chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pressure on side of head tingling of face  tingling of toes ear ringing leg cramps
Flushing, profuse sweating, nausea, light-headed (not severe) subsided after approx. One hour (<24 hr- still feces "washed out") (Began approx. 30 minutes post injection).
Pt became pale, lay himself down, then passed out with tonic-clonic seizure activity c stool incontinence.  Adverse event lasted less than a minute.
I am a physical therapist. I have had intention tremors throughout my entire body, but mostly my UEs since receiving the vaccine. They worsen when my fever goes up, but are continuing to happen even when my temp is a 98.0. I have missed work the past few days & feel overall much better from my sinus infection, but I assumed these tremors would go away when my fever went away. I have difficulty writing & poor fine motor control at this time. I have not contacted my MD because I know what these tremors are.
Parents did not notify physician until todays appt. Family states several hours after inj. child developed low grade fever, very irritable refusing to nurse, spacing out, uncontrollable eye movement. Family states this lasted for about 2 wks.
Patient had syncopal episode and had c/o severe pain from head to toe. Facility staff called 911 and she was taken to local ED.
one of the nurses gave a patient only the liquid part of Pentacel; Initial information received on 07-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves patient (age and gender unknown) who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patients past medical history, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number, expiry date not reported via unknown route in unknown administration site.  It was an actual medication error due to inappropriate reconstitution technique.  It was reported that one of the nurses gave a patient only the liquid part of Pentacel. The reconstitution guide was not provided because the nurse meant to give it this way and it was not done in error on her part  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none. Information on batch number was requested for this case.
sore arm which went away after 2 days; Blood pressure was 145/101 and after two weeks it came down to 133/89 over time but stays a; headache which went away after 3 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm which went away after 2 days), HYPERTENSION (Blood pressure was 145/101 and after two weeks it came down to 133/89 over time but stays a) and HEADACHE (headache which went away after 3 days) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-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 PAIN IN EXTREMITY (sore arm which went away after 2 days), HYPERTENSION (Blood pressure was 145/101 and after two weeks it came down to 133/89 over time but stays a) and HEADACHE (headache which went away after 3 days). At the time of the report, PAIN IN EXTREMITY (sore arm which went away after 2 days) and HEADACHE (headache which went away after 3 days) had resolved and HYPERTENSION (Blood pressure was 145/101 and after two weeks it came down to 133/89 over time but stays a) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications reported were Pill for blood pressure.  No treatment information was provided.   This case was linked to MOD-2021-051810 (Patient Link).
Swelling of eyelids and left hand and arm; seen by HCP 1-12-07; given benadryl
DIARRHEA; THROWING UP; MOUTH FEELS LIKE GARBAGE; NOT EATING; HEADACHE; WEAKNESS; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes, and other pre-existing medical conditions included the patient did not have any known drug allergy. He had not taken any over-the-counter medications. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 14-MAY-2021 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 15-MAY-2021, the patient experienced diarrhea. On 15-MAY-2021, the patient experienced throwing up. On 15-MAY-2021, the patient experienced mouth feels like garbage. On 15-MAY-2021, the patient experienced not eating. On 15-MAY-2021, the patient experienced headache. On 15-MAY-2021, the patient experienced weakness. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from diarrhea, throwing up, mouth feels like garbage, headache, weakness, and not eating. This report was non-serious.
I had red dry patch over the bridge of my nose that developed into a red rash on both sides of my cheeks and down to my jaw. Once it was on my cheeks and very prominent all over my face, I went to my dermatologist. He diagnosed it immediately as a Rosacea flare and prescribed a low dose of doxycycline and a metronidazole topical cream 0.75%. I started treatment immediately and the rash is all cleared up. It took about 5 days. I am completely recovered.
Information has been received from a healthcare worker concerning a 30 year old male who was vaccinated with a dose of MMR II when he was a child. Subsequently the patient had a negative titer for measles. His mumps and rubella titers were normal. No further information was available. The patient was seen in the office for medical attention. Additional information has been requested.
received just the diluent portion; received just the diluent portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) (batch number TP943, expiry date 28th January 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received just the diluent portion of the Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No reactions reported. The reporter consented to follow up.
Headache and neck ache, and sudden temperature spike to 101 lasting 3 hours...took over the counter sinus head ache tablets and Benedryl.  Next day all symptoms gone.
Moderate to Extreme headaches daily since injection; Extreme fatigue/tiredness/Overall feel vary tired; Moderate to Extreme body temperate changes throughout the day; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose via an unspecified route of administration in the right arm on 12Jan2021 at 08:30 at single dose for covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient had no medical history and no concomitant medications. The patient had no allergies to medications, food, or other products. The most recent COVID-19 vaccine was administered in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no other medications received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not been tested for COVID-19 since the vaccination. The patient experienced moderate to extreme headaches daily since injection, extreme fatigue/tiredness and moderate to extreme body temperate changes throughout the day on 12Jan2021 at 20:30. Overall feel vary tired along with headaches since the injections. No treatment was received for the adverse events. The events were considered as non-serious as did not results in death, non-Life threatening, did not cause/prolong hospitalization, non-disabling/incapacitating and no congenital anomaly/birth defect. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Arm swelling, feeling "heavy" and tight fingers. Lump under the L arm pit. No pain.
Have Shingles vaccine in 2019; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received first dose in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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: 9-Dec-2022 Reporter's comment: The reporter was inquiring for the patient (wife of reporter). The reporter stated that the medical record did not clearly stated if the patient had Shingrix, but the physician  did not knew which vaccine.  The reporter asked that would it be harmful to the patient to get a two-shot Shingrix series if actually did have Shingrix in 2019. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Following  receiving the second dose of my COVID-19 vaccine series, I experienced severe sore throat, chills, fever, and a cough. These symptoms did not resolve for several days and caused me to miss days of work.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a 65 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-JUN-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious.
Headache, Myalgia, Fever, itching at injection sie Narrative Per nursing report: "2nd Moderna vaccine yesterday [1/26]. C/o frontal lobe headache since yesterday, arm and neck soreness, low grade temp 99.2 and itching to site."
increased swelling pain given Levaquin 750 11/19/07 better/can use hand slightly/not as red
Information has been received from a nurse concerning a 13 year old white male who on 6/6/00 was vaccinated with a dose of varicella virus vaccine live (lot # 16875 - invalid). The patient was evaluated by a physician and it was noted that on 6/15/03 the patient developed a generalized rash of approximately 50 lesions that lasted 2 days. No fever was noted. No complications were noted. The patient was not hospitalized. The outcome is recovered. Additional information has been requested.
I had common side effects, until Thursday.  Thursday morning, I woke up and my arm hurt, but I figured that was common, until I got to work and the RNs in my clinic said that my entire upper arm was red, swollen, and bruised looking and there were white looking bumps that were raised.  They were very concerned.  They told me to go home and take benadryl right away, and if it continued to spread or did not get better, I needed to go to urgent care.  After taking benadryl, the swelling and bruising went away, but it remained red.  Today, Friday, 8/20, I now have these little white looking spots on my right arm, and it is now also red, but not swollen or bruised looking.  I was told to keep an eye on both arms for swelling/bruising, and if it happens again in either arm, or if any part of either arm gets hot in either way, to go immediately to urgent care.  I was instructed to report this as it is not a common side effect.
No adverse reaction. Given Tdap in lieu of Tdap. Client is 76 years old, past age of 64 years. Should have received TD. Works for health department and was getting updated TD.
Vaccine was administered from a vial that was left out of the fridge for over 12 hours after being punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered from a vial that was left out of the fridge for over 12 hours after being punctured) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered from a vial that was left out of the fridge for over 12 hours after being punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered from a vial that was left out of the fridge for over 12 hours after being punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment medication were not provided.
She says at the injection site her arm is definitely not the same/when she stretches it it's like very tight/her left arm is completely different/it was perfect before; When she stretches it it's like very tight; Like it's a nerve damage; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (She says at the injection site her arm is definitely not the same/when she stretches it it's like very tight/her left arm is completely different/it was perfect before), MUSCLE TIGHTNESS (when she stretches it it's like very tight) and NERVE INJURY (like it's a nerve damage) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, 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 experienced VACCINATION COMPLICATION (She says at the injection site her arm is definitely not the same/when she stretches it it's like very tight/her left arm is completely different/it was perfect before), MUSCLE TIGHTNESS (when she stretches it it's like very tight) and NERVE INJURY (like it's a nerve damage). At the time of the report, VACCINATION COMPLICATION (She says at the injection site her arm is definitely not the same/when she stretches it it's like very tight/her left arm is completely different/it was perfect before), MUSCLE TIGHTNESS (when she stretches it it's like very tight) and NERVE INJURY (like it's a nerve damage) outcome was unknown.            Concomitant product was not provided by the reporter  Treatment information was not provided
Pt given Trumenba instead of Gardasil. After error realized  Pt then gave Gardasil as well. Parent told at this visit of error
On the date of Immunization (11/07/2017) at approx. 7pm, Patient experienced acute onset of stuttering and difficulty with speaking. Patient also stated that he experienced jerking of the neck.
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 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 09Jun2023 to 15Jun2023. No other medication in 2weeks.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300226102 Same patient, different drug/ events;
Red rash on right / left foot then over the day progressed to right and left leg. Very itchy.
pityriasis rosea developed on her abdomen and spread across torso, back, and legs; This is a spontaneous report from a contactable consumer (patient). A 33-year-old female patient received bnt162b2, dose 2 via an unspecified route of administration, administered in left arm on 12Apr2021 (Lot Number: EW0158) as dose 2, single at the age of 33-year-old for COVID-19 immunisation. Medical history included migraines from an unknown date. No known allergies. The patient was not pregnant. Historic vaccine was bnt162b2 received via an unspecified route of administration, administered in left arm on 22Mar2021 (Lot Number: EN6204) as dose 1, single at the age of 33-year-old for COVID-19 immunization. Concomitant medications included spironolactone;  supplements included colecalciferol (VITAMIN D) and iron, all taken for an unspecified indication, in two weeks. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. The patient experienced pityriasis rosea developed on her abdomen and spread across torso, back, and legs on 15May2021. The event resulted in: doctor or other healthcare professional office/clinic visit. Treatment received which included antihistamines and topical medicine. The outcome of event was not recovered.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a nurse referring to a one year old patient of unknown gender. The patient's concurrent condition, historical drugs, medical history and concomitant therapies were not reported. On 26-DEC-2018, the patient started use of M-M-R II (lot#, expiration date, strength, dose and frequency were not reported) intramuscularly rather than subcutaneous, for prophylaxis (Incorrect route of product administration). No adverse effects reported.
LOWER BACK PAIN; TIGHTNESS OF BACK; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 08-APR-2021 to right arm for prophylactic vaccination.  The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021, the subject experienced lower back pain.  On 08-APR-2021, the subject experienced tightness of back. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lower back pain, and tightness of back. This report was non-serious.
Patient specifies that she received Tdap on the left arm on 2/26/18, 1:04pm. By 4:00pm, arm was red and warm to touch. It looks swollen, red and warm to touch.
Severe malaise, fever, chills, very sore arm at injection site, swollen lymph nodes under that arm, and severe tenderness of breast near that arm, headache, large rash at injection site
Nurse documented that Hepatitis A adult dose was given when pediatric/adolescent dose should have been administered.
pt recvd vax & returned JUN92 for 2nd shot & stated following 1st shot felt fine but wife noticed whites of eyes were yellow;
Severe upper truck muscular pain,  both front and back.  Can hardly turn or reach for things.  Getting progressively worse.  Also arthritic pain in both my 1st IP joints bilaterally, unable to grasp to open packages or uncap bottles.  Have had neither before.
Metallic Taste in mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic Taste in mouth) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced DYSGEUSIA (Metallic Taste in mouth). At the time of the report, DYSGEUSIA (Metallic Taste in mouth) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, Heart rate: increased (abnormal) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were being used by the patient.  No treatment medication was taken by patient.
NO ADVERSE EVENT. PATIENT TOLERATED THE INJECTION WELL. Injection given on 6/29/2020 had expired on 5/31/2020.