chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Opened box of Adacel Tdap 49281-0400-10 and the last remaining vial in the box was not labeled. Since we are unable to confirm the identity of the product for safe use it was disposed.
Hypersensitivity Rxn s/p PNEUMOVAX. Erythema, induration (L) post arm, decreased ROM.
Twelve hours after the shot, I had dramatic, onset of symptoms -  I had a cough, runny nose, chills, upset stomach, headache, elevated blood pressure. irregular heart beat and my heart rate was high - 103.   That night I couldn't sleep due to the chills and cough.  I slept most of the following day and that night.  I had no energy and couldn't eat.
Pain, swelling, and a lump at the injection site a full week later. Hasn't gone down or improved at all.
Redness at the injection site; Pain on and off on the arm of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain on and off on the arm of the injection) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Bronchiectasis and Seasonal allergy. Concomitant products included BUDESONIDE;FORMOTEROL and FLUTICASONE;VILANTEROL for COPD and Bronchiectasis, XYLOMETAZOLINE HYDROCHLORIDEunited states (NASAL SPRAY II) for Seasonal allergy.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain on and off on the arm of the injection). On 10-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain on and off on the arm of the injection) had not resolved and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Itching, burning rash on arms, legs, stomach and back; Itching, burning rash on arms, legs, stomach and back; hives are getting worse and lasting longer each day; This spontaneous case was reported by a dentist and describes the occurrence of RASH PRURITIC (Itching, burning rash on arms, legs, stomach and back), SKIN BURNING SENSATION (Itching, burning rash on arms, legs, stomach and back) and URTICARIA (hives are getting worse and lasting longer each day) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 39K204) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism since 2008 and Allergic to cats. Concomitant products included THYROID (ARMOUR THYROID) for Hypothyroidism.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Itching, burning rash on arms, legs, stomach and back), SKIN BURNING SENSATION (Itching, burning rash on arms, legs, stomach and back) and URTICARIA (hives are getting worse and lasting longer each day). The patient was treated with CORTISONE for Itchy rash, at a dose of 1 dosage form. At the time of the report, RASH PRURITIC (Itching, burning rash on arms, legs, stomach and back), SKIN BURNING SENSATION (Itching, burning rash on arms, legs, stomach and back) and URTICARIA (hives are getting worse and lasting longer each day) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was prescribed antihistamines for events.   Events started 1 week after first vaccine and were worsened after second vaccine. The rash responds to cortisone tablets but comes back as soon as treatment stops.   This case was linked to MOD-2021-028881 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Patient demographic, medical history, concomitant medications , event verbatim updated. On 05-May-2021: No significant information was received. On 05-Jul-2021: Significant FU: Patients allergy history  and event updated
Confirmed with caller no other AE occurred; a 26 week 5 day old patient received their first dose of ROTATEQ on 5/31/2023.; This spontaneous report was received from a medical assistant and referred to a 26-week-and-5-day-old patient of unspecified gender. The patient's pertinent medical history, current conditons, previous drug reactions or allergies, and concomitant medications were not reported.  On 31-MAY-2023, the 26 week and 5 days old patient received the first dose (also reported as 1 dose) of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) administered orally as prophylaxis (strength, dose, and vaccination scheme frequency were not reported; lot number 1879875 that was verified to be valid with an expiration date reported and established as 19-NOV-2023) (product administered to patient of inappropriate age). The reporter confirmed that no other adverse event (AE) occurred.    This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2305USA010555:
The Pfizer was drawn up by pharmacist and given to technician to administer to patient. The Pfizer syringe was sitting on the paper work. Tech knew to give that Pfizer syringe but reached for the Moderna one in the red basket. Realized it right when it was injected.
MISSED THE THIRD DOSE; This spontaneous case (PVX2019-1491) was received from a consumer on 10-Jun-2019. It describes a 46-year-old adult female consumer who "missed the third dose". The consumer was receiving Vivotif for an unknown indication.  Case report: The consumer took the first two doses of Vivotif on 05-Jun-2019 and 07-Jun-2019, respectively. She missed her third dose which was due on 09-Jun-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed the third dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the third dose" was considered as not applicable.
The first night I had about 1/3rd cup of a clear slimy no oder discharge. Very weird! Then # nights later in the middle of the night I started bleeding vaginally. it was at least 2 to 3  tablespoons every 30 minutes to an hour. I am 58 and not had a period for 15 years!  I had terrible pain and bloating. I became light headed and weak, I had chills and a slight fever. This lasted three days. I went to urgent care, they sent me to my doctor. they ran tests and could not find any reason for my bleeding. It has since stopped but I still have some pressure by my overies.
Initial misuse report received from a health care professional on 29 October 2013. The cases were received on 21 March 2014 at GPV. A 2-year-old patient received 0.5 ml dose of FLUZONE instead of 0.25 ml (no other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
not able to take her second dose because of pancreas problems and ulcers; Caller said that she had pancreatitis and she has gull stones and they think it was related to that; She developed nausea and started throwing up blood; It started with like a cold flu type of thing; She developed nausea and started throwing up blood; The ulcer was from all of the stomach acid and was near her esophagus and stated that it developed from the strong acid; Caller said that she had pancreatitis and she has gull stones and they think it was related to that; This is a spontaneous report from a Pfizer Sponsored Program by a contactable consumer reported for self. This 37-years-old female patient received bnt162b2, via an unspecified route of administration injection in the upper left arm on 08May2021 17:30 at age of 37-year-old (Lot Number: EW0179, Expiration Date: 31Aug2021) at DOSE 1, SINGLE for COVID-19 immunisation. Medical history included Blood pressure. Concomitant drugs included ongoing Amlodipine 1 tablet a day by mouth sometimes every other day for Blood pressure. The patient previously received Tetanus vaccine and experienced soreness. None prior vaccinations within 4 weeks. She received her first dose on 08May2021 and she was not able to take her second dose because of pancreas problems/ pancreatitis and ulcers and hospitalization from 22Jun2021 to 25Jun2021. She said that she wants to know if she can take her second dose. She had pancreatitis and she has gull stones (Jun2021) and they think it was related to that. It started with like a cold flu type of thing. She developed nausea and started throwing up blood. The ulcer was from all of the stomach acid and was near her esophagus and stated that it developed from the strong acid. She is on some acid reducers and blood pressure medication she was already on. This started on the weekend prior to her hospitalization. It started with her cold and flu symptoms and just kind of escalated. AEs require a visit to Emergency Room and no Physician Office. Outcome of the event developed nausea and started throwing up blood, ulcer was from all of the stomach acid and was near her esophagus and stated that it developed from the strong acid was recovered. Outcome of other events was recovered on Jun2021.  Follow-up attempts are completed. No further information is expected.
Reported to Employee Health on 11.16.18 that she has fine red itchy rash on right forearm that began on morning of 11.15.18. Also reported rash on nape of neck. She had applied BENADRYL cream, stated it stopped the itching and rash was subsiding. 11.16.18 1030, fine, red rash observed on right forearm and none on nape of neck. 1510 she called Employee Health stating she felt like the rash was worsening and felt something "funny" in her throat. Advised her to contact Healthcare Professional (personal doctor) and to follow-up with Employee Health 11.19.18.
2 days after receiving the vaccine I have been diagnosed with Deep vein thrombosis and pulmonary embolisms.
Nerves tingling, insomnia, headaches, diarrhea, feet sweating, extreme nights sweats, eustachian tube malfunction, fluid in both ears, fight or flight anxiety, whole body felt inflamed, TMJ, vision changes, cant go up hill  Started B-12 shots, LEXAPR, XANAX (First 2 months); Holistic physician started her on several supplements to help with inflammation
The vial was exposed to room temperature for 73-74 hours; The vial was first punctured on 13-May-2022 and administered on 16-May-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was first punctured on 13-May-2022 and administered on 16-May-2022) and PRODUCT STORAGE ERROR (The vial was exposed to room temperature for 73-74 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-May-2022 at 9:28 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-May-2022 at 9:28 AM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was first punctured on 13-May-2022 and administered on 16-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was exposed to room temperature for 73-74 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was first punctured on 13-May-2022 and administered on 16-May-2022) and PRODUCT STORAGE ERROR (The vial was exposed to room temperature for 73-74 hours) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that a vial of Moderna vaccine was punctured on 13-May-2022 and it was pulled out on 16-May-2022 and punctured to administer a few doses. On 13-May-2022, the vial was initially stored in the refrigerator. On 13-May-2022 at 08:00 AM time, the vial was first punctured. The vaccine was administered on 16-May-2022 at 9:28 AM Pacific time to the patient. The vial was stored in the room temperature post puncture. Reportedly, the vial didn't undergo any temperature excursions and the total amount of time the vial exposed to room temperature range (8° to 25°C= 46° to 77°F) was 73-74 hours.  No treatment information was provided.
At the 15 minute monitored time patient sitting in chair states, "I dont feel so good". Patient's eyes rolled back and she stooped over to one side-PHN grabbed patient to prevent her falling out of chair. Patient remained AOx3 but complained of "off equilibrium and feeling dizzy" patient unable to sit erect without assistance. PHN directed MSA staff worker to call 911 and ambulance dispatched.
The pt received varicella vaccine on 11/19/2001. On 11/26/2001 mother called to report development of tiny pin-point rash on chest and back with tiny whale papules on the lesions) described as mildly itchy. No fever and no other sign of illness. Mother complained of pruritic rash at the office visit prior to immunization. Lesion continued for 7 days.
he received Pfizer vaccine 2/5 and got symptoms a few weeks after the vaccine.  She experienced a lot of chest pain at work and went to healthcare facility and was diagnosed with pleurisy. She received steroid treatment and a steroid shot and then received another 3 rounds of steroids - this was through February, March, and April.  She saw a pulmonologist 5/20 and CT scan done again and CXR. She was diagnosed with pulmonary edema and elevated calcium levels. She was started on some pain medicine at that time and a steroid. After she came off steroids, was in a lot of pain and had to stop working. Diagnosed with recurrent pericarditis.
10 hours post injection: severe headache, muscle aches, severe nausea,  (hit by a truck or bad flu symptoms), tiredness and injection site pain. Took Advil at 24 hour mark. Still feel awful. The materials given by the pharmacy did not mention whether Tylenol or Advil would help with the symptoms. Neither does the vaccine's website. For patients getting vaccinations at pharmacies, we need more info on treatments to try in the middle of the night when nothing is open! I was wary of using Advil as it often irritates my stomach.
I am breastfeeding (14 weeks postpartum). I became engorged and was diagnosed with mastitis less than 1 week after receiving my vaccine despite no changes to my breastfeeding routine or other obvious triggers for such infection (e.g., I am not weaning, etc.). The infection caused a fever in excess of 102, which came down after 1 dose of antibiotics, but swelling in the breast and decreased milk production persisted for several days.
Within an hour after injection, my face, around my mouth,  felt a tingling and slightly numb.  Inside of mouth felt strange.  I did not have trouble breathing or swallowing.  Symptoms gradually went away and later in the day I had a headache.
Family reports acute onset facial swelling and scratchy throat within hours of HPV vaccine, required ED visit. Also c/o lightheadedness.
Went to ER -> Pt experienced high fever, seizure & prolonged crying x 2 wks. Also with increased tone in lower extremities.
The morning after receiving the shot I ran 104 fever all day 102 with Tylenol was very tired and slept through to Saturday Saturday was running between 102 and 100° temperature with Tylenol cannot take Advil. I was experiencing headaches all day. The following morning on Sunday I woke up and passed out, I guess my blood pressure dropped and I don?t know why and this is never happened.  Had no appetite since Friday and maybe that?s why but my BP is 120/60 as of 10:08am AFTER I passed out at around 8:30am. I?m now feeling better all of a sudden, can drink coffee and hopefully I?ll get a shower....... oh and my joints are sore, I think whatever could go wrong , did!
I have dermal fillers under my eyes and after the second dose my under eyes are swollen 2 days later.; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 28Apr2021 at 16:15 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included derma fillers under the eye (Derma filler injection). Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 07Apr2021 at 15:45 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had dermal fillers under the eyes and after the second dose under eyes were swollen 2 days later on 30Apr2021 at 08:00. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event eye swollen which included treatment with lisinopril (MANUFACTURER UNKNOWN) 10 mg. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event under eyes were swollen was recovering at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient had no known allergies.  The patient received covid-19 vaccine (suspension for injection, route of admin not reported and batch number: 1808609, expiry: unknown) dose was not reported, 1 total, administered on 19-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. Patient was not pregnant at the time of report. On APR-2021, patient took 3 rapid tests at work which were negative. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Negative (for three rapid test). On 30-APR-2021, the patient experienced suspected covid-19 infection, suspected clinical vaccination failure. she went to the doctor, they performed another rapid test which was positive. Laboratory data included: COVID-19 rapid POC test (NR: not provided) Positive. On 15-JUL-2021, the patient experienced confirmed immunological vaccine failure. Laboratory data included: COVID-19 antibody test (NR: not provided) Negative for antibodies. Patient visited to doctors office. The action taken with covid-19 vaccine was not applicable. The patient recovered from suspected covid-19 infection, and had not recovered from suspected clinical vaccination failure, and confirmed immunological vaccine failure. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000190943.; Sender's Comments: V0:20210851545 -COVID-19 VACCINE AD26.-Suspected clinical vaccination failure, Confirmed immunoloical vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Had tinnitus for a couple years but able to live with it.  Noticed  a few weeks ago that tinnitus got much worse.  Have not had Covid but did have 2 Pfizer vaccines.  Started reading about others who got tinnitus or who had tinnitus get worse after vaccines.
received expired dose; received dose, Left thigh; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-year-old male patient who received HAV (Havrix) (batch number ZJ3G3, expiry date 12th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 22nd June 2022, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On 22nd June 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used and intramuscular formulation administered by other route. On an unknown date, the outcome of the expired vaccine used and intramuscular formulation administered by other route 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 Information: GSK receipt date: 23-June-2022 Reporter's comment: The health care professional reported that the patient received an expired dose of Havrix one day before the reporting, in left thigh.  With dose 2 asymptomatic results were reported.  The reporter had more questions regarding how to proceed.  Medical information, phone number and warm transfer were provided. The reporter consented to follow up. Additional supportive information: The patient received an expired dose of Havrix on left thigh, which led to expired vaccine used and intramuscular formulation administered by other route.
Patient requested/scheduled to received 0.5 ml of COVID 19 Moderna Bivalent booster. Patient was given 0.5ml of COVID 19 Moderna monovalent pediatric dosage for ages 5-11 years old. Patient reports arm tenderness at injection site, no other reported symptoms. Moderna Manufacturer notified of event, awaiting further instructions from manufacturer. Patient notified of event, and will be updated with further instructions for future COVID 19 vaccines doses, as per manufacturer instructions.
PT COMPLAINED OF RED/RAISED AREA ABOUT SIZE OF QUARTER ON 12/12/03 IN THE AFTERNOON; BY 12/13/03 RED/WARM AREA ON ARM DOWN TO ELBOW, SWOLLEN. CONTINUED WITH PAIN AND SWELLING/REDNESS UNTIL 12/16/03.  QUESTION OF REACTION TO MEDICATION VS REACTION TO ADMINISTRATION.  TYLENOL/ADVIL/BENEDRYL OR CLARITIN/WARM COMPRESSES
Chills, Fever, leg cramps, excruciating pain all over body, numbness of arms and legs where can't walk. Doctors ran numerous tests.  Antibotics didn't work, first round of steriods didn't work, then administer antibotics which did not work. The second round of steriods seems to show a small sign but body is still riddled with pain.
After 10 hours extreme pain left arm bicep; This is a spontaneous report from a contactable other HCP (patient).  A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EN6199), via an unspecified route of administration on 05Mar2021 at 02:15 pm (65-year-old at the time of vaccination) on the left arm as a single dose for COVID-19 immunisation. The patient had no known allergy. The Patient's medical history included Type 2 diabetes, prostate cancer 2019 (no signs of cancer 2020). COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. The patient's concomitant medications were not reported. On 05Mar2021, at 09:00 pm, the patient experienced extreme pain in the left arm bicep. The patient did not receive any treatment medication for the events. The outcome of the events was unknown.  No follow-up attempts are Possible. No further information is expected