chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 71-year-old female patient who received SHINGRIX for prophylaxis. On 8th August 2018, the patient received SHINGRIX (intramuscular). On 8th August 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left deltoid. The patient experienced soreness at the injection site. The healthcare professional (HCP) stated that, the soreness remained ongoing, and worsened with range of motion and movement. The vaccine was not administered by the reporting facility. The suspect vaccine batch number was unknown. The reporter gave consent to follow up.
This spontaneous report as received from a registered nurse refers to a 22 year old female patient. Eight years ago, in 2008 the patient was vaccinated with the series of GARDASIL. The patient experienced nausea and fever after the third dose of GARDASIL. The patient reported the adverse effects with the third dose, but no adverse effects after the first and second dose of GARDASIL. The treatment for the patient was unspecified because the patient was not at their practice at the reporting time. On unspecified date, the patient recovered from nausea and fever. Additional information has been requested.
24 hours post shot fever chills aches/pains treated with Tylenol, resolved after 24 hours. 48 hours post-shot, developed heart arrhythmia that has been sporadic since onset.
cellulitis on left lower leg; blisters on 2 toes; redness; swelling; This case was reported by a other health professional and described the occurrence of cellulitis of leg in a 77-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced cellulitis of leg (serious criteria GSK medically significant), blister, erythema and swelling. On an unknown date, the outcome of the cellulitis of leg, blister, erythema and swelling were unknown.   It was unknown if the reporter considered the cellulitis of leg, blister, erythema and swelling to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, however it could be 76 or 77 years old. The patient experienced cellulitis on left lower leg within 48 hours with blisters on 2 toes and redness and swelling. The reporter consented to follow up. This case had been linked with US2020AMR239619, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR239619:same reporter
Patient was administered the 5-11 Covid Bivalent Booster instead of 12+.
Case number PHEH2016US023838, is an initial spontaneous report from a medical assistant received on 14 Sep 2016. This report refers to a 33 years old female patient. Past medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with one single dose of FLUVIRIN (batch number: 1514801, expiry date: May 2016) into deltoid, at a dose of 0.5 ml, intramuscularly on 13 Sep 2016. Medical assistant reported that 8 patients received expired FLUVIRIN vaccine from last year over several days. No adverse event was reported following this medication error expired product administered). Follow up report received from a medical assistant on 18 Oct 2016: Added patient demographics) patient height and weight) and suspect product information (site of application).
My arms, legs, and stomach broke out in hives. My face swelled up and turned red with red linear bumps below my eyes along my cheek bones. My entire body became itchy.
Sudden onset of extreme mensural cramps after never having them. Breakthrough bleeding multiple times throughout the last several months. Missed periods. Periods every two weeks. None of this has ever been a problem.
immune response; breakouts all over the body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003004.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), 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: IMMUNISATION REACTION (non-serious), outcome "unknown", described as "immune response"; RASH (non-serious), outcome "unknown", described as "breakouts all over the body".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Itchy hives all over body from my head to my feet. Day 3 is worse than day 1.
Vaccine administration error: Child was given sister's immunizations initially, the MMR, Tdap and IPV. The nurse then, without discussion with the physician, administered a Quadracel and Hep B. Child did not receive varivax, which was ordered and will have to return for this. No adverse events or reactions  documented. Counseling and follow up recommendations provided to mother by physician.
Extreme muscle aches; mild chills; moderate/severe headache; extreme pain at the injection site (left arm); moderate pain throughout left arm; low grade fever of 99.0; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Dec2022 at 17:45 as dose 4 (booster), single (Lot number: GJ2524) at the age of 25 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "anemia" (unspecified if ongoing); "Known allergies: lamb" (unspecified if ongoing), notes: Known allergies: lamb; "Birth control" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Ibuprofen, reaction(s): "Known allergies: ibuprofen", notes: Known allergies: ibuprofen; Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies: Amoxicillin. Vaccination history included: Covid-19 vaccine (DOSE 1; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; Manufacturer Unknown), for COVID-19 immunization.  The following information was reported: MYALGIA (non-serious) with onset 10Dec2022 at 09:00, outcome "recovering", described as "Extreme muscle aches"; VACCINATION SITE PAIN (non-serious) with onset 10Dec2022 at 09:00, outcome "recovering", described as "extreme pain at the injection site (left arm)"; PYREXIA (non-serious) with onset 10Dec2022 at 09:00, outcome "recovering", described as "low grade fever of 99.0"; CHILLS (non-serious) with onset 10Dec2022 at 09:00, outcome "recovering", described as "mild chills"; PAIN IN EXTREMITY (non-serious) with onset 10Dec2022 at 09:00, outcome "recovering", described as "moderate pain throughout left arm"; HEADACHE (non-serious) with onset 10Dec2022 at 09:00, outcome "recovering", described as "moderate/severe headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of myalgia, chills, headache, vaccination site pain, pain in extremity, pyrexia.  Additional information: no other vaccine in four weeks. Other medications in two weeks was birth control. AE treatment with Tylenol. vaccine facility type at pharmacy or Drug Store. No covid prior vaccination and  covid tested post vaccination.   No follow-up attempts are possible. No further information is expected.
1st dose Moderna, 2nd dose Janssen; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Moderna, 2nd dose Janssen) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) 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) .5 milliliter. On 09-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Moderna, 2nd dose Janssen). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Moderna, 2nd dose Janssen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The Janssen Covid-19 vaccine was administered at 0.5ml, intramuscular on the right deltoid. Lot number 204A21A  The action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication reported.  No treatment was provided.    Reporter did not allow further contact
Bodily pains, fever of 101.8, large rash on arm of injection, headache, nausea,
severe flu-like symptoms; Low BP; 102 F; Rash - left arm and chest; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (severe flu-like symptoms), HYPOTENSION (Low BP), BODY TEMPERATURE INCREASED (102 F) and RASH (Rash - left arm and chest) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included TADALAFIL (CIALIS), EPILOBIUM PARVIFLORUM, SERENOA REPENS, URTICA DIOICA (PALMETTO PLUS [EPILOBIUM PARVIFLORUM;SERENOA REPENS;URTICA DIOICA]) and TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for BPH, CHONDROITIN for Cartilage repair, LEVOTHYROXINE SODIUM (SYNTHROID) for Hypothyroidism, GLUCOSAMINE for Osteoarthritis.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (severe flu-like symptoms), HYPOTENSION (Low BP), BODY TEMPERATURE INCREASED (102 F) and RASH (Rash - left arm and chest). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (severe flu-like symptoms), HYPOTENSION (Low BP), BODY TEMPERATURE INCREASED (102 F) and RASH (Rash - left arm and chest) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature:. In February 2021, Coronavirus test: (Negative) COVID test result negative. On 24-Feb-2021, Body temperature: 102 F body temperature.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient described burning on injection, some "regurgitation" of vaccine after injection was noted. Mild redness and swelling noted at vaccine site on recheck few minutes after vaccination. Pt denied itching or other sx (including problems breathing). Called patient to follow up few hours after vaccination (4:40 PM) - no redness noticable, no other sx.
Quadracel was given to a two-year old patient in the left thigh; Initial information received on 01-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 2 years old patient who received 0.5 ml fourth dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] lot C5532AA, expiry date 09-Oct-2020 via unknown route in the left thigh, on 01-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to inappropriate age at vaccine administration.  It was unknown whether 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 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.
This spontaneous report as received from a registered medical assistant refers to unknown number of patients of unknown age and gender. On an unknown date, the unknown number of patients were vaccinated with ROTATEQ. On an unknown date, the patient may had received improperly storaged ROTATEQ. No adverse effects reported. This is one of several reports from the same source. Additional information is not expected.
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Heart rate increased from normal 56 bpm to over 100 bpm and stayed there from April until June treatment.
Everyday since the day after my Moderna #2 shot, I been having this ?warm water falling? onto my left knee sensation. It happens standing, sitting, lying on the sofa or even exercising. I have been going to Physical Therapy for another issue, and I ran this sensation by her and we are just in observation mode.
Within a few hours aside from the expected soreness, a numbness in my upper left arm and shoulder accompanied by tingling in left arm and hand that has persisted to this day.   On Friday, May 21st noticed upon waking a knot or lump on my left collarbone. As of today, Sunday, May 23rd, there are now two visible lumps on my left side collarbone. no noticeable pain initially, now only a mild discomfort  when I touch it.
I took the shot and stayed there about 15 to 20 minutes. When I stood to leave, I got dizzy and stayed another 10 minutes. I left unassisted. When I went to bed around 10pm and I woke up around 1am. I was shivering, my teeth were chattering. I took a hot bath to warm up, and went back to bed around 3am. That day, I felt weak but I didn't feel bad. The day after though I woke up, a little before 10am and I felt off. It wasn't bad but it wasn't good either. My jaw then began to hurt, so did my arm, and chest. We called the ambulance and by the time they got here I was fine, but they took me to check anyway. They did an ekg and it was fine, my blood pressure keeps bouncing up and down, my pulse as well. The doctor believed that it was in my head and it was anxiety from the vaccine. They did not keep me in the ER due to I have my 6 month cardio check up soon.
Patient came to pharmacy for flu shot on 10/14/19 at 10:15am complaining of pain in arm that radiated down arm and burned. In discussing with RPH pt reports that she had a recent shoulder transplant in the left arm where she got the immunization, She did not mention to RPH at the time, or disclose this on her Vaccine Consent and Administration Record. Pt planning to reach out to md that did shoulder surgery.
Mild fever, fluctuated over next several days, reaching peak at 101.5 degrees F. Developed rash of pink spots on neck, back, chest on 09/12/2015.
Pt had circular slightly raised are of red inflamed tissue at injection site. It was 1.5-2" in diameter. Pt reported no significant pain at the site. Pt was advised to keep an eye on it and report if no improvement in a few days.
Severe flu like symptoms; Fever of 101.4; Headache; Nauseousness; Aches; Fatigue; Red; Itchy; Hot to touch; Swollen at injection site; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm on 15Apr2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient has no history of COVID and was not tested for it prior vaccination. The patient previously received the first dose of BNT162B2 on 24Mar2021 02:00PM, on left arm, for COVID-19 immunization, and experienced only slight swollen arm. On 15Apr2021 20:00, the patient experienced severe flu like symptoms including fever of 101.4, headache, nauseousness, aches, fatigue for about 24 hours, red, itchy, hot to touch; then swollen at injection site. The patient did not receive treatment for the events. The outcome of the events was recovering.  Information about lot/batch number has been requested.
diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report from a contactable consumer (Pfizer colleague). A non-pregnant adult female patient received the dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) at dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  On 21Sep2021, the patient was diagnosed with COVID-19. No treatment was received. The patient underwent COVID-19 test on 21Sep2021 with positive result. Outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Broke out in hives arms/ broke out in hives legs/ broke out in hives a little on her back; Broke out in rash legs, arms and broke out in rash a little on her back; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broke out in hives arms/ broke out in hives legs/ broke out in hives a little on her back) and RASH (Broke out in rash legs, arms and broke out in rash a little on her back) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Allergy to penicillin).    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced URTICARIA (Broke out in hives arms/ broke out in hives legs/ broke out in hives a little on her back) and RASH (Broke out in rash legs, arms and broke out in rash a little on her back). At the time of the report, URTICARIA (Broke out in hives arms/ broke out in hives legs/ broke out in hives a little on her back) and RASH (Broke out in rash legs, arms and broke out in rash a little on her back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment medication include antibiotic 1000mg for 7 days .   This case was linked to US-MODERNATX, INC.-MOD-2021-116493 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Non-Significant Follow-up  on 09-Jul-2021 was  received for initial 1 and it mentioned reporter's Home address On 21-Jul-2021: Non Significant Follow-up Append; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-116493:dose 2
ITCHY HIVES; SWOLLEN LYMPH NODES NEAR THROAT; RED RASH ON LEG; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 204A21A, and batch number: 204A21A expiry: 23-JUN-2021) dose was not reported, administered on 04-MAY-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 04-MAY-2021, the subject experienced swollen lymph nodes near throat. On 04-MAY-2021, the subject experienced red rash on leg. Laboratory data included: Vital signs measurement (NR: not provided) not reported. On 04-MAY-2021 17:00, the subject experienced itchy hives. The action taken with covid-19 vaccine  was not applicable. The patient recovered from itchy hives on 04-MAY-2021, was recovering from red rash on leg, and had not recovered from swollen lymph nodes near throat. This report was non-serious.
On February 7, 2023, I noticed that I was having pain in back around 4:00PM sitting in my office chair. I tried a massage chair, but it didn't help. I also was unable to walk without assistance. The pain was so severe I had someone drive me home, and it progressed throughout the day to the point I couldn't move without pain. Two days later I saw a doctor who diagnosed it as muscle spasms. He gave me Ketorolac for quick relief, and Methocarbamol and Nabumetone to take.  Around Saturday night, I was good with the medicine and came off of it on that next Tuesday.
no adverse effects; 19-year-old patient who received GARDASIL 9 this week after patient was administered complete HPV series ofGARDASIL (quadrivalent) in the past (on unspecififed dates); This spontaneous report was received from a nurse via company representative referring to a 19-year-old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, concomitant therapies and drug reactions/allergies were not reported.  On an unspecified date in August 2019 (reported as this week), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9)  (strength, dose, frequency and route of administration were not reported; lot# and expiration date were unknown by the reporter) for prophylaxis, after the patient completed the series of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) in the past (on unspecified dates) (inappropriate schedule of product administration). No adverse effects were reported.
This spontaneous report as received from a physician refers to a patient of unknown age and gender who on 06-APR-2015 was vaccinated with an improperly stored dose of M-M-R II (lot # K001230, expiration date 27-JAN-2016), 0.5 ml, subcutaneous. No adverse effects reported. It was unknown if the patient sought medical attention. This is one of several reports from the same source. Additional information has been requested.
The patient came back to the pharmacy on 11/7/2014 and complained that the pharmacist gave him a flu shot at the wrong spot (???) on 10/8/2014. He has severe deep muscle pain on his left shoulder, arm and cannot move his arm completely.