chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 1:35 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 1:58 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 74.88 for dose administered on 14-Feb-2021 and 74.98 for dose administered on 21-Mar-2021. No concomitant medications were reported. Batch number 031L20A underwent temperature excursion on 14-Feb-2021 with temperature 32 degrees Fahrenheit from 9 AM to 11 AM, 35 degrees Fahrenheit from 2 PM to 3PM. This vial was moved to fridge on 09-Feb-2021 and beyond use date for the vial was reported as 10-Mar-2021. Product moved to clinic on 13-Jan-2021. Batch number 003B21A underwent temperature excursion on 21-Mar-2021 with temperature 34 degrees Fahrenheit at 09:00 AM, 32 degree Fahrenheit at 10:00 AM and 34 degree Fahrenheit at 11:00 AM. This vial was moved to fridge on 16-Mar-2021 and beyond use date for the vial was reported as 15-Apr-2021. Product moved to clinic on 21-Mar-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported   This case was linked to MOD-2022-566976 (Patient Link).
Pt reported about 7 hours after vaccination that pt was really cold. She also had an upset stomach. Husband put several blankets on her for a while and wasn't feeling better. Possibly pertinent that she had 1/2 glass of wine without eating between vaccination and time of calling pharmacy. Pt checked her BP and it was in normal range. She did not have fever. Pulse was around 130. Recommended they call the ER to see if they wanted to see the pt. Next morning I called pt to follow up. She was no longer feeling very cold but still had upset stomach.
The patient's condition following the COVID-19 vaccine was notably severe and multifaceted. She experienced a significantly limited ambulatory distance, frequently falling, and an inability to walk unassisted. Her situation was further complicated by a considerable loss of grip strength and the development of joint pain, impairing her ability to perform daily tasks, including feeding herself. Alarmingly, she also lost self-awareness, becoming disoriented with respect to her own identity, her surroundings, and even people she previously recognized. Her medical evaluation culminated in a diagnosis of Guillain-Barré syndrome, a rare disorder where the body's immune system attacks the nerves. This diagnosis was accompanied by a spectrum of other critical conditions:  ? Acute hypoxemic respiratory failure (196.01: Acute respiratory failure with hypoxia), indicating a severe reduction in oxygen levels in the blood.  ? Acute inflammatory demyelinating polyneuropathy (G61.0: Guillain-Barre syndrome), the most common form of Guillain-Barré syndrome, causing rapid onset of muscle weakness and paralysis.  ? Alzheimer's dementia (G30.9: Alzheimer's disease, unspecified), contributing to her loss of self-awareness and cognitive decline.  ? Functional quadriplegia (R53.2: Functional quadriplegia), a state where the patient, despite having intact motor systems, is unable to move due to extreme weakness or disability.  ? Hematoma (T14.8XXA: Other injury of unspecified body region, initial encounter), possibly related to her frequent falls.  ? HTN - Hypertension (110: Essential (primary) hypertension), a common condition that may exacerbate other health issues.  ? Pulmonary embolism (126.99: Other pulmonary embolism without acute cor pulmonale), a blockage in one of the pulmonary arteries in her lungs.
pt recv vax 3DEC96 & 22JAN97 pt had IGG titers taken for varicella & was found to be negative;
I had my first dose in September and it hit me 4-5 hours later. I had a high fever, body aches, chills and just overall flat on my back in bed for 2 days. I had my second shot yesterday and my symptoms are worse but this time my entire arm is stiff and incredibly painful. I had nightmares all night and can't eat anything. I had shingles when I was 12 and at the time, my doctor told my parents it was the worst case he ever saw in anyone. I'm so glad I don't have to get a 3rd shot!
Sore arm; Tiredness; Minor headache; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 03Mar2021 at 11:30(at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior the COVID vaccine. Concomitant medications were not reported. On 03Mar2021 at 13:30, the patient experienced sore arm, tiredness, headache. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event sore arm, tiredness, headache was recovering at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
UTI symptoms began rapidly around 5:30am with mild blood in urine. Treating with AZO maximum strength 95mg 3x a day until symptoms have improved.
BREAKTHROUGH COVID CASE. PATIENT COMPLETED MODERNA SERIES 2/4/21 AND THEN TESTED POSITIVE 6/8/21. UNKNOWN EXPOSURE
This is a spontaneous report from a contactable physician assistant. A 20-years-old female patient of an unspecified ethnicity received TRUMENBA, via an unspecified route of administration on 22Jul2016 at single dose. The patient medical history and concomitant medications were not reported. The patient experienced fever (102, unit unknown), achy, and fatigue on 22Jul2016 at night with outcome of recovered. On 23Jul2016 experienced arm was a little warm and sore with outcome of recovered. The patient underwent lab tests and procedures which included body temperature: 102 (unit unknown) on 22Jul2016. The caller declined to complete a report at this time. No additional information was obtained. Follow-up (14OCT2016): Follow-up attempts are completed. No further information is expected.
Right arm became very swollen, very painful and red and hot.  So painful that she could not move it. Next morning went to the doctor and was told the arm was severely infected and started on antibiotics. Stated she had a large hematoma as well.
Shortly after the vaccine confusion and hard time focusing along with fatigue, muscle aches, chills, and swollen glands around his neck,
autonomic dysfunction; orthostatic intolerance; dizziness; headache; fatigue; This spontaneous report was received from a lawyer regarding a case in litigation concerning a 12-year-old female patient (pt). Information on the pt's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the pt was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (dose, route of administration, lot# and expiration date were not reported) for prophylaxis. In 2013 following vaccination, the pt experienced autonomic dysfunction, orthostatic intolerance, dizziness, headache, and fatigue. The outcome of the events was not provided. The reporter stated that the events were deemed or should had been deemed causally related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) vaccination. This is one of multiple cases from the same reporter.; Sender's Comments:  US-009507513-2301USA006946:
left retinal artery occlusion resulting in a permanent loss of vision, antiplatelet treatment started.  Seen by neurology/ophthalmology.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. No concurrent condition or medically history were reported. On an unknown date, unspecified number of patients were vaccinated with a dose of RECOMBIVAX HB (lot number, Expiry date, route and dose were not reported), that underwent temperature excursion. No concomitant medications were reported. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected due to no consent for follow up.
Received vaccine approximately 7/19/07 - (cough x 3 days prior) hoarseness 7/19 PM and wheezing next AM went to ER seen at medical center ER told "possible reaction to HPV shot".
Red, swollen, squinty, watery eyes, red face, face hurt.  Had some itchiness and bumpy pinpoint rash on arms and upper chest.  Rash presented more on inner arm than outer arms.  Face felt hot.  Took benadryl Sunday (11/10) which helped with the rash on arms but not the face.  Monday (11/11) eyes seemed worse and could barely see.  Had a headache.  Went to the clinic at 8:30am and received prednisone.  Took patient until Friday (11/15) to recover.
This spontaneous report as received from a physician via a company representative and refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX injection, subcutaneous (dose, units, anatomical location, lot number were not reported). On an unknown date, after receiving ZOSTAVAX the patient was diagnosed with the shingles. There was no treatment given for the adverse event. The patient sought medical attention via visiting an office on an unspecified date. The outcome of adverse event was not reported. The relatedness between event and ZOSTAVAX was not reported. Additional information is not expected because the physician refused to be contacted.
''My'' left arm has been tingling/pins and needles from ''my'' shoulder down to ''my'' fingers for the past few days. It has been almost a week since ''my'' second injection; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02May2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on unknown date as a single dose for COVID-19 immunisation. On 03May2021 at 11:00, the patient experienced her left arm had been tingling/pins and needles from her shoulder down to her fingers for the past few days. It had been almost a week since her second injection. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of event. The clinical outcome of the event left arm had been tingling/pins and needles from her shoulder down to her fingers for the past few days was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse practitioner refers to a 12 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. No information on patient's concomitant medication was provided. On 14-JAN-2015, the patient was vaccinated with the dose of LIQUID PEDVAXHIB lot # K004541; exp. date: 04-DEC-2016 (dose, strength and route of administration were not reported) which had temperature excursion (incorrect product storage). This is one of several reports from the same reporter. Additional information has been requested.
Patient felt weak and tired after immunization and extreme tenderness at injection site with erythema, 4 days later there was less tenderness/pain but about a 10 cm diameter red blotch at injection site and felt warm to touch.
I received my COVID booster (3rd Moderna shot) on Nov 12, 2021. On Nov 22, I started getting hives on my chest. These spread and moved all over my body over the course of the week, including my face (eyelids / forehead). At the advice of my doctor, I started taking antihistamines 3x/day, and this got the hives under control. However, once I stopped taking the antihistamines, the hives came back. I talked to an allergist, So, who diagnosed me with chronic hives and recommended that I continue taking the antihistamines, but just one a day. I have done this. Whenever I forget a day or two of the antihistamines, the hives come back. It has now been over 4 months.  I wouldn't have thought that this was an adverse reaction to my booster, except that the exact same sequence of events happened to a friend of a friend: Booster, 10 days later: hives, developed into chronic hives.
Localized swelling, erythema, redness. MEDROL pak, BENADRYL provided.
3 days after I got the vaccine I started losing flavors, everything tastes like acid metal, everything smells the same as it tastes, and it?s being like that  since the moment that start
Arms, legs very weak and couldn't lift them for very well for 8 days, severe sinus drainage with bloody buildup everyday, neuropathy got 50% worse. The muscles (thigh) in my legs became very weak with only walking short distances now and become very painful. I have always gotten the flu shot for the past 13 years that I worked in the medical field and never had a reaction before. Nor had any after shot symptoms, but when I got this flu shot this time and when the needle was being injected into my arm and the nurse pushing the fluid in and I never felt such pain before as it's being injected in my arm, and kind of had a slight burning feeling, so my (L) arm became sore very quick and stayed like that up until 8 pm when I started to become tired very quickly and my (B) arms and (B) legs started to become very painful and weak. Then I started to have nosebleeds throughout the night. The next morning I didn't wake up until 10:45am and I usually don't wake up that late and when I went to stand up I fell back down in severe weakness and pain in my legs and couldn't lift my arms as they was to weak. I went to the bathroom and back to bed I went until 3:40pm  and pushed myself to get up and the nosebleed started all over again and the thigh muscles was hurting really bad in both legs and the nerve pain is so painful, and it hurts to walk short distances. My current neuropathy I have already have for Lyme disease was not as bad as it is now after the flu shot and had to increase the dose of KLONOPIN as the neuropathy got worse from the shot.
administered expired doses of IPOL with no reported adverse event; Initial information received on 09-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old female patient and was administered expired doses of IPV (VERO) [IPOL] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Varicella Zoster Vaccine (Varicella Vacc.); measles vaccine, mumps vaccine, rubella vaccine (MMR); and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) for Prophylactic Vaccination (Immunisation).  On 29-Mar-2023, the patient received a dose of suspect IPV (VERO) Suspension for injection strength: not reported lot U1A601M expiry date: 27-Feb-2023 via intramuscular route in the left thigh for prophylactic vaccination (immunization).  On 29-MAR-2023 the patient developed a non-serious administered expired doses of ipol with no reported adverse event (expired product administered) on the same day following the administration of IPV (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event administered expired doses of ipol with no reported 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 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.
Koplisla spots, diffuse maculopapular rash and Bilateral posterior cervical lymph node enlarge and posterior phogeal exdural
No additional AE; ROTATEQ was administered after a temperature excursion; inappropriate age at vaccination ; This spontaneous report has been received from an Other Health Professional, regarding to a 4-years-old patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 16-DEC-2022, when the patient had 4-years-old (Product administered to patient of inappropriate age), was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), oral liquid, orally administered, for prophylaxis (lot number: 1892784, which was determined to be valid, with an expiration date on 03-DEC-2023) (strength, dose, vaccination scheme, route of administration, and anatomical site of injection were not reported).   Administered dose was stored at a temperature of 47.9, during a time frame of 47 minutes (product storage error).   No additional adverse events were reported in the patient.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Medium
TDap given on 9/20/13. Pt had redness and warm to touch site of inj.
Patient was injected with an expired dose of Covid-19 injection(Moderna). The vaccine expired on 06/28/22 at 8:40PM. Vaccine was administered on 06/29/2022 at 5:01PM. No symptoms were present at the time of vaccination.
(L) deltoid pain x 2 + days impeding use of (L) UE
Confirmed Breakthrough  1st Dose Moderna Lot #  044B21A 2nd Dose Moderna Lot # 023C21A 3rd Dose Moderna Lot # 039F21A
Still experiencing joint pain 7 days later on 2nd dose. Muscle aches until day 6
1st hour after Injection  shooting pain in arm, 5to  6 hrs after Injection no appetite ,feeling yuck,y nausiated, back pain at  midnight from neck to butt ,joints achy and pain feel like  flu,  rash across trunk.  complete arm red and  blotchy , swollen .    Abdomen toward back patchy, sleepy all day long , not able to eat
Immediately after administration, he started taking deep breaths and holding his chest with chest pain. He then lay down on the exam table and symptoms improved in a few minutes.  14 days later, on 6/17/2021, he developed severe muscle pain and was hospitalized two days later on 6/19/2021 for rhabdomyolysis. Discharged 6/22/2021 from Medical Center. He is an active athlete, plays alot of basketball and lifts weights. This was his first episode of rhabdomyolysis.
Leg swelled so badly, he couldn't walk on it for 3 days; cried for several hours; had a fever; fell down frequently afterwards; lost equilibrium.
That evening, I came down with a fever and chills. I just took some Tylenol to get rid of it. I never visited the doctor for my symptoms. It went away on it's own.
Information has been received from a physician concerning a male pt, 59 years old at the time of the report, who was vaccinated with a dose of varicella zoster virus vaccine live. Subsequently the pt experienced a diffuse rash. Unspecified medical attention was sought. No further information was available. There was no product quality complaint involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/8/2006. Information has been received from a physician concening a 59 year old Caucasian male patient with no known medical history who was vaccinated with a dose of ZOSTAVAX. There was no illness at the time of vaccinatin. Subsequently the patient experienced a diffuse rash. Unspecified medical attention was sought. No further information was available. There was no product quality complaint involved. Additional information indicated that on 11-AUG-2006 the patient developed a diffuse rash which did not improve with PREDNISONE and FEXOFENADINE. The patient was given ACYCLOVIR. Additional information has been requested.
Patient was given the pfizer Bivalent vaccine today in office, without previously having the initial pfizer recommended first series
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 11-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L012482, expiration date: 10-APR-2017) (Incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Initial report received from a health care professional at physician's office on 19 Oct 2010: On 13 Oct 2010, this patient received a intramuscular dose of only the MenCYW-135 liquid conjugate component of MENVEO (batch number: 100026), (dose: unknown). The patient did not receive MenA lyophilized conjugate component of MENVEO. No adverse reaction was reported. The outcome of the event was not reported.