chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SOME OF THE SERUM CAME OUT AFTER GIVING THE INJECTION (PRODUCT LEAKAGE); SOME OF THE SERUM CAME OUT FROM THE ARM ABOUT 0.3 (POSSIBLE PARTIAL DOSE ADMINISTERED); This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-APR-2021, the subject experienced some of the serum came out from the arm about 0.3 (possible partial dose administered). On an unspecified date, the subject experienced some of the serum came out after giving the injection (product leakage). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the some of the serum came out after giving the injection (product leakage) and some of the serum came out from the arm about 0.3 (possible partial dose administered) was not reported. This report was non-serious. This report was associated with product quality complaint: 90000175305
Dizziness; Did not get 2nd dose on due date; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and PRODUCT DOSE OMISSION ISSUE (Did not get 2nd dose on due date) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness) and PRODUCT DOSE OMISSION ISSUE (Did not get 2nd dose on due date). At the time of the report, DIZZINESS (Dizziness) was resolving and PRODUCT DOSE OMISSION ISSUE (Did not get 2nd dose on due date) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, COVID-19: 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.   Patient had a steroid shot on hip, and have been taking a z-pack of antibiotics and some Antivert for the dizziness, also received Bamlanivimab infusion on 12FEB2021. She has not yet received the 2nd dose as per the report because she heard that she has to wait 90 days after the infusion. No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Significant follow up appended
Information has been received from a registered nurse (RN) concerning a 24 hour old female who on 02-NOV-2007, 03-MAR-2008 and 12-MAY-2008 was vaccinated po with the first, second and third 2.0 ml doses respectively of ROTATEQ vaccine live (human-bovine) (first dose lot #656392/0239U), second dose lot # 659772/1636U and third dose lot #660376/0019X). There was no illness at the time of vaccination. On approximately 12-MAY-2008 the patient developed diarrhea which lasted 6 to 7 days after receiving the third vaccine dose. It was reported that the patient recovered from the diarrhea. Unspecified medial attention was sought. Diarrhea for 6 to7 days was considered to be an other important medial event. Follow-up information was received from a registered nurse (RN) who reported that the patient received the first dose of ROTATEQ vaccine live (human-bovine) (lot # 656392/239U) on 02-JAN-2008 (previously reported as 02-NOV-2008). On 29-MAY-2008 (previously reported as approximately 12-MAY-2008) the patient experienced diarrhea for about 6 days and vomiting (duration unspecified). The patient was seen in the ER on 01-JUN-2008, a stool sample collected was positive for Rotavirus. The patient was seen in the office on 02-JUN-2008. The patient was reported as recovered (date unspecified). The event is no longer considered serious by the reporter. Additional information has been requested.
Legs hurting; Night mares; Swelling of neck lymph nodes; Muscle aches; Fatigue is not going away / Exhausted despite sleeping; Bad Headache; Soreness at the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Legs hurting), NIGHTMARE (Night mares), VACCINATION SITE PAIN (Soreness at the injection site), HEADACHE (Bad Headache) and LYMPHADENOPATHY (Swelling of neck lymph nodes) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site). On 21-Mar-2021, the patient experienced HEADACHE (Bad Headache). On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (Legs hurting), NIGHTMARE (Night mares), LYMPHADENOPATHY (Swelling of neck lymph nodes), MYALGIA (Muscle aches) and FATIGUE (Fatigue is not going away / Exhausted despite sleeping). At the time of the report, PAIN IN EXTREMITY (Legs hurting), NIGHTMARE (Night mares), VACCINATION SITE PAIN (Soreness at the injection site), HEADACHE (Bad Headache), LYMPHADENOPATHY (Swelling of neck lymph nodes), MYALGIA (Muscle aches) and FATIGUE (Fatigue is not going away / Exhausted despite sleeping) 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 provided.
Vaccine was administered on the afternoon of January 19, 2007.  The following evening Zoey developed croup like symptoms and showed signs of difficulty breathing.  On the morning of January 21, 2007, Zoey was given liquid Benedryl and responded well.  The following day Zoey continued having trouble breathing and was no longer responding to the Benedryl.  Zoey was prescribed liquid steroids.  Before taking the steroids, at about 6:00pm on January 22, 2007, Zoey broke out in hives.  The steroid was ingested and the difficulty breathing subsided on the following morning.  The hives were still present on the 23rd and were very mild for the following two days (24th & 25th).  On the 26th Zoey's hives were covering her body and were very severe.  They have continue to come and go since then.  In December, 2006, Zoey had her 4 month vaccines and had the same reaction of difficulty breathing a day and a half later.  She did not get the hives and both the doctor and patient's parrents assumed it was due to the croup, however when Zoey had the same reaction after her 6 month shots, it was agreed that she must be allergic to something.
Patient with elevated hematocrit (though has other reasons for this)  Asytmpomatic but found on lab testing
lt arm red, swollen, warm to touch;pt c/o soreness;T97;
pt recvd vax & 30 minutes later devel swelling which inc the size of arm & which progressed to erythema to the elbow heat & induration; pt also devel lymphadenopathy, fever, sweating & h/a;
Received Pfizer vaccines on 3/6, 3/27/21 COVID-19 positive by PCR on 1/7/22 admitted to hospital on 1/7/22 d/t AKI, hyponatremia underlying Type 2 DM, HTN, CKD
Administered to a 15 day old patient; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-day-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 7L9PZ, expiry date 24th November 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th May 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 18th May 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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:18-May-2022 Reporter's comments: Pediarix was administered to a 15 days old patient. No reactions were reported. The consent to follow up was given. The vaccine administration facility was the same as primary reporter. Additional Supportive Information: The fifteen days old patient received Pediarix, which led to inappropriate age at vaccine administration.
Pt reports post vaccine she experienced throat soreness and hives that lasted for over 2 months. In follow-up, the pt's physician reported that the pt's mother thought there were an increase in allergic symptoms like rhinitis and urticaria. The pt recovered from the increase in allergy symptoms, allergic rhinitis, and urticaria. The pt's compplete blood count and serum immunoglobulin test was within normal limits. On 09/27/2000, the pt was vaccinated with the second dose of hep b vaccine IM. Unspecified medical attention was sought. No further info is expected.
The patient immediately reported a headache upon vaccination - before vaccination was even complete, before the needle was removed from her arm. The patient called on 04/16/18 to report that she has had a headache every day for 6 days since vaccination.
On the morning of May 4 (less than 24 hours after vaccine) I passed out while eating breakfast. I was out for about 15-20 seconds according to my husband. When I woke up, I was alert and weak feeling. Had been incontinent and wet the chair that I was sitting in. I did not fall out of the chair.
PATIENT STATED VACCINES WERE ADMINISTERED ON WED ON SATURDAY MORNING CHILD AWOKE WITH SWELLIN OF LEFT ARM AND BLISTERS. CHILD WAS THEN TAKEN TO ER WHERE SHE RECIEVED AN ANTIBIOTIC SHOT AND PHYSICAN STATED IT MAY BE AN INFECTION AND POSSIBLE REACTION TO VACCINE. PATIENT CAM INTO OFFICE ON MONDAY FOR FOLLOW UP BY PEDIATRICIAN.
delayed transient numbness in his face; delayed transient numbness in his hands; This spontaneous case was reported by a physician and describes the occurrence of HYPOAESTHESIA (delayed transient numbness in his face) and HYPOAESTHESIA (delayed transient numbness in his hands) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jan-2021, the patient experienced HYPOAESTHESIA (delayed transient numbness in his face) and HYPOAESTHESIA (delayed transient numbness in his hands). At the time of the report, HYPOAESTHESIA (delayed transient numbness in his face) and HYPOAESTHESIA (delayed transient numbness in his hands) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.
SHORTLY AFTER RECEIVING THE DOSE, THE PATIENT FELT NAUSEOUS AND ASKED TO GO TO THE RESTROOM.  I BROOUGHT HER A GARBAGE CAN BECAUSE I DIDNT WANT HER OUT OF MY SITE.  I GAVE HER A COLD BOTTLE OF WATER AND MINTS. SHE TOOK ABOUT 8 MINUTES UNTIL SHE STATED SHE WAS FEELING BETTER, BUT WEAK.  HER MOTHER CAME TO SIT WITH HER FOR 20 MINUTES THEN TOOK HER HOME.
Information has been received from a health professional concerning a 12 year old male who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot# 659730/1781U). On 22-FEB-2008, the patient experienced injection site redness and swelling. Subsequently, the patient recovered. No product quality complaint was involved. Additional information has been requested. Follow up information for the health professional indicated that on 22-FEB2008, the patient has developed a 2% inch hard red bump and swelling. Treatment was not reported.
Medical history included Mitral valve prolapse, Hypothyroidism and white blood cell count never came back to normal after cancer treatment. Concomitant medication included levothyroxine. The patient previously received first dose of BNT162B2, Lot number EP7534, expiration date 31Jul2021, on 27Mar2021 in left arm and experienced sore after the first dose. The patient received her second Pfizer covid 19 shot on Saturday 17Apr2021. After the second dose of the vaccine, the patient woke up in the middle of the night at 3:00am on Sunday 18Apr2021 and she had a sore arm from the shot and the next day it was in and out. Yesterday, 20Apr2021 the patient started getting dizzy, having nausea, vomiting, no fever, the patient threw up 4 times that day. Today she felt like throwing up but was eating things that were safe. She still had this queasy tummy and a headache on 21Apr2021. Her stomach was still like an ocean and she still isn't feeling well. She slept like 12 hours on Sunday. Her arm burned as soon as the pharmacist put the vaccine in, it was sore just at the site. The outcome of Nausea, Vomiting/ threw up 4 times, Dizzy, Headache, still isn't feeling well was not resolved. The outcome of other events was unknown.  No follow-up attempts are needed. No further information is expected.
Initial report received from a consumer on 03 Dec 2009: The patient, 36 months old mistakenly received treatment with FLUVIRIN, on an unspecified date. No adverse event was reported.
pt recvd vax 5JUN95 & cried when vaxed;w/in 20-30seconds p/vax pt's eyes opening & closing as if about to fall asleep;pt became pale, limp & devel circumoral cyanosis & bradycardia;MD immed started stimulating pt-tickling bottom of feet
soreness in arm (where shot was administered), headache, achiness in muscles and joints, severe fatigue, overall feeling of malaise
Hives in left foot, around the toes.  Received shot at 9:30 AM reaction at 3:30 PM.
Shortness of breath and chest tightness, feet tingling, immediately following H1N1 vaccine. Sent to ER. Dx. Acute allergic Rx/ Urticarial Angioedema. Given (Benadryl, Ativan, Prednisone and IV Solumedrol in ER).Follow-up information received 1/26/10; vaccine administration date 12/11/09, 09:05 am; adverse event onset date 12/11/09, 09:15 am.
Patient received bivalent booster on 10/15/2022 and then again received an incorrect extra booster 2/18/2023
Patient felt faint and began sweating profusely. Patient said something in the middle of her chest. She recovered after another 5 minutes and said she felt better.
around 2 p.m. on 4/12/2021, while at work, I started to break out in hives on both arms, a large part of my right leg, and part of my left leg. It was bright red, very itchy, and hot to the touch. I put Cortizone cream on the areas and also took a Benadryl. This morning, 4/13/2021, no more redness or itching. I'm concerned though because something like this has never happened to me before as I'm not allergic to anything. I assume it is a side effect of the vaccine, but am not sure.
arm was sore; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (arm was sore) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced MYALGIA (arm was sore). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 15-Apr-2021, MYALGIA (arm was sore) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 130-180 (abnormal) 130-180.     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.
SHORTNESS OF BREATH, LOW OXYGEN LEVELS, ADMITTED TO HOSPITAL, MAB TREATMENT
This solicited report was received from a 66 year old male patient referring to himself enrolled in a Market Research Program. The patient's concurrent conditions included diabetes and high blood pressure. Concomitant therapies were not reported. On an unspecified date in September 2016, reported as Fall 2016, the patient received a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) in the arm (unspecified) (dose, route of administration, lot number and expiration date were not provided) for pneumonia. In Fall 2016, the patient experienced a little bit of swelling in the arm after getting the pneumonia shot (injection site swelling). After 2 days, reported as lasted a day or 2, the patient recovered from injection site swelling. The reporter considered injection site swelling to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown). Additional information has been requested.
next day mild headache (next morning) for  3 hours  inflammation of the inferior lips ( 1 month ago i was inyected with fillers). for 2 hours
Pt. received yellow fever vaccine on 5/25/10.  He developed a body rash on 6/2/10.  Rash is pruritic.  He states rash is improving.  He reported this event on 6/9/10.
got so sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 90-year-old female patient received BNT162b2 (BNT162B2), in Aug2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "dementia problems" (unspecified if ongoing), notes: dementia problems. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "recovered", described as "got so sick".  Additional information; Warm transfer from name with Pfizer Medical Information, GRACE: INT-#. Caller was told by the CDC to contact Pfizer. She had her first Pfizer BioNTech COVID-19 Vaccine at the end of Aug and 10 days later she had the second dose administered. Her sister gets the flu vaccine but got so sick one year. She looked at her age and if anything happens and looked in the newspaper and television and people were dying like flies. She got the vaccine because of family. She states her sister got the basic vaccine and her and her husband got the vaccine and was really sick for 3 days. Her sister went religiously right after she remembers her getting very sick. She told her sister the flu shots are brought around and she read in the paper the flu shots wasn't effective. Her sister and her brother in law are both 90 years old and have dementia problems. Her sister is the only one she has left of 7. She can't understand what you are saying anymore and her husband is in the same boat. She states this is a very sad way to live this long only for your brain to go.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient was given a concentrated dose of Pfizer. Diluted with 0.8ml of sodium chloride instead of the 1.8ml
Pt. states that after receiving the 2nd dose of Moderna 05/11/2021, started experiencing loose stool, chills, memory loss, muscle spasms throughout the body, and difficultly walking/balance. Vertigo feeling still continuing with headaches on/off. Neurologist visit (estimated mid-May) with recommendation of Physical Therapist. Joint pain throughout with left hand loses grip with weakness.
Every single time my sons get the flu shot they come down with the flu; They don't always work; Initial information received on 16-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp (patient's mother) via social media.  This case involves an Adult male patient who every single time got the flu shot came down with the flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) 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 and expiry date: not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date the patient developed a non-serious "every single time my sons get the flu shot they come down with the flu (influenza)" (unknown latency) following the administration of INFLUENZA VACCINE. On an unknown date the patient developed a non-serious "they don't always work with no adverse event (drug ineffective)" (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Every single time my sons get the flu shot they come down with the flu one son was so bad he was on a nebulizer and a z-pack they thought it might have been covid but it wasn't bad bad case of the flu so don't tell me shots work they don't always work."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  Nebulizer and a z-pack was received as a corrective treatment for the event (Every single time my sons get the flu shot they come down with the flu).  At time of reporting, the outcome was Unknown for the event every single time my sons get the flu shot they come down with the flu.; Sender's Comments:  SanofiPVPortal20220124000809:
UPPER ARM IS HARD & SWOLLEN, TENDER TO THE TOUCH, LIMITED RANGE OF MOTION WHEN RAISING ARM.MEDICAL XRAY SHOWED NOTHING. PT TAKING IBUPROFEN 600MG TID & IS RESPONDING.
On Tues, April 20, I began to get an tingle/itch all over my body. By 9:30pm, both of my legs and feet began to tingle, ache, and have a burning sensation, but they were cold to the touch. This intense sensation continued throughout the day on Wednesday, April 21. I visited urgent care on Wednesday at 2:45pm. After the physical exam, the PA could not find any life-threatening symptoms (Temperature 97.3 degrees, BP 174/84, pulse 88, strong pulse in both feet) and I was instructed to return home and take Aleve. It is 11:30pm on Wednesday, April 21 and the burning, tingling, and pain has not subsided even after taking the Aleve. I don?t what to do because the sensation will not go away.
On the second morning after the first vaccine shot, I felt faint and couldn't stand for more than a few minutes without nearly passing out. Starting the fourth morning after, this became a regular issue and I could barely get ready for work and had to teach sitting down or I'd start fainting. It was bad in the morning and got better as the day went on. That lasted for a few weeks. I also had cold sweats a few nights and enormous swelling and redness at the injection site. I had other symptoms but I can't recall a year later. The doctor said I had orthostatic hypotension, which I'd never had a problem with in the past.   The second morning after the second vaccine shot, I also felt faint and couldn't stand for more than a few minutes but that did not last weeks like with the first shot. I had some swelling and redness at the injection site and might have had cold sweats a few nights.
Tetanus shot was given on Friday, June 5th appointment was at 9:15 for a physical. Left arm hurt immediately after and began to swell and was very hot continued for 4 days. Got very hoarse the following day and completely lost voice for 2 1/2 days and now voice is barely coming back but very very hoarse.(6-9-2009)