chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching and burning sensation around the face, ears and arms and continued down the back, legs to the feet; itching and burning sensation around the face, ears and arms and continued down the back, legs to the feet; This is a spontaneous report from a contactable health professional, the patient. A 72-year-old non-pregnant female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL3246), via an unspecified route of administration in the left arm on 20Jan2021 at 11:45 (at the age of 72-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were none.  The patient had no known allergies. The patient was not diagnosed with COVID prior to the vaccination. The patient did not receive any other vaccines within 4 weeks of the vaccination. On 20Jan2021 at 23:30 (the evening after receiving the first dose), the patient experienced an itching and burning sensation around the face, ears and arms and continued down the back, legs to the feet. The patient was treated for the events with 1 tablet of expired diphenhydramine (BENADRYL), one to one and a half hours after which the symptoms started to improve and by 02:00 the patient was able to get some sleep. Since the vaccination, the patient was not tested for COVID. The clinical outcome of "itching and burning sensation around the face, ears and arms and continued down the back, legs to the feet" was resolved on 21Jan2021.
COVID-19; COVID-19; Runny nose; mild fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 26Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 10Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing), notes: ADHD. Concomitant medication(s) included: ADDERALL. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19"; RHINORRHOEA (non-serious) with onset 2022, 9 days 10 hrs after the suspect product(s) administration, outcome "unknown", described as "Runny nose"; PYREXIA (non-serious) with onset 2022, 9 days 10 hrs after the suspect product(s) administration, outcome "unknown", described as "mild fever". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical course of the events: Other medication in 2 weeks: Yes. Other medication details: other medication in 2weeks product-Adderall. other medication in 2weeks product-Hailey Birth Control. No Known allergies. Reaction/event as reported by primary source: Testing positive on at home rapid test on day 10, Runny nose, mild fever. the patient previously received a COVID-19 Vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Nausea; Headache; severe fatigue; Severe chills; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), HEADACHE (Headache), FATIGUE (severe fatigue) and CHILLS (Severe chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.    Co-suspect product included non-company product BISOPROLOL for an unknown indication.    The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), PANTOPRAZOLE and ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started BISOPROLOL (unknown route) at an unspecified dose. On 31-Mar-2021, the patient experienced NAUSEA (Nausea), HEADACHE (Headache), FATIGUE (severe fatigue) and CHILLS (Severe chills). At the time of the report, NAUSEA (Nausea), HEADACHE (Headache), FATIGUE (severe fatigue) and CHILLS (Severe chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a female consumer who was vaccinated on an unspecified date with a "single dose" of zoster vaccine live (Oka/Merck). On 17-OCT-2007, the patient experienced a temperature of 100 degrees after receiving zoster vaccine live (Oka/Merck). It was unspecified if medical attention was sought. The outcome was not reported. No product quality complaint was involved. No further information is available.
Rotarix was inadvertently administered IM; This case was reported by a other health professional via media and described the occurrence of inappropriate route of vaccination in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation (intramuscular) and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the inappropriate route of vaccination 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 details were provided as follows: The age at vaccination was not reported. The patient was inadvertently administered with Rotarix intramuscularly, which led to inappropriate route of vaccination. The reporter wanted to know need to know what to do. The follow up would not be possible as no contact details were available.
Severe pain in  neck and bilateral arms radiating all the way down to hands. Pins and needles feeling in bilateral arms with numbness and tingling.  Feels like Nerve pain unbeliever by Tylenol and motion.  Unable to sleep in either sidelying position  since numbess, tingling and pain develops in corresponding arms and then quickly moves to hands. Unable to make a fist with right hand where vaccine was administered. Fine motor and gross motor strength decrease.
Positive for Covid; loss of smell; lethargic; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive for Covid), ANOSMIA (loss of smell), LETHARGY (lethargic) and FATIGUE (Feeling tired) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B214) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive for Covid), ANOSMIA (loss of smell), LETHARGY (lethargic) and FATIGUE (Feeling tired). On 27-Apr-2021, LETHARGY (lethargic) and FATIGUE (Feeling tired) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (Positive for Covid) and ANOSMIA (loss of smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported No treatment information was reported
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 04-NOV-2015, the patient was vaccinated with improperly stored dose of VARIVAX (Merck) injection (lot# K010437, expiration date 22-JUL-2016, dose, anatomical location and route of administration were not reported). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Red, Swollen, Painful left arm approximately 1 week after injection:  saw practitioner and placed on antibiotics
admission 2/26 underwent combined liver-kidney deceased donor transplant on 02/11/2022, from a COVID positive donor.  She completed a five day course of remdesivir posttransplant with multiple negative SARS-CoV-2 NP PCR tests following transplant.    vaccine administered at hospital
Severe chills with body and bone pain, skin tenderness, fever 102-103.4 F, vomiting 1x, liquid diarrhea 10x or more, eardrum pain, headaches, stiffness in joints, having a hard  time walking, nausea, no appetite, no smell or taste.
This spontaneous case reported by a consumer, describes the occurrence of dizziness (dizzy), pain in extremity (tiresome in the legs), vaccination site pain (soreness on the injection site), fatigue (tired, tiresome in legs) and headache in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 041L20A) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Jan 22, 2021, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jan 22, 2021, patient experienced vaccination site pain (soreness on the injection site). On Jan 28, 2021, patient experienced fatigue (tired, tiresome in legs), headache and pyrexia (running a temperature). On Feb 1, 2021, patient experienced pain in extremity (tiresome in the legs). On Feb 2, 2021, patient experienced dizziness (dizzy). The patient treated with Tylenol (paracetamol) on Jan 28, 2021 for headache and increased body temperature (unspecified dose and frequency). On Jan 23, 2021, vaccination site pain (soreness on the injection site) resolved. On Jan 28, 2021, headache and pyrexia (running a temperature) resolved. At the time of the report, dizziness (dizzy), pain in extremity (tiresome in the legs) and fatigue (tired, tiresome in legs) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 intramuscular: unknown. No concomitant medications reported.
MOC states patient was seated in car and passed out.  Eyes rolled back, face pale, not breathing.  No shaking/seizure.  Episode lasted for 10 seconds.  Then patient alert and felt nauseated.  No vomiting.  Pt urinated self when passed out.  MOC reports this happened 5 min's after vaccine.  Pt returned to clinic.  Pt alert and oriented X 3.  VSS. PE WNL.
After my second dose of the Pfizer vaccine I experienced severe headache, fatigue, disorientation, and a runny nose. My symptoms lasted one week.
Site: Pain at Injection Site-Mild, Systemic: Chills-Mild, Systemic: shaking-Mild, Systemic: Shakiness-Mild
Severe rash on shin of both legs (never get rashes) and on both forearms as well as chest.
Day 7 minor itching at injection site. Day 8 mild to moderate itching with tenderness. Day 9 hot red patch along with itch and tenderness. Day 10 itch less while  redness is bigger and tender. Red patch is really hot it melt the ice fast.
This spontaneous report was received from a health care worker, referring to unspecified number of patients of unknown ages and genders. Medical history or concurrent conditions were not reported. Since on unknown date, the patients received improperly stored dose of (Oka/Merck) VARIVAX (lot # L029466, expiration date 06-AUG-2017, Lot # L035128 expiration date 14-SEP-2017) (strength, dose and route were not provided). Concomitant medication was not provided and no adverse effects were reported. It was also reported that temperature was 6 F, time frame was 10 minutes, there was not a product complaint involved and there was not previous temperature excursion. Additional information has been requested.
Red area below 3 inches below the injection site; Swollen area below 3 inches below the injection site; This case was reported by a consumer via call center representative and described the occurrence of erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2020, the patient received the 2nd dose of Shingrix. On 22nd January 2020, 2 days after receiving Shingrix, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were unknown.   It was unknown if the reporter considered the erythema and swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had deep red swollen area below 3 inches below the injection site.
Extreme fatigue joint pain watery eyes nasal congestion dizziness when I stand up a little difficulty breathing. No fever took a day off from work all I wanted to do was sleep on Friday today
Patient seen in Emergency Room with intermittent chest pain ~ 4pm on 2/11/21 after receiving 2nd vaccine dose ~ 8:30 am that morning.
Rash on both arms: circular and red around the elbows and bumps going down the forearms.  Very itchy and red.  Did not respond to hydrocortisone cream.  Started approximately 3 days after the shot and Went away on it?s own approximately 5 days later.
Sore arm 3/6/21 Bad headache, nausea, chills   3/8/21 Headache, body sore all over, slight fever , worn out.  3/9/21  Slight headache, worn out. 3/10/21
Patient was receiving first dose and as the nurse went to retract the needle some of the vaccine came out of the patients arm. The patient requested to have the full first dose so an additional one was provided. No adverse reactions occurred.
Patient with abnormal movements and unresponsiveness. Observed by ER MD as well. Transferred to tertiary care facility. Work up negative.
This spontaneous report as received from a registered nurse refers to a male patient of unknown age. The reporter stated that a patient was administered with expired ROTATEQ orally (lot H016842 exp date 14-MAR-2014, dose, strength not reported), on 19-MAR-2014, as the second dose of ROTATEQ. First dose of ROTATEQ was administered on 08-JAN-2014. No adverse experience reported. Additional information is not expected.
Information has been received from a healthcare worker concerning a 70 year old female patient who on 24-NOV-2008 was vaccinated intramuscularly with a dose PNEUMOVAX (LOT # 661577/1161X). Concomitant therapy included LIPITOR. On 25-NOV-2008 the patient had a red, swollen, painful injection site after vaccination and the reaction went from the injection site to the elbow. The healthcare worker reported that the patient was given warm soaks and recovered. Additional information has been requested.
Immediate warm flushing sensation lasting a couple seconds/coincident with change in taste to a metallic taste. Lasted only a few seconds.
Reporter indicated 6 recipients of 3 doses of Engerix & did not respond;
pt recvd vax on 15NOV93; On 25NOV93 pt broke out in red, dry, pokadot rash over face, trunk & legs; fever of 99;; had runny watery eyes x 1 day; c/o h/a on 25NOV93;
Information has been received from an unspecified office manager, who worked with a physician assistant, via a company representative, concerning a female patient of 19 years old. The patient's pertinent medical history and concurred conditions were not reported. It was reported that on unspecified dates, around the patient's age of 16 years old, she received unspecified doses of GARDASIL (lot #, dose, route and expiration date were not provided). Concomitant therapies were not reported. On an unknown date, at the patient's age 19 years old, she was diagnosed with "high grade cervical lesion" an unspecified time after receiving GARDASIL. It was also reported that the patient would need "part of her cervix removed due to the high grade cervical lesion", but it was not specified if that was scheduled yet. The outcome of high grade cervical lesion was unknown at the time of the report. There was no product quality complaint (PQC) involved. Additional information has been requested.
Severe cephalgin onset w/in 30 hrs of multiple immunizations. Subsequent hospitalization for negative meningitis w/u
Patient reported having symptoms of nausea Patient provided with Gatorade  Patient seen by medical team Refused medical transport and signed AMA form Patient stated symptoms resolved
Allergic reaction to a previous influenza vaccine; This spontaneous case was received on 14-Oct-2021 from other health professional (nurse) via Communications (reference number: SEQW21-03878) and concerned a female patient of unspecified age.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with Influenza virus vaccine polyvalent (brand name unknown; dose, route of administration and anatomical: not reported) for prevention of seasonal influenza. The batch number was not reported.  On an unspecified date, an unknown amout of time after receiving with Influenza virus vaccine polyvalent, the patient experienced severe allergic reaction to influenza vaccine.  At the time of initial report on 14-Oct-2021, the outcome of the event was not reported.  The reporter assessed the event to be related to Influenza virus vaccine polyvalent.  The case was assessed as non-serious.  Company comment: The event of 'allergy to vaccine' is considered as unassessable to influenza virus vaccine polyvalent.; Sender's Comments: The event of 'allergy to vaccine' is considered as unassessable to influenza virus vaccine polyvalent.
Physician reporting possible late 2nd dose and physician unsure of date of when he received 1st dose of Shingrix. He reports it as "6 months ago".; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 6 months ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Physician reporting possible late 2nd dose and physician unsure of date of when he received 1st dose of Shingrix. He reports it as "6 months ago".). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-JUL-2023 and 19-JUL-2023 The reporter was reporting possible late 2nd dose of Shingrix.  The reporter was unsure of date of when he received 1st dose of Shingrix and he reported that it was 6 months ago. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave consent for safety team follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Pt received DAPTACEL (L) delt and varicella (R) delt cried a little but then calmed walking out with mom and had LOC with ? decorticate posture 10-15 sec. Hit tooth jaw alert/consolable with difficulty.
Within 24 hours of second dose- Fever, dizziness, arm tingling,  headache
muscle discomfort; general inflammation; lymph system is inflamed/swollen; muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE DISCOMFORT (muscle discomfort), INFLAMMATION (general inflammation), LYMPHADENOPATHY (lymph system is inflamed/swollen), MYALGIA (muscle pain) and ARTHRALGIA (Joint pain) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE DISCOMFORT (muscle discomfort), INFLAMMATION (general inflammation), LYMPHADENOPATHY (lymph system is inflamed/swollen), MYALGIA (muscle pain) and ARTHRALGIA (Joint pain). At the time of the report, MUSCLE DISCOMFORT (muscle discomfort), INFLAMMATION (general inflammation), LYMPHADENOPATHY (lymph system is inflamed/swollen), MYALGIA (muscle pain) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Fever, Fatigue, Red painful rash that stretched across the top of the chest from the arm of injection and was hot to the touch.
BLACKED OUT, HOT AND COLD SWEATS FOR 2 DAYS, FLOATING SPOTS IN HER EYES, ALTERED TASTE AND SMELL
tested positive after the first dose; tested positive after the first dose; This is a spontaneous report from contactable consumer (reported for father) via a Pfizer-sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 03Feb2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on an unspecified date, patient father tested positive after the first dose. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date 2021. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Pt. states at 1:00 p.m. on 3/27/2019 she began experiencing soreness and tightness in her throat - she was driving a school bus at the time and did not have her albuterol inhaler so she kept sipping water until she was finished with bus route about 3:30 p.m. She was able to use her albuterol inhaler, which she left in her car, at that time and reports after using her inhaler she felt "somewhat better." At about 5:30 p.m. pt. states she "still was not feeling completely well" and took a BENADRYL LIQUIGEL and shortly after taking the BENADRYL she felt much better. She did not use her albuterol inhaler or take any other doses of BENADRYL after that.
This is a spontaneous report from a non-contactable consumer from a program. A patient of unspecified age and gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 29Jul2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced symptoms of COVID-19 on 07Aug2021 and received two rapid antigen tests and a PCR test to determine presence of COVID-19 infection. Caller stated both rapid tests came back negative, but the PCR test resulted positive on 15Aug2021. The patient outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.