chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 55-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 24-JAN-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
kidney bean sized lump under her chin; This is a spontaneous report from a contactable consumer. A 14-year-old female patient received unknown dose number of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0168) via an unspecified route of administration as single dose for COVID-19 immunization. Medical history and concomitant medications of the patient were not reported. On an unspecified date patient experienced a kidney bean sized lump under her chin. Event took place after use of product. Outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in her right arm) and HYPOAESTHESIA (Numbness on right side of body) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013620A) for COVID-19 vaccination.     Concurrent medical conditions included Kidney transplant (The patient has a history of kidney transplant).    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in her right arm) and HYPOAESTHESIA (Numbness on right side of body). At the time of the report, PAIN IN EXTREMITY (Soreness in her right arm) and HYPOAESTHESIA (Numbness on right side of body) outcome was unknown.
A 100+ degree fever developed approximately 36 hours after vaccination and lasted for 8-12 hours. I developed extreme fatigue that lasted for 48 hours after the fever began. Approximately 36-48 hours after the fever began, my period started, and I had severe cramps, blood clots, and bleeding that were notably abnormal for me. I am on birth control and have very minor, if any, withdrawal bleeding.
31 yo male physician who developed erythematous, non-progressive, maculopapular rash 10 days after smallpox vaccination.  Lesions mostly on torso and upper extremities.  No pustules or vesicles present - no specimens sent for testing.  Patient was otherwise asymptomatic.
a temperature excursion involving IPOL and ACTHIB, both of which were administered twice post excursion with no adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 8 months old female patient while receiving vaccines HIB (PRP/T) VACCINE [ACT-HIB] and IPV (VERO) [IPOL] and had temperature excursion involving ipol and acthib, both of which were administered twice post excursion.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Jul-2022, the patient received a dose of 0.5 ml of suspect IPV (VERO) (formulation, strength: unknown) lot V1A121M via intramuscular route in the right thigh as Immunization.  On 20-Jul-2022, the patient received a dose of 0.5 ml of suspect HIB (PRP/T) VACCINE (formulation, strength: unknown) lot number not reported via intramuscular route in the right thigh as Prophylactic vaccination.Lot number was requested.   On 20-JUL-2022 there was a temperature excursion involving ipol and acthib, both of which were administered twice post excursion with no adverse event (poor quality product administered) same day following the administration of all suspect vaccines. The condition was 31.5F for 1 hour and 58 minutes due to a refrigerator malfunction (not human error). This situation was reported as a medication error due to vaccines being administered post excursion  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the 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 the guidelines. 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.
Caretaker at Facility contacted me to tell me that this morning, patients left arm is red and raised all the way to the elbow and very painful. Patient gets scheduled ibuprofen for arthritis which is helping.  She has had no other problems with other vaccinations including flu shot Fall 2020. Denies SOB, swollen tongue or throat, or rash/red areas anywhere else on body. Wondering if getting vaccine 3-1/2 months after getting COVID may be reason she is reacting. Caretaker anticipates she will recover just fine but is concerned about giving 2nd shot of series.
Noticed small red spot over injection site, spiked a fever, got diarrhea, next day spot had doubled in size, arm became sore, spot started itching, began vomiting with shaking chills, spot grew to size of a baseball and I started getting an extremely bad cough
Red spot on left arm near injection site. Oblong in shape and warm to the touch. Occasional itchiness where Spot is. Tender to the touch the first one to two days it appeared
He stated that about midnight on 11/21/09, he had arm/shoulder pain in the left arm that progressed to full body aches/pain at about 2am, 11/22/09.  The pain continued to "move throughout his body" including back and legs and he reports a pain of 8-8.5 on a 10 point scale.  He self medicated with 1 Lortab and then repeated it 4-6 hours later, but he said it did not provide relief. On Sunday afternoon/evening he went to Emergency Department because the pain was so severe.  He was given ketorolac for pain and discharged home.  On Monday (11/23/09) he went to his private PCP who said he had symptoms consistent with allergic reaction/GBS type symptoms.  He was provided a Methylprednisolone dose pack and reports that today, his symptoms are  much better.  He denies residual weakness or tingling in any extremities. Patient reports that he has received seasonal flu vaccines yearly for many years and received the 2010 seasonal flu vaccine about 3 weeks ago without any adverse effects.
Case number PHEH2014US022153, is an initial spontaneous report received from a nurse received on 31 Oct 2014 and a follow up report from the nurse received on 09 Dec 3014. This report refers to an 18-year-old female patient. Medical history and concomitant medications were not reported. The patient received only 0.5 ml of Men CWY liquid component of MENVEO (batch number: X12024) without reconstitution with Men A lyophilized component intramuscularly in the right deltoid on 16 Sep 2014 at 03:30 pm. No adverse event was reported following this medication error. Follow up report from the nurse received on 09 Dec 2014: Updated MENVEO batch number (M12024 to X12024), dose, site and time of vaccination.
Information has been received from a nurse concerning a 12 year old female who on 24-JAN-2008 was vaccinated IM with the first dose of GARDASIL. On 28-MAR-2008, the patient was vaccinated IM with the second dose of GARDASIL. The patient reported pain in the arm at the injection site for 3 days after the vaccination was given. The pain in the arm included not being able to lift the arm. The nurse also reported that since multiple patients (3 patients) reported pain in their arms, they started giving the vaccination in the buttocks to an unspecified number of patients. Unknown medical attention was sought through contact with the nurse. Patient outcome was unknown. No product quality complaint was involved. This is one of the multiple cases from the same source (WAES # 0804USA05546 and 0805USA01522). Additional information has been requested.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting,  fatigued Narrative:
Pt recv vax on unknown day; within 1 mon post vax pt exp lightheadedness & dizzy
I went to 5 doctors. All started  after first shot after 2/23/21 when first shot was given. I started getting red dots on my feet . I went to my regular Dr and said I need it looked by a dermatologist. I went to see him he said it?s vasculitis and gave me steroids. I took it and went away. Then I went to take my 2nd shot and then few days after I got red bumps on my feet but worse this and dermatologist said I need to see a rheumatologist which I did and they drew blood work and and car scans for chest and kidneys make sure vasculitis was not internal.  The rash is still on my feet I am going to see rheumatologist tomorrow April 16th to discuss what I can take to make this red bumps go away that spread all over my legs and now spreading on my stomach. All the Dra I seen can?t verify or say it?s the vaccine that caused this but the timing they say when it happened it same time when vaccine was taken.
cough, nonproductive cough, shortness of breath, body aches, sinus congestion, nasal congestion, chest congestion, wheezing. starting 11/28/21
Information has been received from a registered nurse concerning a female (age not reported) who on approximately 12-MAY-2007 "about a month ago" was vaccinated with the first dose of GARDASIL vaccine (yeast). Concomitant therapy was not reported. On approximately 12-MAY-2007 after being vaccinated, the patient became pale and she was laid back in the chair. The patient was very pale and weak but she did not faint. The patient was treated with ice that was applied to her forehead and neck. She was monitored for approximately 15 minutes. The patient felt fine and left the physician's office. The nurse considered the events as non-serious and related to therapy with GARDASIL vaccine (yeast). Additional information is not expected.
I noticed a headache in the very top of my head within an hour of getting the vaccine. I thought it was normal because everyone I know said they got a headache from it. Over the next few hours, the pain moved down the back of my neck and became a burning sensation at the bottom of my skull. The pain was not excruciating but was constant. I thought it would eventually go away.  I'm a pilot and fly for a living. Two days after receiving the vaccine I flew my plane and immediately noticed something was wrong with me. I was having a very hard time focusing. Approximately 2 hours into my flying I felt sudden and extreme pressure in my head and nearly blacked out. I immediately landed and stopped flying. Two days later I tried flying again and the exact same thing happened again after 20 minutes. The burning in my neck intensified and was now accompanied by dizziness, nausea, disorientation, confusion, uncontrollable shaking, and tinkling in my toes and fingers. I immediately went to my hometown doctor and he diagnosed me with vertigo. He prescribed me meclizine on Friday 02/05/2021.  I took the medicine as prescribed all weekend with no relief. Monday 02/08/2021 I made an appointment for that Wednesday at the Institute. During Wednesday 02/10/2021-02/11/2021 I had roughly 10-15 test performed on me including balance, eye and hearing test, CT scan, MRI, and measured my spinal fluid pressure. The physician determined on 02/11/2021 that I had an allergic reaction to the Pfizer COVID vaccine the severely increased the pressure in my spinal cord and brain stem. That pressure causes my vision problems and ultimately ruptured my left inner ear breaking off several crystals in the process. I cannot fly with this condition. I'm currently taking Diamox to reduce the pressure in my spinal cord and brain stem.
Injection site tenderness and pain that radiates to the neck. Vaccine give on 9/22/09. Patient is taking MOTRIN and TYLENOL for pain control.
1st  day sore arm & tired. Then, folowing morning. sever pain around injection site & sore arm from shoulder to elbow. At 9:00 am, sever body pain & aches, sever tired feeling. I had to stay in bed & took 2 Alieve caplets, slept all day long with periods of waking with body aches. NOTE: I had the flu shot 1 week prior at my doctor's office.
Yesterday, nine days after receiving my first Covid Moderna vaccine, I developed a large, red, raised, lump on my arm at the spot where I was vaccinated. I still have it today. It is uncomfortable and concerning. For the two days immediately following the vaccine, my arm muscle was very sore. That went away.
After receiving the 2nd dose, within 17 hours my fever spiked to 103, was shaking uncontrollably, extremely nauseous, and felt very dizzy. This lasted approximately 12 hours.
neuropathy in her hands and feet; This case was reported by a nurse via sales rep and described the occurrence of peripheral neuropathy in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis and umeclidinium bromide, vilanterol trifenatate (Anoro Ellipta) unknown for chronic obstructive pulmonary disease.   Concurrent medical conditions included chronic obstructive pulmonary disease and osteopenia.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2019-2020 season at an unknown dose and PNEUMONIA VACCINE at an unknown dose. In November 2019, the patient started Anoro Ellipta 25 mcg/mg once daily (25 mcg/mg daily). On an unknown date, less than 4 months after receiving Influenza vaccine Quadrivalent 2019-2020 season and Anoro Ellipta, the patient experienced peripheral neuropathy (serious criteria GSK medically significant). Anoro Ellipta was discontinued. On an unknown date, the outcome of the peripheral neuropathy was unknown.   It was unknown if the reporter considered the peripheral neuropathy to be related to Influenza vaccine Quadrivalent 2019-2020 season and Anoro Ellipta.  Additional details were provided as follows: The age at vaccination was not reported. The patient was diagnosed with chronic obstructive pulmonary disease (COPD) and the patient was put on ANORO. The patient also received flu shot and pneumonia vaccine the patient suffered from neuropathy in her hands and feet. The patient had never been on any other medications ever until her diagnosis of COPD and osteopenia. The patient was discontinued ANORO after 3 doses. The reporter agree to follow up from GSK.
9/17-evening-Chills, severe pain in the lower abdomen, took ibuprofen and rest and it calmed some,  9/18-evening-Severe lower abdominal pain , same treatment, 9/19-evening-Severe lower abdominal pain, same treatment 9/20 -all day pain in upper and lower abdomen worse upon moving, 9/21-all day pain in upper and lower abdomen worse upon moving, went to the doctor at 4 pm, blood work at 4:50, CAT scan of abdomen at 6:15 revealed acute appendicitis, hospitalized  9/22- surgery to remove appendix
Patient was here for Moderna Bivalent vaccine on 10/7/22 around 330pm. During injection when needle was in patient's muscle, I saw a small amount of vaccine squirt back out from the barrel of needle (between needle and syringe).  The syringe I used for the injection already has needle attached.  Patient complained of feeling liquid dripping down his arm. I saw a few drops of blood and some clear liquids.  I wiped off them, but he complained of feeling more liquids down his elbow (which I could not see), and questioned if  he received the full vaccine dose.   I told patient that I did see some vaccine squirt back out and looked liked it was due to syringe defect, and it was likely he did not receive the full dose.  I offered to call his primary doctor. I was able to reach his PCP Dr.   and manufacturer.  I told Doctor that manufacturer recommended following CDC guideline on administration errors and deviations because they don't have data on bivalent booster yet.  Doctor said he did not want patient to get another dose today because we do not know how much patient actually received (partial or nothing), he will monitor patient.  Patient has a scheduled appointment, and he plans to have patient to repeat the full dose in a few weeks after he monitors patient.   Doctor's office called patient and related doctor's message as well.  Patient stayed for 15 minutes after vaccine to make sure he's feeling okay.
Knot at the injection site; Injection arm very itchy; Redness in the injection arm; Swelling (it's really swollen) in the injection arm; Exhausted; Did not feel well; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel well), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE MASS (Knot at the injection site), VACCINATION SITE PRURITUS (Injection arm very itchy) and VACCINATION SITE ERYTHEMA (Redness in the injection arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter. .  Concomitant products included LISINOPRIL, METOPROLOL, ALPRAZOLAM and GABAPENTIN for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced MALAISE (Did not feel well) and PAIN IN EXTREMITY (Sore arm). On 17-Feb-2021, the patient experienced FATIGUE (Exhausted). On an unknown date, the patient experienced VACCINATION SITE MASS (Knot at the injection site), VACCINATION SITE PRURITUS (Injection arm very itchy), VACCINATION SITE ERYTHEMA (Redness in the injection arm) and VACCINATION SITE SWELLING (Swelling (it's really swollen) in the injection arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site erythema and Vaccination site swelling, at an unspecified dose and frequency. At the time of the report, MALAISE (Did not feel well), PAIN IN EXTREMITY (Sore arm), VACCINATION SITE MASS (Knot at the injection site), VACCINATION SITE PRURITUS (Injection arm very itchy), VACCINATION SITE ERYTHEMA (Redness in the injection arm), VACCINATION SITE SWELLING (Swelling (it's really swollen) in the injection arm) and FATIGUE (Exhausted) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 15-OCT-2018, the patient was vaccinated with improperly stored ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccine was exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA001125:
Patient  requested BIVALENT Covid-19  PFIZER BOOSTER dose but received Regular Adult Covid-19 dose instead. Received in left deltoid with his annual flushot. Contacted by immunizer at 1242 pm to discuss. Reports NO adverse effects, and will inform us if any develop. We will contact his PCP Monday(tomorrow) to inform. Will inform him also of when he should seek the correct Bivalent dose.
an hour and a half after getting a regular flu shot(1040am) my heart rate suddenly  increased and my blood pressure dropped (1210pm). about 4:00pm my heart rate remained elevated, but my blood pressure dropped futher. i called my cardiac health nurse line to report my condition. they advised water and rest. about six hours after the reaction started, my heart rate returned to normal. my blood pressure rose, but it continued to be irratic.
Janssen COVID-19 Vaccine EUA 11 hours after shot I started to experience a fever with extreme chills and uncontrollable shaking. I felt light headed and nauseous and threw up multiple times. The following day (4/10/21) I was back to my normal self.
Pt to ED 5/9 c/o chest pain and hypertension. Pt states she was on antibiotics last week for a "cold", only c/o cough  and congestion currently. COVID test positive. Pt with no resp distress, no audible wheezes, no acute distress, A&OX3. Pt discharged home with self care no apparent distress noted 5/9.
Body ache; Head ache; Felt tired; Had a fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache), PYREXIA (Had a fever), HEADACHE (Head ache) and FATIGUE (Felt tired) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol.    On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PYREXIA (Had a fever). On 30-Mar-2021, the patient experienced MYALGIA (Body ache), HEADACHE (Head ache) and FATIGUE (Felt tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MYALGIA (Body ache), PYREXIA (Had a fever), HEADACHE (Head ache) and FATIGUE (Felt tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Body temperature: inconclusive (Inconclusive) Inconclusive.         Concomitant products included blood pressure medication and cholesterol medication.  Action taken with mRNA-1273 in response to the events was not Applicable.  Patient reported that she still has the headache and tiredness. Patient also reported that she did not had these symptoms with her first dose.   Treatment information included paracetamol.
I sneezed thousands of times during the day. I have a really itchy and runny nose. I couldn't sleep at night because my nose is super itchy. I might also have itchy eyes. I never had any allergy in my life before having this vaccine.