chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 4:43 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 16-Nov-2021 at 4:43 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial was moved from freezer to refrigerator on 19-Nov-2021, when the Moderna COVID-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursions were reported. Total 280 patients received Moderna COVID-19 stored at minus 82 degrees Fahrenheit.  No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-402935 (Patient Link).
24 hours after vaccine developed cellulitis in the arm of administration (L) arm (swelling, redness, warm, tender).
SEVERE BODY ACHES; FEVER; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced severe body aches. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and severe body aches was not reported. This report was non-serious.
Soreness and rash the first week near injection site in upper left arm.  Now (about a week later) rash seems worse - more itchy and noticable, soreness alleviated in upper part of arm, but now there is soreness is in lower part of arm and hand.  Tingling wrist and fingers in left hand.
A few days after the vaccine my tongue became tingly and continues to this day. It has since been very sensitive to spicy food, particularly ones that are acidic (salsa, jalapenos, etc). This was not the case before the vaccine.
patients who have received vaccines that were previously exposed to temperatures below 32 degrees F; Initial information received on 12-Jul-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 months and 26 days old female patient who received a 0.5 ml dose of vaccine IPV (VERO) (lot: PIA461M and expiry date: 03-May-2020) via intramuscular route in unknown administration site, On 28-Jun-2019.  Patient medical history, vaccinations, family history not reported.   No other vaccine was given.  It is an actual medication error due to incorrect product storage.   It was reported that patient received vaccines that were previously exposed to temperatures below 32 degrees F.  At the time of reporting, no adverse reaction was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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.
Head spinning; Body ache/Intense body ache; Aching or having such an intense ache that even her thumbs and ears on the inside hurt and she did not want to touch her thumbs; Felt horrible; Aching or having such an intense ache that even her thumbs and ears on the inside hurt and she did not want to touch her thumbs; Temperature of 101/Had a temperature of 101; She just feels like the remnants of how you feel after you have a headache ; did not want to move; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0172 and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Right on 03Jun2021 as 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 04Jun2021 the patient experienced head spinning , body ache/intense body ache, aching or having such an intense ache that even her thumbs and ears on the inside hurt and she did not want to touch her thumbs, felt horrible, thumbs and ears on the inside were aching, aching or having such an intense ache that even her thumbs and ears on the inside hurt and she did not want to touch her thumbs, Temperature of 101/Had a temperature of 101. Also, At 5:00 am this morning, she took 325 mg Aspirin (treatment) and is feeling so much better now.  She just feels like the remnants of how you feel after you have a headache ; did not want to move. The patient underwent lab tests and procedures which included body temperature: 101 on an unspecified date. The outcome of event was recovering.  Follow up attempts are needed. Further information has been requested.
This spontaneous report was received from a nurse practitioner and a nurse concerning a 12 year old female patient with no pertinent medical history or drug reactions/allergies who on 27-JAN-2014 was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular. No concomitant medications were reported. It was reported that on 28-JAN-2014, the patient experienced 3 syncopal episodes. The patient was evaluated at a local emergency room but no details of the evaluation were provided. The patient experienced another syncopal episode on 29-JAN-2014 (reported as today). The patient had not received any treatment for the event; at the time of the report, the patient had not recovered from the event. Additional information has been requested.
This spontaneous report as received from a medical assistant via a company representative refers to a 15 year old female patient who was not pregnant. The patient was vaccinated with the second dose of VARIVAX (lot number, expiry, route and site not reported) about a year ago, approximately in April 2012. On an unknown date the patient experienced broke out in a case of chickenpox all over her body. The adverse event improved on an unspecified date. The outcome of the event was reported as recovered/resolved (date unspecified). It was unspecified if the patient had sought medical attention. Additional information is not expected.
I was administered the new H1N1 vaccine on 9/23/2009 in the company of a friend. It was administered by Pharmacy manager, who had recently been trained to administer the vaccine. By 9/27/2009, I had begun suddenly stumbling, tripping and falling hard onto concrete without warning. My walking began to weave and I was tripping over every little crevice on the sidewalks. At the same time, I began to have unexpected bicycle crashes. I experienced tingling in my feet and lower legs. Within a few days I saw my primary physician, who noticed an absence of nerve response in my left leg. He referred me to a neurologist. Neurology Dept. chair, conducted extensive nerve tests, including my first EMG. He conducted extensive blood workups and ordered a sample of my spinal fluid, which as clear. Recognizing increasing loss of distal nerve response, Dr. issued a diagnosis of Guillain-Barre Syndrome. He later refined that diagnosis to Chronic Inflammatory Demyelinating Polyneuropathy and put me on a regime of Immuran. Dr. ordered quarterly IVIG infusions (five days each sequence). I moved in 2010, whereupon another doctor refined the diagnosis to CIDP with anti-MAG.
Breakthrough Case of COVID I had a high fever, headache, really tired, really bad body ache, l had sore throat, brain fog and congested. I did get the Pexlovid from the the pharmacy. Still feeling very tired.
Patient received Moderna COVID vaccine on 2/4/21 and 3/4/21.  Patient lives in a multigenerational home with 8 other adults, 3 tested positive for Covid. On 11/8/21, patient tested positive for COVID and was admitted to our facility for COVID pneumonia and acute hypercapnic respiratory failure. Patient discharged home on oxygen two days later on 11/10/21.
This patient presented stating that she had an anaphylactic reaction after receiving a pneumonia vaccine.  She spoke with her PCP about receiving a Janssen COVID 19 vaccine.  The patient's PCP advised her to receive the Janssen COVID vaccine.  This patient went to a pharmacy and her PCP to receive a Janssen COVID vaccine.  Both facilities refused to vaccinate her secondary to HX of anaphylactic reaction to the pneumonia.  This facility pre-medicated this patient with 50 mg. of Benadryl PO at 11:30 AM.  She developed left sided throat "tightness", diaphoresis, and vertigo at 12:20 PM.  Epinephrine 0.3 mg. IM administered left thigh x one injection.  911 called.  VS HR 92.  RR 24.  152/88.  99% on RA.  Pink color.  No rash.  No SOB. Patient transported to hospital at 12:40 PM.
I felt fine for an hour or so, but was experiencing a tight chest, heavy and difficult breathing for the first 1-2 days. I was a little scared but was hoping to avoid the hospital due to the pandemic and how crazy it was there in April, so my roommate (healthcare professional) was monitoring me, and I went to bed early. That evening and for the next month, my face and body would break out in hives out of nowhere. I would get slightly hot and lightheaded and not even benedryl would work all the time. 2 weeks after my shot, I was experiencing severe intestinal muscle-spasm-like pains. My doctor later let me know my histamines in my gut were activated as well, so I took medication to reverse this. I still get random spurts of full face and neck hives (not brought on by my Celiacs) for days at a time, but they are less frequent now.
Information has been received from a Physical Therapist who is the mother of a 15 month old male patient who on approximately 10/26/2002 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(no lot number reported).  The patient was concomitantly vaccinated with varicella virus vaccine live and HIB conj-hepatitis B vaccine.  Since vaccination the patient developed behavioral changes that were described as the patient was non-responsive when called and pushed family away when hugged.  The patient also developed diarrhea since vaccination and it was reported that prior to vaccination the patient had a very solid hard stool.  In October 2002 the patient developed croup 6 days post vaccination.  Unspecified attention was sought.  Additional information has been requested.
Dizziness; pain on R arm of injection; difficulty in breathing, can breath 70-80%; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PAIN IN EXTREMITY (pain on R arm of injection) and DYSPNOEA (difficulty in breathing, can breath 70-80%) in a 45-year-old female patient 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), PAIN IN EXTREMITY (pain on R arm of injection) and DYSPNOEA (difficulty in breathing, can breath 70-80%). At the time of the report, DIZZINESS (Dizziness), PAIN IN EXTREMITY (pain on R arm of injection) and DYSPNOEA (difficulty in breathing, can breath 70-80%) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.
This is a non serious spontaneous case from a consumer who reports nasal congestion after receiving FluMist. The reporter did not provide causality between events and FluMist. This case is submitted according to the agreement for FluMist. On 08Mar05 a 45 year old male received FluMist IN and subsequently three days later experienced runny nose, nasal congestion, cough, and malaise. He treated himself with an unspecified over the counter medication for his nasal congestion. On 14Mar05, the pt claimed his symptoms are worse. The pt also developed fever of 102 degrees F on 14Mar05. On 15Mar05, the pt stated he is feeling better. The pt has not yet recovered. The reporter did not provide causality between events and FluMist vaccination.
Gout flare; This is a spontaneous report from a contactable consumer, the patient. A 62-years-old patient of unknown gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown, Dose number: 1) via an unspecified route of administration in the left arm on 25Feb2021 at 13:30 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient's medical history and concomitant medications were not reported. On 26Feb2021 at 14:30 (start day after vaccination), the patient had gout flare. The patient was treated for the event gout flare with Indomethacin (INDOCIN). The clinical outcome of the gout flare was unknown. Information about lot/batch number cannot be obtained. No further information is expected.
The health professional gave the injection higher than I expected in  the arm and I had a sudden shooting pain down my left arm to my pinky. That resolved but within three hours I had severe pain in my left upper arm and shoulder with some discomfort down the dorsal surface of the left forearm. The injection was given maybe one finger-breadth below the acromion and I am very tender right under the bone as well as into the upper arm. It is hard to lift my arm. This is much worse than my previous vaccine. I expected that, but this is higher up and may actually involve the shoulder joint. The same woman injected my husband and he is having similar symptoms. His injection was also given high on the arm. I am concerned about our shoulder joints.
Extreme fatigue. Slept. Felt better.  Moderate soreness at injection site. Soreness continues 2nd day.
erythema and hives developed at injection site, benedryl given, hives resolved and erythema decreased. Patient discharged from clinic without any further complications.
Fever, sweating, chills, nausea, extreme body aches and muscle pain, extreme migraine, vomiting. Symptoms lasted 15 hours and were debilitating.
both are sick; Diarrhea; very hard weakness; Throw up a lot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (both are sick), DIARRHOEA (Diarrhea), ASTHENIA (very hard weakness) and VOMITING (Throw up a lot) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced ILLNESS (both are sick), DIARRHOEA (Diarrhea), ASTHENIA (very hard weakness) and VOMITING (Throw up a lot). The patient was treated with TRAZODONE for Pain, at a dose of 1 dosage form. At the time of the report, ILLNESS (both are sick), DIARRHOEA (Diarrhea), ASTHENIA (very hard weakness) and VOMITING (Throw up a lot) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided.   This case was linked to MOD-2021-033897, MOD-2021-033897 (Patient Link).
Patient came in and talked to pharmacist 12/22/21 saying he had an adverse reaction and was going to discuss further with provider. Today he came in and told me provider diagnosed him with PMR, Polymyalgia rheumatica. 12 hours after the vaccine he said he had pain starting from his jaw all the way down his body, resulting with him walking with a cane. Patient also stated he had Covid vaccine 2 weeks before in opposite arm, which was painful. After the flu shot he started having pain at the injection site of the Covid vaccine. At present time patient states he is having residual shoulder pain in both arms.
something's going on with the body that's not normal; she had more symptoms to the shot; bacteria is coming out of skin; virus was going to head/ticking around in the head; can't feel her body/ she states that it's worsened and she can't feel her body; Dose Number of 1 Pfizer and Dose Number 2 of  Moderna; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (something's going on with the body that's not normal), VACCINATION COMPLICATION (she had more symptoms to the shot), SKIN INFECTION (bacteria is coming out of skin), HEAD DISCOMFORT (virus was going to head/ticking around in the head) and HYPOAESTHESIA (can't feel her body/ she states that it's worsened and she can't feel her body) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in February 2021. Previously administered products included for Product used for unknown indication: Pfizer (Dose Number 1 and Lot number EN5318) on 02-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Drug allergy (Allergy to metformin).    On 05-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose Number of 1 Pfizer and Dose Number 2 of  Moderna). On an unknown date, the patient experienced FEELING ABNORMAL (something's going on with the body that's not normal), VACCINATION COMPLICATION (she had more symptoms to the shot), SKIN INFECTION (bacteria is coming out of skin), HEAD DISCOMFORT (virus was going to head/ticking around in the head) and HYPOAESTHESIA (can't feel her body/ she states that it's worsened and she can't feel her body). At the time of the report, FEELING ABNORMAL (something's going on with the body that's not normal), VACCINATION COMPLICATION (she had more symptoms to the shot), SKIN INFECTION (bacteria is coming out of skin), HEAD DISCOMFORT (virus was going to head/ticking around in the head) and HYPOAESTHESIA (can't feel her body/ she states that it's worsened and she can't feel her body) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose Number of 1 Pfizer and Dose Number 2 of  Moderna) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medications were not reported.  The adverse events caused the patient to seek medical care. The patient stated that the bacteria is coming out of her skin. She stated that the virus was going to her head, but no one gave her antibiotics or whatever she needed to get it out. It was ticking around in her head. It started 30 years ago. Patient stated that it has worsened and she was not able to feel her body.  Treatment information was not reported.
The patient presents with 6 day Hx of fever with nausea, vomiting, cough, and fatigue. The pt's husband was diagnosed with COVID-19 infection 11 days ago. Denies chest pain, denies dyspnea, denies abdominal pain. Pt vaccinated for COVID-19 infection 5 months ago.  The onset was 6  days ago.  The course/duration of symptoms is fluctuating in intensity.  Risk factors consist of none and COVID-19 exposure.  Associated symptoms: denies chest pain, denies abdominal pain, denies nausea, denies vomiting, denies shortness of breath, denies fever, denies chills, denies headache, denies dizziness and denies back pain.
On March 16 at approx. 8:15pm, I experienced shortness of breath coming up flight of stairs from my basement.  Normally can sprint up and down these 8 steps with ease. As breathing became more labored, I sat in a chair after making it upstairs to the next floor up from basement.  I, then, experienced a tightness in my chest on the left side near my breast. A slight squeeze of the heart muscle, then palpitations and rest. Then, again, a slight squeeze of the heart muscle, palpitations, then rest or calming. I called my doctor's office immediately to request an appointment to check vitals.  I shared my symptoms with the intake specialist and the person asked if I wanted to go to the emergency room since this was after