chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe, Acute Inflammatory Demyelinating Polyneuropathy (Guillain-Barré syndrome), with no other antecedent upper respiratory illness or GI illness. First developed extremity paresthesias, followed by rapid onset and progression proximal > distal, upper >lower extremity weakness on 4/6/2021, reaching peak on 2nd day of IVIG (4/13) initially with subtle improvements on his 3rd dose of IVIG (4/14; received total 2g/kg over 5 days) and then rapid worsening since 4/21/2021 to quadriplegia and bulbar weakness, requiring intubation on 4/26. Now on plasmapheresis and still hospitalized.
Took the shot on a Friday, 1/15/2021 and felt fine on Saturday and Sunday. Woke up Monday with a low grade fever and sore throat. Ran fever for two days.  Head congestion and started coughing on as well but not certain when that started.  As of 1/25, I'm still congested with a sore throat my temp is 97.7.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Mar-2021 at 9:31 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:31 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Age of patient was reported as 49:57 for dose administered on 31-Mar-2021. No concomitant medications were reported. Batch number 019B21A administered on 31-Mar-2021 underwent temperature excursion with temperature 32 degrees Fahrenheit at 08:00 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 31-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour. No treatment medications were reported.
First shot was 1/22/21, light headedness afterwords but no other. On  Jan 27th blood pressure dropped so stopped high blood pressure meds. on 1/29 noticed blood pressure going up. Began meds with no effect. Has been going up to 198/112 during the week. Went into Hospital on 2/1. BP high, did blood work, ecg, released when BP dropped to 156/90.  On 2/2 possible atrial fib and blood pressure up to 180/106, drove 280  miles to Clinic where they kept me overnight and did blood work, ecg, echocardio, xray and released me on 2/3 with double dosage of linisipril to 40 mg.  Blood pressure did not go down and seemed to go up when I took the linisipril.  2/6 Drove back to clinic again and went into ED.  BP 175/103, ecg switched bp meds to 50 mg Losartan and discharged. Drove home on  2/7.  2/8 blood pressure back up to 173/108 bpm 62 at 1:15 pm.
This spontaneous report as received from a Licensed Vocational Nurse regarding 3 patients of unknown demographics. There was no information about pertinent medical history, drug reactions or drug allergies. On 31-AUG-2015, the patients were vaccinated with (Merck) PROQUAD lot# L005297 and expiry date: 17-AUG-2016, that was improperly exposed to defrost cycling. No adverse effect was reported. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Fever of 102.5, Non stop crying for over 3 hours, Arching of back, unconsolable. I called the pediatrician after hours care and the doctor told me to wait it out and then decided that I should take him to the hospital to be safe. I took him to the hospital that night and they kept us for a few hours and he finally calmed down and fell asleep. They gave him Tylenol.
pt lt hand felt uncoordinated weak both legs, no restriction movement or dexterity; pt states feels sl improved today;
arm hurts; red spot; arm is warm; This case was reported by a consumer and described the occurrence of injection site pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2019, the patient received the 1st dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site warmth. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at administration was not reported. The age group was captured as adult as per vaccine indication. The patient received Shingrix and patient's arm still hurts a bit. There was also a red spot (approximately 4 inches round) next to the shot mark.  The arm was also warm to the touch.  The patient asked if this was normal?
This case was reported by a nurse and described the occurrence of a positive pertussis identification test in an infant subject gender (unknown) who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. At an unspecified time, the subject received a dose of Pediarix (lot number unknown). At an unspecified time after vaccination with Pediarix, the subject had a pertussis identification test that was positive. The nurse stated that she called to "find out if Pediarix could cause a false positive on the polymerase chain reaction (PCR) for pertussis". The outcome of the events was not reported.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72-year-old male patient. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported.  On or about 28-FEB-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated in emergency department for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: Herpes Zoster. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).     Additional information has been requested.
This spontaneous report as received from an office manager refers to a 59 years old patient. The patient was vaccinated with a dose of VARIVAX (Merck) (Lot number, dose and route not reported) on 19-JUL-2012. On the same date, the patient received ZOSTAVAX (Lot number, dose and route not reported) in another arm. No concomitant medications were reported. The patient was supposed to get PNEUMOVAX 23 and not VARIVAX (Merck). The patient was not experiencing any known symptoms. Additional information has been requested.
Started dialysis at 5:30 AM.  flu vaccine at 7:26 AM.    patient's eye rolled up into head, unresponsive to verbal stimuli and sternal rub.    no pulse or chest movement.   CPR started.  Pulse regained.  EMS transferred patient to ED (unsure which ED).
Erythema and swelling right arm. Minimal tenderness to palpation. Full range of motion. No drainage. No systemic symptoms.
Patient is fully vaccinated and boosted. Patient was diagnsed with COVID this past week. Presents to the ED on 5/10/2022 with productive cough with yellow sputum.  No fever. no chills, nausea, vomiting.  + for body aches. BP 138/77  | Pulse 83  | Temp 98.2 °F (36.8 °C) (Oral)  | Resp 18  | SpO2 98% Clinically, the patient has clear lungs bilaterally with stable vital signs.  Chest x-ray was performed which again demonstrates no evidence of pneumonia.Discharged to home.
patient that was administered ActHIB with expired diluent with no reported adverse event; Initial information received on 17-Mar-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient (unknown age and gender) who had administered HIB (PRP/T) vaccine [ACT-HIB] with expired diluent with no reported 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 HIB (PRP/T) vaccine (strength, dose, formulation, route: unknown) (lot number: UJ423AAA: Expiry date: 07-03-2022) in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event patient was administered HIB (PRP/T) [ACT-HIB] with expired diluent with no reported adverse event (expired product administered) (unknown latency).   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired product administered.   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 guidelines. 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.
developed stage-2 hypertension after the vaccination; Headaches that have not subsided and continued for 3 weeks post vaccination; pain the right arm for 3-4 days; Fatigue that lasted for 2 to 4 days; Fever that lasted for 2 to 4 days; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (developed stage-2 hypertension after the vaccination), HEADACHE (Headaches that have not subsided and continued for 3 weeks post vaccination), VACCINATION SITE PAIN (pain the right arm for 3-4 days), FATIGUE (Fatigue that lasted for 2 to 4 days) and PYREXIA (Fever that lasted for 2 to 4 days) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069H21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy (Seasonal allergies).    On 04-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2022, the patient experienced HYPERTENSION (developed stage-2 hypertension after the vaccination), HEADACHE (Headaches that have not subsided and continued for 3 weeks post vaccination), VACCINATION SITE PAIN (pain the right arm for 3-4 days), FATIGUE (Fatigue that lasted for 2 to 4 days) and PYREXIA (Fever that lasted for 2 to 4 days). The patient was treated with HYDROCHLOROTHIAZIDE for Hypertension, at an unspecified dose and frequency. In February 2022, VACCINATION SITE PAIN (pain the right arm for 3-4 days), FATIGUE (Fatigue that lasted for 2 to 4 days) and PYREXIA (Fever that lasted for 2 to 4 days) had resolved. At the time of the report, HYPERTENSION (developed stage-2 hypertension after the vaccination) and HEADACHE (Headaches that have not subsided and continued for 3 weeks post vaccination) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were taken by patient. The patient had not undergone any previous positive COVID test or was not previously diagnosed with COVID-19. The patient had experienced multiple adverse reactions post vaccination.  On 23-Feb-2022, the patient went to check with the physician and was prescribed with Hydrochlorothiazide.
This 13-year-old patient received the 5-to 11-year-old dose of Pfizer (0.2 mL) on 11/19/21 and 12/10/21. After difficulty billing for the vaccine on 12/20/21, the pharmacy realized that this patient received a dose that was too low per ACIP/CDC. Pharmacist called Pfizer to make them aware of the mistake and report the incident. Pharmacist called the parent of the patient to let her know of the mistake. The patient's mother said that she intentionally signed her daughter up for the lower dose based on a recommendation from a physician in Kansas. The mother refused to give the name of the physician for fear of the physician getting in trouble for making this recommendation. The mother said that this recommendation was based on the patient's medical conditions. There are no symptoms or issues noted from getting a lower dose of the vaccine.
I received an RSV (Respiratory Syncytial Virus, GSK manufacturer) injection in my left arm. The day after the injection, there was tenderness and slight swelling below my left ear and neck but the pharmacist said to not worry; that it?s an occasional, but natural immune response. The tenderness and slight swelling continued for nine days, until September 29, 2023.
Vomiting, body aches and chills, fever, sore arm. only vomiting has resolved.
RASH STARTING AT THE LEFT HIP AND CONTINUING IN GROIN AREA, BURNING SENSATION FROM SCRATCHING
Patient received an expired booster as per lot # on vaccination Card; Patient received an expired booster as per lot # on vaccination Card; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired booster as per lot # on vaccination Card) and NO ADVERSE EVENT (Patient received an expired booster as per lot # on vaccination Card) in a 24-year-old female patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 015F21A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2022, received third dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 08-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired booster as per lot # on vaccination Card) and NO ADVERSE EVENT (Patient received an expired booster as per lot # on vaccination Card). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired booster as per lot # on vaccination Card) and NO ADVERSE EVENT (Patient received an expired booster as per lot # on vaccination Card) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (Patient received an expired booster as per lot # on vaccination Card) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received an expired booster as per lot # on vaccination Card).    Concomitant medications were not reported. No treatment information was provided by the reporter.   Reporter did not allow further contact
The patient is a very pleasant 43-year-old female with morbid obesity (167 kilos at 5 foot 6 inches height) and asthma.  She is without a prior cardiac history.  She has been under significant emotional stress after the unexpected death of her husband approximately 2 weeks ago.  She remained medically well, however, until approximately midnight this morning, 06/13/21, when she developed acute onset of chest discomfort at rest.  These symptoms were sufficiently severe such that the paramedics were summoned.  Her EKG en route was suggestive of anterior ST-segment elevation.  However, upon her arrival, her presenting EKG was without significant ST segment changes.  Despite the latter and despite aggressive medical therapy, including high-dose heparin, aspirin and Brilinta, at 0215 hours, she developed recurrent severe chest discomfort, as well as new anterior ST-segment elevation on her EKG.    In summary, the patient presented with an evolving anterior ST-segment elevation myocardial infarction diagnosed by qualifying EKG at 0215 hours.  For this, she underwent successful thrombectomy, angioplasty, and drug-eluting stenting with excellent result both by angiography and by optical imaging.
Patient complained of throat closure. Patient was given one shot of EpiPen on right thigh. Paramedics were called on-site. Patient was able to speak and vocalize her symptoms. Patient was taken to a nearby hospital for further evaluation.
Patient was given COVID booster (3rd dose) too early by a staff member here at our office. See timeline below... 09/29/2021- Pfizer COVID Vaccine 11/02/2021- Pfizer COVID Vaccine 12/02/2021 - Pfizer COVID Vaccine Patient was monitored for 30 minutes after injection, and experienced no side effects. We will continue to call and monitor patient for the next few days.
Information has been received from a registered nurse (RN) concerning a 6 year old male who on 15 July 2002, was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (lot# 641985/0293M). There was no concomitant therapy. The RN reported that on 18 January 2006, the patient developed atypical chickenpox characterized by a rash formation like chickenpox which never developed a blister. The RN noted that the patient case of chickenpox was mild due only having less than 20 "blisters'. Unspecified medical attention was sought and the patient's symptoms were treated. At the time of this report, the outcome was unknown. Additional information has been requested.
Complaints of nausea, dry heaves, diarrhea, feeling very weak. Said she started to itch; noticed hives on arms, stomach, back and inside part of legs. Hives were oblong in shape and got very big. Husband called doctor; instructed to call EMS and transported to hospital. Discharge Summary received on 1/12/2005 states gastroenteritis, syncope and dehydration.
Severe pain all over body. Muscles ached, joints were on fire and everything hurt. Lower back by kidneys was very sore and painful. Hurt to lay on back, laid on side of body. This pain continued from 4/23/18 at 2:30 am until 10:00 am on 4/24/18. The vaccination site (upper left arm) was severely painful and could barely lift it. Vaccination given at 3:30 pm on 4/22/18 and severe body pain started at 2:30 am on 4/23/18 until 7:30 pm 4/23/18. Weak, tired and lethargic from 2:30 am 4/23/18 through 4/24/18 1:30 pm. Missed two days of work because of this.
got sick and tested positive with COVID; got sick and tested positive with COVID; This is a spontaneous report from a contactable consumer via Pfizer Sponsored Pfizer First Connect. A contactable consumer reported similar events for four patients. This is second of four reports.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient got sick and tested positive with covid on an unspecified date. It was further reported that patient who received the COVID vaccine, tested positive for COVID, and experienced side effects afterwards. The outcome of the events was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021013589 same drug, similar events, different patient
In June, I began experiencing fatigue and pain during urination as well as back pain. That went on for 2 weeks. I woke and felt dizzy and light-headed. I went to the ER and could barely walk and had low energy. They said I had very low BP and they had to invert me and run fluids and anti-biotics. After the bloodwork they told me I was septic. Everything had returned to normal by the next afternoon and was on anti-biotics for the next 2 weeks.
Pt reports mild, itchy, light pink rash to L arm & L upper thigh x 1 week post 1st injection.
I woke up on March 8th with a huge red circle on my left  arm around the site of the vaccination -- it is approx the size of a lemon or medium orange,  It does not hurt or itch, it doesnt feel raised or hard
Approximately 20 hours later, I began getting chills. When I put on a jacket, I began sweating profusely., yet freezing cold. My head was pounding. Came home from work a couple hours later and took a nap for a few hours yet woke up multiple time covered in sweat, yet again freezing cold
pt got the vaccine at the pharmacy and then 15 minute later started vomiting and since then has felt warm, had hives, sore and swollen arm and shoulder area.
Swollen injection site-9/30 Painful injection site-9/30 nausea-9/30 dizzy-9/30
28 days after receiving 1st dose, had a small menstrual period (I'm 65 and have been in menopause since I was 48).; This is a spontaneous report from a non-contactable consumer or other non hcp. A 65-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 28Feb2021 16:30 (Batch/Lot Number: EN6202) as DOSE 2, SINGLE for covid-19 immunization. Previously the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 07Feb2021 15:30 (Batch/Lot Number: EN9581) as DOSE 1, SINGLE for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Medical history included high blood pressure from an unknown date. The patient is in her menopause since she was 48-year-old. Concomitant medication included candesartan (CANDESARTAN) 8mg taken for an unspecified indication, from an unknown start date. The patient is allergic to aspirin and amoxicillin. On 07Mar2021, the patient experienced 28 days after receiving 1st dose, had a small menstrual period (I'm 65 and have been in menopause since I was 48). Had a second smaller incident on 20Jun. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received treatment for the event. The outcome of the event was reported as unknown at the time of report.  No follow-up attempts are possible. No further information is expected.