chrisvoncsefalvay/vaers-outcomes huggingface dataset:
temperature; fatigue; soreness and redness on her arm; soreness and redness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (soreness and redness on her arm), PAIN (soreness and redness on her arm), PYREXIA (temperature) and FATIGUE (fatigue) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced ERYTHEMA (soreness and redness on her arm), PAIN (soreness and redness on her arm) and FATIGUE (fatigue). On an unknown date, the patient experienced PYREXIA (temperature). The patient was treated with PARACETAMOL (TYLENOL) for Body temperature, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (soreness and redness on her arm), PAIN (soreness and redness on her arm), PYREXIA (temperature) and FATIGUE (fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is breastfeeding. No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-068281 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068281:CROSS LINKED WITH CHILD CASE
Patient is a 70 year old male with past medical history of HIV (most recent CD4 count 378/ viral load negative on 3/31), latent TB treated in 2019, alcoholic cirrhosis, Hypercholesteremia comes in from his neurologist office for concern for AIDP, CIDP. His symptoms started back in March of this year. He received his COVID vaccine (second dose) on March 6th and then went on a trip out of the country where he went deep sea fishing from March 7-15th. Three days later, on March 18th he developed a flu like illness, fevers, chills, headache, cough and diarrhea one week later. His COVID test at that time was negative. He reports that he drank the water in other country and also used ice cubes at smaller restaurants when he went out to eat. He denies eating any raw/ uncooked foods. His wife states that he typically walks 5 miles per day normally however since his trip, he has had to use a walker and needs assistance when walking.   He is followed closely by a Dr in ID clinic for his HIV and was found to have positive stool cultures for Blasto and Giardia. He was treated with Tinidazole and his repeat stool studies were negative. Since that time, he has been experiencing worsening GI bloating and abdominal distension, back pain, and trouble walking. He was seen by NSG for his back pain however his scans showed bilateral degenerative changes. He was seen by GI and was given lactulose without improvement in his symptoms. CT head at that time showed evidence of ventriculomegaly however he denies urinary and bowel incontinence. He reports worsening shortness of breath and states that he "feels like a balloon is inside his stomach" He feels a band like sensation across his abdomen and states that his symptoms are worse at night time. He has not been walking since May 7th and has basically been immobile.
Vomiting, dizziness, fever, severe body aches,  chills, and injection site pain. Symptoms started six hours after injection and lasted 24 hours in total.
experienced anaphylaxis after receiving the second dose; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously, patient received first dose PFIZER-BIONTECH COVID-19 VACCINE (Batch/Lot number and expiration was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. On an unknown date, the patient reported that as someone who experienced anaphylaxis after receiving the second dose of your COVID vaccine, she was wondering whether Pfizer was attempting to modify future RNA vaccines, in particular the booster, so that they were less likely to cause allergic reactions. She hoped she will not need to forego the benefits of this wonderful new technology in the future and said thank you very much. The outcome for was unknown.  Information about the Lot/batch number has been requested.
Patient came into clinic requesting Moderna Bivalent Booster.  Patient given second Moderna Bivalent Booster in Error.  First Bivalent Booster given 10/26/22.   Spoke with patient after determination of error as she had not left clinic.  Asked her (a former nurse) why she came in for second booster as she was Alert and Oriented X 3.  She said she thought she heard it in the news.
I tested positive for COVID-19 5/1/23. I had fatigue, body aches, sore throat, congestion, drainage, low grade fever, and a cough. I contacted my doctor and was not prescribed medication, but the nurse suggested that I take a full dose of Mucinex D. I am still dealing with congestion, fatigue, and a cough.
Palpitations & Tachycardia Narrative:  Employee received the covid shot at 12 and at 2 pm went into A-fib, has hx of a-fib, took flecanid with no relief, went to ER tachy at 140 bolus Diltizem 12am converted back Was admitted to hospital at 10 pm. Reports doing much better at home now and has a f/up appt with cardiologist on 1/25/21.
Fells like a rash around 'my' torso, started on 'my' belly above the belt line. Spread around to 'my' back in a circle. No rash visible but skin was very sensitive to the touch.; Fells like a rash around 'my' torso, started on 'my' belly above the belt line. Spread around to 'my' back in a circle. No rash visible but skin was very sensitive to the touch.; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm left on 12Apr2021 at 09:00 (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and penicillin allergy. Concomitant medications included valsartan (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 07:00, the patient fells like a rash around his torso, started on his belly above the belt line. Spread around to his back in a circle. No rash visible but skin was very sensitive to the touch. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event fells like a rash around 'my' torso, started on 'my' belly above the belt line. Spread around to 'my' back in a circle. No rash visible but skin was very sensitive to the touch was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Dose administered >12/24 hours post puncture; The patient received a dose of the Moderna Covid-19 vaccine that had been first punctured greater than 12 hours ago; Tiredness; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (Tiredness), EXPIRED PRODUCT ADMINISTERED (The patient received a dose of the Moderna Covid-19 vaccine that had been first punctured greater than 12 hours ago) and PRODUCT STORAGE ERROR (Dose administered >12/24 hours post puncture) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9237B and AS1416B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jul-2022, the patient experienced FATIGUE (Tiredness). On 25-Jul-2022 at 9:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a dose of the Moderna Covid-19 vaccine that had been first punctured greater than 12 hours ago). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered >12/24 hours post puncture). At the time of the report, FATIGUE (Tiredness), EXPIRED PRODUCT ADMINISTERED (The patient received a dose of the Moderna Covid-19 vaccine that had been first punctured greater than 12 hours ago) and PRODUCT STORAGE ERROR (Dose administered >12/24 hours post puncture) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was initially stored in the refrigerator on 22-Jul-2022. The vial was first punctured on 22-Jul-2022 at 3:40 PM. The vial did not undergo any temperature excursions. The vial was stored in refrigerator post puncture. The total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): one to two minutes on both 22-JUL-2022 and 25-JUL-2022. It was reported that patient had no adverse reactions to her first dose. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2022: Live Follow-up contains significant information: reporter information, patient information updated and event(tiredness) added.
6 months since 1st COVID shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (6 months since 1st COVID shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (6 months since 1st COVID shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (6 months since 1st COVID shot) had resolved.            No concomitant medications reported.  No Treatment medications provided.
One day after VAR #2 c/o red, swollen, hot area at VAR site.  Two days after vaccine the area was more red, swollen, hot and firm to touch in the center of the redness.  No fever.  No vesicles.
Sore arm with her first injection of Moderna vaccine in her right arm but it did spread to her left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm with her first injection of Moderna vaccine in her right arm but it did spread to her left arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.    On 06-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm with her first injection of Moderna vaccine in her right arm but it did spread to her left arm). At the time of the report, VACCINATION SITE PAIN (Sore arm with her first injection of Moderna vaccine in her right arm but it did spread to her left arm) outcome was unknown.            Concomitant product use was not provided. Treatment information was unknown.   This case was linked to MOD-2021-262572 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: TCR received on 10 Sep 2021,contains Non Significant Information.
Muscle pain; swelling of tissue; Muscles bunch like a charlie horse and don't go away for weeks; The MRI and biopsy showed inflammation of tissue and muscle with the biopsy saying allergy to covid vaccine; The MRI and biopsy showed inflammation of tissue and muscle with the biopsy saying allergy to covid vaccine; The MRI and biopsy showed inflammation of tissue and muscle with the biopsy saying allergy to covid vaccine; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EN6198) via an unspecified route of administration (Age at vaccination 68-year) in Left Arm on 25Feb2021 as dose 1, single for COVID-19 immunization. Medical history included lupus (The patient stated she was told years ago she had lupus, but recent in-depth testing says she don't), from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN); atorvastatin; ascorbic acid, copper gluconate, tocopheryl acid succinate, xantofyl, zeaxanthin, zinc oxide (AREDS 2 VISUAL ADVANTAGE); silicon dioxide (VIVISCAL [SILICON DIOXIDE]); all taken for an unspecified indication, start and stop date were not reported. The patient previously took Penicillin and Plaquenil and experienced drug allergies. It was reported that the patient received the second dose of BNT162B2 (Lot number: EN6208) administered in Left arm on 18Mar2021 for COVID-19 immunization. Historical vaccine includes Flu (influenza vaccine) administered within fourweeks of COVID vaccine, in left arm on an unspecified date in Jan2021. No COVID prior vaccination was reported. The patient not tested COVID post vaccination. On 02Mar2021 the patient experienced muscle pain, swelling of tissue, muscles bunch like a muscle spasm and don't go away for weeks, the MRI and biopsy showed inflammation of tissue and muscle with the biopsy saying allergy to COVID vaccine. AE resulted in Doctor or other healthcare professional office/clinic visit. It was reported that she has seen 4 Drs. and now she was scheduled to see an allergist. The patient underwent lab tests and procedures on an unspecified date which included biopsy and magnetic resonance imaging: The MRI and biopsy showed inflammation of tissue and muscle with the biopsy saying allergy to COVID vaccine. Therapeutic measures were taken as a result of the adverse events, patient was treated with Prednisone. The clinical outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
On about 4/22/2021 at around 7PM, I took a shower. When I got out, I noticed that there was a huge, black and blue bruise above my right breast and below my clavicle. I kept an eye on it and went to the doctor to have it examined. I was told that I should just keep an eye on it, and as long as it didn't hurt, I shouldn't be alarmed. The bruise gradually faded over the following 2 weeks. On about 4/26/2021, I noticed a large, swollen nodule in the area where the clavicle articulates with the manubrium. I consulted my daughter-in-law about it, as she is studying nursing. She told me that the same thing had happened to my grandson when he was vaccinated, so we assumed that the nodule was probably caused by the vaccine. I had the nodule for about 2 weeks before it finally vanished.
MENACTRA was scheduled to be delivered on 5/31/19, but they did not get the vaccine until 6/4/19 and when they opened ice packs were in the container but it was not frozen; Initial information received on 09-Jul-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA193301, 2019SA193302, 2019SA193303, 2019SA193304, 2019SA193305, 2019SA193306, 2019SA193307 and 2019SA158240 (same reporter).   This case involves 11 years old male patient with who was vaccinated with dose MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number: U6365AA and expiry date was not reported) via intramuscular route in the arm NOS, on 31-May-2019.  The patient's past medical history, medical treatment(s) and family history were not provided.  It was a case of actual medication error due to incorrect product storage. It was reported that MENACTRA was scheduled to be delivered on 31-May-2019. Caller stated they did not get the vaccine until 04-Jun-2019. Caller stated when they opened ice packs were in the container but it was not frozen. It was stored incorrectly from 31-May-2019 to 09-Jun-2019.  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 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   List of document held by sender: none.
Shortness of breath or difficulty breathing,  Chest pain, covid pneumonia, hospitalization in ICU
Zostavax Sub-Q administered using a Vanishing Point syringe. Vaccinator pressed release button causing needle to retract into body of syringe. Vaccinator unfamiliar with syringe "wondered where needle went" causing patient to worry that "is needle still in my arm?". Undeterred by vaccinator's advice that needle was "not still your arm", patient & sister went for an xray at hospital ER. X-ray was of course negative.
Erythema, redness, swelling, tenderness left deltoid area centered more around the Meningococcal B vaccine than the HPV 4 vaccine injection site, with fever, malaise. 100.8 degree F temperature.
bell's palsy; This spontaneous case was reported by a patient and describes the occurrence of BELL'S PALSY (bell's palsy) in a 22-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient was never diagnosed with or tested positive for COVID-19. The patient had no acute illnesses at the time of vaccination and up to one month before. The patient had no chronic or long-standing health conditions.  Concurrent medical conditions included Penicillin allergy.    On 09-Jan-2023 at 1:00 PM, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In February 2023, the patient experienced BELL'S PALSY (bell's palsy) (seriousness criterion medically significant). On 20-Jul-2023, BELL'S PALSY (bell's palsy) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter considered BELL'S PALSY (bell's palsy) to have an unknown relationship.    No concomitant medications were reported.  The event caused the patient to seek physician's office/urgent care visit.  The other potential cause was wisdom teeth removal 3 days post vaccine.  The patient did not experience a similar event in the past.  No treatment medications were reported.  Company Comment This spontaneous case concerns a 22-year-old female patient with medical history of penicillin allergy who experienced the seriousness criterion medically significant expected AESI of Bell´s palsy the following month after 1st. dose of SPIKEVAX NOS vaccine. Concomitant medication details nor Treatment details were reported On 20-Jul-2023, Bell's palsy had resolved.  The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.   This case was linked to MOD-2023-746659.
Chills, body ache, headache; Chills, body ache, headache; Chills, body ache, headache; This is a spontaneous report from a contactable consumer. A 41-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: unknown) via an unspecified route of administration, administered in Arm Left on 05Apr2021 at 11:00 (at the age of 41-years) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (Lot Number: EN6208) via an unspecified route of administration, administered in Arm right on 14Mar2021 at 15:30 (at the age of 41-years) as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. On 06Apr2021, the patient experienced chills, body ache and headache. The patient did not receive any treatment for the events. Since the vaccination, the patient was not tested for COVID-19. The outcome of events was resolved on an unspecified date in Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Throat tightness  Trouble swallowing  Chest pains  Sore throat
sick for 2 days; felt yucky; didn't feel well; sore arm; fever/ highest was 101.2 F; really tired; headachy; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 2 days), DISCOMFORT (felt yucky), MALAISE (didn't feel well), MYALGIA (sore arm) and PYREXIA (fever/ highest was 101.2 F) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by reporter.  Concurrent medical conditions included Cancer. Concomitant products included IMATINIB MESILATE (GLEEVEC) for Chemotherapy.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick for 2 days), DISCOMFORT (felt yucky), MALAISE (didn't feel well), MYALGIA (sore arm), PYREXIA (fever/ highest was 101.2 F), FATIGUE (really tired) and HEADACHE (headachy). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, ILLNESS (sick for 2 days), DISCOMFORT (felt yucky), MALAISE (didn't feel well), MYALGIA (sore arm), PYREXIA (fever/ highest was 101.2 F), FATIGUE (really tired) and HEADACHE (headachy) outcome was unknown.
Very painful joints hands and hips 1 week following vaccination. 2 weeks later unilateral neck pain and lower back pain feeling unwell.
Myasthenia Gravis Exacerbation - slurring of speech, bulbar symptoms
4 hours after shots got chills, SOB, throat tightness, right arm swelling. Next day red hive all over the whole upper arm, red swollen, very itchy. Seen in urgent care 8/29 given KENALOG shot, BENADRYL, and cold compresses. Seen in our office 9/1 improving continue BENADRYL and cool compresses.
"Covid toes" Swollen, red, a little painful. I think I had Covid-19 beginning March 21, 2020 and lasting through April of that year.  I never had a positive test, however, because none were available in my area until mid May, when I tested negative. The toes were evident then, too, though they were hardly the worst effect of the virus!
Resident in long term care facility and needed 2nd dose. Advised by facility first dose was a Pfizer vaccination. Facility did not have vaccination card available for review due to family member having card at home but stated did contact hospital and was advised it was a Pfizer injection.
Red itchy patch on injection site location. Patch is 3 by 2 inches in size. Itch patch matches shape of band aid used to cover the injection site. RSV administered to right arm and rash occurred. COVID administerred to left arm with no rash.   Achy and tired after both shots. Congestion from cold returned.