chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 04-Mar-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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications included High blood pressure medicine.  No treatment details were reported.    This case was linked to MOD-2022-530147, MOD-2022-530162 (Patient Link).
SEVERE HEAD PAIN ITCHING SHOOTING PAIN. BURNING STINGING EXCRUCIATING pain cant even touch hair. Left side only.
Supraclavicular and posterior chain cervical lymphadenopathy and pain; ipsilateral arm
Initial information received on 24-Aug-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a three years old female patient who was administered with a 0.5 ml dose of FLUZONE HIGH DOSE (lot number: UI998AC, expiry date: 30-Jun-2019 and dose in series was not reported) via intramuscular route in the right thigh on 23-Aug-2018. It was a case of actual medication error due to inappropriate age at vaccine administration. It was reported that patient moved so only partial dose received. It was unknown if the patient had any adverse event. 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 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.
Hot painful hard lump at injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MASS (Hot painful hard lump at injection site) in a 48-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031488) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 21-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced VACCINATION SITE MASS (Hot painful hard lump at injection site). At the time of the report, VACCINATION SITE MASS (Hot painful hard lump at injection site) was resolving.            No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events.  No treatment medication was reported.
4 days later/ swelling in left testicle/ pain Hospital / emergency room Diagnosis/ Varicocele in left testicle Ultrasound
Sore hip after second shot; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore hip after second shot) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer, Mastectomy, Bursitis and Immunocompromised.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (Sore hip after second shot). On 15-Feb-2021, MYALGIA (Sore hip after second shot) had resolved.            Medical history includes Radiation. She is immunocompromised and would like to get a booster (3rd shot) in the hip. The pharmacist refused to give the 3rd shot in the hip. No concomitant medications were not reported. No treatment medications were not provided.   This case was linked to MOD-2021-304475 (Patient Link).
Patient was administered the AFLURIA flu vaccine on 10/8/14 at 8:15 a.m. No adverse event reported until 10/13/14 - patient said her (L) arm was sore in the evening of 10/8/14 and continued to hurt until 10/13/14. On 10/14/14 - it was "about the same". She was not sure if it was due to an injury since she had a large student she was working with physically has to deal with him when he gets agitated.
Pt. have swollen lymph nodes on Rt. side of neck, Rt. facial swelling and drooping, with tingling, numbness and bad taste in mouth. Symptoms occurred 24 hours after FLUMIST vaccine.
Redness over the injection site looks like a Bullseye/ red area growing; fever; Really hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness over the injection site looks like a Bullseye/ red area growing), PYREXIA (fever) and VACCINATION SITE PAIN (Really hurting) 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.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness over the injection site looks like a Bullseye/ red area growing), PYREXIA (fever) and VACCINATION SITE PAIN (Really hurting). At the time of the report, VACCINATION SITE ERYTHEMA (Redness over the injection site looks like a Bullseye/ red area growing), PYREXIA (fever) and VACCINATION SITE PAIN (Really hurting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
muscle body ache; Pain Discomfort; Headache; Fatigue Tiredness; Nausea; This is a spontaneous report from a contactable consumer.  A 80-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 19Feb2021 11:00 (Batch/Lot Number: EL9267; Expiration Date: 31May2021) (age at time of Vaccination: 80 year-old) at single dose for covid-19 immunisation.  The patient received the first dose of vaccine Intramuscular on 28Jan2021 at 10:00 (Batch/Lot number: EL9263; Exp: 31May2021). Medical history included Short of Breath on 12Jan2021, went to ER checked out all normal got breath treatment, negative swab for Covid.  The patient's concomitant medications were not reported.  On 20Feb2021 the patient experienced pain discomfort, muscle/body actress, headache, fatigue/Body actress, Nausea. The outcome of the events was unknown.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021216583 same patient, same vaccine different dose
Having menstrual bleeding 5 days early; More than 35 days between 1st and 2nd dose; After 2nd dose-fuzzy brain; After 2nd dose-never been this sick in life; After 2nd dose-headaches; After 2nd dose-chills; After 2nd dose-12 hours of vomiting; Fever; After 2nd dose-no energy/couldn't get off bathroom floor; This spontaneous case was reported by a consumer and describes the occurrence of POLYMENORRHOEA (Having menstrual bleeding 5 days early), ASTHENIA (After 2nd dose-no energy/couldn't get off bathroom floor), FEELING ABNORMAL (After 2nd dose-fuzzy brain), ILLNESS (After 2nd dose-never been this sick in life) and HEADACHE (After 2nd dose-headaches) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026P21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Oct-2021, the patient experienced ASTHENIA (After 2nd dose-no energy/couldn't get off bathroom floor), ILLNESS (After 2nd dose-never been this sick in life), HEADACHE (After 2nd dose-headaches), CHILLS (After 2nd dose-chills), VOMITING (After 2nd dose-12 hours of vomiting) and PYREXIA (Fever). On 11-Oct-2021, the patient experienced FEELING ABNORMAL (After 2nd dose-fuzzy brain). On an unknown date, the patient experienced POLYMENORRHOEA (Having menstrual bleeding 5 days early) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between 1st and 2nd dose). On 10-Oct-2021, ILLNESS (After 2nd dose-never been this sick in life) and CHILLS (After 2nd dose-chills) had resolved. At the time of the report, POLYMENORRHOEA (Having menstrual bleeding 5 days early), ASTHENIA (After 2nd dose-no energy/couldn't get off bathroom floor), FEELING ABNORMAL (After 2nd dose-fuzzy brain) and HEADACHE (After 2nd dose-headaches) had not resolved and VOMITING (After 2nd dose-12 hours of vomiting), PYREXIA (Fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between 1st and 2nd dose) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-348452 (Patient Link).
Will the IBG infusion interfere with the second dose of the vaccine; little sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date 24Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Low immune system" (unspecified if ongoing), notes: Takes IBG infusion monthly. She has to take a steroid, Tylenol and Benadryl along with infusions. The patient's concomitant medications were not reported. The following information was reported: POTENTIATING DRUG INTERACTION (non-serious), outcome "unknown", described as "Will the IBG infusion interfere with the second dose of the vaccine"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "little sore arm".  Additional information included: The patient would receive the next IBG infusion on 12Mar2021 and would take steroid, Tylenol and Benadryl along with infusion. Her second dose of vaccination would be on 17Mar2021. She wanted to know if that will interfere with the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I was diagnosed with Bells Palsy one week after getting the covid vaccine. Half of my face is numb and paralyzed.
This case was reported by a physician via other manufacturer and described the occurrence of vomiting in a adult female patient who received Influenza vaccine Quadrivalent unspecified season. Concurrent medical conditions included drug allergy (ciprofloxacin, sulfa antibiotics, duloxetine HCL, metronidazole, alo-gabapentin, amitriptyline, bupropion, escitalopram oxalate, lactose, loratadine, meloxicam, nitrofurantoin monohydrate macrocrystals, phenobarbital and venlafaxine hydrochloride). On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vomiting, fever, allergy to vaccine and feels awful. On an unknown date, the outcome of the vomiting, fever, allergy to vaccine and feels awful were unknown. It was unknown if the reporter considered the vomiting, fever, allergy to vaccine and feels awful to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were reported as follows: On 17th August 2017, outpatient medication list for the patient were as follows- Alprazolam 0.3 mg oral tablets taken by mouth 2 times daily as needed for anxiety, chlorpheniramine 4 mg  oral tablets taken 4 mg by mouth every 6 hours as needed, LASIX 20 mg. taken 1 tablet by mouth daily, NORCO 5-325 mg taken 1 tablet by mouth every 8 hours as needed for pain, PLAQUENIL 200 mg, taken 1 tablet by mouth 2 times daily, ibuprofen 800 mg oral tablets taken 1 tablet by mouth 3 times daily as needed, lactase enzyme orally daily as needed, SINGULAIR 10 mg tablet taken 1 tablet by mouth every evening, NORFLEX 100 mg, 12 hours, taken 1 tablet by mouth twice daily as needed for pain, LYRICA 75 mg capsule taken 1 capsule by mouth 2 times daily, PROAIR HFA 108 (90 base) mcg/act aerosol solution use 1-2 inhalations by mouth every 6 hours as needed for wheezing.
Patient states that she has been in pain since the immunization; had missed 1 week of work; and is having mobility issues with her right arm for which she is seeing a doctor for on November 13, 2017. Patient believes that the issues with her right arm are due to the administration technique by the pharmacist and not the vaccine itself.
Tiny headache after the 1st dose; Little soreness of the arm after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Tiny headache after the 1st dose) and MYALGIA (Little soreness of the arm after the 1st dose) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concomitant products included CETIRIZINE for Allergy, LEVOTHYROXINE and DOXAZOSIN MESILATE (DOXAZOCIN) for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced HEADACHE (Tiny headache after the 1st dose) and MYALGIA (Little soreness of the arm after the 1st dose). At the time of the report, HEADACHE (Tiny headache after the 1st dose) and MYALGIA (Little soreness of the arm after the 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-133398 (Linked Report).; Sender's Comments:  MOD-2021-133398:Dose 2 case
My arm went numb down to my hand 5 minutes after both doses. That?s January 20th 2021 and February 17th 2021. A week or two after the second dose the numbness and tingling progressed to other limbs. I started having migraines and tinnitus. Dizziness and vertigo. Nerve twitches (neuropathy) and later severe panic attacks which had progressed into agoraphobia.  I?ve not been able to drive in months. I?ve lost a year of my normal life and I am 100% sure it?s due to the vaccine. Please help!
Within 10 minutes of receiving the vaccine, pt reported having tingling to left side of tongue and lips. BP 199/88 and continued to rise over the course of 15 minutes to 239/103. Pt denied shortness of breath, but tingling did not improve so Benadryl 50mg PO adminsitered but offered minimal relief. Pt then began to complain of blurry vision to left eye and headache. EMS called and manual BP was 258/100. Pt transported to local ED and treated. ED physician noted that he felt that this was a drug reaction related to the COVID vaccine.
back spasms; FEVER 102 for several hours; This is a spontaneous report from a contactable consumer.   A non-pregnant adult female patient of unknown age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date in Feb2021 as a single dose for COVID-19 immunisation. It was unknown if patient had any medical history. It was unknown if patient had allergies to food, medications, or other products. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation and experienced back spasms. It was unknown if prior to vaccination the patient was diagnosed with COVID-19. It was unknown if since the vaccination the patient had been tested for COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. It was unknown whether the patient received other medications within 2 weeks of vaccination. On an unknown date in Feb2021, the patient experienced back spasms and fever of 102 for several hours with the second shot. On an unknown date, the patient underwent tests which include body temperature and the result was 102 (units unspecified). It was unknown whether the patient received treatment for the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event fever 102 and back spasms was recovered on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pfizer / BioNTech: Dose Number: 1, 2, 3; Paxlovid: COVID 19 Treatment; Pfizer / BioNTech: Dose Number: 1, 2, 3; Paxlovid: COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 08Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 05Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Pfizer / BioNTech: Dose Number: 1, 2, 3; Paxlovid: COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jun2022) negative, notes: a positive RAT after 5 days of negatives on day 13 (7 days post last paxlovid dose); (13Jun2022) Positive, notes: a positive RAT after 5 days of negatives on day 13 (7 days post last paxlovid dose). Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: patient received Paxlovid for COVID 19 Treatment.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt. was given an adult dose of Hep. A instead of a Pediatric dose called and was told that the Adult vaccine was not harmful.  No action needed.
Patient developed an approximately 5 cm circular, localized swelling, pinkness and blanching at site of varicella vaccine. Benadryl was given and within 20 minutes the size of the reaction was receding. Patient had no further signs and symptoms noted. Follow up on 6/20/01 showed the symptoms were totally cleared.
Red, round rash at injection area size of tennis ball. Lasted for 8 days (gone Day 8). Sinus headache 2nd day. Migraine pills didn't help which is unusual. Lasted until 2 AM 7-11-12 - fell asleep. All day headache sinus area and later over right eye.
This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 15-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL lot # K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours, This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
I have had 4 shots of COVID 19 vaccines. 2 of them Pfizer. I have tested positive for COVID 19; I have had 4 shots of COVID 19 vaccines. 2 of them Pfizer. I have tested positive for COVID 19; I am very sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I have had 4 shots of COVID 19 vaccines. 2 of them Pfizer. I have tested positive for COVID 19"; ILLNESS (non-serious), outcome "unknown", described as "I am very sick". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Clinical information: COVID-19 vaccines don't work. Patient had 4 shots of COVID-19 vaccines. 2 of them Pfizer. Patient had tested positive for COVID-19. Patient was very sick.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Cough for over a month; This spontaneous case was reported by a patient and describes the occurrence of COUGH (Cough for over a month) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Cough for over a month). At the time of the report, COUGH (Cough for over a month) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.   Reporter did not allow further contact
2/18/22 pt brought to ED with cough, SOB, increasing edema bilateral LE; positive for Flu AB and COVID; admitted; started on Lovenox and O2 supplementation; CXR showed large pleural effusion and signs of CHF; Albuterol Inhaler, Lasix, ABX; pt passed away in the hospital
15 minutes following administration, the patient came back to the pharmacy with arm pain. Upon further discussion, she noted feeling dizzy with pain under the armpit (scale 6/10). I observed a red splotchy rash at the injection site. She indicated she had swelling under the armpit and the pain was stabbing from the inside out. She did not have hives or feel like her throat was closing. She was nervous about the vaccine and felt clammy. I recommended she speak with the Clinic before leaving the pharmacy or calling her primary care provider to discuss the reaction. For nonpharmacologic care, I recommended she ice the area, rest, and stay hydrated. She could use ibuprofen or acetaminophen for pain. Her mother was driving her home and I advised her on what to watch for and to seek emergent medical care if the situation got worse. I also advised her to monitor her closely and follow up with her primary care if it did not resolve. The patient left the pharmacy with her mother and the pharmacy will follow up tomorrow.