chrisvoncsefalvay/vaers-outcomes huggingface dataset:
overdue to take the second dose; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (overdue to take the second dose) in a male patient of an unknown age 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. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (overdue to take the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (overdue to take the second dose) 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.   Concomitant medications was not provided by the reporter. Treatment information was not provided.
Less than a week later developed chest pain, palpitations, feeling lightheaded, dizzy and fatigue. Symptomatic persisting almost a month later with mostly palpitations and fatigue.
I sat there for 15 min after getting the shot. I felt tired 5 min after. got home about 4:00 p.m.  i started  feeling really nauseas and end up throwing up part of my tong is swollen. when i couch it feels like glass my arm that the shot was given in keeps going on  and off of tangling
about an hour after receiving my second vaccine,  my neuropathy started flaring up.  That night, I developed painful joints along with cold flashes.  Today, I am experiencing  major headaches along with total body aches and pains.
Pt received AVA (4) prior to knowledge of pregnancy. Date of last normal menstrual period: 18 Apr 09. No adverse event / Received vaccine prior to knowing she was pregnant. Son was born on January 25th 2010. He was 22 inches long and weighed 9 lbs 1 oz. He has had two checkups with the pediatrician to date and so far he is completely healthy.
Pt recd 3 doses of vax; 1st & 2nd doses uneventful; 24JUN91 recd 3rd dose; 25JUN91 Pt's entire upper arm red @ inject site; same day Pt expd itching & t99; 26JUN91 Pt had h/a, nausea, & t100; 27JUN91 redness improving & no other c/o;
Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer concerning an approximately 57 year old female patient There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 07-JAN-2010, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a healthcare provider at a clinic. On or about 12-NOV-2014, the patient was treated by an advance practice registered nurse physician at a health system for the following injuries resulting from the patient's ZOSTAVAX use: shingles and post-herpetic neuralgia. The patient claims damages as a result of injury to self, loss of services and economic losses. The outcome of the event is unknown. The causality of the event is related. Additional information has been requested.
10 1/2 - 13 1/2 cm red, swollen, hot, tender area R deltoid
inadvertently administered expired doses, with no reported adverse event; Initial information received on 09-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old male patient for whom inadvertently expired dose of IPV (Vero) [IPOL] was administered, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 23-Mar-2023, the patient received a dose of suspect IPV (VERO) at dose 0.5 ml (1x) suspension for injection of standard strength (lot: U1A601M, expiry date: 27-Feb-2023) via intramuscular route in the right thigh for prophylactic vaccination (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
I have been very sensitive to the heat since my second dose and I experience some swelling in my hands and feet. Within three weeks of the second dose of the vaccine I became very sensitive to shampoo. After I shampooed my hair it would make me itch where my hair touched. My scalp is very itchy and a little red. The doctor prescribed ketoconazole shampoo but it did not work because I still needed to use regular shampoo. It is impossible to find shampoo with no coconut ingredients. I have had food allergies to coconut, but it has never been a topical sensitivity before. I had Covid-19 in early January of 2021. My hair was falling out for a while, and I still have fatigue, headaches and other symptoms of Long Haul Covid-19.
After taking the vaccine I did have a headache. But then after a day I did notice some mucus in my stools and uneasiness in my stomach. I had urge to defecate a few times. This thing kept on happening for a week and alternating between  Mucus in Stools with passing 3-4 times a day to constipation. But starting 10/12 it became worse. The mucus/slime like liquid started to come out every time I passed gas and my bowel movement increase drastically to 6-7 times a day. So I had to wait 1 more week as I got doctors appointment on 10/19 even then I didnt get any medicine and I had to still go through the same situation. Some Stool test were ordered in which Viral and Bacterial infection came out as negative. I still have the persistent diarrhea with mucus in stools and when I pass gas.  Now I have been asked to get the colonoscopy on 11/4
received Kinrix, the intended vaccine was Boostrix; 14 year old received Kinrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 14-year-old female patient who received DTPa-IPV (Kinrix) (batch number 237C4, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th October 2021, the patient received Kinrix (intramuscular) and Kinrix Pre-Filled Syringe Device. On 27th October 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were 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 patient inadvertently received Kinrix via intramuscular route in the left deltoid instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.  The reporter consented to follow up
Initial unsolicited report received from a consumer on 16 September 2015. This case involves a 16-year-old male patient who was vaccinated with a dose Pneumonia Shot, Influenza vaccine and a dose of Chicken pox vaccine [batch number, expiry date, dose, dose in series, route and site of administration were not reported] on an unknown date. The patient was also receiving another vaccine but the consultant cannot recall which other vaccine. The patient had a medical history of allergy to cillin antibiotics and diabetes. Previous medications included Humalog on sliding scale along with a lower dosage (35 units, then later 45 units) of LANTUS. The patient's body was rejecting Humalog i.e with burning of the skin and huge welts at the injection sites which lasted 8 to 10 hours. Concomitant medications included LANTUS at a dose of 85 units q pm. The patient's diabetes was managed with LANTUS but the problem with LANTUS was it "only comes in 100 unit pens" and reporter heard about Toujeo which "comes is 300 unit pens". The current dosage requires 4 to 6 shots to empty the needle which was helping blood sugar to "work itself out". On an unknown date, following the vaccination, the patient seems to be allergic to many things, including, the pneumonia shot, the flu shot, the chicken pox vaccine. Laboratory data included sugar level which was 85 currently and it was 200 in the past. The patient's A1C was decreased from 14 to 10. Corrective treatment was not reported. The outcome of the event was unknown. List of documents held by sender: none.
Rash all over the body with temperature 100.6. Went to U care. Prednisone given.
This spontaneous report as received from a consumer refers to herself, a 73 year old female patient with no drug reactions or allergies. The patient's pertinent medical history included asthma, high blood pressure and hypothyroid. The patient had a case of shingles in her right eye in September 2015 and was treated with an unspecified antiviral. On an unknown date in the last week of November 2015, the patient was vaccinated by a local pharmacist with a dose of ZOSTAVAX (dose, route of administration, lot number and expiration date were not reported). Concomitant therapy included unspecified low dose medications for blood pressure and thyroid. On an unknown date in 2015 (reported as two weeks later), the patient felt like she was getting the shingles again in her right eye, she described it as a line on her forehead above her right eye, itchiness, heaviness and blurriness of the right eye. She had been treating her right eye with a medication reported as "CLEAR EYES" and it made her eye feel better. The patient sought medical attention and she noted that she had spoke to her pharmacist who told her there was nothing that could have been done to treat those symptoms. The outcome of the event was reported as not recovered. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Swollen a week after injection; Hot at injection site; Itches like crazy,itches around waist; feels nauseas; Legs are achy like flu; Legs are achy like flu; headaches; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen a week after injection), VACCINATION SITE WARMTH (Hot at injection site), PRURITUS (Itches like crazy,itches around waist), NAUSEA (feels nauseas) and PAIN (Legs are achy like flu) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen a week after injection), VACCINATION SITE WARMTH (Hot at injection site), PAIN (Legs are achy like flu), INFLUENZA (Legs are achy like flu) and HEADACHE (headaches). 06-Feb-2021, the patient experienced PRURITUS (Itches like crazy,itches around waist) and NAUSEA (feels nauseas). At the time of the report, PERIPHERAL SWELLING (Swollen a week after injection), VACCINATION SITE WARMTH (Hot at injection site), PRURITUS (Itches like crazy,itches around waist), NAUSEA (feels nauseas), PAIN (Legs are achy like flu), INFLUENZA (Legs are achy like flu) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Patient received Pfizer COVID vaccine on 3/3/21 and 3/24/21. On 1/14/22, patient admitted to our CCU with acute respiratory failure with hypoxia (intubated) and sepsis due to bilateral pneumonia, acute kidney injury, acute metabolic encephalopathy, and COVID-19 positive status. As of today (1/21/22), patient is still intubated in CCU.
Pt awoke with rash on entire body (concentrated on trunk and arms). About 36 hrs post vaccination.
Patient fainted immediately after receiving the Pfizer vaccine. She regained consciousness immediately as soon as patient was placed on her back on the floor with feet elevated. Her blood pressure was normal and she was kept under watch for 20-25 mins after receiving the vaccine and she left the clinic  after we observed her for 20-25 mins and she was doing absolutely fine.   Followed up with the parent on Wednesday 5/26/21 at around 7:45pm. Mother reported patient is doing absolutely fine. I told patient's mom, fainting can be caused due to nervousness and drop in oxygen levels to the brain. However, this adverse effect will be reported to patients doctor and also to the VAERS for Pfizer covid-19 vaccine.
pt recvd flu vax & the following day, pt devel soreness, redness, itching, & warmth @ the inject site;
Arrived in emergency Department with rectal temp of 104.2.  Parents reported patient seen to stop breathing in car.  Appearred rigid and to be staring at the ceiling.  Father performed CPR briefly.  On arrival patient was crying lustily.
Patient may have received a higher dose of Pfizer covid vaccine than recommended for her age group. Patient potentially had a headache post vaccination that resolved on its own.
pt recvd vax & rt arm was sore & began to hurt; pt began to have pain in arm & then under arm that noc; next morning had a red streak @ site of inject; MD ER dx as lymphenitis;
influenza vaccine made the patient sick for a week; Initial information regarding an unsolicited valid non-serious case was received from a consumer (patient) via social media and transmitted to Sanofi on 17-Nov-2020.  This case involves a patient of an unknown age who reported influenza vaccine made the patient sick for a week (illness), while he/she received INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (lot number unknown) via an unknown route in an unknown administration site for prophylactic vaccination which made the patient sick for a week (illness).   No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as unknown for illness.  There will be no information regarding the batch number for the case.
had pneumonia three times; had pneumonia three times; received 3 doses of Prevnar 13; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202200276208 (Pfizer).  An 83 year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), administration date Oct2020 (Batch/Lot number: unknown) as dose 3, single, administration date 2018 (Batch/Lot number: unknown) as dose 2, single and administration date 2016 (Batch/Lot number: unknown) as dose 1, single for immunisation; pneumococcal vaccine polysacch 23v (PNEUMOVAX 23), administration date 2008 (Batch/Lot number: unknown) as dose 1, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant), outcome "unknown" and all described as "had pneumonia three times"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "received 3 doses of Prevnar 13".  The lot number for pneumococcal 13-val conj vac (dipht crm197 protein) was not provided and will be requested during follow up.
On Sunday morning he noticed abdominal pain and he's been noticing that off and on since Sunday.
Complains of fatigue  History of covid  Infection in 02/2021 Notes worsening fatigue/low energy  since after second covid vaccination over 1  Month ago  Has been taking b12  Notes  Fatigue not as bad as when she had covid infection  Sometimes fatigue  triggers anxiety- taking herbal supplements which helps with anxiety  She is not reporting associated symptoms  Denies depressed mood ,but feels irritable sometimes   no suicidial  Ideation  + psychosocial stressors - recently bought a  New home   , has been having to move in between homes  Social support - family  +  intermittent palpitations only occurs with anxiety , resolves with deep breathing   , + dizziness  Described as lightheadedness , denies spinning sensation or syncope She denies insmonia  No chest pain no shortness of breath , no dyspnea on exertion
PAIN ON RIGHT CALF; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 17-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAY-2021, the subject experienced pain on right calf. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain on right calf. This report was non-serious.
Erythema and itching from Left deltoid to left bicep. Began 24 hours post amdinistration, evaluated here in the ER at 48 hours post.
Check out large 3 x4 red knot on arm, hot to touch, pain decreased arm.
p/vax pt devel pruritus rash which lasted 3 days & went away on their own-not brought for eval;
Patient reported tongue swelling approximately 2 hours following vaccination with the COVID immunization.   Patient is a health care provider/ surgeon and managed her symptoms at home. Reported reaction to her assigned PCP.
pt recvd vax & had a negative antibody titer;No further details were provided;
Body aches; dizziness; ear ache; sore throat; experiencing fever; chills; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Body aches), DIZZINESS (dizziness), EAR PAIN (ear ache), OROPHARYNGEAL PAIN (sore throat) and PYREXIA (experiencing fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PAIN (Body aches), DIZZINESS (dizziness), EAR PAIN (ear ache), OROPHARYNGEAL PAIN (sore throat), PYREXIA (experiencing fever), CHILLS (chills) and HEADACHE (headache). At the time of the report, PAIN (Body aches), DIZZINESS (dizziness), EAR PAIN (ear ache), OROPHARYNGEAL PAIN (sore throat), PYREXIA (experiencing fever), CHILLS (chills) and HEADACHE (headache) had not resolved.        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.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-022474, US-MODERNATX, INC.-MOD-2021-047944 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-047944:Crosslinked (MOD21-018034) US-MODERNATX, INC.-MOD-2021-022474:Crosslinked (MOD21-018034)
Moderate to severe generalized joint pain, pitting edema in lower legs, slight edema to joints at base of great toes, index fingers and thumbs, and slight edema of knees. This started on 10/31/07 is is still present today. Examined by Dr. 11/16/07.
Broke out in a rash from head to toe.  Beet red and very warm.
fever for almost 24 hours (spiked at 101.3), severe body aches, severe headache, loss of cognitive thinking, sensitivity to light 5 Acetaminophen (500 mg each), 2 Ibuprofen (100 mg each) reduction of body aches and fever
vomiting; diarrhea; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2nd October 2020).   On 7th January 2021, the patient received the 2nd dose of Shingrix. In January 2021, 12 hrs after receiving Shingrix, the patient experienced vomiting and diarrhea. On an unknown date, the outcome of the vomiting and diarrhea were recovered/resolved.   It was unknown if the reporter considered the vomiting and diarrhea to be related to Shingrix.  Additional information was provided as follows: The case was reported by member of public (patient). The age at vaccination was not reported. The patient experienced gastrointestinal symptoms (diarrhea and vomiting) The symptoms during night. The reporter did not consent to follow up.
Patient presented with dyspnea and found to have COVID 19 infection. Treated with steroids and oxygen but clinically deteriorated and died
Temp. 101-103.4-cellulitis L upper arm. Body and muscle aches. Blisters inside mouth. Symptoms lasted 72 hours.
deathly ill; Initial information regarding an unsolicited valid serious case received from a consumer via Social media and transmitted to Sanofi on 06-Dec-2020.  This case is linked to case 2020SA351069 (same reporter).  This case involves female patient of unknown age who was deathly ill (illness) while she received INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious deathly ill (illness) (Unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  It was not reported if the patient received a corrective treatment.  Event outcome was unknown for illness.  There will be no information regarding batch number for the case.; Sender's Comments: Sanofi company comment dated 07-Dec-2020: This case concerns an adult female patient who presented with Illness after vaccination with INFLUENZA VACCINE. However, patient's medical condition, laboratory tests ruling out alternate etiologies and concomitant medications were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Patient received vaccination 0.5 ml, then immediately sat down in chair. At approximately 5:08, he fell out of the chair, exhibiting seizure like activity noted by vaccination staff. He fell into the floor, striking the back of his head which resulted in a golf ball size hematoma and laceration. EMT assessed c spine for injury. Reassure applied to active bleeding laceration. emergency was called at 5:06. Vital signs stable. He was diaphoretic. LOC assessed. Able to verbal name and location. Respirations even and unlabored. Neck supported while transferred to gurney and care taken over by emergency responders at 5:15 pm. Patient was alert at departure to hospital by rescue squad. His father was present and stated the patient was apprehensive prior to vaccination.