chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm was inflamed, and so swollen; arm was inflamed, and so swollen; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received the first dose of BNT162B2, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient had a reaction after the vaccine. The first vaccine her arm was inflamed, and so swollen, she couldn't move it. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Didn't receive second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Didn't receive second dose) in a male patient of an unknown age 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) (unknown route) 1 dosage form. On 19-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Didn't receive second dose). On 19-Jul-2021, PRODUCT DOSE OMISSION ISSUE (Didn't receive second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter reported Adverse Event. Consent for follow-up Denied by Patient. He recieved the first dose but didnt go back for second dose.   Reporter did not allow further contact
Pt s mom notice that child was extremely lethargic running a fever of 100.0 child just not himself
Patient had received flu in past years with no problem. Once patient received flu shot about 20 mins later pharmacy was notified that patient had passed out and ambulance called. Patient came to right away. Patient reported to EMT that he hadn't eat yet today. EMT thought that was why the episode occurred. Patient did not leave in ambulance.
This spontaneous report as received from a pharmacist refers to himself, a male patient of unknown age. On 23-SEP-2013 the patient was vaccinated with ZOSTAVAX (route and dosage unknown; lot # J001005 exp 24-APR-2014) for immunization. After the dose of ZOSTAVAX the patient experienced cold or flu like symptoms including chills, aches, and runny nose for about 36 hours post vaccination. The patient did not sought medical attention nor received treatment. The outcome of patient experienced cold or flu like symptoms was reported as recovered approximately on 24-SEP-2013 (reported as: for about 36 hours). Additional information has been requested.
This spontaneous report as received from health professional refers to a female patient of unknown age. Patients concurrent condition and historical condition unspecified. On an unknown date, the patient was vaccinated with third dose GARDASIL (dose and frequency unspecified), intramuscular. Concomitant medication were unspecified. On an unknown date, the patient had experienced seizure (medically significant) with third dose of the patient was vaccinated with third dose GARDASIL. The outcome of the event seizure was unknown. The reporters causality assessment for the event seizure with the therapy of GARDASIL was not reported. Upon internal assessment the event seizure was considered as medically significant. This case is linked with case 1401USA010204 as sibling case. Additional information has been requested.
Starting 5 minutes after administration, patient started to feel numbness in both of her hands. She started to feel really anxious with some palpations. She notes that it when away until later that even evening.  Felt as if her limbs were loose that night. She started to feel a subjective fever with some associated chills.  Reports that the symptoms went away that night and she did not experience any other symptoms besides right arm soreness.
Patient's left arm from shoulder to elbow is swollen, red, and hot to touch. Patient also states it is sore.
Expired Havrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 55-year-old female patient who received HAV (Havrix 1440) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th February 2023, the patient received the 1st dose of Havrix 1440 and Havrix Pre-Filled Syringe Device. On 13th February 2023, unknown after receiving Havrix 1440 and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 14-Feb-2023. Reporter's Comment: The reporter stated Havrix was administered after the expiration date. The reporter consented to follow-up. Additional Supportive Information: The patient received an expired Havrix 1440, which led to expired vaccine used.
Sore arm near injection site as well as shoulder area, fever up to 100.6 (lasted 20 hrs), tired, took Tylenol, drank extra water, rested. By morning of 3/12 temp normal and had more energy but arm still somewhat sore.
I have a silver dollar size bruise at the base of my thumb. It was initially itchy, then just bruised. Appeared about 1 hour after vaccine was administered. It is not painful to touch.
low grade fever for two days, muscle aches entire body, headache, bad joint pain starting in the feet working it's way up to hips with burning sensation,joint pain in upper body as well but not as bad as the lower part,  fatigue, pain woke me around 2am and did not go to sleep until around 7am for an hour, chills, slight nausea, set off my tinnitis, general fatigue over a week later, feel like there is not something quite right with the right side of my brain (like a headache starting in the back of my head).
Prickly rashes on ankle and back of thigh, started ~9 hrs after injection.  I tried to describe rashes in detail, but was kicked out of site after spending time to describe them carefully.  Plese call if you need more info
Received dose from vial punctured more than 12 hours ago; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vial punctured more than 12 hours ago) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A, 014M20A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Seizures.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vial punctured more than 12 hours ago). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vial punctured more than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported. The vial was initially stored and punctured on 26-Oct-2021.
Sept 1: Patient requested a vaccine - Pharmacy understood she requested a pneumonia.  Pharmacist prepared the vaccine and administered it.  When adding it to the immunization program,  it was realized that the patient also received the same dose on 8/24.  Pharmacist called Pfizer for recommendations for the patient  - there are no recommendations at this time.  I called the patient and made her aware - I will calling the patient to monitor her symptoms.
Pt vaccinated with MMR/Tetanus developed paresthesia of hands & feet w/numbness, fatigue, weakness, aches, fever 99.9.
Pt had full left thigh swelling, redness, induration and warmth at 48-72 hours, post vax. He was admitted to the hospital X 24 hours for IV antibiotics in case it was cellulitis.
Got very sick; Has lost work; Severe pain; Rash; Fever "and all that"; Head pain; Severe case of shingles on the right side of their face affecting the mouth, going up their chin; Ear is extremely swollen; Lesions on their cheek bone/e lesions in their ear; This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (Got very sick), HERPES ZOSTER (Severe case of shingles on the right side of their face affecting the mouth, going up their chin), EAR SWELLING (Ear is extremely swollen), SKIN LESION (Lesions on their cheek bone/e lesions in their ear) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has lost work) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939902 and 054C2VT) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HERPES ZOSTER (Severe case of shingles on the right side of their face affecting the mouth, going up their chin), EAR SWELLING (Ear is extremely swollen) and SKIN LESION (Lesions on their cheek bone/e lesions in their ear). On an unknown date, the patient experienced ILLNESS (Got very sick), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has lost work), PAIN (Severe pain), RASH (Rash), PYREXIA (Fever "and all that") and HEADACHE (Head pain). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) for Rash, at an unspecified dose and frequency; GABAPENTIN for Pain, at an unspecified dose and frequency and IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, ILLNESS (Got very sick), HERPES ZOSTER (Severe case of shingles on the right side of their face affecting the mouth, going up their chin), EAR SWELLING (Ear is extremely swollen), SKIN LESION (Lesions on their cheek bone/e lesions in their ear), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has lost work), PAIN, RASH, PYREXIA and HEADACHE outcome was unknown.            Concomitant medication was not provided.  2 weeks after the second dose, the patient developed a severe case of shingles on the right side of their face, affecting the mouth, going up their chin, and developing lesions on their cheek bone and ear. The ear was extremely swollen.At one point they went to the ER where they took a CT scan of their head because they were having severe pain but no rash had presented yet for the shingles. Patient mentioned that they were normally healthy.   This case was linked to MOD-2021-347545 (Patient Link).
This spontaneous report as received from a consumer refers to an approximately 82 (currently 84 year old) mother with being breast cancer with no known allergies and a medical history of cardiac stenting. On 25-AUG-2010 the patient was vaccinated with a dose of ZOSTAVAX. Route, lot number and expiration date not reported. Concomitant medication were not reported. Shortly after vaccination, on an unknown date, the patient was diagnosed with bullous pemphigoid. The consumer reported that on an unspecified date an unspecified dermatologist started the patient on unspecified doses of corticosteroids (manufacturer unknown) which led to the patient becaming very weak and almost falling down (MARRS 1303USA007082). The consumer reported that the weakness improved when the corticosteroids dosage was reduced, but that the corticosteroid therapy had not really improved the bullous pemphigoid (MARRS 1303USA007082). The outcome of bullous pemphigoid was reported as not recovered/not resolved. Additional information has been requested.
2 days following shot I had major muscle and body pain through out my entire body (lasted about 24 hrs) 10 days following shot I had a first time seizure on May13th. On June 4th I had another seizure.   I have never had any signs or symptoms with epilepsy and now Im stuck with this diagnosis. I had mant tests done.
Have never had any sexual partners until two months before receiving the three shot series. My self nor my partner was never diagnosed with genital warts until I received the second shot and they shortly appeared and had to receive treatment for them for six month for them to reside and my partner was not effected. So I would like some information because I have found some on the internet stating Gardasil can cause genital warts.
pt recvd vax & 24 hrs later devel fever, shaking chills, nausea, vomiting & muscle contractions; these sx peaked the 3rd day p/vax then subsided; pt was treated w/OTC DPH & APAP;
Impression Patient with generalized urticaria which began 24 hours after administration of KINRIX/PROQUAD/HiB and continues today. No swelling of lips or mouth. Differential diagnosis is immunization reaction versus idiopathic urticaria. Unusual that reaction started greater than 24 hours after immunization. Diphenhydramine 7.5 ml every 6 hours as needed. Call for worsening. Recommend allergy consultation regarding TdaP in the future (all other immunizations complete). Referrals: Allergy and Immunology. Consult within 4 Months.
Patient developed hives on entire body within 24 hours of receiving vaccines. BENADRYL was administered.
WIthin 30-45 seconds of receiving the shot, my body (mainly torso) got very hot and I felt faint. Nurses laid me down, put my feet up and began to fan me. I continued to have waves of the same feeling off and on for about 45 minutes to an hour. At one point I had the feeling of "impending doom" and told nurses to call 911. I also had fast heartbeat.
On Day 10  after the injection, I developed a red itchy hot rash on the left arm..  It continued to get larger and redder  until it cover most of the outside upper arm.  It did not start to go away until  Day 16.  By Day 18 it was only slightly visible.  On Day 10,  I started taking benedryl  because i thought it might be an allergic reaction.  By Day 11 I consulted with my doctor because it was so large and fire red.  I was given prednisone  and told to use cool compresses.
"Malaise, weak, fever, myalgias, side effects & reaction to Tdap". Not released to work through 8-5-12 with follow up scheduled for 7-31-12.
Within 5 hours from the time that the vaccine was administered, patient was taken to the ER and was hospitalized as a result of the slurred speech, marked loss of cognitive abilities including any memory of the hours after this shot and fall with a broken clavicle. December 17, 2019, at 3:34 pm, patient received her first dose and required ER and hospital observation on December 18, 2019, due to seizure with marked loss of cognitive abilities including any memory of the hours after this shot but patient and family were told that this was not due to the Shingix vaccination.
Irritability, depression, anxiety, nausea, headache, fever, joint pain, muscle aches and pain, chills, electrolyte imbalance, dehydrated, low potassium and magnesium, muscle cramping in arms, hands, legs, calves, feet
She broke out in a hive around the injection site about 1.5 inches in diameter. The site itches and she complains that she itches or touches it, it hurts. She did not experience any fevers, but did seem crabbier and more tired than normal.  The welt was noticed in the PM hours upon changing from her regular clothing to her pajamas.
Information has been received from a physician concerning a 21 year old female patient who on 21-JUN-2007 at 02:00 PM was vaccinated IM into left deltoid with a second dose of Gardasil lot #657737/0522U.  On 22-JUN-2007, the patient experienced flu like symptoms.  Subsequently, the patient recovered from flu like symptoms.  Additional information is not expected.
Swollen lips, small bumps on face, arms, legs redness.  Patient has no history of adverse reaction to influenza vaccine in the past and no egg allergy.  He has a history of Pulmonary Atresia.  25 mg of Benadryl administered orally which he tolerated well.  Continued erythema and progression of urticarial rash.  Decadron administered intramuscularly.  No new hives, slow decrease in erythema.  Tranfered to ER for further management due to hypotension and poor perfusion.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX23. Dosing information, route of administration and lot number were not provided. The pharmacist reported that the patient was inadvertently administered a dose of PNEUMOVAX23 2 days in a row. Dosing information, route of administration and lot number for second dose were also not provided. The dates of administration were not provided. No adverse effects reported. Additional information is not expected.
This case is one of a cluster of 3 patients who experienced adverse events following administration of FLUZONE, lot number U4124BA. The events for the other patients were captured in cases 2011-09190 and 2011-09191. Initial report was received on 22 September 2011 from a healthcare provider. A 9-year-old male patient had received FLUZONE  intramuscular injection in right deltoid on 17 September 2011. On 18 September 2011, the patient was seen for upper respiratory symptoms, fever, red arm, hot and swollen approximately seven centimeter in size. No further information was available at the time of the report. The patient's outcome was reported as not recovered/not resolved. Follow-up information was received from a healthcare professional on 06 January 2012. On 18 September 2011, the patient was seen for a follow up for red, swollen, warm to touch at the injection site. The patient received corrective treatment with Ibuprofen for fever and discomfort and ice pack. No further follow-up needed. The patient outcome was reported as recovered/resolved. Documents held by sender: none.
cherry color pin point papules v.s. every 4 hrs x 24 hrs O2 sat
Nausea, vomiting, dizziness, weakness, light headedness, diarrhea. Patient unable to get out of chair and requested ambulance. EMTs came to administer care and transport to hospital for further evaluation and care.
No adverse effects. PREVNAR was not supposed to be given. It should have been MENACTRA.
No adverse event; Patient given expired dose, contacted Moderna, lot analysis determined vaccine maintained the activity necessary to protect.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given expired dose, contacted Moderna, lot analysis determined vaccine maintained the activity necessary to protect.) and NO ADVERSE EVENT (No adverse event) in a 40-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 23-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given expired dose, contacted Moderna, lot analysis determined vaccine maintained the activity necessary to protect.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given expired dose, contacted Moderna, lot analysis determined vaccine maintained the activity necessary to protect.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient given expired dose, contacted Moderna, lot analysis determined vaccine maintained the activity necessary to protect.).    Concomitant medications were not reported.  Patient was given expired dose.  It was unknown if the patient experienced any additional symptoms/events.   Treatment information was not reported.
Vaccine administered on 1/28/2021, slight pinkness at site and sensitive to touch.  on 2/4/2021, started to notice site was itching slightly, color more pink and raised and hot to the touch.  No injury to the site, no insect bite, not scratching area. No fluid in area. Put lotion on site and site stopped itching but still raised. Area is irregular, not perfectly round. Physician recommended using cold pack, tylenol and benadryl.
pt had quite a bit of bleeding following the shot, local pain  which has not subsided and nerve pain that has been progressing since around day 2 or 3 which has extended down his arm and recently started to extend the other direction and effect his chest.  He has seen a doctor but has not received any treatment.
Patient developed chills and headache a few hours after injection and then severe diarrhea and muschle ache in th emiddle of the first night. Symptoms lasted 3 to 4 days.
Day of the vaccination, patient went home and developed a bilateral nosebleed and had a seizure. Patient continues to feel poorly as of 1/15/2021 but has returned part time to work.
No adverse event; On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 067H22A) for COVID-19 prophylaxis.     It was unknown if patient had acute or chronic long-standing health conditions at the time of vaccination.     On 10-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 10-May-2023, the patient experienced UNDERDOSE (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (On 10 May 2023, 27 patients received 0.25ml of the Moderna bivalent vaccine).    No relevant concomitant medications were reported.   The vaccine was administered in the deltoid site. On 11-May-2023, 26 patients were contacted, on 12-May-2023, 18 patients received an additional 0.25ml, 2 patients made appointments to receive the following week and 1 declined to receive the additional 0.25ml dose. A husband and wife pair stated that they would go to the clinic to receive the additional dose but gave no specifics and one patient was mailed a letter as he was not able to be reached by phone.  No treatment medications reported.   This case contains information for the 22nd patient out of 27 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723833 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723833:Master case