chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaginal bleeding- reported.  Diaper filled with pink tinged urine. Episode at 2145 and the following morning around 0700.
Patient's husband informed us that on 4/20/21 Wednesday 2 days after vaccine administered patient  had fever, chills, nausea, trembling and vomiting not being able to keep anything in stomach.  On Friday 4/22/21  patient went to er with a full body rash 65 to 70% head to toe torso, head, neck face and arms.  Er did not think reaction from vaccine.  She was given steroid and Benadryl and sent home with prednisone and Benadryl.  On 4/25 started feeling better and on 4/26 was fine.
Information has been received from a nurse concerning a "13 or 15 year old" female patient who "within the last two weeks", on approximately 28-JAN-2010, was vaccinated intramuscularly with her first 0.5 ml dose of GARDASIL (Lot # 663694/1316Y). It was reported, that immediately after receiving the GARDASIL the patient fainted. The patient recovered on the same day. The patient sought unspecified medical attention. Additional information has been requested.
Around 09/04 or 09/05, I had nausea and vomiting and pain in my right shoulder and down to my shoulder blade. The symptoms lasted for like 5 days, I adjusted my diet and my symptoms changed a little bit.  I notice what was happening, and I figured out it was my gall bladder because I have had issues with my gall bladder before . I changed my diet and the symptoms alleviated a little .  09/20/20 - I had an appointment with my gastroenterologist. He said my symptoms were consistent with gall bladder disfunction. He will do more diagnostics to confirm it.    10/11/ 2021 I have an appointment to have a scan to do some diagnostics,  and then monitor it from there.
Presented to hospital with complaint of diarrhea, nausea, vomiting, shortness of breath.  Admitted for COVID19 19 infection related pneumonia.  Treated with the steroids, O2, abx, VitC, zinc; dc'd home w/O2
administer expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patient, after the manufacture date of expiration) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter. The vial did not undergo any temperature excursions. Date vial was initially stored in the refrigerator was unknown. Total of 168 doses were given from LOT 048C21A with expiration date 09-Nov-2021. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up contains non-significant information.
A mother reported that her infant son received  his first doses of Prevnar, diphtheria, tetanus and acellular pertussis (manufacturer unknown), haemophilus influenzae type B (manufacturer unknown) and IPV (Aventis Pasteur SA) vaccines on 8/2/012 and that same day, began crying and developed an injection site reaction characterized by redness, swelling and hardness. As of the date of this report, no further information was available. Information regarding this event has been forwarded to Aventis Pasteur, manufacturer of IPV. See related report:HQ6416326SEP2001. Additional information rec'd 10/9/01 indicated that the pt recovered. The lot number for Acel-imune was reported as UO515AA; the lot number for Hib-TITER was reported as UA604AA; however, these are not valid Lederle lot numbers.
This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (Loss of Energy), HEADACHE (Headache), NAUSEA (NAUSEA), CHILLS (Chills) and PYREXIA (Low grade fever) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L28) for COVID-19 vaccination.     The patient's past medical history included no adverse drug effect.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced ASTHENIA (Loss of Energy), HEADACHE (Headache), NAUSEA (NAUSEA), CHILLS (Chills) and PYREXIA (Low grade fever). In February 2021, ASTHENIA (Loss of Energy), HEADACHE (Headache), NAUSEA (NAUSEA), CHILLS (Chills) and PYREXIA (Low grade fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   There is no concomitants drugs information was provided. No treatment information provided.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2021 at 13:45 as dose 1, single (Lot number: EN6201), in left arm, on 11Mar2021 at 13:00 as dose 2, single (Lot number: EN6206), in right arm and on 17Aug2021 at 16:00 as dose 3 (booster), single (Lot number: EW0179) at the age of 63 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Feb2022 at 10:30 as dose 4 (booster), single (Lot number: 045L21A), in left arm and on 29Jul2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "psoriatic arthritis" (unspecified if ongoing); "overweight" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient received other medication in 2weeks. Anti-viral details for COVID 19 Treatment included Paxlovid, treatment start date: 01Sep2022 and treatment stop date: 05Sep2022.
A rash of small, raised, pink bumps that started on his back, spread the next day to his butt and legs, then the next day to his face, neck and arms.  On day 3 it began to itch in select places (butt and legs) and began to fade in approximately the order in which it appeared.  We applied OTC cortisone for itching and consulted our pediatrician.
Severe nerve pain in both feet. Couldn't walk. Plantar fascitis ruled out by hospital tests  Pain lasted 18 months. Virtually disabled by it. Initially both feet swelled up to twice their size and when swelling went down after two days, the pain started. I still suffer on and off with it. GP prescribed gabapentine. And naproxen. Steroid injections in soles of both feet.
PATIENT WAS SCHEDULED FOR A SECOND DOSE OF MODERNA COVID VACCINE BUT THE PATIENT RECEIVED A DOSE OF JANSSEN FIRST. THE PATIENT DID NOT NEED A DOSE OF MODERNA
She does feel she is getting sleep; annoyed; left eye twitching; both eyes feel as if she has cried for a long time; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# either GL0140 or EL0140, Expiry date and NDC number were not written), via an unspecified route of administration in left arm on 23Dec2020 at single dose for COVID-19 immunization.  There were no medical history and concomitant medications. Patient pregnant: No. She has had No positive test for covid before the vaccine, and No Antibody test before the vaccine either. She has had No issues with vaccines in the past. The patient had the vaccine on 23Dec2020 and then on 01Jan2021 she began to experience eye twitching and it hasn't gone away and it's very bothersome. It's still happening. Her first dose was on 23Dec2020. The eye twitching began on 01Jan2021, it's just the left eye, she can see the eye lid moving when it twitches, she felt it, like the eyeball itself was twitching or spasming. There were no issues with the vision in that eye. She did feel she was getting sleep, she was conscious about seeing if she was tired, both eyes felt as if she had cried for a long time but she had not cried at all and the eye that was twitching she felt it more in. She thought it was getting better in the morning because at that time she didn't feel it, but by mid-afternoon it was consistent. The twitching happened often sporadically every couple of minutes, and she was annoyed of it. Investigation Assessment: No. The outcome of the event left eye twitching was not recovered, outcome of other events was unknown.
Pt recvd Td vax & devel body ache, fever, back pain, & an "extremely low" platelet count; Platelet count returned to normal in approx 4 days;
warmth at injection site and spread across forearm; redness at injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warmth at injection site and spread across forearm) and VACCINATION SITE ERYTHEMA (redness at injection site ) 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 24-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (warmth at injection site and spread across forearm) and VACCINATION SITE ERYTHEMA (redness at injection site ). At the time of the report, VACCINATION SITE WARMTH (warmth at injection site and spread across forearm) and VACCINATION SITE ERYTHEMA (redness at injection site ) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable No concomitant medications were reported No treatment drugs were reported
Pt received 2nd Pfizer vaccine in right arm at 1439. Pt complained of swollen tongue and left side of face at 1515. Pt immediately transported to ED via wheelchair for further evaluation and care. LPN called ED Charge RN to give report
I went on vacation and came back with the flu, I don't blame the vaccine. I saw my doctor, he prescribed me inhaler.
Administration error. A 63 year old male received 0.5 mL of Td intradermally instead of a PPD, on 02/14/11. The patient developed redness, swelling, pain and warmth at the injection site, immediately after receiving the vaccine. The patient was advised to treat the symptoms with an ice pack. Patient also received a PPD on the same day. Patient recovered by 02/18/11.
Client has extensive scar tissue on both arms. First attempt at vaccination today was unsuccessful-- the needle was not entering the tissue correctly. No dose was given in this attempt. Whole syringe and needle with dose inside was wasted. New dose attempted with success in right arm, full dose administered.
Fever within 4 hours that lasted 24 hours, then on 7/15 noted whole body red, splotchy rash that got progressively worse by 7/16. Not yet resolved (as of 7/16)
Acute Pulmonary Embolism, and Acute Deep Vein Thrombosis. He is active every day doing arm exercises and walking in place for exercise, and moving about his house with his walker, and this day was no different. He finished making breakfast and went to sit down on the couch, and had sudden-onset pleuritic chest pain. No other recent risks such as long car ride, illness, plane ride, or other immobility. Patient says the vaccine was Moderna second dose, given at pharmacy.
Chills, fever, muscle aches and nauseous. Vomited twice; Chills, fever, muscle aches and nauseous. Vomited twice; Chills, fever, muscle aches and nauseous. Vomited twice; Chills, fever, muscle aches and nauseous. Vomited twice; Chills, fever, muscle aches and nauseous. Vomited twice; This is a spontaneous report from a contactable Other Health Professional that reported for herself.  A 25 year old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL9262 on 26Jan2021 09:00, as single dose (at the age of 25 years) via unspecified route in left arm for COVID-19 immunisation. The patient medical history was not reported.  Concomitant medication includes fluoxetine (FLUOXETINE).  Historical vaccine included dose one of BNT162B2, lot number EL0142, on 07Jan2021 11:30, unspecified route, vaccine location Left arm for COVID-19 immunization. The patient did not have Allergies to medications, food, or other products.  The patient was not pregnant at the time of vaccination.  Prior to vaccination, the patient was not diagnosed with COVID-19.  Since the vaccination, the patient has not been tested for COVID-19.  The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine.  On 26Jan2021 at 20:00 the patient experienced chills, fever, muscle aches and nauseous. The patient vomited twice. No treatment was given.  The patient is recovering from Chills, fever, muscle aches and nauseous as well as vomited twice.  The case was reported as non-serious by the reporter.
The patient received a dose that was expired by 2 days. I confirmed with the manufacturer and CDC guidance that the patient was in no imminent danger and they should redo their dose with no limitations on a waiting period for their specific demographics. The patient has been scheduled to receive their vaccine and is aware of the incident.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP), Program ID:  The reporter is the patient. An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna, for COVID-19 immunization, reaction(s): "no adverse effect". The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "I felt like I was being programed"; OFF LABEL USE (non-serious), outcome "unknown"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown".  Additional information: She felt like she was being programed. She had both types of COVID shots she reacted to Pfizer not to Moderna.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
double vision; This case was reported by a consumer via call center representative and described the occurrence of double vision in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2019, the patient received the 1st dose of Shingrix (intramuscular). In July 2019, 3 days after receiving Shingrix, the patient experienced double vision. In July 2019, the outcome of the double vision was recovered/resolved.   It was unknown if the reporter considered the double vision to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported that he received the 1st dose of Shingrix approximately 3 to 4 days ago and three days later he experienced double vision. He went to the emergency room and they did an Magnetic resonance imaging and found nothing. The double vision resolved within 24 hours. The reporter consented to follow up.
7/25/07 Patient presented to clinic with vesicles all over. Afebrile. Over 100 lesions. Patient received Varivax on 7/3/07. Denies hx of exposure to disease. Aveeno, Benadryl, Calamine, Tylenol. No ASA.
I GOT THE SEASONAL FLU SHOT AND THE SECOND PNEUMONIA SHOT IN MY LEFT ARM. I DON'T KNOW WHICH  PRODUCT WAS USED. MY SHOULDER WAS SWOLLEN AND PAINFUL THE FIRST NIGHT. THE NEXT DAY I WAS VERY SICK AND IN BED ALL DAY WITH SEVERE PAIN WITH SHOULDER MOTION UNABLE TO ELEVATE TO 90 DEGREES. WHEN I WENT TO BED AT 10 PM, I KNEW I WAS DEVELOPING A FROZEN SHOULDER AND STARTED DOING STRETCHING EXERCISES RESULTING IN 80% OF ROM. OVER A WEEKS TIME..
Information has been received from a physician referring to unspecified patients of unknown age and gender. No information about medical history, concurrent conditions were reported for the patients. On unknown dates, the patients were administered with improperly stored doses of VAQTA (dose, strength, route, lot # unspecified). No adverse effects reported. This is one of the several reports received from the same source. Additional information has been requested.
THERE IS TECHNICALLY NO ADVERSE EVENT TO REPORT. THE 3RD DOSE WAS ADMINISTERED ONLY 100 DAYS AFTER THE 2ND DOSE AND THE PATIENT IS NOT IMMUNICOMPROMISED. THE PATIENT HAS REPORTED NO ILL EFFECTS THUS FAR
Patient received the vaccine on 9/10/21, on 9/13/2021 the patient started experiencing heart flutters, on 9/16/2021 the patient began experiencing shortness of breath, heart palpitations and generalized weakness.
Pt developed malaise, bilateral soft tissue facial swelling (pre-auricular). No other symptoms.
?Covid? arm, large swollen area on injected arm that is itchy, red, swollen, and warm to the touch. About 2 inches in diameter. Only found in the one area on body
The same flu vaccine was administered twice with 1 week apart between doses. Patient is being monitor for any potential adverse event. No adverse event have been identify as of today 9/22/23.
COULD NOT MOVE ON; FELT TERRIBLE; SWEATING; COUGH; FEELING SICK; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age, race and ethic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received vaccination with covid-19 vaccine ad26.cov2.s (series 1) (suspension for injection, route of administration not reported, and batch number: JNJ041A21A and expiry: Unknown) dose was not reported, administered in right arm on 07-APR-2021 for prophylactic vaccination. On unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1), The patient experienced chills and headache on 07-APR-2021 and events cough, could not move on, feeling sick, felt terrible, fever and sweating on 08-APR-2021 (all events dose number in series 1) . The patient received of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of administration not reported, batch number: Unknown and expiry: Unknown) dose was not reported, administered on 29-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 29-OCT-2021, After receiving the booster dose of JNJ the patient experienced same effects as (dose number series 1). On unspecified date he could not move on, felt terrible, sweating, cough, feeling sick, chills, fever and headache(all events dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. Outcome on events could not move on, felt terrible, sweating, cough, feeling sick, chills, fever, and headache was unknown. This report was non-serious. This case, involving the same patient is linked to 20210421476.
nausea/there was nothing in my stomach to throw up (dry heaving); nausea/there was nothing in my stomach to throw up (dry heaving); she hasn't been able to eat today.; Moderately severe headache; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6200, Expiration Date: 30Jun2021) via intramuscular route in left arm on 23Feb2021 at 10:30 (at the age of 65-years-old) as 2ND DOSE, SINGLE for covid-19 immunisation. Previous vaccine included first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9265, Expiration Date: 31May2021), administered in left arm on 02Feb2021 10:00 for covid-19 immunisation. After first dose, she had a little sore arm but no problem. Medical history included atrial septal defect diagnosed about 10-12 years ago approximately. The patients concomitant medications were unknown. On 23Feb2021, about 18:00, the patient started getting headache. The next morning on 24Feb2021 at 03:00 AM, woke up with a terrible headache and nausea, took 200mg ibuprofen with no effect. At 13:00 took 650mg of acetaminophen. Headache gradually subsided and was gone by about 18:00 on 24Feb2021. At around 8 or 9 it was much worse and nausea but there was nothing in her stomach to throw up (dry heaving). For the headache she had a hard time staying up and needed to lay down all the time. She hasn't been able to eat today. She took Advil early in the morning and it did nothing, she took one 200mg, LOT: ME2776A, EXP: September 2021. She says that she took Tylenol 325mg, she took two of them, LOT P120074, with EXP April 2023, the UPC must have been on an outer box that was discarded. She says that the Tylenol she took a few hours ago and helped a little. She got the vaccine she was told if she had a little headache or fever to take some Tylenol or Advil, but she has normal headaches off and on, one or so a week, which she usually takes Excedrin for that and it works, she has never had Tylenol. She says she would like to know if there might be a reason not to take Aspirin for this, and also if it doesn't get better in x amount of days, when should she seek medical care? She says reading through the paperwork she thinks it would be two days. She gets headaches occasionally. Excedrin Migraine is that ok to take for this the patient asked. Usually, Tylenol does not work for her. Ibuprofen did not help, did not make it go away. The outcome of the event for sever headache was recovered and for other events it was unknown.
Information has been received from a nurse practitioner concerning a 8 week old male infant with presumptive milk soy protein intolerance who on 11-JUN-2008 was vaccinated with ROTATEQ. Concomitant vaccination on the same day included PREVNAR, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown), poliovirus vaccine inactivated (unspecified) (manufacturer unknown), PEDVAXHIB and RECOMBIVAX HB. It was reported that the patient developed diarrhea and blood in stools following the administration of the vaccine. On 14-JUN-2008 the patient developed loose green stools 3 days after receiving the vaccine. On 17-JUN-2008 the patient had clumps of blood in the stool. There was no fever or vomiting. The patient was just fussy. Medical attention was sought, the physician was contacted. A stool culture was performed. The stool culture was positive for rotavirus and negative for "OMP." It was noted that the patient was being treated with PEDIALYTE. At the time of the report the patient has not recovered. There was no product quality complaint involved. Upon internal review "clumps of blood in the stool" was considered an other important medical event. Additional information has been requested.
Presented to the ED for confusion. Admitted for acute UTI. Tested positive for COVID-19 six days into stay but was asymptomatic