chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site soreness; terrible aches in her neck; pain shoulder; aches in her back; aches in her sternum; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th April 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th April 2019, 1 days after receiving Shingrix and an unknown time after starting excedrin unknown and Motrin, the patient experienced injection site pain, neck pain, shoulder pain, back pain and sternal pain. The patient was treated with excedrin unknown and ibuprofen (Motrin). On an unknown date, the outcome of the injection site pain, neck pain, shoulder pain, back pain and sternal pain were unknown.   It was unknown if the reporter considered the injection site pain, neck pain, shoulder pain, back pain and sternal pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in the evening, and the next morning she woke up with terrible aches in her neck, shoulders, back, sternum.  She also was very sore around the injection site. She was going to call the pharmacist who gave her the injection at the time reporting. She took some Excedrin and some Motrin which helped for a little while, but then all the pain came back. She wants to call pharmacist at the time of reporting.
4/12/21 Vaccination About 10 hours later, I had 102 fever for couple hours, chills, HA, muscle pain, weakness.  4/13 HA pain, muscle pain, muscle weakness, not chills no fever.  Lasted 5 days after vaccine. Muscle twitching, weakness, HA. I couldn't work for 3 days.  telemedicine consult that Friday; Tylenol but wait till Monday if the pain was still present. Was feeling better by Monday so I didn't take.
AT 12:30 AM,2/20/2021, experienced headache, body aches, nausea and chills/shivers.   Lasted for 24 hours.
Patient received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 50-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 229AN, expiry date 5th July 2022) for prophylaxis.   On 9th August 2022, the patient received Boostrix. On 9th August 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's Comments: The pharmacist reported that a male patient received an dose of Boostrix which was expired on 5th July 2022. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Boostrix, which led to expired vaccine used. This case has been linked with case US2022119634 reported by same reporter.; Sender's Comments:  US-GSK-US2022119634:Same reporter. Patient 2.
Patient passed out after receiving flu shot. Mother was paying at cash register and he told her he felt lightheaded and then passed out. Another customer and mother caught him and lowered him to floor. He was sweating and pale, pulse and breathing stayed normal.
This spontaneous report was received from a certified medical assistant refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-JUL-2015, patient was administered a dose of GARDASIL (lot #, expiry date, dose, frequency and route of administration not reported). Then was subsequently administered a dose of GARDASIL 9 on 21-DEC-2015. This was outside the labeled recommendations in both the GARDASIL and GARDASIL 9 prescribing information. No adverse effect reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. Additional information has been requested.
I had never had these kind of headaches before in my life. Two weeks ago I went to the doctor because I was having these excruciating headaches. I know it has been a few months since getting vaccinated but I do kind of want to report it. This has never happened to me. In my temple area in felt like blood was going through my veins but they were too small to pass through my veins. I felt like my head wanted to explode. They started the last week of October 22nd and 23rd of 2022 and started getting progressively worse. I went to the hospital on October 24th 2022. I got there and they gave me a TYLENOL drip for 6 to 7 hours, and a CAT scan. I had been released me and gave me some pills for migraines, but they determined it wasn't migraines. I had no sensitivity to light or noise. After taking the pills for a couple days the headache went away. I felt like there is residue of it coming back the other day. It is a groggy feeling that is not springing into the full headache.
On 2/15/21 I experienced stroke like symptoms on left side face, weakness on left side (arm and leg) at around 11:00am or so.  Within around 20 minutes of the onset of these symptoms a CT scan of head was performed. I was admitted and spent 2 nights in the hospital as inpatient. While there I had  an MRI, MRA, with contrast and without, Echo, Doppler Neck Scan, blood tests and more. My symptoms did not totally resolve (was still a little numb around the left side of mouth) until right before I was discharged the evening of 2/17/22.  While inpatient I was began taking Plavix and aspirin. Upon discharge I continued taking Plavix for 21 days along with Aspirin 81mg.  I now continue to take just the Aspirin. I followed up with a Neurologist.
Soreness at injection site; stiffness/ache in shoulderblade; stiffness/ache in shoulderblade; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 53-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EL 3247) via an unspecified route of administration (age at vaccination 53-year) in Right Arm on 10Feb2021 at 09:00 AM as dose 2, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN]); amlodipine besilate (NORVASC); hydrochlorothiazide; lisinopril; all taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes first dose of BNT162B2 (lot number: EL3247) administered in left arm on 21Jan2021 for COVID-19 immunization. No COVID prior vaccination was reported. The patient not tested COVID post vaccination. The patient received no other vaccine in four weeks. On 10Feb2021 at 02:00 PM the patient experienced soreness at injection site, stiffness/ache in shoulderblade. No treatment was received by the patient for the adverse events. It was reported that "the report submitted was for herself. she received the vaccination on 10Feb, developed symptoms late that day and reported on 11Feb within 24 hrs of symptoms first developing". The clinical outcome of the events was recovered on an unspecified date in Feb2021.   Follow-up attempts completed. No further information expected.
Vial which was expired on 03-Oct-2021 was placed in refrigerator on 22-Sep-2021 and was administered; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vial which was expired on 03-Oct-2021 was placed in refrigerator on 22-Sep-2021 and was administered) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial which was expired on 03-Oct-2021 was placed in refrigerator on 22-Sep-2021 and was administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Vial which was expired on 03-Oct-2021 was placed in refrigerator on 22-Sep-2021 and was administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported.  Vial did not underwent any temperature excursion. The patient did not experience any adverse event.  Treatment information was not provided.
Patient reported swelling and redness at the injection site, also experienced lightheadedness and sick to her stomach.
Tested positive after three days; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive after three days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Lung disorder and Psychotic disorder.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive after three days). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive after three days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, SARS-CoV-2 test: tested positive, three days later (Positive) Tested positive, three days later.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
About 24 hours after I had the vaccine, I was very tired, and I laid down to take a nap, I was going to take a short nap. And I didnt wake up up until about 4 hours and 15 mins later, when I woke up my body was achy all over, I was sore. And then more than 48 hours later, on the 24th, around midnight around 1am, that's when I noticed the arm that I had the vaccine in, was really red and not a bumpy rash, but it was below where I had the shot, and it took up the top part of my arm. It was very very red, and swollen and hot. It went all the way down the top of that arm and even went below the elbow, on the forearm and it was very red. That lasted till the next day and all day Sunday, and by Monday, it was starting to fade. I went and showed the pharmacy. He told me to take some Benadryl and I took some of those.
Generalized measles rash & fever 10-11 days p/vax as described by mom; not actually observed by MD;
Case number PHEH2016US023387, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 24-year-old patient of an unknown gender. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscular into left arm on 01 Dec 2015. It was reported that, the patient received FLUVIRIN that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error (incorrect product storage).
Child took varicella vas on 07/24/2001. In Dec 1st 2005 developed wide spread varicella.
IMMEDIATELY AFTER VACCINE, FELT ANXIOUS, SAW SPOTS, SWEATING, HANDS SHAKY, NATINGLING FINGERTIPS. NO LOSS OF CONSCIOUSNESS. ASSISTTED TO FLOOR, LEGS ELEVATED ON CHAIR. ASSISTED TO STRETCHER AND BROUGHT TO OBS IN HOSPITAL. VSS, HR LOW AT BASELINE PER PATIENT REPORT. STATES FEELS BETTER UPON ARRIVAL TO OBS. ONCE VSS ASSESSED STANDING, AND S/S RESOLVED, ASSISTED TO EXIT WITH STEADY GAIT, REFUSING WC, WITH NO ISSUES AT 1222. 1208 INITIAL BP 122/76 HR 47 RR 18 SATS 99% RA (HR LOW AT BASELINE) 1217 BP 118/74 HR 53 RR 18 SATS 99% RA 1220 STANDING BP 122/74 HR 56 RR 17 SATS 99% RA
She reports with a few minutes she felt light headed, dizzy and mentally disconnected. Symptoms included feeling nonspecific discomfort, hot, cold, palpitations, nausea. She states her chest cavity felt strange and can best describe it as internal burning. She states breathing was strange, and was 'almost' SOB. She felt palpitations. They seated her in a chair for 15 minutes and observed her for 35-45 minutes. Her VS were  normal. She denies pruritis, urticaria, flushing, sweating, cough, wheeze, oral/facial/throat/tongue swelling, red/watery eyes. She went home and continued to feel uncomfortable and restless. She had one emesis. She took a Tylenol pm at 19:00 and slept until about midnight. She reports the restlessness and discomfort stopped, but she then felt flulike symptoms (malaise, myalgias) for the next 3 days. She noted onset of edema at the injection site day 1, but no erythema or dermatitis.
muscle pain was stated as making them breath shallower; muscle pain was stated as making them breath shallower because it hurt; Strange pain in left pectoral muscle; muscle aches; muscle pain; This spontaneous case was reported by a patient and describes the occurrence of HYPOPNOEA (muscle pain was stated as making them breath shallower), MUSCLE DISCOMFORT (muscle pain was stated as making them breath shallower because it hurt), MYALGIA (Strange pain in left pectoral muscle), MYALGIA (muscle aches) and MYALGIA (muscle pain) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes. Concomitant products included LISINOPRIL and METFORMIN for an unknown indication.   On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced HYPOPNOEA (muscle pain was stated as making them breath shallower), MUSCLE DISCOMFORT (muscle pain was stated as making them breath shallower because it hurt), MYALGIA (Strange pain in left pectoral muscle), MYALGIA (muscle aches) and MYALGIA (muscle pain). At the time of the report, HYPOPNOEA (muscle pain was stated as making them breath shallower), MUSCLE DISCOMFORT (muscle pain was stated as making them breath shallower because it hurt), MYALGIA (Strange pain in left pectoral muscle), MYALGIA (muscle aches) and MYALGIA (muscle pain) outcome was unknown.            Only medication taken for treatment was a generic Tylenol.
Headache, Myalgia, Arthralgia, fatigue, "felt like a ton of bricks ere weighing down on me and I was stuck and couldn't move", chills, sweating, metallic taste in mouth Narrative:
Got sick both times; Initial information was received on 01-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a Consumer .  This case involves a patient (unknown age and unknown gender) who got sick both times (illness) while receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number not reported and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious got sick both times (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Only had 2 my entire life. Got sick both times. Never again for me. And they can keep that covid vaccine as well".  It is unknown if the patient experienced any additional symptoms/events.  Other relevant tests were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on batch number for this case.
1/6/2022- Presents to ED, Covid + test, and has chest pain and SOB. T-100.2, D-Dimer 268. Chest x ray-Right lower lobe pneumonia. Admit with acute hypoxic respiratory failure related to Covid-19 pneumonia.  IV remdesivir, doxycycline, ceftriaxone, Eliquis and Decadron. 1/8/2022-Refusing remdesivir. Continue IV antibiotics 1/9/2022- Afebrile. O2 sat 98% on RA. Discharge to home, on cefdinir, doxycycline, Decadron  and Eliquis
Developed a blood clot in left lung; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), on 12Nov2021 as dose 3 (booster), single (Lot number: 320308D) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD in bottom lung Diagnosed with a long time ago" (ongoing), notes: The caller has a preexisting condition in the lungs.; "Had Pneumonia 5 times in bottom left lung" (unspecified if ongoing), notes: Had Pneumonia 5 times in bottom left lung and the left lung doesn't work; "the left lung doesn't work" (unspecified if ongoing), notes: Had Pneumonia 5 times in bottom left lung and the left lung doesn't work. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (First dose: 26Mar2021 , lot: ER8730, NDC: Unknown, expiration: Unknown , Route of administration: left arm), administration date: 26Mar2021, when the patient was 62-year-old, for COVID-19 immunization, reaction(s): "couldn't breathe"; BNT162b2 (First dose: 26Mar2021 , lot: ER8730, NDC: Unknown, expiration: Unknown , Route of administration: left arm), administration date: 26Mar2021, when the patient was 62-year-old, for Covid-19 Immunization, reaction(s): "Dry drowning in lung", "got worse in lungs", "except for taste and smell"; BNT162b2 (First dose: 26Mar2021 , lot: ER8730, NDC: Unknown, expiration: Unknown , Route of administration: left arm), administration date: 26Mar2021, when the patient was 62-year-old, for COVID-19 Immunization, reaction(s): "except for taste and smell"; BNT162b2 (Second dose: 16Apr2021 , lot: EW0170, NDC: unknown , expiration: unknown , Route of adminstration: left arm, the caller had no reaction to the second dose), administration date: 16Apr2021, when the patient was 62-year-old, for Covid-19 Immunization, reaction(s): "had no reaction to the second dose". The following information was reported: THROMBOSIS (medically significant) with onset Feb2022, outcome "unknown", described as "Developed a blood clot in left lung".  Clinical course: Caller states prior to receiving the first dose Unknown Pfizer Vaccine, the caller had no lung issue and no cold, did not have Pneumonia or bronchitis, nothing. Developed a blood clot in left lung: The caller developed a blood clot in the left lung.never had a blood clot before. The blood clot was found in Feb2022 but doesn't know when the blood clot occurred. The caller had never had blood clots before. Eventually, later down the road the caller was in the hospital five times. Caller not able to provide dates for hospitalization.
No additional AE details; Customer calling for TE evaluation on frozen products states that 7 vaccines stored outside of recommended range were administered to patients.   Names of vaccines involved (including lot/exp) PROQUAD; U039258; 6/9/2023        ?    Temperature 6°F; This spontaneous report was received from an administrator concerning a 5-years-old male patient.   The patient's concurrent conditions, medical history, drugs reactions or allergies and concomitant medications were not provided.  On 22-APR-2022, the patient was vaccinated with an improperly store (stored outside of recommended range) dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant human albumin [rHA]) lot # U039258, expiration date: 09-JUN-2023, (dose, route and anatomical location were not reported) for prophylaxis. The vaccine was reconstituting with a sterile diluent (DILUENT MERCK)  (product storage error).  The storage temperature was 6 degrees Fahrenheit (F) up to 14 degrees Fahrenheit (7.9 F) for 4 hours 8 minutes 0 seconds. No previous temperature excursions reported. On 09-MAY-2022, it was reported the office was unaware of the temperature excursion until she completed a data logger download (on 02-MAY-2022). No adverse events have been reported to the office at the time of the report.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2205USA000973: US-009507513-2205USA001061: US-009507513-2205USA001202: US-009507513-2205USA001272: US-009507513-2205USA001205: US-009507513-2205USA001271:
Covid-19; Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "ankylosing spondylitis" (unspecified if ongoing); "kyphoscoliosis" (unspecified if ongoing); "disc abnormalities" (unspecified if ongoing), notes: Other medical history: disc abnormalities; "autoimmune hepatitis" (unspecified if ongoing); "reflux disease" (unspecified if ongoing); "mild anemia" (unspecified if ongoing); "vitamin D Deficiency" (unspecified if ongoing). Concomitant medication(s) included: COZAAR and an unspecified medication. Past drug history included: Remicade, reaction(s): "known allergies: Remicade"; Gabapentin, reaction(s): "known allergies: Gabapentin"; Methylprednisolone, reaction(s): "long term use issue", notes: possible methylprednisoline long term use issues. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jul2022, outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jul2022) Postive; (18Jul2022) Postive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient tested positive on 03Jul2022, when there for what patient thought might be signs of heart attack. No cold symptoms. Patient took Paxlovid and completed. 16Jul2022, started feeling some nasal congestion and increased fatigue. 18Jul2022, had positive antigen again which was either rebound or infection for 15 days.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
My arm was bruised at the injection site for 2 weeks following the 1st vaccine.  Two weeks after the first vaccine I woke up with extreme vertigo.  I saw my PCP and and he referred me to an ENT because he believe I had Vertigo.  The dizziness still continued.  I made the appointment with the ENT.  I had my 2nd vacine on April 12, 2021 and 48 hours later the dizziness got worse.  It was at that point I thought my side effects were due to the vaccine.  I also had what their calling Covid Arm which started a week after the 2nd vaccine.  My arm was red 4" by 6" at the injection site and started about a week after the 2nd injection.
Information has been received from a physician concerning a female (age unknown) with unknown medical history, who in "September 2007", was vaccinated intramuscularly with a first 0.5 mL dose of GARDASIL (Lot # unknown). Subsequently after the first dose, on an unspecified date, the patient experienced "internal bleeding" after first dose. Outcome unknown. No product quality complaint was involved. Additional information has been requested.