chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shrill screaming, arched back, fever, excessive sleeping, rigid, cried when touched, red where shots were administered, sweating, constipation/diarrhea resulting in bowel area bleeding all resulting in death.  3/13/08 PCP medical records reviewed which reveal patient subjected to second hand smoke.  1/31/08 vs had nasal congestion, irritability, cough, red throat.  No treatment Rx.  Returned to office 2/12 w/vomiting, diarrhea, fever, diet refusal.  Dx: dehydration & tx w/fluids & antipyretics.  Returned to office 2/22/08, found to be healthy & vaccines given. 4/4 Autopsy report states COD as SIDS & manner of death as natural. Report reveals parent was smoker.  Patient lived w/single parent & dog.  Patient placed in crib in own bedroom on side w/swaddling blanket.  Found face down in center of crib, cyanotic & limp w/very small amount of pink tinged sputum 3 hrs later. Ambulance to ER momentarily got vitals but resuscitation ultimately unsuccessful.  Investigative notes from PCP indicate patient had period of brief screaming w/rigidity followed by listlessness & lethargy 24-48 hrs after shots.
On 11/14/01, MD was sent a note stating the child had a cold. Mom said she had a temperature the night before of 100.5F, stuffy nose and chest congestion. Received shots on 11/13/01. Note also stated that the child had lower lateral thigh and right upper medial thigh was swollen and tender. Also said that child had asthma. She faxed the doctor a copy of "after the shots".
I have a rash on my left arm in three spots.  Not at the vaccine site (although thats red) but on the inside of my arm.  Happened at 7:00 on Monday after a shower.  Started in crease where my elbow bends, and now is on forearm and wrist.  Red splotchy rash.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   The patient had no adverse events.  No treatment details were reported.   This case was linked to MOD-2021-395985 (Patient Link).
Extreme itching fill body above waist (back, front, arms, face, neck). No rash, just unquenchable itching.
Extreme weakness, constipation, decreased appetite. Shortness of breath with activity. How many living in to Atrial Fibrillation and heart failure.
Arthritis of neck and lower spine, carpal tunnel, numbness of arm, fatigue, general achiness, increased liver enzymes, neuropathy of wrist, lumbar neuropathy.
This case was reported by a consumer via sales rep and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On 14th February 2019, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. The patient was treated with ibuprofen and TAMIFLU. On an unknown date, the outcome of the vaccination failure and influenza were unknown. It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season. Additional information was reported as follows: On an unspecified date, within this past flu season, the patient received a dose of unspecified influenza vaccine. On 14th February 2019, the patient was tested positive for flu. No additional information was provided. This case was considered, as suspected vaccination failure as details regarding time to onset of event was unknown.
Patient came in for a covid vaccine.  He was registered into a clinic that did not have Pfizer.  He was inadvertently given the Moderna vaccine since we did not realize he was 16.  No side effects noted.
Fever, malaise. Then flat, non-pruritic rash to abdomen and lymphadenopathy and fatigue.
Developed a rash (three spots on the inner part of the lower left arm.  It did not bother me (no itching or burning).  There was no treatment.  It went away on it?s own the next day.
Information has been received from a physician assistant concerning a 46 year old female who was vaccinated twice with varicella virus vaccine live (Oka/Merck) and subsequently has a negative varicella titer. Subsequent to the vaccinations the patient has had exposure to chickenpox and shingles, but did not develop chickenpox. No adverse symptoms were reported. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Temperature of 103.3 degrees Fahrenheit on 1/18/2021 @ 5:42pm. Acetaminophen 650mg administered as well as cold compresses.  Temperature of 101.5 degrees Fahrenheit on 1/18/2021 @ 9:18pm. Orders obtained to administer one liter of normal saline via intravenous route due to patient's poor oral intake. IV fluids initiated.  Temperature of 99.9 degrees Fahrenheit on 1/18/2021 @ 11:25pm. Patient resting comfortably.  Temperature of 98.4 degrees Fahrenheit on 1/19/2021 @ 05:47am.
Information has been received from a physicians assistant concerning a female who "a couple of weeks ago" was vaccinated with her first dose of Gardasil.  Subsequently the patient experienced shingles 2 or 3 days after vaccination.  Unspecified medical attention was sought.  There were no diagnostic or laboratory tests performed.  Additional information has been requested.
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 61-year-old female 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.   No concomitant medications were reported. The vial did not undergo any temperature excursions. The vial initially stored in the refrigerator was unknown. No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information, reporter added
This spontaneous report as received from a nurse refers to an unspecified number of patient of unknown age and gender. No information on patients' medical history, concurrent conditions or concomitant medications was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot# K02800 with expiration date 05-JUN-2016 (dose and route of vaccination were not reported). No adverse effects were reported. No concomitant medication was reported. This is one of the two reports from the same reporter. Additional information has been requested.
patient felt nauseas after getting her covid shot,  kept monitoring the patient , and then  she said she felt much better.
No known symptoms of adverse effect; Pt was given dose of Rotateq after the age of 8 months; This case was retrieve during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2427502-1. The original narrative from the sender is the following:  Pt was given dose of Rotateq after the age of 8 months, no known symptoms of adverse effect.  Due to the nature of the events, the causal relationship between Vaxelis and "Pt was given dose of Rotateq after the age of 8 months" and "No known symptoms of adverse effect" was not applicable.  No further information is expected.
Mom called approx. 0830 and stated "my got shots saturday with you all and now his arm is red and swollen."  Upon further questioning, found out from mom LUE is only swollen where shot was given with a small lump.  No fever, LOC, decrease in appetite noted.  Child able to move all extremities without difficulty.  Mom encouraged to apply cool compress to area and massage area gently.  If concern continues, follow up with primary care physician or pediatrician.
Whole body aching; Headache; Blood pressure elevated; This is a spontaneous report from a contactable nurse, the patient. A 29-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 the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS) from an unknown date. The patient received other medicines (unspecified) within two weeks prior to the COVID-19 vaccine. The patient previously received the 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 the age of 29-years-old) as a single dose for COVID-19 immunisation. The patient previously took peanut on an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 29Apr2021 at 00:00, the patient experienced whole body aching, headache and blood pressure elevated. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events whole body aching, headache and blood pressure elevated was not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Ringing in ear, continued to get worse after second vaccine, pressure, and loss of hearing.  After booster, head is completely roaring and ringing and hearing loss has worsened.
Pain and soreness at injection site, headache, sharp shooting pains all over body and tiredness
Date and time adverse event started: 1st Moderna dose 1/6/2021 time unknown but ADEs occurred on 1/7/2021, and then 3 days it reoccured.  2nd Moderna dose 2/3/2021 time unknown but sxs occurred same day. 1st Moderna dose 1/6/2021 time unknown, pt reported he experienced dizziness on 1/7/2021 (which went away), then 3 days later the dizziness came back and he also had weakness. 2nd Moderna dose 2/3/2021 time unknown but sxs occurred same day, pt reports the second dose the dizziness and weakness is more pronounced than the from the 1st dose and he is feeling shaky. The dizziness, weakness and shakiness is still occurring; pt reports neck is hurting when turning his head, and get more dizzy with slight head movements.  Pt has been seen by his PCP (did MRI - no findings of anything). Also seen by specialists (ENT, Cardiologist, Neurologist). Pt is scheduled for an inner ear exam on 5/10/2021. Pt advised no one was able to help him with his symptoms, more tests are ordered. Additionally, pt reported he had reached out to Moderna and they were unable to provide him with any assistance.  Pt reports that he stays hydrated and tired vertigo exercises recommended by his chiropractor for the past 3 weeks. Nothing has helped.  4/18-Follow up call by JD- Patient continues with dizziness and weakness. Doctor has prescribed scopolamine patch  but is has made dizziness worse. Advised to continue to stay hydrated, get up slowly when standing from sitting position. Will be following with ENT doctor on 5/10/21.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 29Dec2020 as dose 1, single (Lot number: EJ1685), in left arm, on 19Jan2021 as dose 2, single (Lot number: EL3249), in left arm, on 27Sep2021 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 06Jun2022 as dose 4 (booster), single (Lot number: FP7135) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "DM" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing); "BPH" (unspecified if ongoing); "Known allergies: PCN" (unspecified if ongoing). Concomitant medication(s) included: TERAZOSIN; CLARITIN [LORATADINE]; PEPCID [FAMOTIDINE]; METFORMIN; HCTZ; MULTI VITAMINS.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient took Anti-viral drug Paxlovid from 14Jun2022 to 19Jun2022 for treatment of COVID-19.; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product bnt162b2 cannot be ruled out.
Patient returned to the pharmacy 10/28/19 around 5:00 pm stating she had a reaction. She described the site as burning & had 3 visible blistered, raised areas. Patient said she first noticed the irritation last night. After visibly inspecting the site, I suggested the patient contact her physician & go in for a visit.
Patient said she had shoulder pain for 2 days then she had chest pain. She went to her doctor and he had an X-ray done then prescribed a ZPAK.
PATIENT WAS GIVEN AN UNDILUTED DOSE (0.2 ML) OF THE PFIZER PEDIATRIC COVID VACCINE. NO ADVERSE REACTIONS WERE REPORTED.
This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt she had flu), DYSGEUSIA (Metallic taste in mouth), PAIN IN EXTREMITY (Arm was painful), INFLUENZA (Felt flu-y) and MALAISE (did not feel like herself) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029120A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt she had flu), PAIN IN EXTREMITY (Arm was painful), INFLUENZA (Felt flu-y), MALAISE (did not feel like herself), FATIGUE (Extreme fatigue) and CHILLS (Intermittent chills). On an unknown date, the patient experienced DYSGEUSIA (Metallic taste in mouth). At the time of the report, INFLUENZA LIKE ILLNESS (Felt she had flu), DYSGEUSIA (Metallic taste in mouth), PAIN IN EXTREMITY (Arm was painful), INFLUENZA (Felt flu-y), MALAISE (did not feel like herself), FATIGUE (Extreme fatigue) and CHILLS (Intermittent chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. Treatment information was not reported. This case was linked to MOD-2021-060937.
stomach cramps; stomach "noises"/noises in her stomach; diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (patient) and physician. A 67-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN6198; Expiration Date: 30Jun2021) via an unspecified route of administration, administered in arm right on 22Feb2021 (at the age of 67-year-old) at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient is 67 y/o. Received her first dose of the Pfizer Covid vaccine on Monday 22Feb2021. On 23Feb2021 around 8 pm she experienced stomach "noises" and diarrhea. On 24Feb2021 she said she was ok with no diarrhea. On 25Feb2021 around 11:30 pm she had stomach cramps and diarrhea, and on 26Feb2021 she has experienced just stomach cramping. She wants to know how long will the diarrhea last. Additional Context: Reporter stated that she has questions about reactions to the vaccine, states she had the vaccine on Monday 22Feb2021, and initially had no reaction, states Tuesday she thought she felt ok, states she took her dog to the park, Tuesday night around 8PM she started having diarrhea and noises in her stomach, on Wednesday she was fine, mostly solid stools, states yesterday 25Feb2021 she had one small bowel movement and last night around 11:30PM she had diarrhea again. Should the side effects be lasting this long. Reporter encouraged to reach out to health care provider for any medical advice. Outcome of the event diarrhea was not resolved and remaining other events was unknown.  No follow-up attempts are possible. No further information is expected.
Numb tongue; Numb lips; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Numb tongue) and HYPOAESTHESIA ORAL (Numb lips) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced HYPOAESTHESIA ORAL (Numb tongue) and HYPOAESTHESIA ORAL (Numb lips). On 09-Mar-2021, HYPOAESTHESIA ORAL (Numb tongue) and HYPOAESTHESIA ORAL (Numb lips) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications details were reported by the reporter. Treatment details was not reported by the reporter.
received only first dose in 2019; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix b (received 1st dose on 22nd May 2019, batch number: 9T25S).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK Receipt Date: 25-May-2022 Reporter's Comments: The health care professional reported patient received only first dose of Engerix-B and never came for the rest. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Engerix-B which led to incomplete course of vaccination.
Swollen lymph nodes 6 days after shot.  Enlarged, hardened, and will not dissipate
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 9:52 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 66.01 years. No concomitant product use was reported. It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Vial was stored on cooler 1, on 27-Oct-2021, Excursion duration at 8 am: 41, at 9 am: 29, at 10 am 32, at 11 am 43, at 12 am 43, at 1 pm 43, at 2 pm 46, at 3 pm 46, at 4 pm 46 and at 5 pm 45.  On 27-Oct-2021, excursion time and temperature at 09, 10 am 29,32 was respectively, total doses given for the day was 116, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 29-Sep-2021 and 05-Oct-2021, vial was moved to clinic on 27-Oct-2021. 2 and 4 vial was moved to clinic. Vaccine BUD date was 29-Oct-2021 and 04-Nov-2021.  Temperature recordings were taken by using a traceable temperature monitor at every hour. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided
The employee received one vaccination in her left deltoid on 10/8/09. On 10/10/09 began to have low grade fever, developed swollen preauricular lymph node left side and mild sore throat.
One patient today was given second dose of Pfizer vaccine around 5 pm.  While he was waiting in the chair for the 15 mins period, he came up and complained about sweating, nausea, lightheaded and dizzy . I took the emergency kit to him and gave him cold compress for sweating and also observed that he was bit nervous/ shaky, and he mentioned his throat was itching. I gave him EpiPen IM in his left thigh. Called code white and store manager came with an associate and recorded all the details. Checked his blood pressure twice with in 5 to 10mins which read 139/90. Patient in the next 15 to 20 minutes started feeling better. I asked the patient to wait for another 30 minutes just to watch his progress. Pt felt better and normal and walked around the store.