chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My arm still does not function; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "My arm still does not function".  Additional information: Patient was asking where patient report side effects of vaccine. Was there any type of form for that. Patients arm till does not functions like it did. Patient got a shot in March.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
ITCHY INJECTION SITE; SWOLLEN INJECTION SITE; RISE IN BLOOD PRESSURE; DIZZINESS; FOGGY; HEADACHE; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 65 year old female. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced flu like symptoms. On 08-MAR-2021, the subject experienced headache. On 12-MAR-2021, the subject experienced rise in blood pressure. On 12-MAR-2021, the subject experienced dizziness. On 12-MAR-2021, the subject experienced foggy. Laboratory data included: Blood pressure (NR: not provided) 158/108 mmHg. On 14-MAR-2021, the subject experienced itchy injection site. On 14-MAR-2021, the subject experienced swollen injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu like symptoms on 10-MAR-2021, dizziness, foggy, and headache on MAR-2021, and itchy injection site, and swollen injection site on 14-MAR-2021, and had not recovered from rise in blood pressure. This report was non-serious.
Information has been received from a licensed practical nurse concerning a female patient of colleague age who on an unspecified date was vaccinated with her first dose of GARDASIL (lot # not reported). Two months later or a short time after, the girl was diagnosed with Lyme disease and they did not know that she had Lyme disease. They were claiming that the GARDASIL exacerbated the Lyme disease and saying the vaccination brought the symptoms on of the Lyme disease. She got vaccinated and all the sudden her symptoms came out to the point where she could not work or go to school. They thought it could have been an auto-immune response but they did not know for sure. The only thing that they thought might have triggered her symptoms becoming a parent was her vaccination of GARDASIL. The provider told the patient not to get any more GARDASIL vaccines so they were not completing the series. The patient went and saw a specialist because of the Lyme disease symptoms. At the time of the report, the patient had not recovered. Upon internal review, Lyme disease was considered to be disabling. Additional information has been requested.
Day 2-3 post injection hyper somnolence. Day 3 increased confusion. Day 4 altered mental status with confusion and weakness. Went to hospital by ambulance. Vegetative state for 3.5 days until after IV steroids initiated on hospital Day 3.
The patient developed a high fever of 104 around 11pm. The fever was associated with hallucinations. The patient has also experienced nausea, vomitting, and lethargy. The parent has been alternating tylenol and ibuprofen to keep the fever around 101.
Pain started after 2nd dose of Moderna Covid vaccine at 3/13/21.  Asked pharmacist and primary care doctor about the pain but they said it could be common side effects from Moderna shot and it was expected to get better over time.  However, Patient still had severe pain since the 2nd shot.  She can hardly lift left side arm so visited Ortho doctor for diagnose .  There was no evidence of inflammation during doctor's visit. Now she feels some tingling feels sometimes with pain.
Complain of right eye swelling and right sided facial rash for 3 days.  No other symptoms, no complaints, symptoms or trace of initial reaction.
Injection site is currently itchy / A lump is itchy; Injection site is currently red / I have a red lump; I have a red lump and is itchy; Consumer is concerned that the injection was delivered subcutaneously / she believes that it may not have been an intramuscular injection; This spontaneous case was received on 07-Nov-2022 from other non-healthcare professional (consumer) via regulatory authority (reference number: SEQW22-05541) concerned a female patient of an unspecified age.  The patient had no relevant medical history and was not taking any concomitant medications.  On 05-Nov-2022, on Saturday, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; anatomical location: left arm; dose and route of administration: not reported) as influenza prophylaxis. The patient was concerned that the injection was delivered subcutaneously, she believed that it might not have been an intramuscular injection (explicitly coded as 'Inappropriate route of vaccination'). The batch number was not reported.   On the same date, after receiving Flucelvax Quadrivalent, the area at the injection site was itchy and red. There was a red lump and it was itchy. The patient stated that the injection was not in the "upside down triangle" area on the outer side of the left arm where the deltoid muscle is, instead, it seemed like the injection was more towards the back of her left arm.   At the time of initial reporting, the patient was recovering from the events. As reported, the events were still ongoing.  The reporter did not provide causality assessment.  The case was assessed as non-serious.  Company comment: A female patient of an unspecified age was vaccinated with Flucelvax Quadrivalent. The patient was concerned that the injection was delivered subcutaneously, the patient believed that it might not have been an intramuscular injection (explicitly coded as 'Inappropriate route of vaccination'). On the same day following vaccination, the patient developed vaccination site pruritus, vaccination site erythema and vaccination site mass. The patient had no relevant medical history and was not taking any concomitant medications. Causal role of the suspect vaccine is assessed as possibly related, with the currently available information and plausible temporal relationship. Inappropriate route of vaccination is assessed as not related per company's conventions.; Sender's Comments: A female patient of an unspecified age was vaccinated with Flucelvax Quadrivalent. The patient was concerned that the injection was delivered subcutaneously, the patient believed that it might not have been an intramuscular injection (explicitly coded as 'Inappropriate route of vaccination'). On the same day following vaccination, the patient developed vaccination site pruritus, vaccination site erythema and vaccination site mass. The patient had no relevant medical history and was not taking any concomitant medications. Causal role of the suspect vaccine is assessed as possibly related, with the currently available information and plausible temporal relationship. Inappropriate route of vaccination is assessed as not related per company's conventions.
I (the provider) went to put in Meningococcal order into the computer and clicked off MMR.  Patient received a dose of MMR  instead of meningococcal due to incorrect computer order.
1:30 am 102.4 fever, body ache, chills, and headache throughout the night 6:30 am severe headache
Pt was given 2 pneumovax and Fluzone inj on 11/02/06 (afternoon). Pts wife called 11/02/06 in the evening to say pt had fever, vomiting and soreness. On 11/04/2006. PT had worsening of symptoms w/large areas of redness and swelling. Pt went to ER on 11/4/06 and was diagnosed with cellulitis and given antibiotic on that date.
Redness, swelling, drainage, reported blisters, itching. Worse 04/11/2014.
I could not sleep after getting the vaccine; soreness in my arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (I could not sleep after getting the vaccine) and VACCINATION SITE PAIN (soreness in my arm at injection site) 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 an unknown date, the patient experienced INSOMNIA (I could not sleep after getting the vaccine) and VACCINATION SITE PAIN (soreness in my arm at injection site). At the time of the report, INSOMNIA (I could not sleep after getting the vaccine) and VACCINATION SITE PAIN (soreness in my arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.   Reporter did not allow further contact
p/vax pt nausea; flushed; wheezing in lungs; cough
Initial misuse report received from a healthcare professional on 13 September 2013. This is an invalid case as individual patient identifiers are missing. It was reported that sterile water was used to reconstitute ACT-HIB vaccine and was administered to the patients. No adverse event was reported. List of documents held by sender: none.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 25-SEP-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5ml, lot # K005957, expiration date 08-MAR-2015, route unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 2544 hours with lowest recorded temperature of 20 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
started breaking out in a rash 30-45 mins p/immun w/itching; was referred to ER:
Recieved pneumonia vaccine 4/20/09 in left arm. Stated it was immediately painful.  Localized swelling occured over the next 6 hours.  Swelling increased down to elbow by 5 pm on 4/21/09.  Called MD and was told to use ice packs and Benadryl as needed.  Swelling has continued to increase and is now affecting left hand and fingers.  It is warm to the touch and redness at injection site and forearm.  Advised to call MD.
Spot where shot was given is itchy and red bumps have surfaced. Area is very itchy.
pt recv vax & devel lymphadenopathy described as golf ball sized lumps in the axilla of the arm into which the vaccine was injected;this is 1 of 5 pt from this facility to exp this event p/vax;
Information has been received from a 67 years old male concerning himself. The patient's concurrent condition included blood pressure abnormal and allergic to penicillin. Concomitant therapy included blood pressure medication. On an unknown date, the patient was vaccinated with VARIVAX (Lot number, expired date, dosage and frequency were unknown), subcutaneously. On an unknown date, the patient experienced "injection site pain and headaches". The patient did not seek medical attention. No lab test was performed. No treatment was given for the events. The outcome of injection site of pain and headache was reported as not recovered. Additional information has been requested.
ADVERSE REACTIONS OF THE VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced adverse reactions of the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reactions of the vaccine was not reported. This report was non-serious.
Vial was expired on 13-Aug-2022, initially stored on 15-Aug-2022 and administered to the patient on 16-Aug-2022/Expired vaccine stored in refrigerator; No adverse event; Vial was expired on 13-Aug-2022, and administered to the patient on 16-Aug-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 15-Aug-2022 and administered to the patient on 16-Aug-2022/Expired vaccine stored in refrigerator), EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-Aug-2022, and administered to the patient on 16-Aug-2022) and NO ADVERSE EVENT (No adverse event) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (First booster dose), COVID-19 VACCINE (second dose) and COVID-19 VACCINE (first dose). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, COVID-19 VACCINE and COVID-19 VACCINE.    On 16-Aug-2022 at 10:28 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-Aug-2022, and administered to the patient on 16-Aug-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 15-Aug-2022 and administered to the patient on 16-Aug-2022/Expired vaccine stored in refrigerator) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 15-Aug-2022 and administered to the patient on 16-Aug-2022/Expired vaccine stored in refrigerator), EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-Aug-2022, and administered to the patient on 16-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (Vial was expired on 13-Aug-2022, initially stored on 15-Aug-2022 and administered to the patient on 16-Aug-2022/Expired vaccine stored in refrigerator) and EXPIRED PRODUCT ADMINISTERED (Vial was expired on 13-Aug-2022, and administered to the patient on 16-Aug-2022).    No relevant concomitant medications were reported.  No treatment information was provided.
Area was cleaned on deltoid muscle with alcohol - FLUVIRIN 0.5ml was administer it bleed - she stated she had been on Ibuprofen. She claimed somehow a gland near her clavicle is swollen.
5x5cm area light induration, no redness, tender, immediately inferior to injection site.
Approximately 20min prior to admin of 1st dose of vaccine, patient developed tingling and numbness sensation of lips. Over the course of 3min this tingling and numbness sensation progressed to the left side of her face and the left side of her tongue. 0.3mg of epinephrine was administered via autoinjector 3min following onset of s/s. 50mg PO diphenhydramine was administered 5min following onset of s/s. Pt developed no further s/s, No: rash, pruritus, chest tightness, chest pain, angioedema, abdominal pain, nausea, emesis, dizziness, syncope. VS stable throughout evaluation. Ambulance arrived approximately 10min following onset of s/s and pt was transported to ED for evaluation.
welts around body, buttocks, arm, legs. vaccine site redness, puffiness, warm to touch
Individual was vaccinated for COVID-19 with the Moderna vaccine when they were under age 18. A second dose was given in alignment with CDC recommendations for off label use on  4/24/21. No reported adverse effects.
Child irritable for 12 post, trouble sleeping and staying asleep which is uncharacteristic for the child, low grade fever, and diarrhea x 2 12 hours post vaccine administration
My reaction started about 8 hours after receiving the shot. I started to get sick with a fever, chills, and shivers. At night I started shaking really bad because I felt so cold. I felt hot, cold, and I had a headache that lasted for 3 days. It took about a week until I started to feel better again.
Area of injection is hard, red and itchy, but did not start until 10-11 days after the shot.
Left thigh red, warm to touch and swollen. Treated with hot pack, Benadryl and  Augmentin. Father has had problems in past with immunizations.
Moderna COVID?19 Vaccine EUA Have missed period that would have started April 29. I have confirmed I am not pregnant. I have never been off cycle or missed a period.
Double vision, swollen glands in neck and throat, cough, when I try to eat my mouth is on fire, swollen eyes
hospitalized for 10 days with significant kidney issues following Pfizer covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 16-year-old patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RENAL DISORDER (hospitalization, medically significant), outcome "unknown", described as "hospitalized for 10 days with significant kidney issues following Pfizer covid vaccine". The patient was hospitalized for renal disorder (hospitalization duration: 10 day(s)). The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Itchy throat & hotness in eyes. Rapid Response Team  called. Benadryl given, Patient returned to work after 1 hr.
KINRIX expired 8-29-14 given 9-9-14. No reaction, no treatment.
Per phone call from father - patient developed symptoms of abdominal cramping, nausea, sweating and headache approximately 12 hours after taking 3rd dose of oral typhoid - ordering physician contacted. Instructions obtained from ordering physician to follow-up with father and instruct father not to administer the last dose of oral typhoid. That patient to maintain food and beverage precautions while on this trip. Also follow-up typhoid vaccine if needed in the future for international travel should be injectable. Encourage to offer fluids as needed and increase diet as tolerated. Also encourage to follow-up with primary Dr. if persist aware to call clinic if questions.
Symptoms started 9 hours post vaccination. Started feeling feverish, chills, body aches, headaches, and general malaise. After 8 hours of suffering, brought myself to ER to be seen. Fever at that time was recorded at 100 degrees Fahrenheit.
On 01/04/2023, I started to experience symptoms of a headache, slight cough, sneezing, runny nose, fatigue and slight chills. My husband started with symptoms on 01/01/2023. I tested positive on 01/04/2023. I contacted my doctor and she told me to try some herbal medication. As of today, I'm experiencing better energy, but my cough does seem to be deeper with congestion. The headaches have decreased, but I am still noticing them.
cannot move it; hand is swollen / Fingers are so swollen they look like sausages; in great pain; COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of MONOPLEGIA (cannot move it) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A, 024M(Zor2)0A and 041L(Zor2)0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MONOPLEGIA (cannot move it) (seriousness criterion medically significant), PERIPHERAL SWELLING (hand is swollen / Fingers are so swollen they look like sausages), PAIN IN EXTREMITY (in great pain) and VACCINATION SITE REACTION (COVID arm). At the time of the report, MONOPLEGIA (cannot move it), PERIPHERAL SWELLING (hand is swollen / Fingers are so swollen they look like sausages), PAIN IN EXTREMITY (in great pain) and VACCINATION SITE REACTION (COVID arm) had not resolved.            The patient stated that she had a condition for that she went to the emergency room for yesterday (at the time of report). She was told it could be a reaction, but it was an uncommon reaction to getting the Moderna booster. She stated her doctor has even indicated there can be swelling in parts of the body after the injection because of other things like rheumatoid arthritis in the body. The patient could not move her hand quick enough as she was trying to answer questions regarding the adverse event she was reporting.  She had gone to her physician and they took X-rays and blood work, but she was continuing to have symptoms and went to the emergency room yesterday on 03-Oct-2021. The patient stated her physician gave her a brace to keep the swelling down. She will be talking with a rheumatologist. She had no underlying medical conditions.  Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Oct-2021: Follow up received and Reporter's contact information updated, added dosing information, events outcome updated as not recovered and emergency room visit ticked and lab data was added in I-narrative.
immunocompromised ./did not receive 40 mcg; This case was reported by a consumer via call center representative and described the occurrence of underdose in a 73-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device injection syringe for prophylaxis.   Concurrent medical conditions included transplant (patient had an unknown transplantation). Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On 23rd September 2021, the patient received the 1st dose of Engerix B (intramuscular) 20 µg and hepatitis B vaccine pre-filled syringe device. On 23rd September 2021, unknown after receiving Engerix B and hepatitis B vaccine pre-filled syringe device, the patient experienced underdose. On an unknown date, the outcome of the underdose 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 details were provided as follows: The immunocompromised patient received 20 mcg of Engerix B instead of 40 mcg, which led to underdose. The patient also received a dose of Havrix on same day in the right deltoid. The reporter did not consent to follow up.
Child had redness, swelling and blistering on entire arm where DTaP given. Reaction began 07/08/2004. Child went to ER and received abx shot and Rx for abx to take home. Mother states that child is now recovered.