chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Total loss of taste; pain in ear; tingling in face; This is a spontaneous report from a contactable (patient herself). A 61-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN9581; Expiration date: unknown) via an unspecified route of administration, administered in Arm Right on Feb2021 10:00 (at age of 61-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. Patient had not known allergies. Other medical history was none. Patient did not receive any other vaccines within 4 weeks of COVID vaccine nor received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that, on an unspecified date in on Feb2021 patient experienced total loss of taste, pain in ear and tingling in face. The patient underwent lab tests and procedures which included SARS-COV-2 antibody test which was negative; (Nasal Swab) post the vaccination on an unspecified date inFeb2021. The outcome of all events was not recovered.  Follow-up attempts are completed. No further information is expected.
Hives on back and face developed the first day after both shots.  Tinnitus and a metal taste in mouth that still affects me.  March 2021 had a cardiac event and I thought I was dying.  I could not catch my breath and had severe chest pain.  There was odd external swelling near my carotid artery.  Over the course of 10 months I lost 50 pounds unintentionally and was down to 130 lbs and I never changed my activity level or eating habits.  I had severe cognitive impairment and had to undergo a brain MRI December 2021. Insomnia still plagues me.  My immune system was destroyed based on annual blood work comparisons, as well as increased inflammation in my body.   My arthritis pain is 1000% worse and I have had severe fatigue ever since the shots.
This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting), MYALGIA (Pain in all over her body), PYREXIA (Fever) and CHILLS (chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced VOMITING (vomiting), MYALGIA (Pain in all over her body), PYREXIA (Fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, VOMITING (vomiting), MYALGIA (Pain in all over her body), PYREXIA (Fever) and CHILLS (chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Menstrual cycle came about 10 days early (on April 7) began as spotting and then became very heavy as of April 10. For context, my cycle is very regular.
Within 12-15mins of getting vaccine, I started to feel tingling under my skin, then prickly itching all over my body including the back of my throat and inside ears, dry eyes, also small random muscle twitches. I also experienced the other common side effects of severe headache, runny nose, and feeling mailaise. reported it to Pharmacists and nurse. I was recommended to take Benadryl. I took it that night and the side effects decreased but lasted pretty intensely for about 3 days.  The symptoms have decreased over time but remain mildy even till this day.
Information has been received from a NP concerning a patient who was vaccinated with one dose of varicella virus vaccine live. Subsequently, the patient had a negative titer. The reporter did not consider this an adverse event. The patient sought unspecified medical attention. Additional information has been requested.
Severe conjunctivitis, Gatifloxacin without improvement, worsening symptoms. Then started on Pred-Forte with some improvement to daate.
About 12.5 cm X 10 cm red warmness around vaccine site. Treat with ice pack.
Patient returned to pharmacy and expressed that he developed pain/soreness in arm after the shot and it never went away.
Client received AstraZeneca Covid vaccine with no reaction. Previous vaccine unavailable. Janssen given as an alternative on 9.15.21.
Initial report received on 09 October 2013 from a health care professional. A 43-year-old female patient whose medical history and concomitant medications were not reported, received a dose of FLUZONE ID (lot number U4898AD, expiration date 30-Jun-3014) by unknown route and site of vaccination was deltoid 19-Oct-2013. It was reported that a patient over 43-year-old have received the FLUZONE ID. On 2-Oct-2013, reporter states patient had stuffiness in throat and itching in ears 5 hours after vaccination, lasting 3 to 4 hours. List of documents held by sender: none.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Hypotension-Medium
made me ill; experienced loose head; tingling on her body; confusion over 5 weeks; arm was weak; arm swelling; fatigue; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (made me ill), HEAD DISCOMFORT (experienced loose head), PARAESTHESIA (tingling on her body), CONFUSIONAL STATE (confusion over 5 weeks) and MUSCULAR WEAKNESS (arm was weak) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced ILLNESS (made me ill), HEAD DISCOMFORT (experienced loose head), PARAESTHESIA (tingling on her body), CONFUSIONAL STATE (confusion over 5 weeks), MUSCULAR WEAKNESS (arm was weak), PERIPHERAL SWELLING (arm swelling), FATIGUE (fatigue) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ILLNESS (made me ill), HEAD DISCOMFORT (experienced loose head), PARAESTHESIA (tingling on her body), CONFUSIONAL STATE (confusion over 5 weeks), MUSCULAR WEAKNESS (arm was weak), PERIPHERAL SWELLING (arm swelling), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: inconclusive (Inconclusive) Inconclusive.         No concomitant medications was provided.  Treatment medication were not provided.
No Additional AE; MMR II vaccine was administered after undergoing temperature excursions; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.     On 19-JAN-2022, the patient was vaccinated with second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) (lot # T027914 and expiration date reported 18-AUG-2022), 0.5 milliliter for prophylaxis after undergoing temperature excursions (Product storage error).  The temperature of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) was 9.6 Celsius 47 and there were previous temperature excursions on 18-DEC-2021 was 13.7 Celsius for 6 hours. No additional AE. No PQC.  This is one of several reports received from the same reporter.
Patient received on 12/12/16 2 vaccines PNEUMOVAX 23 and FLUZONE HD. She explained that the same day her deltoid began to swell and she started using ice for hours. She said that it feel like water retention on her arm and by 12/15/16 water started to go down her forearm. She came on 12/15 and arm still a little swollen but not pain.
On 01-Sep-2015, the patient inadvertently received an intramuscular dose of expired AFLURIA (batch number T53909, expiry date: 30-Jun-2015) at a dose of 0.5 ml, once for protection against seasonal influenza. No adverse reaction occurred after the administration. The outcome was reported as recovered. Reporter's outcome: The reported assessed the event as non-serious. Additional information was received from the reporter on 01-Dec-2015: AFLURIA was stored correctly. The reporter assessed the event as unrelated to AFLURIA. The patient was revaccinated with FLUZONE (batch number UI439AA) on 10-Sep-2015 in the right deltoid. No adverse effects reported.
This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. This Pharmacist reported for a female patient of an unspecified age (Reported as Age: Over 65, unit: Unknown) received PREVNAR 13 (Lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for immunisation, SHINGRIX, via an unspecified route of administration on an unspecified date at unspecified dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that patient received a pneumococcal vaccines and a SHINGRIX in different arms. The patient developed redness and swelling on the arm in the area where SHINGRIX was injected accompanied by pain. Pain was so great, the patient had to go to Urgent Care. Outcome of the events was unknown.
pt recv vax 24NOV98 & 25NOV98 pt exp a hypersensitivity rxn, a rash @ the inj site that became disseminated & eye swelling;
(12/2) Friday Night  - Debilitating body aches and pain in the bones, high fever, chills. Could not sleep through the night. Kept waking up every 10-15 minutes (12/3) Saturday - Took Tylenol in the morning. Body ache and fatigue persisted. No fever during the day. High levels of fatigue. Could not concentrate or even do a simple thing like watch TV. Could not eat much. Loss of appetite (12/4) Sunday - Felt better. Loss of taste is discomforting. Everything just tasted horrible. Heavy sweating while sleeping in the night. The rest of the symptoms like wringing body aches subsided.  12/5 Monday - Most of the
BODY ACHES; FEVER; EXTREMELY BAD HEADACHE; This spontaneous report received from a patient 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, fever, and extremely bad headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 101.9 degree. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, extremely bad headache and body aches was not reported. This report was non-serious.
Fatigue, muscle soreness, and dizziness for the first 6 hours.  Then headache and nausea set in around 10pm, with vomiting shortly following.  Last vomiting session around 7-8am (21 hours post injection).  Currently has headache, chills, body aches and nausea (24 hours post inj)
hives, itching , redness across entire neck region, ear to ear, sensation of tingling and swelling in lips
Varivax 2/28/06 - Rash occurred 3/17/06. Seen 3/20/06 - Lesions breast, arms, chest and back. ? vesicular
Patient has a sore left arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Patient has a sore left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, 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 PAIN (Patient has a sore left arm). At the time of the report, VACCINATION SITE PAIN (Patient has a sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient was not immunocompromised. No concomitant drug was reported. The patient received the Moderna vaccine in her left arm shoulder deltoid muscle. The patient received second Moderna Covid-19 vaccine on 14-Feb-2021. No treatment drug was reported.   This case was linked to MOD-2022-529131 (Patient Link).
On internal audit, we discovered that a patient received a vaccination that was not expired but was held at refrigeration temperature for 38  days.  Appropriate steps were taken to notify the state and are coordinating efforts to notify patients to repeat vaccination.
Sharp heel pain in Left heel, likely brought on by having flat feet, and wearing poorly supporting footwear.  Almost entirely resolved after using off-the-shelf product.  I explained to the agent who called me that I do not believe my heel pain and the Moderna vaccine are related. The agent told me to fill out this form, anyway.
After receiving vaccine, pt began to get light headed and stated "I fainted." Pt was placed in a supine position, with legs elevated. Ice packs placed under neck and legs. Pt proceeded to vomit 4 times in the span of 15 minutes. Pt stated after vaccine they did not eat anything prior to vaccine and are afraid of needles. Pt still dizzy and nauseous when legal guardian, against medical advice, removed her from the vaccination site.
Moderna covid 19 vaccine, pt claimed she got the shot too high in the arm so it injured her arm. the patient came to get her booster covid 19 vaccine, and the patient claimed the immunizer administered the shot to high in the arm.
The next day 12/14/2021 I had a lymph nodes under my left side of my arm pit, It was was huge and painful. I also had pain in my joint on my left side of my hip/leg going down to my knee.  I went to see the doctor a week later, this time I wasn't given any medication. Everything got better about after 2 weeks.
She is scheduled for the second dose on 25Mar2021 (48 days after the first dose); It has been over 36 days and she still did not get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She is scheduled for the second dose on 25Mar2021 (48 days after the first dose)) and PRODUCT DOSE OMISSION IN ERROR (It has been over 36 days and she still did not get the second dose) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D13L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She is scheduled for the second dose on 25Mar2021 (48 days after the first dose)) and PRODUCT DOSE OMISSION IN ERROR (It has been over 36 days and she still did not get the second dose). On 17-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She is scheduled for the second dose on 25Mar2021 (48 days after the first dose)) and PRODUCT DOSE OMISSION IN ERROR (It has been over 36 days and she still did not get the second dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported. No treatment information was reported.
The pain was intense enough that I thought I was possibly having a heart attack.; Myocardia; chest pain lasting for approximately seven days.; This is a spontaneous report from a contactable consumer. A 31-year-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm (at the age of 31-year-old) on 25Mar2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient had no medical history. Concomitant medication included fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) taken for an unspecified indication, start and stop date were not reported. On 05May2021, the patient experienced myocardia and chest pain lasting for approximately seven days. The pain was intense enough that he thought he was possibly having a heart attack. It has since subsided. No treatment was received. The outcome of the event was recovered on an unspecified date in 2021.  Information on the lot/ batch number has been requested.
Persistent and severe headache since day after vaccination.; Some nausea starting day 4; This is a spontaneous report from a contactable consumer (patient). A 45-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: Unknown), via an unspecified route of administration on 12Feb2021 09:30 as SINGLE DOSE (at the age of 45-years) in Arm Left for covid-19 immunization. Medical history included: high blood pressure. The patient had no known allergies. The patient did not receive any other vaccine in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: atenolol and amlodipine, taken for an unspecified indication. On 13Feb2021 at 15:00, the patient had persistent and severe headache since day after vaccination and some nausea starting day 4. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was Not recovered.  Information on the lot/batch number has been requested.
Left arm aching approximately 30 after shot.  Fever of 99.4, chills, small headache and tired about 6:00 pm night of shot.  Fever of 100.1, headache and chills  at 4:30 am this morning.  Fever of 99.1 right now at 12:30 pm this afternoon. I gave him Tylenol night time for severe colds and flu at 4:30 this morning and Tylenol daytime at 12:00 pm this afternoon.
was dispensed from to give in- home Covid-19 vaccines.  are given all the supplies needed to prepare and administer Pfizer vaccines. In this case the nurse did not reconstitute the vial of Pfizer vaccine before drawing up the dose. Therefore, this client received a concentrated dose of Pfizer vaccine. The nurse realized there was not much remaining in the vial, and reported her mistake to the health department.
Had two shots,got the shingles anyway / Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had two shots of vaccine and got the shingles anyway. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
This case was reported by a other health professional via call center representative and described the occurrence of injection site hives in a adult patient who received ENGERIX B adult (batch number XM59T, expiry date unknown). In May 2017, the patient received ENGERIX B adult. In May 2017, less than a month after receiving ENGERIX B adult, the patient experienced injection site hives and fever. On an unknown date, the outcome of the injection site hives and fever was unknown. It was unknown if the reporter considered the injection site hives and fever to be related to ENGERIX B adult. Additional details were provided as follows: The case was received from a medical distributor. The age at vaccination was not reported. The patient was also an employee who experienced hives around the vaccine site after vaccination. This case was 2nd case out of the 5 cases, reported by the same reporter.
patient was at appointment for 6 month well child visit.  given vaccines that were due: Pentacel, Prevnar, Rotvirus, and hEP b  Was also given vaccines due for his 12 month visit: Proquad and Hep A
Fluzone Quad had given to a patient yesterday that was invalid, due to delay in shipping time, no AE; Fluzone Quad had given to a patient yesterday that was invalid, due to delay in shipping time, no AE; Initial information received on 12-Nov-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA317566, 2019SA320727, 2019SA320728, 2019SA320730 and 2019SA320729 (same reporter).  This case involved a 14 years old female patient who received a dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number-UJ3058A, Expiry date- 20-Jun-2020) via an unknown route in an unknown administration site on 11-Nov-2019, which was delay in shipping time.  Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant drug were not reported.   It was a case of actual medication error due to incorrect product storage  It was a case of product shipment delay. Vaccine was invalid due to prolonged shipping time.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Extreme joint pain in left shoulder. Unable to move arm past 10 degrees in any direction. 3rd tetanus shot in 34 years and I have never felt this much pain before. Muscles seem extremely weak and even without the extreme joint pain not sure I would be able to lift arm without difficulty. Stepped on nail late Sunday (07/19/2014) and tetanus booster was administered on Tuesday (07/22/14). Starting to feel nauseous as of 9:30 pm 07/23/2014.
Around the shot turned red, spread out to the size of a half dollar became a half inch tall. Was warm and hot to the touch and itchy. I went back to the vaccination site and asked about it. They checked it and told me if it continued to grow to let them know. I went home and put cold on it for the evening. It took two days to go down and it went away with no issue.
Pt. had a nosebleed after receiving a FLUMIST. Nosebleed lasted about 4-5 min per pt. mom.
Tdap given at 10:30 am., 3:00 pm. started having lightheadedness, weakness, nausea, vomiting and then heart palpitations. Seen in ER that evening and instructed to follow up with primary doctor and return to ER if symptoms recur.