chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recv vax 22MAY96 1030AM & the same morning reportedly became febrile, blue & mottled-looking as well as lethargic;
PATIENT GOT THE FLUZONE HD VACCINE AND COMPLAINED OF ITCHING AND REDNESS AT THE SITE OF INJECTION. SHE SAID SHE HAD A BIG WELT, BIG BALL LIKE AROUND THE SITE OF THE INJECTION. SHE DID NOT HAVE ANY PAIN AT THE SITE. THE ITCHING DECREASED OVER THE NEXT FEW DAYS AND THE REDNESS LESSENED ALSO. PATIENT HAD NO OTHER REACTIONS. PT DID NOT TAKE ANY MEDICATIONS FOR REACTION.
congestive heart failure; inadvertently administered another dose (3rd dose); tested positive for Covid-19; A spontaneous report was received from a nurse and other health care professional for a 91-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced congestive heart failure, tested positive for Covid-19 and inadvertently administered another dose (3rd dose).  The patient's medical history was not provided. No concomitant product use was reported.  On 22-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection.   On 23-JAN-2021, 1day after receiving the vaccine the patient was hospitalized due to congestive heart failure. The patient had difficulty of breathing at that time.   On 03-FEB-2021, the patient tested positive for covid-19. The patient was transferred to a rehabilitation facility on an unspecified date to recuperate.   On 25-FEB-2021 at around 11:30 in the morning, the patient was given second dose of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of covid-19 infection at a rehabilitation facility. On the same day at around 02:30 PM, a group of vaccine providers came and inadvertently administered another dose (third dose) of the vaccine mRNA-1273 (lot number: not provided) to the patient. Apparently, there was two patients with the same names, and they did not check the birthdays. The health care professional reported that at the time of this report, the patient was in the hospital and was on a ventilator. Treatment information included ventilation.  Action taken with mRNA-1273 was not applicable.  The outcome of the events, congestive heart failure and tested positive for Covid-19 was unknown and the outcome for the event inadvertently administered another dose (3rd dose) was recovered/resolved.  The reporter did not provide the assessment for the event's congestive heart failure, tested positive for Covid-19 and inadvertently administered another dose (3rd dose).; Reporter's Comments: COVID-19 in this patient is unlikely to be related to Moderna COVID-19 vaccine. Based on the current available information and temporal association, a causal relation between the product and congestive heart failure cannot be excluded. Medication error of extra dose administered for (mRNA-1273), lot # unknown  was reported, with no associated AEs reported after the additional dose.
Initial report was received from a healthcare professional on 06 December 2012. A 29-year-old female patient had received an intramuscular injection in the left deltoid of FLUZONE, lot number UH713AB, on 24 November 2012 and a half hour after the injection the patient had a rash at the injection site. It was learned later that the patient developed a cellulitis at the injection site and was hospitalized. Treatment included intravenous (IV) antibiotics. The physician told the patient's parent that the event may be a flesh eating disease. The patient had no illness at the time of vaccination, an allergy to penicillin (PCN) and a history of diabetes. Outcome was not recovered. Documents held by sender: None.
REACTION TO VACCINE; LEFT THIGH 2-21/2CM INDURATED NODULE WITH 1 1/2CM RED PATCH OVERNIGHT WITH 2 TINY PUNCTURE WOUNDS, MINIMAL TENDERNESS FLUCTUANCE.
Patient sought medical care 12/15/21 for dyspnea. Extensive work up completed. On 12/31/21, patient diagnosed with pulmonary embolus.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 07-DEC-2015 the patient was vaccinated with dose of improperly stored (Oka/Merck) VARIVAX (lot # K006135 with expiration date: 29-APR-2016) (dosing regimen and frequency unknown). No concomitant medications were reported. No adverse effects were reported. The administered dose experienced a temperature excursion of 71 degrees Fahrenheit for 30 minutes. There was no previous temperature excursion. This is one of the many reports from the same source. Additional information has been requested.
Presented to hospital with a eight day history of nasal congestion, malaise and cough. "Was found to be covid positive". In the Emergency Room patient found to have SpO2 >92% on RA, but hypoxic to 87-88% while ambulating. Admitted to Medicine and started on decadron. The following morning walking oximetry test completed which showed no supplemental oxygen requirement at rest or with exertion. Patient discharged clinically stable and with strict return precautions.
Syncope, vomiting,abdominal pain   Patient spouse indicated this is normal when patient sees blood
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On 27-DEC-2010, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 07-JAN-2016, the patient was treated in a primary care center for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the 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 until her death. On an unspecified date, the patient died. It was unknown if autopsy was done. The outcome of other events was unknown. Causality assessment was related. Additional information has been requested.; Reported Cause(s) of Death: unknown cause of death.
ear pain; shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 3EE55, expiry date 11th December 2021) for prophylaxis.   Concomitant products included amitriptyline.   On 27th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 30th September 2019, 3 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced ear pain. The patient was treated with valaciclovir hydrochloride (Valtrex), naproxen and gabapentin. On an unknown date, the outcome of the shingles and ear pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles and ear pain to be related to Shingrix.  Additional details were provided as follows: The patient reported that she developed shingles on her head, neck, and ears 3 days after dose 1 of Shingrix.   The patient went to the emergency department due to the ear pain and was diagnosed with shingles.   The patient was prescribed Valtrex 1 gram three times daily, Naproxyn, and gabapentin and then sent home. The reporter consented to follow up. There was discrepancy in the outcome of the event, in the source document it was reported as recovering/ resolving and it was reported as not recovered/ not resolved.
I am a Type 1 Diabetic, and my blood glucose levels skyrocketed for 48 hours after the vaccine. I am on an insulin pump and had to take 300% more basal insulin than my normal daily dose to get my glucose levels in the mid-100s.
Extreme swelling and pain at the injection site that spread through the arm and up the neck. Fever of 102 for 2 days so far
TWO SIDE EFFECTS: 1) I'VE HAD A RINGING IN MY EARS SINCE THE NIGHT OF THE VACCINE...MAKING IT DIFFICULT TO SLEEP 2) THIS MORNING I WAS AWAKENED BY MY ARM ITCHING AT THE INJECTION SITE. IT'S RED, RAISED SLIGHTLY AND WARM TO THE TOUCH. THERE ARE TWO AREAS - ONE IS ABOUT 2" IN DIAMETER AND A SECOND SMALLER AREA ABOUT 3/4" IN DIAMETER ABOUT AN INCH ABOVE THE INJECTION SITE.
approx 1 minute p/inject, pt apparently fainted, striking head; BP 100/56, P16, R18 PEERL; responsive immed w/o use of ammonia cap; c/o frontal h/a; sent to ER for eval; treated & released; rxn to vax;
Mild fever of 99.7 Headache Muscle aches Fatigue Heart palpitation
Body hurt, also my head.  I was seeing thing last night around 8PM and around 5AM also used the bathroom on myself 1#.
Pt test positive for Covid on Saturday. She has had fever, chills, body aches, cough. Deep breaths make pt short of breath. Pt took Tylenol and Ibuprofen this morning at 1100. Pt vomiting in intake.
ADMINISTRATION ERROR (ONE DOSE ADMINISTERED FROM A PUNCTURED VIAL); EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 42 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 expiry: 07-MAR-2021) dose was not reported, administered on 20-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 20-OCT-2021, the patient experienced administration error (one dose administered from a punctured vial). On 20-OCT-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error (one dose administered from a punctured vial) and expired vaccine administered was not reported. This report was non-serious.
chills; head felt heavy and achy; head felt heavy and achy; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEAD DISCOMFORT (head felt heavy and achy) and HEADACHE (head felt heavy and achy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced CHILLS (chills), HEAD DISCOMFORT (head felt heavy and achy) and HEADACHE (head felt heavy and achy). At the time of the report, CHILLS (chills), HEAD DISCOMFORT (head felt heavy and achy) and HEADACHE (head felt heavy and achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
103 degree fever, shortness of breath, hives, decreased vision, headache, debilitating body pain, chest pain, vomiting, confusion.
First vaccine I had slight fever/ chills. Second vaccine on 01/27/21 I woke up next day with extreme body aches and a temp of 101.1. Going into today 01/31/21, I still have elevated temp been taking Ibuprofen and Tylenol but now having dizziness, left facial pressure/pain, and nausea with neck stiffness.
HYPOXIA 3/22/2023 HOMELESSNESS, UNSPECIFIED HYPOXIA 3/22/2023 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE)
COVID-19 test positive; COVID-19 test positive; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  An 85-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown) and in Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10Jul2022, outcome "recovered" and all described as "COVID-19 test positive". The event "covid-19 test positive" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jul2022) Positive, notes: COVID test type post vaccination=Unknown. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient complained of itching, said previous anaphylaxis started with a deep itch. Vitals stable and no shortness of breath. Patient had pre medicated with prednisone and Benadryl.  As itching continued urgent care MD ordered epinephrine to be administered
pt recv vax 9AM in clinic;pt back to clinic c/o itching all over;BP 128/84, P98, R18-1210PM vital signs repeated BP 132/84, P100, R20;no obvious welts or rash pt accompanied to hosp ER;
At 2:15 am the day after the vaccine, I woke up with a sore left arm (injection site), redness on the left arm, muscle aches, body pain and discomfort, along with a temperature of 101 to 102 that lasted for about 3 days.  I stayed in bed and drank liquids, ate soup and took Tylenol (2 tablets every 6-8 hours) for almost 3 days until I started to feel better.
Rash and itch on left shoulder with many bumps about 2-3mm each. Itch persisted until bedtime on that evening. Bumps were still there the next morning. Did not want to take any antihistamine.
Initial report was received 09 June 2009 from a health care professional. A 33-year-old pregnant female patient with a history of asthma and no prior pregnancies, had received a 0.5 mL intramuscular injection of ADACEL, lot number C3029AA on 03 June 2009. She had also been taking SINGULAIR 10mg and an unspecified inhaler concomitantly for her pre-existing condition of asthma. The patient's last menstrual period occurred on 12 May 2009 and she had been approximately three weeks pregnant at the time of vaccination. It was further noted that the patient had received ADACEL because she was a health care worker. On 8 June 2009, the patient had urine and blood serum pregnancy tests performed; results for both tests were provided on 09 June 2009 which confirmed a positive pregnancy. The patient's expected date of confinement was unknown at the time of the report. According to the reporter, the patient had not experienced any adverse events since receiving ADACEL. Follow-up information was received 05 April 2010 from a healthcare professional. Upon receipt of this information, it was determined that the case meets seriousness criteria and it has been upgraded to serious. The patient had a tubal ectopic pregnancy on an unspecified date and was treated with methotrexate. Subsequently, an emergency laparotomy was performed for a ruptured ectopic on an unspecified date. No further information was provided. Documents held by sender: None.
Small raised red dots which progressed to large red welts. Started on face, around mouth and then progressed to include entire body.
Crying greater than 3 hours, treatment ibuprofen oral 10mg/kg x1 dose.
Reaction/second covid-19 vaccination injection felt like had flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Reaction/second covid-19 vaccination injection felt like had flu) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced INFLUENZA LIKE ILLNESS (Reaction/second covid-19 vaccination injection felt like had flu). At the time of the report, INFLUENZA LIKE ILLNESS (Reaction/second covid-19 vaccination injection felt like had flu) outcome was unknown.            No concomitant medication information was reported.  No treatment medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2021-624066 (Patient Link).
About 2 weeks after the vaccine my left arm starting itching.  I looked at the site, which I hadn't done before, and I had a small rash at the vaccination site.  I put Cortisone  10 cream on it.  In the following days the itch continued and the rash kept getting larger.  I went to the emergency  room 2/13 and started Betamethasone Dipropionate  cream and Cetirizine pills that evening.  The itching is gone,but the rash has not decreased in size.  SHOULD I GET THE SECOND VACCINE SHOT??
My husband has been in increasingly bad pain and limited functionality of left Arm  since 3 hours after he received the Moderna 3rd shot  booster at the pharmacy yesterday at 3pm MST.   Unable to use left arm, yelling in pain, unable to get comfortable or sleep.   This is not a complainer kind of guy.   He hurts badly.    Used cold packs last night and advil.    Today worse, used Icy Hot patch.   Chicken soup.  It is now 10:52 pm ,  a full day later and he is in difficulty.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 22nd June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a month after receiving SHINGRIX, the patient experienced injection site pain and injected limb mobility decreased. The patient was treated with MOTRIN. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm. The patient's injection site was sore, painful and she could hardly lift her arm. She had been taking MOTRIN. The patient's condition was getting worse. The patient gave permission to contact her physician. The patient would follow up with her physician in a week from the date of reporting. No further details were provided. This case has been linked with case US2018130283, reported by the same reporter (same patient for 1st dose).
Disabilitating joint pain, headache, fever, fatigue, severe pain at shot site. This while being under pain management with oxycodone.
first dose more than a year ago; This case was reported by a nurse via sales rep and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX (received first dose more than a year ago).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 18-Aug-2022 Reporter's Comments: The reporter was the patient involved on this situation. Account manager reported by phone that a nurse director of clinical support needed information about Shingrix late second dose. The healthcare professional (HCP) received Shingrix first dose more than a year ago. The healthcare professional (HCP) managed several clinics. Consented to follow-up accepted by postal. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Unresponsive abscess on Injection Site 1 month after booster; Sore with black dot on Injection Site 1 month after booster; Sore with black dot on Injection Site 1 month after booster; Giant hole on Injection Site 1 month after booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Giant hole on Injection Site 1 month after booster), VACCINATION SITE ABSCESS (Unresponsive abscess on Injection Site 1 month after booster), VACCINATION SITE DISCOLOURATION (Sore with black dot on Injection Site 1 month after booster) and VACCINATION SITE PAIN (Sore with black dot on Injection Site 1 month after booster) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 028L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE REACTION (Giant hole on Injection Site 1 month after booster). On 29-Jan-2022, the patient experienced VACCINATION SITE ABSCESS (Unresponsive abscess on Injection Site 1 month after booster). 29-Jan-2022, the patient experienced VACCINATION SITE DISCOLOURATION (Sore with black dot on Injection Site 1 month after booster) and VACCINATION SITE PAIN (Sore with black dot on Injection Site 1 month after booster). At the time of the report, VACCINATION SITE REACTION (Giant hole on Injection Site 1 month after booster), VACCINATION SITE ABSCESS (Unresponsive abscess on Injection Site 1 month after booster), VACCINATION SITE DISCOLOURATION (Sore with black dot on Injection Site 1 month after booster) and VACCINATION SITE PAIN (Sore with black dot on Injection Site 1 month after booster) had not resolved.            No concomitant medication was provided Treatment included Antibiotic and Steroids which did not improve her arm. Patient reported that she had unresponsive Injection Site abscess to Antibiotics  and steroids after booster on 29-Jan-2022   This case was linked to MOD-2022-477081 (Patient Link).
headaches; dizziness; loose stomach feeling/ loose stools; This is a spontaneous report from a contactable consumer or other non hcp. A 70-year-old female patient received (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, lot number was not reported) via an unspecified route of administration on 19Feb2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced headaches for several days and today he woke with a horrible headache it so happens that when they gave her the vaccine it started to hurt again, it was hurting the side of her forehead, probably had to do with the ear, dizziness, loose stomach feeling on an unspecified date. Therapeutic measures were taken as a result of headaches. She took Meclinizine and antivert for headache and dizziness. The outcome of the events was unknown.  Information of lot/batch number is requested.  Follow-up attempts are completed. No further information is expected.
10 days p/vax had 2 days of a low grade fever on days 12-14 was extremely fussy, cried & had tantrums all day; slept well @ noc;