chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tuesday 1/5/21 at 12:30p.m. I recieved the Moderna Covid 19 vaccine EUA in my left arm. I had no reaction at all untill about 3:00a.m. on 1/6/21. I woke up with the chills and a headache. At 8:00a.m. I also experienced in addition to those symptoms, fatique, body aches and diarreha. I also lost my appetite completely. When I had covid in October, I experienced thses very same symptoms. These lasted all day untill around 7:00p.m. and I felt good almost all at once the symptoms seemed to be gone. The next day I was a little fatigued still and still no appetite. Everything became normal on friday 1/8/21.
SEVERE MIGRAINE FOR 2 WEEKS WAS GIVEN TORADOL AND PROMETHAZINE
Information has been received from a physician concerning unspecified patients. The patients' concomitant medications, pertinent medical history, and drug reactions and allergies have not been provided. On unspecified dates, improperly stored doses of ROTATEQ (dose and frequency unknown) (lot # L046318, expired date 28-SEP-2017; Lot# M005732, expired date 19-OCT-2017; M007125, expired date 06-OCT-2017) were administered to the unspecified patients for prophylaxis. No adverse experience has been reported. The ROTATEQ was exposed to 35F for a time frame of 60 hours. No data logger and previous temperature excursion were reported. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA010289: US-009507513-1611USA010129.
I received the injection in my upper left arm and immediately felt it in my upper left wrist. Then after my arm quit being sore after a couple of days, my wrist area continued to be sore and the wrist bone looked swollen. It still looks swollen and it is now 16 days later.  I was given the shot on July 1 and it is now July 17.  During this interim period I also experienced a sore area on my left foot around my arch that started around July 6 or 7th  and then on Sunday, July 14th, my lower back went into a painful spasm. It is still not feeling good although it has improved with rest.  I was totally fine prior to the injection so I'm wondering if there could be a connection to it.  I saw my doctor about my wrist and they said it could be tendinitis but at the time I didn't connect it to the time frame of the injection.
06/23/2022 I was traveling and I started to lose my voice. 06/24/2022 I lost my voice completely  06/27/2022 I started to develop a cough, so I drank hot tea with honey, and it helped along with a hot shower.  06/28/2022 I wasn't feeling great, and I was actually supposed to catch a flight back home but my flight was canceled. 06/29/2022  I started taking the airborne, decongestion (which I only took it once it kept me from sleeping) and couch drops. I was feeling very fatigue. 06/30/2022 I got my flight home, and I took an at home COVID-19 Test and it came up negative. My voice is started to come back, and I still have the cough but only at night.  07/01/2022 I went to the COVID-19 Testing site and I was given another test and a PCR. The Rapid came back negative. I started having a low-grade fever. 07/02/2022 I received my PCR results and, they were positive. I called my PCP and she said it was too late to do the Paxlovid. The doctor also told me to keep doing my home remedies like airborne lots of fluid, tea and rest 07/08/2022 I would say I had recovered, and I was back to myself.
expired dose administered; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered). On 23-Apr-2021, EXPIRED PRODUCT ADMINISTERED (expired dose administered) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow up was received on 01 jun 2021 included no new information.
Patient C/O itching to face and then stated that her throat felt itchy.  Gave EpiPen to Left thigh.  Patient stated that she felt the itching subside and throat felt fine withing 5 minutes.    HR 111 BP 128/80 Ox Sat 100 throughout  No wheezing, SOB, Stridor or visible scratching of face.  Patient released to EMS
Itchy rash on legs (mostly thighs) and trunk (front and back). Probably was hives. Lasted about five days.
The patient was thoroughly informed that there are no studies regarding the benefits and risks of mixing different vaccines from different manufacturers. Though the clinical team and the patient came to an understanding that the patient is in a "high-risk" situation whereas he cannot afford to risk any delay in care due to being a PEH that we had to give the patient a second dose not of moderna but of pfizer
Pt recvd 3 doses of Engerix-B 1NOV90, 27NOV90, & 2MAY91 & 9SEP91 it was determined that pt titer was neg p/3 doses of Engerix-B;
COVID 19 Treatment; COVID 19 Treatment; Dose Number: 4 ; moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 at 12:45 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Mar2021 at 14:45 as dose 1, single (Lot number: EN6207), in left arm, on 02Apr2021 at 15:15 as dose 2, single (Lot number: FW0150), in left arm and on 08Oct2021 at 15:15 as dose 3 (booster), single (Lot number: 30155BA), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Apr2022 at 13:00 as dose 4 (booster), single (Lot number: 002M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Apr2022 at 13:00, outcome "unknown", described as "Dose Number: 4 ; moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Feb2023) Positive, notes: COVID 19 Treatment; (19Feb2023) Negative, notes: I took an at-home covid test and was negative; (23Feb2023) Positive, notes: Four (4) days later I tested positive again for covid,. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
patient had a rash on chest and face the next day after vaccination. Also reported a very bad head ache
Itchy at times; a red rash; I have a rash almost in my whole arm; I felt like I had the flu all day; achy; arm was very tender; arm was very swollen; I feel like there is something in there; Lot of phlegm in my throat; feverish; I was really tired; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (I felt like I had the flu all day), PAIN (achy), TENDERNESS (arm was very tender), PERIPHERAL SWELLING (arm was very swollen) and FEELING ABNORMAL (I feel like there is something in there) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced FATIGUE (I was really tired) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 31-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (I felt like I had the flu all day), PAIN (achy), TENDERNESS (arm was very tender), PERIPHERAL SWELLING (arm was very swollen), FEELING ABNORMAL (I feel like there is something in there), OROPHARYNGEAL DISCOMFORT (Lot of phlegm in my throat), RASH (I have a rash almost in my whole arm) and PYREXIA (feverish). On an unknown date, the patient experienced PRURITUS (Itchy at times) and RASH ERYTHEMATOUS (a red rash). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 28-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (I felt like I had the flu all day), PAIN (achy), TENDERNESS (arm was very tender), PERIPHERAL SWELLING (arm was very swollen), FEELING ABNORMAL (I feel like there is something in there), OROPHARYNGEAL DISCOMFORT (Lot of phlegm in my throat), RASH (I have a rash almost in my whole arm), PYREXIA (feverish), FATIGUE (I was really tired), PRURITUS (Itchy at times) and RASH ERYTHEMATOUS (a red rash) outcome was unknown.            The concomitant medication include Cholesterol pill 20 mg. The other treatment medication was Anti itch cream to stop the rash on leg and arm.   This case was linked to MOD-2021-019620 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jun-2021: Follow up information was received: Itching and red rash were added
High fever 103.4, vomiting, excessive crying. Treatment included alternating Tylenol and ibuprofen, lukewarm baths, plenty of fluids (breastmilk). Lasted 2 days. Full recovery to old self was a week.
Pfizer short-dated this lot number and we were unaware of this and administed an expired vaccine. No reaction reported from pt.
pt recvd vax; 7 hrs later, exp migraine & chills,were tx w/ biaxin and apap; resolved 3-4 days
Kinrix administered to a 4 months-old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number PX27D, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd November 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 2nd November 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-NOV-2022 Reporter's Comments: The reporter reported that the patient inadvertently received a dose of Kinrix at the age of 4 months.  The reporter consented to follow up. Additional Supportive information: The patient received a dose of Kinrix at the age of 4 months, which led to inappropriate age at vaccine administration.
Injection site was painful (more than with my typical flu shot) after 2nd COVID injfection on 2/4 (Thursday). The arm continued to be sore.  On Saturday 2/6 after removing Bandaid I noticed a large red/warm area that was painful to the touch but not indurated.  I outlined the area. Took NSAID and antihistamine PO daily, ice PRN. Today 2/9 the redness continues to increased in size.  It is sore, red and feels itchy. Today the area measures 6 inches x 4 inches.  I have communicated with my PCP via medical message.  If the area continues to increase in size I will make an appointmen in the next 1-2 days due to concerns about developing cellulitis.
About 2 weeks after the vaccine I developed SOB and went to the Urgent Care where I received an irregular EKG so I was transported to the ER and was admitted into the hospital for 3 days.  On 5/1 I developed severe chest pains again so I went so I went to another Hospital and was informed that my D-Dimer was elevated  and was transferred to a different hospital where I was monitored for 24hrs and was released.  I visited the Cardiologist who performed a Stress test which was abnormal so I have another Stress Echo tomorrow but I have never had any heart issues in the past.
This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE VIA BREAST MILK (Breast feeding mother took first dose of Moderna vaccine) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced EXPOSURE VIA BREAST MILK (Breast feeding mother took first dose of Moderna vaccine). On 09-Apr-2021, EXPOSURE VIA BREAST MILK (Breast feeding mother took first dose of Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Prenatal vitamins are used as concomitant medications but not specifically mentioned the vitamins.  No treatment medications included.  Additional information: She gave birth to her baby girl on 20Mar2021 following invitro fertilization (IVF) due to one year of infertility. She is currently breast feeding. This is her first pregnancy. Pregnancy was via spontaneous vagina delivery. She has no AE from the vaccine so far.; Sender's Comments: This is a case of product exposure during breastfeeding with no associated AEs. Patient will continue to be contacted for further monitoring of AEs.
Hives at the injection site 2-2.5 hours later extremely itchy and bumpy, self limited to the upper arm, resolved 3 hours later only intervention was ice as uncertain if Benadryl or steroids would have blunted an immune response
Sore arm; stomach cramps; daily diarrhea still 4 months later; This is a spontaneous report from a contactable other health care professional (patient). A 59-year-old nonpregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was unknown) via an unspecified route of administration, administered in Arm Left on 02Apr2021 14:00 (age at vaccination 59-year-old) as single dose for COVID-19 immunisation. Medical history included High blood pressure, degenerative erasure disc disease, arthritis. Patient had no covid prior vaccination. Concomitant medication(s) included lisinopril, pravastatin, hydrocodone all taken for an unspecified indication, start and stop date were not reported. Patient did not receive any prior vaccination in four weeks. Patient had known allergies to penicillin. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown) via an unspecified route of administration, administered in Arm Left on 13Mar2021, 12:00 PM (age at vaccination 59-year-old) as single dose for COVID-19 immunisation. On 09Apr2021 12:00, the patient experienced sore arm, stomach cramps and daily diarrhea still 4 months. AE resulted in physician office visit. The patient received treatment for the events with medication (unspecified). Patient tested covid post vaccination. The patient underwent lab tests and procedures which included rapid test (nasal swab) negative on 05May2021. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
43 Y female with chief complaint of ALLERGIC REACTION (pt had covid vaccine shot around 1430, pt started feeling like her throat was closing up and urticaria in torso.  pt was given epinephrine 0.15mg IM on scene and benadryl 50mg IV by EMS upon arrival.  symptoms greatly improved upon arrival to ED.)
Fatigue, fever starting 06FEB2021; cough, sore throat starting 09FEB2021; nasal congestion starting 10FEB2021; exposure to positive patient on 07FEB2021. Symptom duration through Tuesday 16FEB2021.
Date of first vaccination: First dose: 2 April 2021 Second dose: 22 'June' 2021; Date of first vaccination: First dose: 2 April 2021 Second dose: 22 'June' 2021; Muscle ache; Joint pain; Extreme cold like fever; Extreme cold like fever; This is a spontaneous report from a contactable consumer reporting for himself. A 20-years-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration on 22Jun2021 as single dose (at age of 20-years old) for covid-19 immunization which was administered outside of the range 19 - 42 days after the first dose. The patient previously took first dose of BNT162B2 (solution for injection, Batch/Lot number and expiration date were not reported), via an unspecified route of administration on 02Apr2021 for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, after getting the second dose on 22Jun2021 (yesterday), he experienced a side effect like muscle ache, joint pain and extreme cold like fever on unspecified date in Jun2021. Consumer added, he was just trying to figure out symptoms were that he was experiencing if he needed to go to the ER or not. The outcome of all events was unknown.  Information regarding the lot/batch number has been requested.
Fatigue; in bed for 3 days; This non-serious case was reported by a physician and described the occurrence of fatigue in a elderly male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fatigue (Verbatim: Fatigue) and bedridden (Verbatim: in bed for 3 days). The outcome of the fatigue was not reported and the outcome of the bedridden was resolved (duration 3 days).   The reporter considered the fatigue to be related to Shingles vaccine. It was unknown if the reporter considered the bedridden to be related to Shingles vaccine.     The company considered the fatigue to be related to Shingles vaccine. It was unknown if the company considered the bedridden to be related to Shingles vaccine.   Additional Information: GSK receipt date: 28-APR-2023 The patient self-reported this case, during program on shingles The reporter did not consent to follow up.
Chills, Fever, Sweats, Fatigue, HA, Body Aches. Narrative:  Other Relevant History:
just left with covid. By Jan 29th we both had covid; Itching and rash are gone now; Itching and rash are gone now; Covid cough; This case was reported by a consumer and described the occurrence of covid-19 in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 27th January 2023, the patient received Shingles vaccine. In January 2023, less than a week after receiving Shingles vaccine, the patient experienced cough. On 28th January 2023, the patient experienced covid-19, pruritus and rash. The patient was treated with codeine + promethazine (Promethazine-Codeine) and nirmatrelvir + ritonavir (Paxlovid). On an unknown date, the outcome of the covid-19 was not recovered/not resolved and the outcome of the pruritus and rash were recovered/resolved and the outcome of the cough was unknown.   It was unknown if the reporter considered the covid-19, pruritus, cough and rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 05-FEB-2023 Reporter's comments: This report was submitted and was submitted by public reporting reference via the online direct entry reporting system. The reporter reported that his wife and he took the new Shingles vaccine and from 28th January 2023 to the date for by January 29th both had covid, plus had rash and itching on back and trunk. The patient received other products paxlovid and promethazine-codeine syrup. The itching and rash were gone at the time of reporting and was just left with Covid. The reporter had consented to follow-up. Additional supportive information: This case was linked with US2023017485 which was reported by same reporter. Note: The cough was coded as event based on drug indication as after vaccination patient had covid cough for which received treatment.  Onset date for Covid kept as 28th January 2023 as reported from 28th but by 29th both had means we are not sure who experienced 1st. One day after receiving Shingles vaccine, the patient experienced covid-19, pruritus and rash.; Sender's Comments:  US-GSK-US2023017485:Same reporter
Pt was given the vaccines above on 9/12/23. The mother reports patient woke up this morning and noticed that his left thigh was swollen and hot to the touch around the vaccination site. She called the Clinic to make an appointment for evaluation. Pt. was seen by Dr. and given a prescription for antibiotics. The mother is to contact Dr. if symptoms do not resolve after the course of antibiotics.
1 day after vaccine, chills, body aches, headache. 2 days later was feeling better but noticed lots of hair loss during shower. Noticed lots of hair on pillow, concerned with handfuls of hair loss.
SHE DEVELOPED HIVES AND UTICARIA ON UPPER AND LOWER EXTREMETIES
vomited clear stuff; after 1.5hrs vomited clear stuff; This non-serious case was reported by a physician via sales rep and described the occurrence of vomiting in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation. On an unknown date, 1 hr 30 min after receiving Rotarix lyophilized formulation, the patient experienced vomiting (Verbatim: vomited clear stuff) and accidental underdose (Verbatim: after 1.5hrs vomited clear stuff). The outcome of the vomiting and accidental underdose were unknown.   It was unknown if the reporter considered the vomiting to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.     It was unknown if the company considered the vomiting to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 25-JUL-2023 The reporter reported that the Patient went home, took a nap, after 1.5hrs vomited clear stuff. The reporter wanted to know if the patient need another Rotarix dose. The reporter consented to follow up. The patient vomited clear stuff after vaccination which led to accidental underdose.
PATIENT WAS BEING GIVEN HER 2ND DOSE OF MODERNA COVID-19 AND WHILE ADMINISTRATOR WAS PUSHING IN PLUNGER THE SYRINGE AND NEEDLE SEPARATED.  THE NEEDLE STAYED IN PATIENT'S ARM AND SOME OF THE VACCINE FLEW INTO THE ADMINISTRATOR'S FACE AND SOME DRIPPED DOWN THE ARM.  ADMNISTRATOR WASN'T SURE HOW MUCH VACCINE WENT INTO THE PATIENT'S ARM BUT SOME OF IT DID.  PATIENT WASN'T HURT AND NEITHER WAS ADMINISTRATOR.  PATIENT IS COMING IN TO GET A SECOND VACCINE.