chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 9-25-13 pt stopped by pharmacy, stated she had severe joint pain and unable to raise her arms in both arms after receiving FLUZONE HD and PNEUMOVAX took Aleve OTC for pain. Still experiencing some effects in her left arm. Pt did not seek medical treatment. States shoulder joints still hurt can not lift arm all way.
10/12/00 at 08:00, woke up with pain and swelling in upper left arm. Red and swollen from shoulder to elbow.
Cough, loss of smell/taste, fatigue, runny nose, diarrhea starting on 9/30/21
Pt recvd 2 doses of Recombivax HB on 27OCT89, 29NOV89, & 3rd dose was Engerix-B given 23APR90 & was found to be a non-responder;
No fever, but day after injection developed area of erythema and induration over (L) tricep and several small vesicles.
Hives appeared a few hours later. Patient also complained of scratchy throat. She self treated w/BENADRYL and was prescribed MEDROL dose pack. By 11/18/15 she is 90% better.
It band in left leg has been extremely painful for the last 10 weeks.  I can not walk on left leg.  I fall a lot now. I think it is attacking my large nerve connection.  There is no injuries ever on this leg.  Nothing showed in mri.
A spontaneous non-serious report of single nostril administration was received from a pharmacist concerning a 39 year old male patient. No medical history nor concomitant medications were reported. On 20-Nov-2008, the patient received FLUMIST in a pharmacy which was administered by pharmacist. The clip was off when FLUMIST was administered and the patient received the whole dose in one nostril. He said he felt drainage in the back of the throat. The pharmacist decided to administer another half-dose into the other nostril. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Additional information was received on 02-Dec-2008 and incorporated into the narrative. No adverse events occurred after dosing.
Herpes type of eruptions lesions x3 across student left knuckles. Small area on left arm slight pink flat rash. Started fading before parent arrive. Parent admn. CLARITIN 10/30/14. No rash or eruptions lesions present.
Bruising; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (Bruising) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thrombocytopenia. Concomitant products included MELATONIN for Insomnia, BIOTIN and MULTIVITAMIN & MINERAL for an unknown indication.    On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced CONTUSION (Bruising). On 31-Mar-2021, CONTUSION (Bruising) had resolved.            No treatment medications were given. Patient experienced autoimmune issue tested for negative included Von Willebrand disease which was negative.
Two days after the vaccination I started getting severe pain in my left shoulder injection site. I went to see a doctor after 8 days ans was given a muscle relaxer. It had no effect. After two weeks the pain lessened a bit but I started getting electrical pulses and tingling down my arm and up to my neck. My left arm was week and my grip was week. Symptoms were worse at night causing lack of/ no sleep. Numbness in my feet in the mornings. Went to see a doctor and was put on a 5 day treatment of Prednisone. Symptoms lessened considerably for 5 days then returned on day six. A CT scan was taken on my neck, results were negative. Symptoms are still occuring after 4 weeks. I now get a sensation that the hair is getting pulled off my body like a bandaid being ripped off.
Itchiness and discoloration arm from elbow/forearm to shoulder, pinkish/purple, after about a week, reduced to only 3 in area, but still present
On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PYREXIA (Fever) and MYALGIA (Body aches). On 09-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is super hot) and VACCINATION SITE SWELLING (Injection site is swollen). On 10-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection site is red). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Injection site is super hot), VACCINATION SITE ERYTHEMA (Injection site is red) and VACCINATION SITE SWELLING (Injection site is swollen) outcome was unknown and PYREXIA (Fever) and MYALGIA (Body aches) was resolving.        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.
After recieving the second dose of the COVID vaccine, I have an abnormally late period. Please make this side effect knowledge.
flu-like symptoms; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 INFLUENZA LIKE ILLNESS (flu-like symptoms) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was provided by the reporter. No treatment medication was provided.
has been dizzy since receiving the shot; is having trouble with balance; This case was reported by a consumer via patient support programs and described the occurrence of dizziness in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st February 2020, the patient received Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced dizziness and balance disorder. On an unknown date, the outcome of the dizziness and balance disorder were unknown.   It was unknown if the reporter considered the dizziness and balance disorder to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had dizzy and trouble with balance as well and would like to talk someone who was clinical. The caller was not clinical but could had talk to the pharmacy to see about get help with his clinical question.
Second day after 5/2/21 6:30 a.m. : body aches , fatigue , severe headache, severe diarrhea, nausea, feeling of skin burning. 5/10/21 , 8 days after injection 4:30 pm : pain , swelling and itching at injection site ( right arm ).
Patient described chest pain, requested transfer to ED due to complex medical history.  Patient was treated with benadryl and "discharged quickly" per patient
Soreness at injection site Tired/run down feeling body/muscle aches all over body upset stomach/ light nausea mild headache (no fever)
past away a few hours after getting the Moderna booster; This spontaneous case was reported by a physician and describes the occurrence of DEATH (past away a few hours after getting the Moderna booster) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypertension (Patient had hypertension, gout and atrial fib for 6 years), Gout (Patient had hypertension, gout and atrial fib for 6 years), Atrial fibrillation (Patient had hypertension, gout and atrial fib for 6 years) and Catheterization arterial (Patient had a catherization of an artery 6 years ago). Concomitant products included DIGOXIN for Atrial fibrillation, PROBENECID for Gout, POTASSIUM, VERAPAMIL, COLCHICINE and ALLOPURINOL (ALOPURINOL) for an unknown indication.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 25-Oct-2021 The patient died on 25-Oct-2021. The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that patient did not had covid-19.  Patient was very active, biked 12miles a day and roller skated 3-4 hours a day, 3 days a week, with no cardiac symptoms. Patient was not overweight. Patient passed away at 6pm.  Treatment information was not provided.  Company Comment: This case concerns a 75-year-old, male patient, with medical history hypertension, atrial fibrillation and arterial catheterization, who experienced the serious, unexpected event of death. The patient passed away on the floor of his house on the same day after the third dose of mRNA 1273 vaccine. It is unknown if an autopsy was done. The patient history of hypertension, atrial fibrillation and arterial catheterization remains as confounder to event death. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Follow up information included no new information.; Sender's Comments: This case concerns a 75-year-old, male patient, with medical history hypertension, atrial fibrillation and arterial catheterization, who experienced the serious, unexpected event of death. The patient passed away on the floor of his house on the same day after the third dose of mRNA 1273 vaccine. It is unknown if an autopsy was done. The patient history of hypertension, atrial fibrillation and arterial catheterization remains as confounder to event death. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Boostrix was administered on 11/02/2023 and expired on 10/27/2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2G3PH, expiry date 27-OCT-2023) for prophylaxis.   On 02-NOV-2023, the patient received Boostrix. On 02-NOV-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Boostrix was administered on 11/02/2023 and expired on 10/27/2023). The outcome of the expired vaccine used 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: 02-NOV-2023 The health care professional reported that the Boostrix was administered on 11th February 2023 and expired on 27th October 2023 which led to expired vaccine used. No reactions reported. The reporter consented to follow up.
Information has been received from a registered nurse referring to a 10 year old female patient. There was no concurrent condition or medical history reported. On 06-OCT-2015 the patient was vaccinated with GARDASIL 9 (lot # L007560, expiration date unspecified) (dosage and strength not reported) intramuscularly. There was no concomitant medication reported. On 07-OCT-2015 (on the following day), the patient developed hives at the injection site after receiving the GARDASIL 9 which lasted for 9 days. On 11-OCT-2015, the patient also developed swelling and pain at the injection site 6 days after receiving GARDASIL 9 which lasted for 2 weeks. The patient called the physician and treatment with BENADRYL was given. No lab diagnostics studies was performed. The outcome of the events was reported as recovered. Additional information has been requested.
Pregnant patient received the first dose of moderna vaccine; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose of moderna vaccine) in a 36-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in August 2020 and the estimated date of delivery was on an unknown date. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose of moderna vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received the first dose of moderna vaccine) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, Pregnancy test: positive (Positive) Positive.     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 treatment information was provided. No concomitant medication was provided. Gestational stage  20 weeks was reported. Estimated due date was in Jun 2021.
A spontaneous report was received from a Consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events throbbing arm in the same spot the vaccine was given/vaccination site pain. The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On an known date, two weeks later throbbing arm in the same spot the vaccine was given/vaccination site pain. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The seriousness criteria of event was reported as serious other as per source document. On an unknown date the outcome of events, throbbing arm in the same spot the vaccine was given was not reported. Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
ACHES/PAIN; STOMACH ISSUES; HIGH FEVER; EXHAUSTION; TURNED HER ALLERGY WORSE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced aches/pain, stomach issues, high fever, exhaustion, and turned her allergy worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches/pain, stomach issues, high fever, exhaustion, and turned her allergy worse. This report was non-serious.
Patient received shot in right deltoid at 08:00 on 11/17/02. Reaction began at 15:00 same date: swelling, red welts, difficulty moving arm from soreness, body aches. Patient stated all better by 11/21/02, except small amount of body aches.
08/26/2022 presented to ED for cough and hypoglycemia. PMHx of CAD, CKD and dementia.
3rd dose booster; vial diluted with 1.4 mL instead of 1.8 mL, received 27% more vaccine (0.3 mL).
w/in 2 days of vax pt devel knot & deltoid pain;subjective fevers;body aches, & fatigue as well as inj site abscess/sinus tract requiring multiple I&D procedures, outpatient & inpatient;devel anxiety neurosis & depression & fibromyalgia,n
This spontaneous report as received from a female patient of unknown age, who was a licensed practical nurse. The patient referred to herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patient received "numerous" booster doses of RECOMBIVAX HB (route and site of administration, lot# and expiration date were not reported) due to unspecified reasons. Other suspect therapies included influenza virus vaccine (unspecified) (route and site of administration, lot# and expiration date were not reported). On an unknown date, after she received an unspecified influenza virus vaccine, she developed "worse than normal flu-like" symptoms. The outcome of the event and the relatedness between the event and RECOMBIVAX HB were not reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA007288.
After 12 hours of receiving 1st dose of Shingrix vaccine, patient woke up out of sleep, feeling bad. She walked to restroom and fainted, loss consciousness. When she came to, patient felt weak, and could not walk or stand up. After 30 minutes, patient started to sweat badly. Sweat beading off of body. After sweating stopped, patient was back to normal (which was approximately one hour after losing  consciousness).
Patient reported to clinic at work place 6/18/15 stating pain in arm where injection took place (6/10/15), said pain was getting worse, was not seen/evaluated by anyone in clinic, advised to follow up w/ MD.
Patient filled out vaccine consent form stating no to all questions (denying anything that might exclude her from receiving the vaccine), fever was taken (non-feverish), and signed under the bolded statement stating the patient is to wait in the pharmacy at least 15-20 minutes after receiving vaccination. Patient was then given the J&J covid-19 vaccine in left deltoid and told that it is recommended by CDC to wait in the pharmacy for 15-20 minutes after vaccination. However, the patient immediately proceeded to leave. Patient states upon getting to her car in the parking lot, she started noticing signs of anaphylaxis such as throat swelling, however patient did not come back into the pharmacy and left the premises. Patient did not report seeking any sort of treatment for her anaphylaxis side effects. Patient received vaccine on 3/30/21, did not report this event to the pharmacy until 4/2/21. Patient also states she is a registered nurse.
Started on 6/18/2018 at about 5 pm with a mild fever (99.8) and aches. Treated with TYLENOL. Continued with fever, aches, chills, sweats, joint pain, nausea, difficulty breathing the following morning. Continued to treat with TYLENOL but added MOTRIN on 6/19/18. around 5 pm on 6/19/18 nausea set it in for 4 hours and treated with MAALOX. On 6/20/2018 aches and nausea gone but soreness in muscles still felt.
First day patient broke out in rashes and had itching. Couple days later she had a rash at the site of injection that spread down the left arm, was warm to touch and had swelling.
This spontaneous report was received from a registered pharmacist via a company representative refers to an approximately 80-year-old female patient (reported in her 80's). On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # and expiration date not reported) subcutaneously. On an unknown date (reported as the following day) the patient experienced "pronounced raised and red reaction" around the injection site. Treatment information and lab diagnostic studies were unspecified by the reporter. It was unspecified whether the patient sought medical attention for the events. The outcome of "pronounced raised and red reaction" around the injection site is unknown. Causality was not reported. Additional information is not expected.
Patient came in office for  6-mos well child visit was given vaccine. 7/14/21 returned to office with hives over the entire body
This spontaneous report as received from a physician refers to a patient of unknown age. On 29-MAY-2014 the patient was vaccinated with unspecified doses of ROTATEQ (dose, route, lot# number not reported) and COMVAX (dose, route, lot# number not reported) that had been improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a  patient of unknown age and gender .  Medical history and concomitant medications were not provided. On or about 09-JUL-2014, the patient was vaccinated with ZOSTAVAX at a  pharmacy as recommended for routine adult health maintenance for the prevention of shingles (route and lot # not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 13-JUN-2016, the patient was treated by a nurse practitioner for a vesicular outbreak that was diagnosed as severe shingles. The patient was treated on unspecified date by a physician for worsening symptoms and was prescribed  acyclovir, gabapentin, and hydrocodone-acetaminophen for management of  painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages.  The outcome was singles was not recovered. Additional information has been requested.
Extremely lethargic  Swelling in vaccinated arm  Pain in vaccinated arm Body aches Headache Congestion
Fever; Chills; Body aches; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) 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 treatment information was provided.   No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Fever are chills are consistent with the product safety profile
Lightning shooting pain through injected arm.  Flu like symptoms for approximately 12 hours.  Severe arm weakness, that resolved after about 18 hours.
child exposed to sibling & devel chickenpox characterized by nasal congestion w/greater than 30 vesicular lesions;f/u info recv MD r/t the episode as a poss case of secondary transmission;
PATIENT HAD A (50 CENT PIECE SIZED) RED CIRCLE AROUND THE INJECTION SITE,  RED MARK HAD SPREAD TO ELBOW. ADVISTED PT TO SEE PROVIDER.
Adverse effect of other vaccines and biological substances, initial encounter on 2022-08-26.
Initial misuse report received from a healthcare professional on 11 February 2013. It was reported that ACTHIB may have been reconstituted with Merck diluents instead of the diluents provided. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.