsius), 49 (9.444444444 Celsius), 47 (8.333333333 Celsius) and 59 (15 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
mistakenly mixed MMR vaccine with men A lyophilized powder; mistakenly mixed MMR vaccine with men A lyophilized powder; This case was reported by a physician via sales rep and described the occurrence of inappropriate preparation of medication in a 15-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details provided were as follows; Age at vaccination was not reported. The Medical Assistant at the practice mistakenly mixed an MMR vaccine with the men A lyophilized powder and it was administered which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. Follow-up would not be possible as no contact details available.
large local rxn w/swelling, warmth, erythema extending from deltoid where inj given to elbow likely hypersensitivity, had sx consistent w/serum sickness;
Chills Narrative: The following day after vaccine administration, patient's wife called reporting that patient was experiencing worsening fever. Wife reports that fever had started at 100 and increased to 103. Patient was shaking, but wife was not certain if they were chills as he had tremors.
After receiving injection patient walked about 40 feet to register and indicated she felt dizzy.  We gave her a chair to sit in and then she completely passed out.  We laid her down on the floor and called 911.  She came to right after we laid her down.  She said this has happened in the past but had been at least 5 years.  She indicated it was nothing to worry about as she was fine.  The Ambulance service arrived and they checked her blood pressure, pulse and blood sugar which were all okay.  She said when she was younger they thought she was having seizures but they determined it to be vasovagal syncope.  She did not tell us this until after we gave her the injection and she had passed out and came to.  She refused transfer to the emergency room as she said she was fine.  She sat in a chair for 5 minutes or so and then she walked to her car and her mother, who was with her, drove her home.
Extreme pain in bilateral breasts and nipples, extreme diuresis (urinating without taking in fluids every 15 minutes for approximately 12 hours with 500ml of urine each time), dizziness, at hour 12 post-vaccine fever of 102.5 that lasted for 1 day until dropping to 100.5.  Extreme pain to all teeth starting at hour 12 through 48.  Body pain, insomnia, burning sensation in lungs, and numbness in left facial area.  Extreme headache with pressure from left neck area just below ear extending into middle top of skull that felt like having your head in a vice grip.  The symptoms with the exception of the headaches and breast pain resolved within 50 hours.  The headaches are now episodic.  Breast pain is still present as of 9-18-21.
received 1st dose in 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in year 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. At the time of reporting, the patient wanted to complete schedule. Lot number and expiration date of 1st dose was not provided since patient didi not get the vaccine in at the facility. The reporter did not consent to follow up.