chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 08-Aug-2022.; No adverse event; Administered Moderna COVID-19 Vaccine after 30-day use by date.; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 08-Aug-2022.) and NO ADVERSE EVENT (No adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 08-Aug-2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date.), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 08-Aug-2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 08-Aug-2022.).    No concomitant medications were reported.   Patient administered COVID19 6MO-5YO Moderna Pediatric 25/0.25 blue. The healthcare professional was not aware of any symptoms for any patient after the vaccine was given.  No treatment details were reported.
A report was received from a health care professional on 1/8/04 concerning a 78 year old male vaccinee who developed a rash and fever and was diagnosed with Stevens Johnson Syndrome on 11/02/2003 and hospitalized on the same day, after receiving Fluvirin vaccine on 10/29/03. Concomitant medications included phenytoin, amlopidine besilate and lisinopril which were commenced two months prior to hospitalization. On 11/02/03, the vaccinee, who is a lung cancer patient, developed a rash, fever, and was admitted to hospital on the same day and diagnosed with Stevens Johnson Syndrome. Skin biopsy results of the left chest were determined to be consistent with erythema multiforme. The vaccinee also experienced erythema of the conjuctiva and erythema with palmar involvement. The vaccinnee was treated with topical and systemic corticosteroids. The vaccinee recovered and was discharged from hospital on approximately 11/11/03. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Follow up on 04/29/04 states: "Further information was received from a health care professional indicating that the vaccinee experienced erythema multiforme and erythema with palmar involvement on 10/30/03.  On 11/03/03 the vaccineee underwent a skin biopsy on 0.4cm of a conical piece of skin of the left chest, which was consistent with erythema multiforme.  The epidermis revealed minimal spongiosis, necrotic keratinocies, exocytosis and focal vasuolar degeneration in the basal cell layer. On 10/29/03 the vaccinee visited a center and the attending physician reported that he had a superficial skin reaction on his scalp due to radiation therapy. The vaccinee has no known allergies. The vaccinee has a medical history of non-small cell lung cancer-metastatic lung adenocarcinoma with metastases in the brain and adrenal glands. A brain lesion was subsequently diagnosed in Sept 03. The vaccinee also has a  history of seizure, hypertension and coronary artery disease and underwent CABG surgery on an unspecified date. The vaccine had a radiation therapy with palliation of the brain metastasec from 10/03/03 -010/24/03.  Concomitant medication included phenytoin sodium for seizure, dexamathosone and bran metastases, simvastatin, acetylealicyclic acid for coronary artery disease and trazodone.  The vaccinee's dermatologist was consulted and he was treated with hydrocortisone cream to be administered twice a day to the face.  The vaccinee was also treated with an increase of dexamethalosone, dexamethssone eye drops and cefatolin. Phenytoin was discontinued. The reporter has assessed the relation ship of the vaccinee to the erythema multiforme with palmar involvement and fever as possible, although stating that the vaccinee was also taking phenytoin sodium at the time of the event. Follow up pending." Follow up on 05/17/04 states: "No new information at this time."
Red welt below injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Red welt below injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced VACCINATION SITE URTICARIA (Red welt below injection site). At the time of the report, VACCINATION SITE URTICARIA (Red welt below injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided. No treatment medication was provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Vertigo; Nausea; Ear fullness; Slight tinnitus; Fatigue; Brain fog; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP00151) via an unspecified route of administration in the left arm on 07Apr2021 at 11:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other concomitant medications. The patient previously received erythromycin (MANUFACTURER UNKNOWN) on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 10Mar2021 at 11:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 07:45, the patient experienced sudden onset and lasting vertigo, nausea, ear fullness, slight tinnitus, brain fog and fatigue. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of events and included treatment with physical therapy from an unknown start date. The clinical outcome of the events lasting vertigo, nausea, ear fullness, slight tinnitus, brain fog and fatigue was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
2 days after receiving my 2nd dose of Moderna, I started to get severe joint pain, headaches and body aches.  I also noticed that I was having heart palpitations, and it was making me feel short of breath and dizzy.   I addressed this with my PCP and he said we needed to keep a close eye on my symptoms and to wait and see if they resolve.   The body aches, joint pain and headaches eventually subsided, however my palpitations did not.   They became more of an issue.  They got to the point of increasing so much, that I needed to be placed on Atenolol in order to control them.    Within the last 3 months,  the medication seems ineffective in controlling my PVC's and I had to be changed to Metoprolol XL.
3/10/2021 first dose moderna 15 minutes post vaccine onset of headache, lightheadedness, euphoric. 1 week later back pain with increasing pain from back down to lower left extremities pain 10+/10 and felt like "electricity" in body  leading to pt being unable to ambulate.  by lymph node surgery date on  3/25/21  patient was able to ambulate again. Second Moderna dose on 04/ 10/21 pt continued to experience lethargy and mobility issues. Neurologist consult 06/2021 work up done. Booster dose 12/27, during dose administration pt felt as if a "nerve was hit". Reported redness and swollen lymph odes on left arm.
Following the administration of Hep A vaccine (second) and 1st Gardasil, pt became lightheaded and fainted, falling from sitting positive on table to floor. Pt awakened after few seconds Hr-2, BP 98/58 Rested in office 30 minutes, given fluids p.o. Hr 62, BP 118/10
Information has been received from a physician concerning a female patient "in her 80's" who "over a year ago" was vaccinated with "single dose" of ZOSTAVAX (Oka/Merck) (lot # not available). The patient developed a terrible case of shingles recently and was hospitalized. The patient had sought medical attention from physician. As of 05-MAR-2008 the patient's terrible case of shingles persisted. The physician considered the patient's terrible case of shingles to be disabling. Additional information has been requested.
Left arm hot, hard and swollen. Severe ache, cannot lift arm to do daily tasks. 5:30 PM at home - shaking - heart palpatating - chills - went to bed at 7PM and slept all night. 2/3/15 Arm a little better, but have chills and flu like aches.  Tired - want to leave work to go home and sleep.
Severe chills, and fever of 102.7. Numbness and tingling of both upper extremities. Mottling of both upper extremities. Patient taken to ER at 10:48 AM. Upon admission, Temp 103.9, BP 153/77, HR 103. IV fluids and Ceftriaxam given. CXR performed and blood work done. All negative. After 2 hours, patient sent home. Fever down to 101. Chills and body aches continued throught the next 24 hours.
it hurt; tired; Flu symptoms; sick in the stomach; feeling sick; levels of phosphorous had increased; This case was reported by a consumer via call center representative and described the occurrence of blood phosphorus increased in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose on 17th August 2022 on left arm). Concurrent medical conditions included bone disorder (patient had bone issues).   On 30th November 2022, the patient received the 2nd dose of Shingrix. In December 2022, less than a week after receiving Shingrix, the patient experienced blood phosphorus increased. On an unknown date, the patient experienced pain, tiredness, flu symptoms, upset stomach and feeling unwell. On an unknown date, the outcome of the blood phosphorus increased, pain, tiredness, flu symptoms and upset stomach were unknown and the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the blood phosphorus increased, pain, tiredness, flu symptoms, upset stomach and feeling unwell to be related to Shingrix.     Additional Information: GSK receipt date: 09-DEC2022 Reporters comment: Patient reported feeling sick for about 1-2 days.  Patient reported Flu symptoms, sick in the stomach, tired, and it hurt. Patient reported she had a test 2-3 days ago because had bone issues. Patient did report that her bone issues was a previous condition before taking the Shingrix vaccine series (both doses). Patient reported that the increase of phosphorous from 4 to 5 was firstly detected in the test that she had 2-3 days ago. Patient mentioned the name of another shot that she had taken for years but the name was not clear.  Not all information was available. Lot and expiry date were not provided. Patient mentioned the name of another shot that she has taken for years but the name was not clear "Polie" . Patient was just concern if this increase was the vaccine or is it something else. Lab work was to check Calcium, Phosphorous and Vitamin D. Did not consent to follow-up. Customer did not provide consent for follow up with HCP.
Headache 2 hrs after 2nd shot. Later that day, slight feeling ?out of sorts?  fatigued.  Fatigue continued into next day with no headache.   Approx 26 hrs after vaccine felt nauseated and had very loose  stools 2 times between 26-36 hrs after  and 3 addition very loose stools  48- currently (approx. 63hrs)  after 2nd vaccine still fatigue, out of sorts feeling, slight headache, and bubbly stomach.
Information has been received from a physician concerning a child from a day care who was vaccinated with a dose of varicella virus vaccine live. In February 2004, the patient presented with breakthrough chicken pox with less than 50 lesions and a fever. The patient was sent back to school. No further information was available. No product quality complaint was involved. It was also reported that 5 other children from the same day care were vaccinated with a dose of varicella virus vaccine live and also developed breakthrough chicken pox (WAES0403USA02248). Additional information has been requested.
Halle has had regular periods for over four years. Since receiving the vaccine she has not had a. And is over two weeks late. She is not sexually active and there is no other reason for this to occur. She?s extremely distraught and concerned about her personal health and is scared of taking the second vaccine now
pt recvd flu vax & 1 day later, pt devel redness @ inj site;
I started feeling achy with chills on day 8 in the afternoon and on day 9 I was in bed all day on day 9 with ache/fever and headache. I am never ever just lay around but I had to. I noticed that my arm at injection site was really sore, but the time I took off long sleeves and looked at it that night, injection site was red, swollen and hot. I saw that I had Covid arm (after googling it). I took 2 Benedry, went to bed and in the morning was feeling much better. This is day 11 and I am fine, red swollen area in arm is slowly going away.
Patient received immunization 7/30/19. She was seen for F/U on 8/1/19 due to redness at injection site. First dose of Hep A. Afebrile. Pruritic are with mild swelling (blanching of patch).
tested positive for Covid; This is a spontaneous report from a Pfizer sponsored program.   An unspecified aged female consumer (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration on 08Apr2021 as a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The Consumer(patient) stated that she received her first dose of Covid-19 vaccine on 08Apr2021 and tested positive for Covid last on 10Apr2021 and her(consumer) roommate, received the first dose of Covid-19 vaccine on 10Apr2021 and tested positive for Covid today (13Apr2021). Consumer wanted to know if they need to wait to get the second dose of the vaccine. The patient underwent lab test and procedure which included SARS-CoV-2 test: positive on 10Apr2021. The Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021416341 same drug/reporter, different patient
Pt became diaphoretic felt nauseous and dizzy. She looked pale in her face. Symptoms lasted for approximately 15 minutes.
No additional AE reported; nurse reported an improperly stored ROTATEQ was administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 20-JAN-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) 1 dosage form, orally, lot number 1688829, expiration date 29-NOV-2021 for prophylaxis. No additional adverse events reported.  The vaccines underwent a temperature excursion of 50 degress Fahrenheit (°F) for 1 hour. There were no previous temperature excursions. The call was due to digital data logger.; Sender's Comments:  US-009507513-2101USA010505:
EDGM and pain (approx 10in x 5in) extending from anthrax site to below elbow. Tx: Cipro 500mg x five days bid.
Pt. received influenza vaccine (seasonal) on 10-14-09 on 10-15 developed shortness of breath, "itching" - general body aches - symptoms increase on 10 - 16, went to E.D w/ decrease B/P increase SOB - dx with "Allergic reaction".
Extreme urticaria (itchiness). Mild hives on arm and redness on neck and arm.  Numb lips. Took 50 mg diphenhydramine mild relief slept overnight normal in am, arm only sore
Narrative:  He reports experiencing nausea and vomiting after his first  vaccination. He is not sure of the exact timeline of the events last month. With permission, his records were reviewed. There are a few varations in  documentation regarding symptoms, but it seems between documentation and what patient remembers - that the nausea and/or abdominal cramping started  later that day (not within 4 hours of vaccination), which eventually developed into intractible nausea/vomiting a/w some hematemesis by day 3 post vacciation -  leading him to seek emergent care. While at emergent care, he was diagnosed with viral gastroenteritis (see d/c note summary in chart). He reports having a similar episode like this a few years ago (per chart chest pain, n/v in 2018).  Pathology of gastric biopsy: "chronic inactive gastritis" with negative H. pylori and "LA grade D esophagitis with MW tear as cause of hmeatemesis."
PATIENT IS 37 WEEKS INTO PREGNACY, NO COMPLICATIONS THUS FAR WITH PREGNACY, EXPECTED DELIVERY DATE 11-17-17.
PATIENT WAS GIVEN A BOOSTER DOSE OF 0.5MLS INSTEAD OF 0.25MLS FOLLOWING THE JANSSEN VACCINE. PATIENT REPORTED FATIGUE AND BODY ACHES FOR A DAY.
Covid symptoms started on 05/02/2022; tested positive on 05/04/2022. Symptoms started with sore throat and general stuffy and runny nose. I did come down with a cough but it wasn't severe. It was basically cold symptoms and some exhaustion. I tested on Tuesday but it was showing negative, but I did another one Wednesday 05/04/22 and it was positive. I also had a little congestion, and the cough has been lingering but it's not unusual for me because it takes me a long time to get rid of a cold. Most symptoms were gone by Saturday 05/07/22.
slightly light headed; rt hand got red & hot; rt hand got red & hot; numb,  heat in rt arm/right side of jaw felt numb; Blood pressure went up to something over 90; fatigued; it hurt to open my mouth (gland by rt ear felt swollen); got a line of inflammation in my rt inside cheek; This is a spontaneous report from a contactable other HCP (patient). A 52-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number= EL0140), intramuscular at right arm on 23Dec2020 16:45 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication in two weeks included Multi vitamin, tocopherol (VITAMIN E), vitamin d3, bioidenticle estrogen/progesterone. The patient previously took Iodine, metronidazole (FLAGYL), Doxycycline, clarithromycin (KETEK); and known allergies to them. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient felt slightly light headed. Within 5 minutes right hand got red & hot, numb, heat in right arm & right side of jaw felt numb as if blew up balloons. Blood pressure went up to something over 90. The patient took a benadryl. Next few days v fatigued & on p.m. of 24th it hurt to open her mouth (gland by right ear felt swollen). The patient got a line of inflammation in her right inside cheek & a tissue mound that had not gone away. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovering.
The pt developed itchy rash on 04/20/2002-04/21/2002. The pt was seen at physician's office on 04/23/2002.
Pt. has small white pustule at VARIVAX site. No temp. No itching. Pt. acting normal.
Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Fatigue) 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 FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Fatigue, at an unspecified dose and frequency. At the time of the report, FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter.   This case was linked to MOD-2021-297796 (Patient Link).
Large red rash on site that appeared several days after injection. Red, warm, itchy, swollen, achy
pt recvd vax;approx 4 mo p/ recving 3rd dose, pt exp abnl hair loss; unresolved
Started with fever 11/20 @3;30am--103.3F.Caled MD @8:30am --nurse said not a reaction. Child remained w/ low grade temp until 11/23--spike to 103.4 again .Called MD--went  to clinic. Temp >104. CBC done -wbc normal--4.0. Told it was viral--wouldn't the wbc be even slightly elevated?  Child also had fever >101 with first dose of Prevnar