chrisvoncsefalvay/vaers-outcomes huggingface dataset:
medical Assistant reported that she has administered a Vaccine (ACTHIB) that has expired yesterday to a patient with no reported adverse event; Initial information received on 08-Aug-2023 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 15 months old male patient and medical assistant reported that she has administered a vaccine (acthib) that has expired yesterday to a patient with no reported adverse event while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination.  On 06-Oct-2022, the patient received a dose 1 of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection and on 11-Aug-2022 he also received a dose 2 same vaccine  (with an unknown dosage, strength, expiry date and batch number) via unknown route for prophylactic vaccination (immunization).  On 08-Aug-2023 he also received a dose 3 at a dose of 0.5 ml of the same vaccine (Frequency: once, strength: standard, expiry date: 07-Aug-2023 and lot UJ735AA) via intramuscular route in the right thigh for  prophylactic vaccination (immunization) and medical assistant reported that she has administered a vaccine (acthib) that has expired yesterday to a patient with no reported adverse event (expired product administered) (latency: same day).  Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the 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.
This case was reported by a consumer via call center representative and described the occurrence of leg pain in a patient who received FLULAVAL Quadrivalent. On an unknown date, the patient received FLULAVAL Quadrivalent. On an unknown date, unknown after receiving FLULAVAL Quadrivalent, the patient experienced leg pain and back pain. On an unknown date, the outcome of the leg pain and back pain were unknown. It was unknown if the reporter considered the leg pain and back pain to be related to FLULAVAL Quadrivalent. Additional details were reported as follows: No health care professional information provided. The FLULAVAL Quadrivalent was administered to an 8 or 9 year old patient. After received FLULAVAL Quadrivalent, the patient experienced leg and back pain. On 30th November 2017, the patient visited and Endocrinologist and was back at the doctor's office. GSK representative stated that she will call back with more detailed information after the doctors visit today. No additional information provided.
Arm soreness worse after second injection making it hard to sleep; Arm soreness worse after second injection making it hard to sleep; Arm soreness worse after second injection making it hard to sleep; This is a spontaneous report from a Pfizer-sponsored program, via consumer (Patient). A male patient of an unspecified age received second dose of bnt162b2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization.The patient medical history and concomitant medications were not reported. The patient received first dose included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. On an unknown date, after both injections, the patient experienced arm soreness which was worse after second injection making it hard to sleep. The patient enquired if there was any blood test to check for antibody for immunity. The patient also stated that his wife had vaccine at the same time and did not have any problems. The outcome of the event arm soreness was reported as not recovered and making it hard to sleep as unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Fever, SkinRash, Rash, UrticariaPruritus, Diarrhea,  HIVES started on torso radiated to scalp and toes, "warts on fingers" Narrative:  week post vaccination, developed hives on torso which eventually spread to scalp and toes; "warts on fingers were the worst" increased pruritus, erythema, was off work 1/20 and 1/21 due to the discomfort. After which word remotely but normally is onsite. PCP Rx'ed a fungal cream with steroids which did not alleviate the condition; was referred to Dermatologist who collected a biopsy and prescribed Prednisone 30mg 1/21/21, is currently being tapered off. Endorsees condition is "persistent". PCP d/w employee and the only n ew introduction to body was the Moderna Vaccine. Endorses h/o hives with Penicillin.
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. Total of 168 doses/vials were given for LOT  048C21A.  The vial did not undergone to any temperature excursions. No treatment medication information provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Follow-up received contains non significant information
"her arm hurt"; "may had felt a little tired"; Dose administered after expiration date; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY ("her arm hurt"), EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) and FATIGUE ("may had felt a little tired") in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 031B21A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced PAIN IN EXTREMITY ("her arm hurt") and FATIGUE ("may had felt a little tired"). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) had resolved. At the time of the report, PAIN IN EXTREMITY ("her arm hurt") and FATIGUE ("may had felt a little tired") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Muscle pain in legs, extreme lethargy. Felt like had the flu. Lasted about 20hrs and then I was totally fine.
He started with a fever up to 101 and had arm tremors and didn't seem to focus. He also had some diarrhea and vomiting. The diarrhea lasted 24 hours. The vomiting lasted 3 days and staring & poor focus lasted about 4 days. He is acting normally at clinic follow up 10 days later.
Body Aches; Fever; Headache; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 12Feb2021 14:15 (Batch/Lot Number: EL3247) as a single dose for COVID-19 immunization. Patient received the first dose on an unspecified date. The patient's medical history and concomitant medications were not reported. Patient is not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. On 13Feb2021 02:00, patient experienced body aches, mild fever, headache, and fatigue. No treatment received. Patient is recovering.
Hives on stomach, back 2 days after 12 (lasted 2 weeks).  Temperature: 102 same day (3-4 days).  Never saw MD-consulted ER with MD by phone. Adverse event from 03/11/02.  Immunization not reported to health department until 02/02/04.
Swelling at the injection site, iced and asked to take benedryl watched her for 15 min.
3:40pm child administered MMR, Varicella & KINRIX. After 10 mins? child's face reddened with raised areas - No SOB, itching or edema - child given BENADRYL 12.5mg po (suspension) - No rash, red areas anywhere else on body Mom instr. to take child to ER but did not - could not wait in clinic till 5pm per Dr. order.
Itchy all over.  3 days later I am still itchy face and feet in particular..  Bumpy rash develops where ever I am itchy but then subsides.
Received phone call from (Mom) patient had a reaction right after got back to school, approximately 10:10 or so. He was having problems breathing, red, blotchy, Mom took him to the E.R. He was diagnosed with an Asthma Attack, medications have been changed and rearranged.
Patient had unresponsive episode approximately 3 minutes post J&J covid vaccination that lasted for approximately 60 seconds
I started to get well, Since my mobility is limited, sometimes I sleep in the recliner, I thought I was getting a pressure sore on my back around the belt line. It started going down the right side to the hip and down to about the knee. It was a burning sensation that felt like someone dumped gas on me and lit it in fire. I'd get this sensation up to four times per hour when I would eat the wrong things. The medical people have done a terrible job with shingles. The pain hit when I was in the doctor's office and the staff was freaking out because I was in so much pain. The doctor gave me medications that would tale 45 to 55 minutes before it would work. I am still having nerve pain. No medical tests were done. The nerve damage is done, I am not screaming like I used to. I am afraid to take any medications because we do not know what causes it.
"h1n1/seasonal flu vaccine"   I have pain in my left shoulder at the sight of the vaccine injection. It radiates down my arm - my ring finger and little finger on my left hand are somewhat numb. My left shoulder's range of motion is severely limited. A stabbing pain occurs when this limited range of motion is exceeded. It feels like the needle broke off the syringe and is in my arm... though I know this is not the case.  There has been no fever, redness or discoloration at the site of the injection.  Bathing, dressing and daily activity is very limited with my left arm. Sleeping with this injury is very difficult because my arm aches in almost any position when in bed. Heavy lifting and any other type of physical activity or exercise is greatly impaired.  The pain in the muscle at the site of the injection has increased over time.  I've been taking Advil on a daily basis but it does practically nothing for my discomfort.  To date, no sign of recuperation. Clinic - procedure and diagnosis codes:  Influenza Vaccination-V04.81 Vaccine Injection-90471 Flu Vaccine-With Preservative 90658
wasn't feeling well; intensified her illness; blood pressure and it was elevated; This is a spontaneous report from a contactable consumer (patient's husband). A 48-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient went for her second dose of BNT162B2 yesterday (26Apr2021). She wasn't feeling well a couple days prior to going and she wasn't feeling well yesterday. The vaccination facility checked her blood pressure and it was elevated so they did not administer the vaccine. The patient's husband did not think her illness came from the vaccine but thought it may have intensified her illness. The patient's husband wanted to know if the patient could still receive the dose at 4 or 5 weeks after being evaluated by her doctor. The outcomes of wasn't feeling well, elevated blood pressure, and intensified illness were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
C/o stomach ache that started after vaccine. 24 hours. LLQ, dull, no radiation. movement exacerbates and deep breaths. Constant. Mild, reported as a 3-4/10 in severity at it's worst. Responds to tylenol. Denies changes in BM, bloody bowel movements, obstipation.
Lips and face numb, rash on injection site, anxious, difficulty breathing. Angioedema and bronchospasm seemed likely. EMS was contacted. Gave 50mg of diphenhydramine PO, and 0.5mg epinephrine IM at same site as influenza injection. Patient reported drinking 2 ounces of vodka after vaccine administration and symptom onset. Patient has a cardiac pacemaker and EMS transported patient to ER soon after arrival to pharmacy. In hospital, the patient received IV solumedrol and was observed for 5 hours before being released. Patient was given 60mg prednisone po daily for 2 days.
c/o feeling dizzy & SOB sat down, upper airway wheezes gave epi & transferred to trauma room;
A 2 month was administered 1ml of Engerix-B 20 mcg (adult dose); A 2 month was administered 1ml of Engerix-B 20 mcg (adult dose); This case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 2-month-old male patient who received HBV (Engerix B adult) (batch number 9p9b5, expiry date 7th February 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B adult 1 ml and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are as follows: The reporter was a manager. The reporter stated that a 2 months old patient was administered 1 ml of Engerix-B 20 mcg (adult dose) which led to adult product administered to child and overdose. The reporter consented to follow up.
Rash,  rash covered neck, arms, torso, and legs; swollen hands; severe Itching; Skin irritation; Pain; raised bumps; redness; This case was reported by a consumer via call center representative and described the occurrence of rash in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th April 2022, the patient received the 1st dose of Shingrix. On 15th April 2022, 8 days after receiving Shingrix, the patient experienced rash, hand swelling, pruritus, skin irritation, pain, papular rash and erythema. The patient was treated with prednisone. On 17th April 2022, the outcome of the hand swelling was recovered/resolved. On an unknown date, the outcome of the rash, pruritus, skin irritation, pain, papular rash and erythema were not recovered/not resolved.   It was unknown if the reporter considered the rash, hand swelling, pruritus, skin irritation, pain, papular rash and erythema to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-APR-2022 Reporter's Comments: The patient self-reported this case. The patient reported developing swollen hands and a rash. The patient reported rash covered neck, arms, torso, and legs and was accompanied by severe itching, raised bumps, irritation, and redness.  The patient reported experiencing pain after scratching areas affected by the rash.  On 16-April-2022 the patient going to the urgent care and prescribed prednisone. The reporter stated prednisone had not helped in resolved the rash. On 17-April-2022, swelling in the hands was resolved. The rash and all symptoms associated with the rash (severe itching, redness, irritation, and raised bumps) were ongoing.  The reporter consented to follow up.
Diagnosed with PMR; severe myalgia/muscle aches - shoulders, gluteus muscles, thighs; Arthralgia - shoulders, gluteus muscles, thighs; severe chills; was unable to move; Generalized pains in muscle and joints.; This is a spontaneous report from a contactable physician. This physician reported similar events for two patients. This is one of the two reports.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was diagnosed with polymyalgia rheumatica (PMR), severe myalgia/muscle aches - shoulders, gluteus muscles, thighs, arthralgia - shoulders, gluteus muscles, thighs, severe chills, was unable to move, and generalized pains in muscle and joints. The events resulted to doctor or other healthcare professional visit. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The association between the event polymyalgia rheumatica with BNT1612b2 can not be fully excluded based on the limited information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021405461 same reporter/drug, similar event, different patient
On Day 12 developed red painful and itchy rash at vaccination site.   It became more diffuse over the next few days and cleared in a week.  Used hydrocortisone for the itch.
"they saw something on her lymph nodes" but was so small "they couldn't put a size on it"; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODES SCAN ABNORMAL ("they saw something on her lymph nodes" but was so small "they couldn't put a size on it") in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 039B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Ovarian cancer stage IV in February 2020 and Hysterectomy. Concomitant products included Lynparza , DICYCLOMINE HCL, LOSARTAN POTASSIUM (LOSARTAN POTASSIUM ACCORD), ATORVASTATIN CALCIUM ANHYDROUS, GABAPENTIN (GABAPENTIN "PCD"), Pain medicine as needed, Infusion through port, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT FORTE) and Eye drops for an unknown indication, MONTELUKAST SODIUM.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced LYMPH NODES SCAN ABNORMAL ("they saw something on her lymph nodes" but was so small "they couldn't put a size on it"). At the time of the report, LYMPH NODES SCAN ABNORMAL ("they saw something on her lymph nodes" but was so small "they couldn't put a size on it") outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2021, Computerised tomogram: lymph nodes.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and 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.; Reporter's Comments: Her marker numbers are also going up: Jan 2021 - 54 May 2021 - 155 Jul 2021 - 255
Each day that the pill was taken (at around 7:45 AM -8:15 AM) illness has set in around 12:45 PM. Pills were taken as prescribed, with 8 oz of water without eating or drinking coffee for at least one hour before/after. Symptoms include Moderate to Severe Stomach Cramps, Diarrhea, General Gut/Abdominal Ache, Nausea, Gas, Dizziness, some Disorientation (unable to figure out homework assignments, when on the non-pill day I completed the same problem easily). Symptoms lasted anywhere from 8:00 PM to 11:00 PM. Non-pill days I generally feel fine. Have one last pill in the series.]
Besides just having a sore arm at point of injection, I have had a pox come up on my right forearm. I did have my first shingles shot on November 18th, 2020 at the clinic here. I think it is a single pox and thought I would bring it to your attention. I have had the shingles before so I know what they look like and feel like. Since there is only one, I don't plan on going to my dermatologist to confirm that it is a pox plus I am not sure if the Covid shot is a side effect that caused the pox or not. It is not painful although itching and not responding much to antiseptic cream. I plan to go for my second Covid shot on January 26 and I am looking forward to it. I don't go for my second Shingles shot until February 17. There is a possibility that it could be something else besides a pox but wanted to bring it to your attention just in case. Thanks.