chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient developed rash, swelling, and pruritis at injection site about eight days after the vaccine was given.  Symptoms slowly improved by the fifth day after the reaction according to the patient.
Gillian barre syndrome was diagnosed by the Hospital doctor. Patient lost the ability to walk. Is being treated with intravenous IVIG for 7 days and  slowly recovering in the hospital.
Achiness on the injection site; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1283), via an unspecified route of administration on 18Jan2021 at single dose for vaccinated. The patient medical history and concomitant medications were not reported. The patient got vaccinated earlier this morning (on 18Jan2021). Then after that there was some achiness on the injection site on 18Jan2021. She was asking if she can take TYLENOL. The event outcome was unknown.
Nausea, vomiting, chills, aches all over started 1 hr post dose; lasted until the end of the day.
His L shoulder area @ the site of TDAP injection 2-5 cm x 5 cm round Cellulitis IM ROCEPHIN 10mg and PO AUGMENTIN 500 PO BID x 4 warm compress to area
within 10 minutes of receiving vaccine, patient reported having neck tightness and chest tightness; patient was feeling warm and blood pressure was elevated; diphenhydramine 25mg was given and patient was taken to ER. ER reported it was a mix of a slight reaction and anxiety from receiving the vaccine. Patient was sent home from ER and is doing fine.
Patient seemed otherwise healthy before the vaccination. Patient was hospitalized then shortly passed after getting the 1st dose.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 07-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 lot # H013847 with expiration date: 15-MAR-2014, 0.5 ml, intramuscularly. No adverse effects were reported. Additional information has been requested.
pt recvd flu vax 10NOV93 & stated immed c/o of a sore lt arm; the discomfort lasted 2 months & pt exp tingling & weakness in lt hand; tx included APAP & heat for arm discomfort;
Generalized malaise, fever, chills, fatigue (day 1 post vaccine), Full body rash (day 2 post vaccine).
Facial and mouth tingle initially. Day later dizzy-room spinning with light exercise.  More facial and tongue swelling.  Followed by 1 week of swollen glands and tender jaw.
Migraine-type headache; neck stiffness and shoulder soreness occurred a few days after vaccine per patient.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concomitant products included QUINAPRIL, BISOPROLOL FUMARATE, FUROSEMIDE, LEVOTHYROXINE and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medication reported was Green Girl B supplement (curcumin, black pepper, resveratrol and enzymes).  Patient has not received any treatment for her symptom.
Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023; No adverse event; She had expired vaccine that was administered on 15-Mar-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 62-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023).    It was unknown if the patient was ever diagnosed with or tested positive for COVID-19.  Concomitant medications of the patient were not reported.  The vial was initially stored in the refrigerator on 14-Mar-2023. The vial did not undergo any temperature excursions.  HCP stated that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-Mar-2023. There was potentially a second lot number that was expired and was administered to patients on 03-Mar-2023, but HCP did not have any details on this event at the time of reporting.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
This case was reported by a other health professional via sales rep and described the occurrence of shingles in a adult female patient who was administering the vaccine received SHINGRIX. In August 2018, the patient received SHINGRIX. In August 2018, unknown after receiving SHINGRIX, the patient experienced inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the inadvertent exposure to vaccine and exposure via skin contact were unknown. Additional details were provided as follows: The age at vaccination was not applicable. The age group was not reported but was captured as adult as per the vaccine indication. The staff nurse (patient) was reconstituting SHINGRIX, when drawing the reconstituted SHINGRIX from the vial, the SHINGRIX leaked from the needle hub and got on the nurse's hand and skin in the last week of August 2018, which led to inadvertent exposure to vaccine and exposure via skin contact. The outcome of the event was unknown. Follow up received from other healthcare professional on 5th September 2018: The patient details were updated. Within a day after the skin exposure of the SHINGRIX, the patient experienced local adverse reactions of redness and irritation, by the later part of last week after the receiving, either On 29th August 2018 or 30th August 2018, less than a week after receiving the SHINGRIX she experienced some small bumps on her nose and upper lip. The patient was evaluated by the physician on 31th August 2018 and based on the bumps on her nose and lip, and her skin exposure to SHINGRIX, she was diagnosed with shingles. The patient was planned to see an ophthalmologist in the week of reporting to see if there was any eye involvement.
Information has been received from a consumer concerning her 9 year old son who on an unspecified date was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient developed chickenpox. The patient developed flu-like symptoms on 15-JUN-2007 and a rash appeared on 17-JUN-2007. The patient was pulled out of his swim meet because of his symptoms. He was to stay away from other children for seven days. It was also noted that his sister seemed to be coming down with chickenpox as well and developed a high fever and upset stomach, "the first two signs of chickenpox," according to the reporter. No further information is available.
Sleeplessness; Pain on both ears including the cartilage on the outer aspect of the ears and behind the ears; Headache; FATIGUE; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Sleeplessness), EAR PAIN (Pain on both ears including the cartilage on the outer aspect of the ears and behind the ears), HEADACHE (Headache) and FATIGUE (FATIGUE) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Hidradenitis suppurativa. No Medical History information was reported. On 23-Feb-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram once a week. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram once a week. In April 2021, the patient experienced INSOMNIA (Sleeplessness), EAR PAIN (Pain on both ears including the cartilage on the outer aspect of the ears and behind the ears), HEADACHE (Headache) and FATIGUE (FATIGUE). At the time of the report, INSOMNIA (Sleeplessness), EAR PAIN (Pain on both ears including the cartilage on the outer aspect of the ears and behind the ears), HEADACHE (Headache) and FATIGUE (FATIGUE) had not resolved. No concomitant and treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective email clean-up activity which included identification and booking-in of historical emails. This activity has been described in deviation.
This spontaneous report as received from a consumer refers to a 71 year old female patient with no pertinent medical history or drug reactions/allergies. On 22-JUL-2013 the patient was vaccinated with ZOSTAVAX in the right arm. The patient received the vaccination without prescription. Route of administration, dose number, lot number and expiry date were not reported. The product circular number was reported as uspi-v211-i-1309r017. Concomitant therapies included blood pressure medications which included Lisinopril (manufacturer unknown) and Amlodipine, and unspecified diuretic medication. On 26-JUL-2013, 5 days after onset of therapy the patient experienced dry throat, anxiety, nausea, jitteriness, abdominal agitation and dry mouth. The patient contacted her physician who did not prescribed the vaccination with ZOSTAVAX. The physician only changed the patient's blood pressure medications (nor further specified) and did not feel that these changes were related to the adverse events. The outcome of dry mouth, anxiety, jitteriness, nausea, abdominal agitation and dry throat was reported as not recovered/not resolved. This case was linked to case 1311USA011732 based on the same reporter. Additional information has been requested.
Started off with a terrible cough at night. She started to get a large bump on left leg where shots were given. Returned to Dr on 9/15/16 about cough. Dr gave antibiotic for her cough. I asked if the cough would be from the shots a week ago, dr informed me no. On 9/19 her leg started to develop bumbs, almost bite like, was warm to touch.. very swollen. The night of 9/19 and 9/21 she woke up in night sweats. On 9/21 morning, a few blister bumps appeared on her side of face on cheek.  Her leg bumps were not blistery and she was scratching them. Made appointment with dr on 9/21 at 3pm. Informed that she has chickenpox and is having a reaction to her vaccine of them that was given on 9/8/16. Dr gave another medicine and advised for her not to return to daycare until bumps were gone.
My doctor placed me on atorvastatin because I am diabetic. I had been on metformin since mid-November or December of 2022. In January of 2023, I was prescribed a small dose of atorvastatin once a day in the evening. The response was my morning blood sugar immediately jumped from my normal reading of 140 to 150 to 180 or better every morning. I couldn't think of anything else that changed aside from the atorvastatin. I contacted my doctor. I'm going in on Thursday. I stopped the atorvastatin about 10 days ago. My toes feel like they have cardboard pasted to them. It was worse than frostbite. It stayed like that all day. My blood sugar levels have lowered.
Had generalized seizure approximately 12 hours after receiving DTaP with no other risk factors for seizures.
Patient received the 2nd COVID vaccine (Pfizer, lot # ER8736, use by 07/04/21) at 0950. The client told  EMT, "  am feeling a little light-headed and dizzy" at 1000. The client was immediately assisted to the anti-gravity chair and placed in a semi-fowler's position. The client appeared mildly diaphoretic.  RN arrived on scene and assessed the client who was A & O x 4. The client was offered Benadryl and stated, " I think I will hold off on Benadryl and see how I feel in a few minutes." Vital signs were taken at 1003, BP- 132/84, HR-74, RR-14, oxygen saturation- 98%. The client was given juice and a granola bar.  The client no longer appeared diaphoretic, denied feeling flushed, itchy, shortness of breath, difficulty breathing, angioedema, or chest pain. The client is currently taking Turmeric, denied any chronic medical conditions, or drug allergies. Vital signs taken at 1008, BP- 138/84, HR- 69, RR-14, oxygen saturation at 98%. The client stated, " I'm feeling better and the light-headedness is better." Vital signs taken at 1013, BP- 139/88, HR- 69, RR-14, oxygen saturation- 99%. The client was assisted to a Fowler's position by EMT.  Vital signs taken at 1015, BP- 136/86, HR- 69, RR-14, oxygen saturation-98%. Patient stated " I'm just feeling tired", denied shortness of breath, difficulty swallowing, itching or swelling. Vital signs taken again at 1025 BP- 141/86, HR-66, RR-14, oxygen saturation 99%.  Client stated, " The light-headedness and dizziness is gone, my mouth is just a little dry." The patient then drank water which relieved the mouth dryness.  Last vitals taken at 1030 BP-139/82, HR-66, RR-14, oxygen saturation 99%. The client slowly stood up and denied any dizziness, headache, SOB, or chest pain.  RN educated the client about follow-up precautions with his PCP, Emergency Room precautions, and educated the client about V-safe. The client had a steady and even gait when walking to his vehicle at 1034.
7mins post vaccination pt reported flushing/sweating, Dizziness and Vomiting Vitals: 103/65, 87, 100% -- > 96/66, 73, 100% Pt given apple juice. Pt stable and released from the vaccination site accompanied by Mom @16:16.  Pt was in NAD and Feeling 100% better
Dating back about 1 year ago; patient states to have the following symptoms - loss of circulation in the right arm, body aches all over, nervousness, fatigue and headaches. Patient states that he can't point out a date from onset of symptons. He also states that these symptons can't be pin pointed to one vaccine. This has occured over a period of time.  This document was based on a series of vaccines starting with the first Anthrax vaccine.
Developed confusion. Inability to stand or walk.  Admitted to Hospital on 10/23/2021 or 10/24/2021. Stroke like symptoms. Unable to talk. Lack of coordination. Confusion. Unsteady gait.  These sx started within 24 hrs of Moderna Covid Booster.
Large pulmonary embolism around the time of 3rd COVID19 dose.  No history of blood clots, no other risk factors. Currently in ICU.
This spontaneous report was received from a physician and referring to a 2 months old patient of an unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and drug reactions/allergies were not reported. On an unknown date, the patient was inadvertently vaccinated with 1 dose of VAQTA (lot # reported as R027431 and expiration date 08-SEP-2019; route of administration was not provided) for prophylaxis. No adverse effects reported.
Broke out in rash and hives all over body; Broke out in rash and hives all over body; Itching; Swelling; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Apr2021 at 16:45 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medication included dexlansoprazole (DEXILANT) for an unspecified indication from an unknown date and unknown if ongoing. On 16Apr2021 at 19:00, about two hours after vaccination, the patient broke out in rash and hives all over body and experienced itching and swelling. The event 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 the adverse events and included treatment with unspecified allergy medication. The clinical outcome of the events broke out in rash and hives all over body, itching and swelling was recovered on an unknown date in Apr2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 15-DEC-15, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016 (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to a temperature excursion of 1.1 Celsius degrees for 208 hours with lowest temperature recorded of 34 Fahrenheit degrees. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
App 4 hours after immunization, the pt. reportedly developed blisters on her lips, and her lips and face were swollen.  Pt. refused to seek medical care.  Symptoms completely resolved within 24 hrs, without treatment.
Chills, fatigue, body ache and headache that began 24 hours after vaccine and lasted 48 hours. I took acetaminophen and iced the injection site and started in bed.
This 4-year-old was seen on 10 June 2004 for her Well Child Visit and immunizations.  She received 3 shot: DTaP #5, IPV #4, & MMR #2. Within 24 hours, the childs mother returned stating the childs left thigh was red, swollen, warm and tender to touch. The mother reports a similar reaction with 18 month shots and that the child was diagnosed with cellulitis.  On June 11, 2004 she was seen by her pediatrician who documented an"8x7.5cm erythematous, warm, rash to the left thigh, slight extension out laterally" and diagnosed with left thigh cellulitis. The child remains afebrile, temp 36.2C. She was placed on Keflex 250mg PO TID for 10 days.  She had a follow up appointment on June 28, 2004 with only a knot remaining to the left thigh.  The physcian documented the left thigh had an area of firmness that was nontender with no fluctuation and resolved cellulitis.
Check out 17 x 9 cm of reddness, erythema, warm to touch, tender in LUD.  Dx - Cellulitis
Chest pain (described as someone squeezing heart); Rapid heart rate; Shortness of breath; Sweating; Pale and clammy skin; Pale and clammy skin; This is a spontaneous report from a contactable reporter (Consumer or other non-HCP). The reporter is the patient. A 17 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 12Jan2022 at 15:30 (Lot number: FJ5683) at the age of 17 years as dose 1 (TRIS), single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. Concomitant medication included unspecified birth control medications. Past drug history included: Flu vaccine, for Immunisation, reaction: "Allergy to vaccine", notes: Known allergies : Flu vaccine. The following information was reported: CHEST PAIN (non-serious) with onset 13Jan2022 at 00:15, outcome "recovering", described as "Chest pain (described as someone squeezing heart)"; HEART RATE INCREASED (non-serious) with onset 13Jan2022 at 00:15, outcome "recovering", described as "Rapid heart rate"; DYSPNOEA (non-serious) with onset 13Jan2022 at 00:15, outcome "recovering", described as "Shortness of breath"; HYPERHIDROSIS (non-serious) with onset 13Jan2022 at 00:15, outcome "recovering", described as "Sweating"; PALLOR (non-serious), COLD SWEAT (non-serious), all with onset 13Jan2022 at 00:15, outcome "recovering", and all described as "Pale and clammy skin". Relevant laboratory tests and procedures are available in the appropriate section. The events "Chest pain (described as someone squeezing heart)", "Rapid heart rate", "Shortness of breath", "Sweating" and "Pale and clammy skin" were evaluated at the doctor or other healthcare professional office/clinic visit and emergency room visit. Therapeutic measures were taken as a result of chest pain, heart rate increased, dyspnoea, hyperhidrosis, pallor and cold sweat. Additional Information: The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Treatment included rest requirement for the events chest pain, heart rate increased, dyspnoea, hyperhidrosis, pallor and cold sweat. Since the vaccination, the patient had not been tested for COVID-19.
Swelling, redness, fever, and pus. Incision and drainage was performed.
Pt had relatively immediate localized reaction to PROQUAD vaccine in office was given BENADRYL and recommended ice by MD. Pt received DTaP-IPV and MMRV.
Patient was given monovalent as booster instead of bivalent. No reactions reported while in the office.
Information has been received from a physician concerning a little over 12 month old patient who was vaccinated with a dose of VARIVAX (Oka/Merck) and a dose of MMR II (Wistar RA 27/3) (MSD). Approximately one month later, the patient developed target lesions in different stages, including papules. There were no vesicles and no mucosal involvement. The lesions resolved within a few days. It was unspecified if the patient sought medical attention or not. This is one of several reports received from the same source. Additional information has been requested.
Fever, chills, myalgia, joint pain, headache/migraine, erythema injection site, swelling/induration.
pt started to run a t103; on 2OCT92 mom called MD who advised mom to given pt APAP suppositories; fever broke Saturday morning; fever then started again; pt fussy; acted like had stomachache;