chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough infection with COVID-19 /Tested positive for COVID-19 infection; Breakthrough infection with COVID-19 /Tested positive for COVID-19 infection; This is a spontaneous report from a contactable consumer (Pfizer employee). An adult male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EP7534, Expiry date was not reported), via intramuscular route of administration on 15Mar2021 as dose 1, single for COVID-19 immunization and patient received dose 2 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8734, Expiry date was not reported), via intramuscular route of administration on 06Apr2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. It was unknown that, the patient received any other medications within 2 weeks. It was unknown that, the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 22Aug2021, the patient experienced breakthrough infection with covid-19 /tested positive for covid-19 infection. Symptoms started around 22Aug2021. Suffered watery eyes, congestion, tiredness, chills and headache. Tested positive for COVID-19 infection shortly thereafter. Started having breathing issue and nighttime cough around 28Aug2021. Slowly improving since that time. The Patient visited physician's office and patient did not received treatment. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 22Aug2021. The outcome for the events was recovering.  Follow-up attempts are completed. No further information is expected.
4-5 days p/vax pt w/low fever day 6 26MAR; fever 102.2 diffuse fiery rash all over given DPH; given Atarax for itch;
Fever (100.7), chills, rigors, diffuse skin tenderness, diffuse joint pain (particularly knees, hands, feet), headache,
p/vax pt exp pain in back of head on lt side;pt stated it was not a typical h/a;2days later pt devel lt sided facial pain like a toothache or sinus ache;dentist took X-rays-nl;5/4-1st day w/o pain;pain returned 5/5 not severe;tx:tylenol;
Pt. states that after receiving the 2nd dose of Moderna 08/31/2021, started experiencing symptoms 09/02/2021 of Hives, rash, burning sensation inside the body, chest burning, back pain, sore throat, shortness of breath, heart palpations.  Urgent Care visit 09/02/2021, A-Fib. Treated with Benadryl, Potassium Low. Recommendation follow-up with Cardiologist.
Pt. reported developed softball size red raised area/hot to touch at site of injection.  Stated noticed a red 4 inch line from site of infection running down her arm. Stated is improved at present.
Patient complained her arm felt numb around 10-15 minutes after I gave her the shot. She felt fine otherwise.
After both COVID-19 vaccines (7/27/2022 and 8/17/2022 - same lot#), 3 days later had a few hours of repeated vomiting. OK before and afterward.
Pt was waiting her 15 minutes post vaccine administration when pt began to feel hot & flushed, have difficulty swallowing ( constant need to clear throat), dry mouth, numbness & tingling in feet & legs. 2mL of dexamethasone 4mg/mL given IM to left deltoid by FNP. Epinephrine 0.3mg/0.3mL given IM to right upper thigh by FNP. Pt placed on 2LPM O2 via NC for comfort. Pt tolerated well. Pt recovered & left our clinic at 1635.
Cont crying, unable to be consoled for approx 7 hrs and very restless afterwards when sleeping, child OK today. Mom called MD and was told to given DPH, she did not give it.
currently has Covid; currently has Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): US-PFIZER INC-202200055821 (Pfizer).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single 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 Jan2022, outcome "unknown" and all described as "currently has Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
injection bleeding; withdrawing needle plunger was not done; This case was reported by a nurse via interactive digital media and described the occurrence of injection site hemorrhage in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th June 2022, the patient received Shingrix. On 26th June 2022, immediately after receiving Shingrix, the patient experienced injection site hemorrhage and wrong technique in drug usage process. On an unknown date, the outcome of the injection site hemorrhage and wrong technique in drug usage process were unknown.   It was unknown if the reporter considered the injection site hemorrhage to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comments: This case was received from nurse via interactive digital media. On Sunday the patient had a Shingrix vaccine. The reporter stated that at nursing class that when you put an injection and you need to check for blood by withdrawing the needle plunger this was not done and there was bleeding which indicated to her/him. The follow-up would not possible as no contact details were available.
Information has been received from a Licensed Practical Nurse (L.P.N) concerning a "7 month old" male patient who "when was 2 months old" was vaccinated with the first 2 mL dose of ROTATEQ (Lot # 662951/1432X) by oral route.  It was reported that he received the second 2 mL dose of ROTATEQ at four months of age.  It was reported by the patient's parents that "3 weeks prior to 18-MAY-2009" (approximately on 27-APR-2009), the patient had been having symptoms of rotavirus.  The vaccine was not reintroduced.  The patient sought medical attention with a visit to the physician's office on 18-MAY-2009.  A rotavirus test was performed, and the patient was diagnosed positive for rotavirus.  It was reported that on an unspecified date the patient had recovered.  Additional information has been requested.
This spontaneous report as received from a nurse refers to an unspecified number of patients. Demographic information was not provided. The nurse reported that an unspecified number of patients were "probably" administered an improperly stored dose of M-M-R II (lot number not provided). Dose, dose strength and therapy dates were not provided. The minimum temperature the M-M-R II was exposed to was 31 degrees Fahrenheit for an unspecified number of hours and the maximum temperature the M-M-R II was exposed to was 55 degrees Fahrenheit for an unspecified number of hours. No adverse effect was reported. This is one of multiple reports from the same source. Other case IDs 1307USA012447 and 1307USA013319. Additional information has been requested.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. On 03-MAY-2012, the patient was vaccinated with the first dose of GARDASIL (route and lot # not reported), on 18-FEB-2014, the patient was vaccinated with the second dose of GARDASIL (route and lot # not reported) and on 14-APR-2014, the patient received the third dose of GARDASIL (route and lot # not reported). No adverse effect was reported. Additional information has been requested.
The patient received the bivalent booster on 11/9/22 and was accidentally given another bivalent booster on 11/30. No reaction as of now but wanted to report.
Patient presents for rash to left arm. Pt describes as itchy and red. Associated symptoms included: erythema and pruritus. Had PCV 13 vaccine 7/26/18, noticed on Saturday 7/28/18 arm rash, had fever day 1 and 2, took TYLENOL with fever relief. No fever today. Pt marked rash, improving. Tx: rec cool compress, elevation of arm, Rx: KEFLEX.
I returned home from overseas on 12/2/1999 and post vax, my legs got worse with an itchy rash and my hands started breaking out with water blisters. They would dry out and crack severely. Doctors prescribed steroid ointments and moisturizers.
hive behind her ear; itchy behind the left ear; big welt the size of an egg at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hive behind her ear), PRURITUS (itchy behind the left ear) and INJECTION SITE URTICARIA (big welt the size of an egg at the injection site) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included unspecified cholesterol medication and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced INJECTION SITE URTICARIA (big welt the size of an egg at the injection site). On 07-Mar-2021, the patient experienced URTICARIA (hive behind her ear) and PRURITUS (itchy behind the left ear). On 31-Mar-2021, URTICARIA (hive behind her ear) and PRURITUS (itchy behind the left ear) had resolved. At the time of the report, INJECTION SITE URTICARIA (big welt the size of an egg at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
A rash which was itchy, red and swollen at the site of injection; A rash which was itchy, red and swollen at the site of injection; A rash which was itchy, red and swollen at the site of injection; Hand was sore for a couple of days; ITCHING; A rash which was itchy, red and swollen at the site of injection; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Hand was sore for a couple of days), PRURITUS (ITCHING), VACCINATION SITE PRURITUS (A rash which was itchy, red and swollen at the site of injection), VACCINATION SITE RASH (A rash which was itchy, red and swollen at the site of injection) and the first episode of VACCINATION SITE SWELLING (A rash which was itchy, red and swollen at the site of injection) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history provided). Concomitant products included FISH OIL and VITAMINS NOS.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Hand was sore for a couple of days) and PRURITUS (ITCHING). On 15-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (A rash which was itchy, red and swollen at the site of injection), the first episode of VACCINATION SITE SWELLING (A rash which was itchy, red and swollen at the site of injection) and the second episode of VACCINATION SITE SWELLING (A rash which was itchy, red and swollen at the site of injection). On an unknown date, the patient experienced VACCINATION SITE RASH (A rash which was itchy, red and swollen at the site of injection). At the time of the report, PAIN IN EXTREMITY (Hand was sore for a couple of days), PRURITUS (ITCHING), VACCINATION SITE PRURITUS (A rash which was itchy, red and swollen at the site of injection), VACCINATION SITE RASH (A rash which was itchy, red and swollen at the site of injection) and the last episode of VACCINATION SITE SWELLING (A rash which was itchy, red and swollen at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment were provided
Skin eruptions that are extremely itchy.  They have been erupting for about 3 weeks now, all over my body, arms, legs, hands, eyelids, back, chest and feet.
received only diluent / The Conjugate was administered a week ago / administered only the liquid component; received only diluent / The Conjugate was administered a week ago / administered only the liquid component; This case was reported by a consumer via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA602A, expiry date 31st August 2022) for prophylaxis.   On 15th November 2021, the patient received the 1st dose of Menveo. On 15th November 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The primary reporter was the father of the patient. The patient received Menveo in the left arm. The reporter stated that, the patient was administered only the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with case US2021253723, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021253723:same reporter
Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 102 doses from LOT 026C21A. Expiration date was reported as 24-Oct-2021.The vial did not undergo any temperature excursions.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received included non significant information.
Information has been received from a health professional concerning a 26 month old female, with no medical history and no allergies, who on 14-JUN-2005 was vaccinated with 0.5 ml subcutaneous dose of Varivax (Lot# 648948/0895P). There was no concomitant medications. On 26-AUG-2006 the patient experienced a scattered rash her body with between 50-249 maculopapular lesions, with yellow vesicles with erythema. The patient was itchy and had no fever. The patient was seen in the office on 28-AUG-2006 and was diagnosed with breakthrough varicella. The patient was treated with AVEENO BATH, calamine lotion and BENADRYL. The patient's mother called the physician's office on 31-AUG-2006 and stated that the child was doing better, and that most of the rash was scabbed over with less itching. At the time of the report the patient was recovering. No product quality complaint was involved. No other information was provided. Additional information has been requested. 05/16/2008 Follow-up information was received by the health professional indicating that the child was vaccinated with a 0.5 ml subcutaneous dose of VARIVAX (Oka/Merck) in the left thigh. On 06-AUG-2007, (previously reported as 26-Aug-2007) rash developed on arm, 20-30 1 cm red papules, some vesicular. Patient was afebrile. Treated symptoms with "BENADRYL" for itching and oatmeal baths. No further information expected.
A patient recieved third dose of vaccine late, no AE; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-healthcare professional and transmitted to Sanofi on 02-Mar-2021.  This case involves a 22-year-old male patient who late received the third dose of RABIES (HDC) VACCINE [IMOVAX RABIES] (batch number and expiry date not reported) via an unknown route in an unknown administration site for unknown indication on 18-Feb-2021 (inappropriate schedule of product administration) due to COVID (coronavirus disease of 2019).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 21-Dec-2020, the patient received first dose of the suspect RABIES (HDC) VACCINE (lot R1D11 and expiry date 23-May-2021) and On 29-Dec-2020 he also received second dose of the same vaccine (batch number and expiry date not reported) via an unknown route in an unknown administration site for unknown indication.  This was a case of actual medication error case due to drug dose administration interval too long (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Hives or urticaria. I have never had this level of scratching before. I can also "skin write" on my skin and it results in marks where it was scratched. I never had this before and it started about 2 weeks after the Moderna booster shot.
Starting 01/29/2022, I had scratchy throat, stuffy nose, some coughing, headache, muscle aches, low grade fever and fatigue. I did not lose my sense of taste or smell but food did not interest me for bout 5 days. It just felt like a bad cold. I saw my doctor and followed up at an urgent care was diagnosed with flue and COVID at the same time. I was prescribed Tamiflu. After the 5 days I was feeling better. About a week after my COVID test I got an ear infection as well. But, I have had ear infections my whole life.
my flu-like symptoms; patient  experienced abdominal pain for 1 hour; experienced abdominal pain for about 1 hour. Like gas x 25; 1 day after, it felt like a whooping cough; This spontaneous case was reported by a patient and describes the occurrence of PERTUSSIS (1 day after, it felt like a whooping cough) in a 54-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Nov-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced PERTUSSIS (1 day after, it felt like a whooping cough) (seriousness criterion medically significant). On 23-Nov-2022, the patient experienced FLATULENCE (experienced abdominal pain for about 1 hour. Like gas x 25) and ABDOMINAL PAIN (patient  experienced abdominal pain for 1 hour). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (my flu-like symptoms). On 23-Nov-2022, ABDOMINAL PAIN (patient  experienced abdominal pain for 1 hour) had resolved. At the time of the report, PERTUSSIS (1 day after, it felt like a whooping cough), FLATULENCE (experienced abdominal pain for about 1 hour. Like gas x 25) and INFLUENZA LIKE ILLNESS (my flu-like symptoms) outcome was unknown.            No relevant concomitant medications were reported.  Patient had taken a vaccine on 01 Mar 2021 with batch number 001A21A. Patient got a booster that has made patient sick and had gotten the first 2 shots and the first booster without issue. Patient never lost sense of smell and had no fever.  No treatment medication reported.  Company comment: This spontaneous case concerns a 54 years old unspecified gender, with no medical history, who experienced unexpected serious (medically significant) event of Pertussis, which occurred one day after booster dose of mRNA-1273 bivalent BA.4/ BA.5 vaccine. One day after vaccination patient felt like a whooping cough, patient experienced abdominal pain for about 1 hour, like gas, patient took Mucinex for flu like symptoms. At the time of reporting event is unknown. The benefit-risk relationship of mRNA-1273 bivalent BA.4/ BA.5 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 54 years old unspecified gender, with no medical history, who experienced unexpected serious (medically significant) event of Pertussis, which occurred one day after booster dose of mRNA-1273 bivalent BA.4/ BA.5 vaccine. One day after vaccination patient felt like a whooping cough, patient experienced abdominal pain for about 1 hour, like gas, patient took Mucinex for flu like symptoms. At the time of reporting event is unknown. The benefit-risk relationship of mRNA-1273 bivalent BA.4/ BA.5 vaccine is not affected by this report.
Moderna vaccine was administered to a 17 year old patient, when it is not approved to be used in patients under the age of 18 years old at this time.