chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Pertinent medical histories, current condition, reactions and allergies were not reported. On 11-AUG-2016, the patient was vaccinated with ZOSTAVAX 19400 PFU (dosage regimen were not reported) (lot # M014310, Expiry date: 26-MAY-2017) subcutaneous, but the "hub of the needle came loose and the ZOSTAVAX 19400 PFU leaked out and ran down the patient's arm". Pharmacist reports that the patient experienced no adverse effects (no adverse event), from the topical exposure from ZOSTAVAX 19400 PFU. Pharmacist reported that "because the first dose was less than the recommended 0.65 ML, the pharmacist administered another 0.65 ML dose of ZOSTAVAX 19400 PFU" (same lot/expiry date and the previous dose). No adverse effects reported. No additional information was provided. No Product quality complaint (PQC) was involved. Additional information has been requested.
swelling, redness, heat and inching at injection site.  EXTREME  pain in joints in neck on right side and upper back near left scapula.
having a reaction; very itching; severe rash all over his body; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE REACTION (having a reaction), RASH (severe rash all over his body) and PRURITUS (very itching) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced RASH (severe rash all over his body). On an unknown date, the patient experienced VACCINATION SITE REACTION (having a reaction) and PRURITUS (very itching). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (having a reaction), RASH (severe rash all over his body) and PRURITUS (very itching) outcome was unknown.        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.   No concomitant medications were reported. Treatment: Dermatology gave him multiple medication but not helping. Wife mentioned his is under prednisone and topical steroids.
DR RED ERYTHEMATOUS AREA RAISED ABOUT 3" LARGER AREA SURROUNDING RED AND WARM
Fever at 103.9 and 101.5; About 12 hours later I experienced rigor chills; Body aches; Unable to sleep; This is a spontaneous report from a contactable Other Health Professional (patient) reported for herself that, A 35-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL 3248, Expiration date: unknown), via an intramuscular route of administration in Right arm on 03Feb2021 10:30 AM at Unknown dose, single for covid-19 immunisation. patient received other vaccine product Immunotherapy on 03Feb2021 in right arm SQ, and other vaccine product Immunotherapy on 03Feb2021 in left arm SQ. The patient medical history included asthma and allergies. Patient's concomitant medications was not reported. No Allergies to medications, food, or other products was reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since vaccination, patient had not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered at Hospital. Patient reported that on 03Feb2021 about 12 hours later (after the vaccination) she experienced rigor chills and the start of body aches. Stated she was unable to sleep, and her temperature was 103.9 at 2am and 101.5 at 830am. Patient did not receive any treatment for the adverse event. The outcome of events was unknown.   Follow-up attempts are completed. No further information is expected.
Vertigo ongoing specifically when moving head left or right or up or down or changing from standing to seated or seated to standing or while laying down.
Rash all over face after vaccination on 9/01/2021.  On  9/07/2021, peeling like sunburn.
Received Saturday late morning. Sunday 3:30 a.m., woke up unable to move right arm and in pain. Somewhat better as the day went on. Sunday 5 p.m. experiences chills and teeth chattering. Monday 7 a.m. woke up with swollen lymph node on right side.
Client stated he felt "light headed" approx. 10 min after immunizations. Client placed in supine position with legs elevated while vitals obtained - vitals WNL; client given H2O and stated "I feel much better." Client and client's mother advised to seek medical attention for further s/s - both were negative.
headache; Fatigue; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (Fatigue) and INJECTION SITE PAIN (Pain at the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concurrent medical conditions included Hypertension (It is reported that the patient is taking blood pressure medications regularly.) and Hyperlipidemia (it is reported that the patient is on cholesterol medications.).    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced HEADACHE (headache), FATIGUE (Fatigue) and INJECTION SITE PAIN (Pain at the injection site). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] (oral) on 24-Jan-2021 for Pain relief, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), FATIGUE (Fatigue) and INJECTION SITE PAIN (Pain at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Pt. rec'd routine vaccines 06-12-17 at WCE. Diarrhea began that evening after approximately 8-10 stools (Loose)/day continued. Afebrile. Cough and green nasal drainage at OV 6-22-17. (WT 6/22). Also seen 6/16/17 for diaper rash. Supportive Tx.
About 2 weeks after receipt of influenza vaccine in Dec 05, 8 YO male developed mildly pruritic Eczematoid lesions on extremities and trunk similar to reaction in 2004, looking back mother noted that previous reaction was about 3/4 weeks following his last flu vaccine, and lasted about 1 year. See comments for description of previous reaction.
Erythema, warmth and mild swelling around injection site about 21 cm x 17 cm.
Persistent fever of 101 F and above despite fever reducing medications; Chest pain; Palpitations; Muscle pain; Bone pains; Headache; Nausea; Lack of appetite; Dizziness and feeling faint; Chills; Malaise; This is a spontaneous report from a non-contactable nurse, the patient. A 30-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Aug2021(at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, diagnosed prior to the vaccination. The patient had no known allergies. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. On 27Aug2021 at 00:00, the patient experienced persistent fever with a body temperature of 101 F and above despite fever reducing medications. On 27Aug2021 at 00:00, the patient experienced chest pain, palpitations, muscle and bone pains, headache, nausea, lack of appetite, dizziness, feeling faint, chills and malaise. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event fever which included treatment with unspecified medications. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events persistent fever, chest pain, palpitations, muscle and bone pains, headache, nausea, lack of appetite, dizziness, feeling faint, chills and malaise were recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Generally feeling sick, possible light fever, headache, sore ears, sore teeth, very sore upper arm.
Approximately 15 hours after vaccine had arm soreness and general fatigue.  By that evening, experienced extreme pain in shoulder and armpit with swelling in armpit.  Sunday morning or approximately 36 hours post vaccine, experienced a burning rash on the torso, back, neck and head along with body aches.
This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. The nurse informed that on 18-JAN-2018, the patient was vaccinated with the first dose of VARIVAX injection, subcutaneously, 0.5 ml once, for prophylaxis, lot #N022856 and expiration date 23-AUG-2018, which was reconstituted with sterile diluent (MERCK) (strength, dose, lot number and expiration date were not reported). It was reported that some of the vaccine was not injected, but discharged onto the patient's arm, resulting on a dose that may have been too small. No adverse effects were reported.
Started screaming approx 3-4 hrs /p immun-slept 10 min & started screaming again-No fever, no erythema leg-Cont /w this until 22Feb91 took to MD-> rxn to DTP gave sedation X 1 1/2 days-then OK
Narrative: Reporting medication error due to EUA requirements, Patient  received an extra COVID 19 bivalent booster dose since he reported having lost his vaccine card and had recalled haven gotten the dose. After the vaccine was administered, the patient later found his old vaccine card which showed he  already got a bivalent booster dose.
hives on trunk; Itching everywhere; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of URTICARIA (hives on trunk) and PRURITUS (Itching everywhere) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension (Mild Hypertension) since 2015, Anxiety (Mild Anxiety) since 2015, Arthritis since 2000 and Drug allergy (Sulfa drugs). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, DICLOFENAC for Arthritis, ROSUVASTATIN CALCIUM (CRESTOR) for Blood cholesterol, AMLODIPINE and HYDROCHLOORTHIAZIDE for Hypertension, VITAMIN D3 and BIOTIN for an unknown indication.    On 03-Feb-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced URTICARIA (hives on trunk) and PRURITUS (Itching everywhere). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. On 17-Feb-2021, URTICARIA (hives on trunk) and PRURITUS (Itching everywhere) had resolved.        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.   This case was linked to MOD-2021-072157 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 04-Apr-2021: Follow up received on 04-Feb-2021 included patient's height and weight, other medical history and event start date and stop dates.; Reporter's Comments: Based on reporter's causality and onset of urticaria 2 weeks after the dose the event is assessed as unlikely related to mRNA-1273.
Headache Left axillary painful lympadenopathy Fatigue Right lower quadrant abdominal pain
Information has been received from a healthcare worker (also reported as a nurse) and physician concerning a 25 year old female patient who received second dose of GARDASIL and was found to have genital warts. The patient has stated to the physician that she was not sexually active. Follow up information received on 31-Dec-2008 from the Healthcare worker who reported the patient received her first dose of GARDASIL (lot# 660398/1968U) on 30-Oct-2008 and the second dose of GARDASIL (lot#660389/1968U) on 29-Dec-2008. At the time on the report on 31 Dec-2008 the patient was not recovered The patient sought medical attention was seen in the office. Additional information has been requested. This is in follow-up to report(s) previously submitted on 1/16/2009. Additional information has been received from a physician concerning a patient with irritable bowel syndrome who on 30-OCT-2008 patient received first dose of GARDASIL (lot # 660389/1968U) intramuscularly left gluteus maximum in the morning. On 29-DEC-2008 she received second dose of GARDASIL (lot # 660389/1968U) intramuscularly left gluteus maximus in the morning. On 30-DEC-2008 patient was diagnosed developed genital warts. It was reported that the patient developed 2 lesion on outer genitalia. On 31-DEC-2008, the patient was seen in the physician's office and was treated with ALDANA cream but the lesions have not resolved.
Headache, Myalgia, Arthralgia, Fever, joint injection redness, swelling and pain. chills and fatigue Narrative:
pt recvd vax; devel rash on chest, hands, arms; devel sore throat & T of 99;
11/15/10 MD to discuss back pain, weak legs, pain down both legs. Pt has 30 yr history of back injury, did well until about 1/8/2011. He had L1 - 2 laminectomy on 11/23/2010 - weakness progressed rapidly. Diagnosed with Guillain-Barre Syndrome by hospital.
I felt worn out for about 12-15 hrs/I felt fatigued for about 12-15 hrs.; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (I felt worn out for about 12-15 hrs/I felt fatigued for about 12-15 hrs.) in an 82-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1, Lot number: EL3247. .) on 28-Jan-2021, Pfizer (Dose 2, Lot number: EN5318.) on 18-Feb-2021, Pfizer (1st booster and Lot number:FC3183.) on 29-Aug-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 26-Oct-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 27-Oct-2022, the patient experienced FATIGUE (I felt worn out for about 12-15 hrs/I felt fatigued for about 12-15 hrs.). At the time of the report, FATIGUE (I felt worn out for about 12-15 hrs/I felt fatigued for about 12-15 hrs.) had resolved.            No concomitant medication information was provided. End date of event felt worn out and fatigued for about 12-15 hours was Oct 2022. No treatment medication were provided.
L arm became severely swollen and tight and hard-tender to touch. Very red-to ER-on Benadryl-3 days later still with swelling only.
I can no longer sleep on my left side; no longer sleep on my left side; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (I can no longer sleep on my left side) and DISCOMFORT (no longer sleep on my left side) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (I can no longer sleep on my left side) and DISCOMFORT (no longer sleep on my left side). At the time of the report, INSOMNIA (I can no longer sleep on my left side) and DISCOMFORT (no longer sleep on my left side) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medication were reported. No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Aug-2021: Upon internal review on 17-May-2022, significant correction was performed. The reporter country was updated from unknown.
low-grade fever; achy body; chills; This is a spontaneous report from a contactable consumer (wife of the patient) via Pfizer-sponsored program  Support.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 25Mar2021 on last Thursday as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced low-grade fever, achy body and chills. The reporter would like to know if the side effects were taking that long before it would be experienced. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Fast heartbeat; dizziness; itching all over; This is a spontaneous report from a contactable consumer.  A 56-years-old female patient reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 09Mar2021 15:15 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.   Medical history included hypertension from an unknown date and unknown if ongoing, Sulfonamide allergy from an unknown date and unknown if ongoing.  Concomitant medication included losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported; mometasone furoate (FLONASE [MOMETASONE FUROATE]) taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported.   The patient previously took Rocephin (ceftriaxone) and experienced drug hypersensitivity, doxycycline and experienced drug hypersensitivity, ciprofloxacin and experienced drug hypersensitivity, codeine and experienced drug hypersensitivity, Oyster experienced drug hypersensitivity.  The patient experienced fast heartbeat (heart rate increased) (non-serious) on 10Mar2021 02:00 with outcome of recovering , dizziness (dizziness) (non-serious) on 10Mar2021 02:00 with outcome of recovering , itching all over (pruritus) (non-serious) on 10Mar2021 02:00 with outcome of recovering.  The patient underwent lab tests and procedures which included heart rate: fast   on 10Mar2021.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Started feeling dehydrated.  Drank water but didn't micturate.  Arm started swelling.  Large hard region developed on deltoid of left arm about 6 inches in diameter during the night.  Skin was red and hot.  On Thursday (3 days after injection) the entire upper arm was swelling about 25% larger than normal, the large hard region remained.  Friday the swelling started to decrease.  Saturday (5 days after injection) the swelling stopped.
body odor; This case was reported by a consumer via interactive digital media and described the occurrence of body odor in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced body odor. On an unknown date, the outcome of the body odor was unknown.   It was unknown if the reporter considered the body odor to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient asked about Shingles vaccine , could it cause body odor.  GSK note - product name is Shingrix but the patient mentioned name of vaccine as shingles vaccine, it is coded as reported.
Face and scalp itching, headache, fever, pain to soles of feet, extreme fatigue, body and joint pain. Started approx 3 hours after injection and is continuing on day 3, but symptoms are lessening some. Tylenol and Motrin and rest treatment. Contacted my physician for further advice or treatment needed.
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004545: US-009507513-2005USA004950:US-009507513-2005USA004990 US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993: