chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got the Pfizer COVID-19 vaccine/taking Paxlovid; got the Pfizer COVID-19 vaccine/taking Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "H. pylori" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation; Moderna covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunisation; Moderna covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation; Moderna covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunisation; Moderna covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE), for COVID-19 immunisation; Moderna covid-19 vaccine, bivalent (original and omicron ba.4/ba.5) (DOSE 6 (BOOSTER), SINGLE, The last bivalent which caller had in 2022), administration date: 2022, for COVID-19 immunisation; Flu vaccine (Got all vaccines at doctors office, including flu shots.), for Immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got the Pfizer COVID-19 vaccine/taking Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid. Clinical Course: Patient had always took the Moderna COVID-19 vaccine, was wanted the Moderna COVID-19 vaccine this time but got the Pfizer COVID-19 vaccine, patinet was taking Paxlovid and wanted to knew if there was an issue with those shots interacting. Reporter had been took the Moderna COVID-19 vaccine for 4 boosters and the last bivalent which caller had in 2022, all were Moderna, never switched from one to another. Got all vaccines at doctors office, including flu shots.Then stated caller was taking Paxlovid, had H. pylori.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
It was reported that a pt (2 of 9) received a Tripedia vaccination the week of 3/23/01. Reportedly, sometime after the vaccination (date not specified), the pt developed a large local reaction at the injection site. From additional correspondence received on 5/16/01, additional pt, vaccine administrator and responsible physician information was provided.
- Almost immediate pain at injection site that moved around my arm, into my armpit, arm felt heavy -Rapid heartbeat 5-10 minutes after injection, along with dizziness, rapid pulse and nausea that lasted approximately 5 minutes  -After than, body aches, nausea, arm pain and tiredness  -Nausea, exhaustion, arm pain and body aches for 48 hours following injection -Started monthly period early, 4 days following vaccine, period started heavier than normal (started my period 1 week early which is VERY unusual for me) -Some of my vaccine reactions felt exactly like a condensed and much stronger version of PMS
a patient who is under 50 years old has a prescription to receive Shingrix; a patient who is under 50 years old has a prescription to receive Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a 49-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced circumstance or information capable of leading to medication error and drug prescribing error. On an unknown date, the outcome of the circumstance or information capable of leading to medication error and drug prescribing error were unknown.   Additional details were provided as follows: The age at vaccination not reported. The patient under 50 years old had a prescription to receive Shingrix, which led to drug prescribing error and circumstance or information capable of leading to medication error. The reporter consented to follow up.
This spontaneous report was received from a registered nurse regarding a patient of unspecified age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date in 2010, the patient had previously received PNEUMOVAX 23 (Manufacturer unknown). On 19-OCT-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 injection, (lot # L003188, expiry 06-JUL-2016) in the right deltoid along with FLUZONE (lot number UI443AD) in the left deltoid. The left arm was free of injection site reaction. Concomitant medications were not reported. Beginning on unknown date approximately in 2015, patient experienced redness from injection site of right deltoid to elbow. This area was warm and sensitive to touch. Additionally the patient had nausea. The patient took TYLENOL for symptoms. The patient was seen on 22-OCT-2015. At time of visit, events were resolving and it was unknown if events completely resolved. The nurse considered the events to be related to this specific lot of PNEUMOVAX 23. She further stated that lot # L003188 had been returned by the health department to the vendor. This is one of the several reports received from the same reporter. Additional information has been requested.
dehydration; turning on his autoimmune system to where his body is fighting itself. He states his body is fighting his intestines; lost 15 pounds; diarrhea for over 2 months; This spontaneous case was reported by a consumer and describes the occurrence of DEHYDRATION (dehydration) and AUTOIMMUNE DISORDER (turning on his autoimmune system to where his body is fighting itself. He states his body is fighting his intestines) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Colonoscopy on 12-Aug-2021. Concurrent medical conditions included Autoimmune disorder.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced DIARRHOEA (diarrhea for over 2 months). On an unknown date, the patient experienced DEHYDRATION (dehydration) (seriousness criterion hospitalization), AUTOIMMUNE DISORDER (turning on his autoimmune system to where his body is fighting itself. He states his body is fighting his intestines) (seriousness criterion medically significant) and WEIGHT DECREASED (lost 15 pounds). At the time of the report, DEHYDRATION (dehydration), AUTOIMMUNE DISORDER (turning on his autoimmune system to where his body is fighting itself. He states his body is fighting his intestines), DIARRHOEA (diarrhea for over 2 months) and WEIGHT DECREASED (lost 15 pounds) outcome was unknown.            The doctors were thinking that it caused by the shot, turning on his autoimmune system to where his body is fighting itself. Patient states that his body is fighting his intestines. Patient called to report this that he has been hospitalized 4 times for dehydration; one time he was there for 6 days. Concomitant medications was not provided by the reporter. Treatment information was not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
10:28 - Pt. complains of tingling in mouth. VS initiated. Lung sounds clear upon auscultation. Will continue to monitor. 10:40 - Pt. speech is muffled. Tongue swollen, compared to baseline.  10:41 - Benadryl 25 mg IM via RA administered. 10:45 - Patient reports resolution of tingling of mouth. Tongue swelling resolved.  10:55 - Patient discharged
Injection site was hot and red. The area kept getting larger by the hour. I woke up about every 2 hours because of the pain. When I awoke at 4 AM I felt nauseous and started dry heaving. I also had a headache and a low grade temp (99.5). The area of swelling, redness, and pain encircled my whole arm from shoulder to elbow.
Swollen, red rash itchy, hot to the touch, and painful. Treated with Benadryl and hydrocortisone
S: pt c/o rash & itching on forearms approx 20'; O: hives observed on forearms; A: Epi given; P: observed pt SOB, or futher swelling noted
Information has been received from a nurse practitioner concerning an 18 female with a penicillin allergy and a history of a fractured nose. The nurse practitioner reported that the patient completed the Gardasil series and then miscarried. The patient received her first dose of Gardasil (Lot #655503/0012U) on 05-MAR-2007, her second dose on 05-MAY-2007 (Lot #657621/0387U) and her third dose on 07-SEP-2007 (Lot #658488/0930U). The patient miscarried 3-4 weeks after receiving the last dose approximately 28-SEP-2007. The mother of the patient said the miscarried fetus had developed for about 3 months. The patient went to the emergency room for the miscarriage and was treated there for bleeding post-miscarriage. The patient had also been treated at an unspecified OBGYN post-miscarriage for bleeding and presently vertigo and headaches. The patient has been to the emergency room twice for treatment post-miscarriage and an unspecified neurologist. It was unclear if the patient was ever hospitalized. There was no testing on the miscarried fetus, because it was "flushed" and not recovered. There was no other information to report. Upon internal review a miscarriage was considered an other important medical event. Additional information has been requested.
Pain in arm from injection site to the elbow immediately following injection and continuing for 1 day. Tingling, prickling, and sharp pains in upper and lower back starting within 3 hours of injection continuing through following day.    Abdominal pain/discomfort within 14 hours of injection continuing for several days. Neck and back stiffness.
migraine; neck pain; some numbing stuff for the nerve; body pain; feeling really hot; really really nauseated; sicker than I was when I had COVID; headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (sicker than I was when I had COVID), FEELING HOT (feeling really hot), MIGRAINE (migraine), NECK PAIN (neck pain) and HYPOAESTHESIA (some numbing stuff for the nerve) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 31M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 20-Jan-2021.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced MALAISE (sicker than I was when I had COVID) and HEADACHE (headache). On 18-Mar-2021, the patient experienced FEELING HOT (feeling really hot), MYALGIA (body pain) and NAUSEA (really really nauseated). On an unknown date, the patient experienced MIGRAINE (migraine), NECK PAIN (neck pain) and HYPOAESTHESIA (some numbing stuff for the nerve). The patient was treated with ERENUMAB for Migraine NOS, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (sicker than I was when I had COVID), FEELING HOT (feeling really hot), NECK PAIN (neck pain), HYPOAESTHESIA (some numbing stuff for the nerve) and MYALGIA (body pain) outcome was unknown and MIGRAINE (migraine), HEADACHE (headache) and NAUSEA (really really nauseated) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  Patient stated that she took local injections in the back of her neck .   This case was linked to MOD-2021-062376 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Additional information included ERENUMAB as treatment for migraines, two more events of neck pain and numbing stuff, outcome of the headache changed from unknown to not recovered.
Heart was beating fast and wouldn't slow down, got dizzy , went to  ER at hospital
Breakthrough COVID infection in fully vaccinated patient. Positive date 08/21/2021.
I did not have an adverse reaction to the vaccine. I had a sore throat on 02/23/2023. I tested positive for COVID-19 on 02/26/2023. I went to the urgent care and got a prescription for PAXLOVID. While taking the medication, I had a change in my ability to taste due to a metallic and a dull taste. That cleared up once I stopped taking the medication. As of today, I continue to feel fatigue and I have a cough.
Foul bowel. 2:20 am Clear, mild vomit 2:40 am Clear, intense vomit and foul bowel 3:20 am Sore arm at shot site 10:30 pm -  Dime sized red spot on right forearm 3:00am
Red splotchy rash over torso, neck, arms. Noticed light rash about 24 hours after injection. Has continued to get worse. Skin feels kind of raw and somewhat itchy.
red hives on arms,red hives on torso,red hives on wrist/hives with bumps on arms,hives with bumps on legs,hives with bumps on torso,hives with bumps on wrist; itchy hives on legs,itchy hives on torso,itchy hives on wrist; (left) arm "almost black and blue"; (left) arm swelling "like a balloon,(left) arm swollen "a bit larger than an orange; Vaccination site pain; red (left) arm "a bit larger than an orange"; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING ((left) arm swelling "like a balloon,(left) arm swollen "a bit larger than an orange), VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE ERYTHEMA (red (left) arm "a bit larger than an orange"), URTICARIA (red hives on arms,red hives on torso,red hives on wrist/hives with bumps on arms,hives with bumps on legs,hives with bumps on torso,hives with bumps on wrist) and RASH PRURITIC (itchy hives on legs,itchy hives on torso,itchy hives on wrist) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A. and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PERIPHERAL SWELLING ((left) arm swelling "like a balloon,(left) arm swollen "a bit larger than an orange), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE ERYTHEMA (red (left) arm "a bit larger than an orange"). 11-Mar-2021, the patient experienced SKIN DISCOLOURATION ((left) arm "almost black and blue"). On an unknown date, the patient experienced URTICARIA (red hives on arms,red hives on torso,red hives on wrist/hives with bumps on arms,hives with bumps on legs,hives with bumps on torso,hives with bumps on wrist) and RASH PRURITIC (itchy hives on legs,itchy hives on torso,itchy hives on wrist). On 25-Mar-2021, PERIPHERAL SWELLING ((left) arm swelling "like a balloon,(left) arm swollen "a bit larger than an orange), VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE ERYTHEMA (red (left) arm "a bit larger than an orange") and SKIN DISCOLOURATION ((left) arm "almost black and blue") had resolved. At the time of the report, URTICARIA (red hives on arms,red hives on torso,red hives on wrist/hives with bumps on arms,hives with bumps on legs,hives with bumps on torso,hives with bumps on wrist) and RASH PRURITIC (itchy hives on legs,itchy hives on torso,itchy hives on wrist) outcome was unknown. Not Provided          Concomitant medications include cortisone (topical) and Antihistamines. Treatment information was not provided.   This case was linked to MOD-2021-109666 (Patient Link).
Information has been received from an investigator regarding a 2 month old female who received her 1st doses of Prevnar, Hib-Titer, Infanrix, IPV and her 2nd dose of Engerix-B as part of a post-marketing safety study. On 10/21/01, at 3 months of age, the infant died. Autopsy results showed the cause of death to be SIDS. The investigator believed that SIDS (expected per package insert) was not related to study vaccine administration. The medical monitor's assessment of relatedness in unknown. This report of a serious, labeled event is being submitted in a 15-day time frame, as requested by the FDA. Follow-up info received on 03/13/2002 indicated that the medical monitor agreed with the investigator's assessment that the event was not related to vaccine administration. Per F/U 4/1/02 autopsy states: The pt has apparent healed rib fractures on the lateral aspect of left ribs 6,7 and 8 and rib 6 on the lateral right chest. The thymus has occasional petechial hemorrhages on both the anterior and posterior surfaces. Sectioning of the lungs reveals moderate congestion and edema.
Severe pain and itching in vaccinated arm.  Large, round, red, swollen blotch at vaccination site.
Tingling of all fingers 3 days after receiving 1st dose of GARDASIL - no other vaccines given.
Gillian Barre disease; taken a toll mentally and physically and financially; taken a toll mentally; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Gillian Barre disease"; MALAISE (non-serious), outcome "unknown", described as "taken a toll mentally and physically and financially"; MENTAL DISORDER (non-serious), outcome "unknown", described as "taken a toll mentally". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Additional information: Patient stated that It's almost been a year since I received the second COVID shot, and ended up with Gillian Barre disease. I lost my job and hardly get to see my son and basically lost a year of my life. I can't get no help what so ever that's why I decided to reach out to you. Please help me I have all the medical records if you need proof. This the worst thing to have and it has taken a toll mentally and physically and financially. Please help me.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Light headed with in an hour from taking, muscle pain at injection site, same as dose #1.  Around 5:50pm a "pull" in the chest area, went up stairs climbed 1 flight of stairs felt, out of breath (I workout 5-7 days a week, intense cardio and strength training, out of breath at top of stairs is not the norm) as I was taking deep breath audible wheeze, attempted to call hotline not open, attempted to call hospital to inquire about symptoms they also were unavailable.  Logged in to teladoc, scheudled visit spoke with doctor via video explained symptoms, having hard time with deep breathing and continued wheeze, he stated to go to ER as I was having a "delayed allergic reaction" My husband took me to the ER, they triaged me right away with in the next 1-1.5 hr from when symptoms began, my HR increased, my blood pressure increased, difficulty with nasal breathing, continued with shallow breathing. throat began to feel itchy and coughing began with irritation, my voice became hoarse, could barely speak  The ER doctor listened to my breathing and doctor stated by airway was "tight and constricted", IV fluids were ordered, benadryl was given via IV and breathing treatment to help reduce inflammation and open airway.   Responded to treatment and was discharge by 10pm
SORE ARM; ITCHY ARM; FEVER OF 103.7 F; QUEASY; VOMITING; CHILLS; BLACKED OUT AND ASKED WHERE HER CLOTHES WERE FROM AFTER HER DAUGHTER CHANGED HER CLOTHES; SHE COULDNT FOLLOW THE INSTRUCTIONS TO STAND UP/ KNEES BUCKLING; SHE GOT CONFUSED AND LOST HER ABILITY TO WALK AND SIT DOWN; LOST HER ABILITY TO WALK AND SIT DOWN; A spontaneous report was received from a consumer, a 75-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of consciousness, chills, queasy, vomiting, fever of 103.7F, sore and itchy arms, confusion, lost ability to walk and sit down, knees were buckling, blacked out.   The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the events were quetiapine, atorvastatin 10mg, tramadol, hydrocodone/APAP 5/325mg, gabapentin 300mg, Tylenol PM 500mg, Voltaren cream, Miralax.  On 10 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030M20A) intramuscularly in the right deltoid muscle for prophylaxis of COVID-19 infection.   On 11 Feb 2021, next day after exposure to the first dose, the patient experienced, chills, queasy, vomiting, fever of 103.7F which went down to 100F. On 12 Feb 2021 (Friday) the patient had sore and itchy arms and lost the ability to walk and sit down to extend that was carried to the bathroom. The patient got confusion, knees were buckling and even blacked out. Lab exam performed were reported as GRF-21%. Treatment  for the event included Aleve and Nyquil.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, chills, queasy, vomiting, fever of 103.7F, sore and itchy arms, confusion, lost ability to walk and sit down, knees were buckling and black out was considered to be recovered/ resolved.; Reporter's Comments: This case concerns a 75-year-old female who had serious unexpected loss of consciousness, dysstasia, gait disturbance, confusional state and nonserious expected pyrexia, chills, nausea, vomiting, injection site pain, injection site pruritus.  Event onset 3 days after first dose mRNA-1273. Treatment with naproxen. Events resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Information has been received from a consumer concerning his 27 month old son with an ear infection (at the time of vaccination) who on 08 FEB 2001 was vaccinated with MMR vaccine. Concomitant therapy included HIB conjugate vaccine (HIBTITER), Streptococcus pneumoniae vaccine (PREVNAR) and hepatitis B vaccine recombinant (yeast) (manufacturer unknown). On 03 JUN 2002 the patient was diagnosed with autism. It was reported that the child will undergo additional testing. Upon internal review, autism was considered to be an other important medical event. Additional information has been requested.