chrisvoncsefalvay/vaers-outcomes huggingface dataset:
herpes zoster; dermatitis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 05-OCT-2016, the patient was vaccinated (inoculated) with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and for its intended purpose; the prevention of shingles (herpes zoster) (prophylaxis).Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered painful rashes across his waistline and back and was diagnosed with herpes zoster. Subsequently, suffered another rash outbreak and was diagnosed with dermatitis. All these injuries were caused by zoster vaccine live (ZOSTAVAX). As a direct and proximate results of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations do not present prior to using zoster vaccine live (ZOSTAVAX). Also, experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Also, the patient sustained severe and permanent personal injuries. Therefore, suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Also, suffered and incurred damages, including medical expenses, the loss of accumulations, and other economic and non-economic damages. The outcome of the event was not recovered.
With the first vaccination about 4 days in I started with horrid chills, with goose bumps and pouring sweat at the same time.  Awful migraines that would last for days even with Zomig. Sore arm for only a day. Nausea but no vomiting and a runny nose.
Throbbing, severe pain approximately 2 hours after vaccination. Pain in neck and down arm. Took TYLENOL but little improvement. Spoke with pt 5-25-16 8 am and she reported it was 80% better.
Patient reported a localized rash on her right arm where she received a Prevnar vaccination. The area of the vaccination was bruised and blue and the surrounding rash was red. She reported it being painful and warm to the touch.
8 hours post injection: headache, joint pain and body aches progressively worsened through 48 hours after injection. Arm was sore but nothing compared to joints (especially hips). Temperature was only slight at 98.7. Headache and body aches, joint pain were severe enough that I was forced to rest and unable to continue daily activities. Ache symptoms quickly dissipated after 48 hours, but a 2 inch diameter welt appeared, slightly raised and itching mildly like a mosquito bite. Welt is still present now, 5 days post-injection.
Patient is below the minimum recommended age of 18. The patient is 17 years of age. The immunizing pharmacist neglected to catch that the patient was 17 before giving the vaccine. No adverse reactions have been reported - patient has been checked in and is fine with no symptoms or side effects. Simply reporting the dosing of an underage individual.
Pt called pharmacy on 9/17/2014 at 9:30am stating arm at injection site was swelling and inflammation at injection site. Told patient to apply a cold compress to site and recommend analgesic (i.e. APAP) and antihistamine if no contraindication or drug interaction and to also contact PCP. If it gets worse to seek medical attention. I contacted the PCP however office is closed on Wednesday. Will try again next day. Patient came in at 2:45pm to show arm. Arm was bruised and red around injection site. She did state she bruised easily.
had my second shot a month ago / shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via (Shingrix  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine and unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had 2nd Shingles shot a month ago and still getting shingles. The patient he/she asked when could expect to be shingles free. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
BODY ACHES; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. 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) dose was not reported, administered on APR-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. No concomitant medications were reported. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced headache. On APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on APR-2021, and had not recovered from fatigue, and body aches. This report was non-serious.
On March 31st, I noticed a slight itch spot and welt on my bicep area. Then on April 1st I noticed my bicep area was sore/tight and swollen was starting to get a red area going across my bicep.  Then on April 2nd my bicep area was really red, swollen, warm to touch and a tight feeling when I lifted my arm. Same with April 3rd and by April 4th the reddness was a light red with an outline and by April 5th the reddness was gone and arm was pretty much back to normal.   I had remember that I seen an article about the "covid arm" after a Moderna shot so I looked it up and just use the guidelines about applying a cold cloth to area.  I did not use any pain relief medicine for my arm, it did not hurt that bad to use.
MD - (R) upper arm red, warm/tender to touch (not at inj site). 4 x 4cm largest red area. Advise ice, elevate, MOTRIN, BENADRYL -> if s/sx worse ER.
This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports. A patient of unspecified age, race, ethnicity and gender received a single dose of PREVNAR 13 (lot R28321, expiry date Mar2018) via an unspecified route of administration in the arm on an unspecified date in 2017 for immunization. The patient medical history and concomitant medications were not reported. The patient experienced redness, swelling and warmth at the injection site on an unspecified date in 2017. Outcome of the events was unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017108571 Same reporter/product/events, different patient.
Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 3-year-old male patient who developed non-satisfactory titers. The patient received a dose on an unspecified date. The patient's concurrent illness includes periodic fever disorder. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day ( intramuscular). Concomitant medications were not reported. On an unspecified date. the patient developed non-satisfactory titers (antibody test abnormal) and was being readministered Prevnar. The outcome is unknown. No additional information was available at the time of this report.
This spontaneous report as received from a nurse practitioner refers to a patient (gender and age not reporter) which was vaccinated with PNEUMOVAX23 (dose and route not provided) which was exposed to 11.5C for 80.5 hours. No adverse effect reported. Lot number H022281 is an invalid lot number for PNEUMOVAX23. This is one of several reports from the same source. Additional information is not expected.
This spontaneous report as received from a clinic manager refers to an unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route of administration and lot numbers were not reported). The reporter was not aware of an adverse experience. There was no previous temperature excursion. The call was made because of data logger. Administered vaccine experienced the temperature excursion of 32 to 35 degrees Fahrenheit for 15 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.  ; Sender's Comments: US-009507513-1705USA012739: US-009507513-1705USA012737: US-009507513-1705USA005716:
SORE BODY/ BODY ACHES; FEVER; SLAMMING HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sore body/ body aches, fever, and slamming headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102.6 temperature. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and slamming headache, and had not recovered from sore body/ body aches. This report was non-serious.
Patient received a COVID vaccine. A couple minutes after administration. Patient stated that she was feeling a headache and dizzy. Pharmacist provided a cool compress to the patient's head, neck, and wrists. Patient was also provided water and Gatorade. By the end of her 15 minute waiting period, patient stated that she felt better and left with her family but remained in the store.
Pain in bone; Dizzy; Chills; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Pain in bone), DIZZINESS (Dizzy), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced BONE PAIN (Pain in bone), DIZZINESS (Dizzy), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, BONE PAIN (Pain in bone), DIZZINESS (Dizzy), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-079209
Initial misuse report received from a healthcare professional on 13 November 2013. The patient had received expired DAPTACEL, IPOL. Considered invalid doses and should be reported, no waiting necessary. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
w/in the first hr p/vax pt tongue swelled making it difficult for pt to speak or swallow;w/in a short time this went away (in the next hr or two)-no medication given;
hurts to walk; inflammation in the body; pain in knees,pain in ankles,it is unusual for left knee to hurt; right arm pain,pain in bottom of feet and ankles; chills; fever; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (right arm pain,pain in bottom of feet and ankles), GAIT DISTURBANCE (hurts to walk), INFLAMMATION (inflammation in the body), ARTHRALGIA (pain in knees,pain in ankles,it is unusual for left knee to hurt) and CHILLS (chills) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2022, the patient experienced CHILLS (chills) and PYREXIA (fever). On 17-Apr-2022, the patient experienced PAIN IN EXTREMITY (right arm pain,pain in bottom of feet and ankles) and ARTHRALGIA (pain in knees,pain in ankles,it is unusual for left knee to hurt). On an unknown date, the patient experienced GAIT DISTURBANCE (hurts to walk) and INFLAMMATION (inflammation in the body). The patient was treated with PARACETAMOL (TYLENOL) for Arthritis, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (right arm pain,pain in bottom of feet and ankles), GAIT DISTURBANCE (hurts to walk), INFLAMMATION (inflammation in the body), ARTHRALGIA (pain in knees,pain in ankles,it is unusual for left knee to hurt), CHILLS (chills) and PYREXIA (fever) had not resolved.            No concomitant medications reported. Treatment also included 15 minutes of exercise a day to help the pain and staying hydrated. Patient called the doctor who said that the vaccine attacks inflammatory system.
The patient had a localized reaction with redness and a raised spot about 4-5cm in diameter. Patient had no fever on redness around the injection site.
The patient is having muscle pain 19 days post injection. He pointed to the area with pain and it is in the deltoid as it should be. He was not wanting to call his family doctor today , I suggested ice and massaging the area as he said the massaging had helped.
Client had no adverse event, received two MeningACWY vaccines within 8 days of each other.
Tingling to forehead and top of mouth 15 min after receiving vaccine.  VS 128/88, HR 100, O2 Sat 100.
Large area of red, warm, swollen from Axilla to elbow beginning day after injection and worsening following day.   9/19/08 Seen by Dr.  TX. Ice, advil, Benadryl  Much better after Doctor visit and TX.9/20/08
having faint spells; blood pressure is a little bit higher than normal; Feeling kind of funny; had severe headache; This is a spontaneous report from a contactable healthcare professional, the patient. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER8727, second dose) solution for injection intramuscular in the left arm on 25Mar2021 (at the age of 62-years-old) as a single dose for COVID-19 vaccination. Medical history included thyroid disease (diagnosed with probably 20-21 years ago) and blood pressure increased (takes blood pressure medicine). Concomitant medication included hydrochlorothiazide for blood pressure increased began taking this 4 or 5 years ago. Historical vaccine included BNT162B2 (first dose, lot EN6200) for COVID-19 vaccination on 04Mar2021 with no adverse effect reported. On 25Mar2021, the patient was feeling kind of funny and had a severe headache. In Apr2021, the patient had faint spells and blood pressure was a little bit higher than normal at 137/80 which began after the second dose Pfizer Covid Vaccine. The patient stated she never felt like fainting before in her life. Her blood pressure was never over 150 and can't keep blood pressure under 130 for some reason. The outcome of the events feeling kind of funny and headache was unknown. The outcome of the events faint spells and blood pressure was a little bit higher was not recovered.  Information on batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between event faint spells and BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) cannot be excluded. 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.
Myalgia, Arthralgia, Fever, fatigue, light headiness, injection site tenderness Narrative:
Lost consciousness for 1-2 minutes. Dizziness. Vitals stable. Given water, juice, and crackers.
Best Use Date was 4/21/2022  and actual expiration date was May 31 2022
Patient came in a showed up a 1 inch bump under her skin. It was tender to the touch. It was on the left hand side of the deltoid muscle. She said it appear the next morning following the vaccine. It has started to go down, but it is still there 7 days later.
Dizziness, mental fog, insomnia, severe fatigue, chills, bodyaches, delayed onset (3rd night) muscle/joint pain, delayed onset (day 5) rash at injection site and swollen mass (supraclavicular lymph nodes, larger on left side).
Two hard red itchy quarter size bumps at injection site developed 3 1/2 days after received second vaccination. Tenderness/sore to touch. Took benadryl to treat symptoms. Itching subsided in half hour,  tenderness and bumps remained present
PATIENT RECEIVED THE BOOSTER BIVALENT MODERNA COVID VACCINE AS FIRST DOSE OF SERIES
knee flared; @ the time had been in remission for a yr; each prev flare lasted less than 24 hrs; rxn was very painful; MD aspirated & injected w/Cortisone; 4-5 days later ER visit required; pain killer & leg brace required;
Vomiting, nausea, & slight fever.  In a 5 hour period (12:30am - 5:30am 4/14/08) vomited 4 times.  Very sore arm continued through 4/15/08.
Fever spiked at 102 F. for 6 hours, felt like I had the flu until early afternoon the next day. I just let it run it's course.
After receiving vaccine on 9/3/21 had pain in left arm. This progressed to on 9/5/21 started with rash on face and other parts of body, pain, body aches,  and swelling in lymph node in neck that radiates into chest and back of neck. On 9/10/21 started with nausea, chills, and body aches.  The rash and some of the other reactions resolved without treatment. On 9/13/21 still with pain in lymph node radiating to chest, left shoulder, down left arm, and to back of neck.
The pharmacist believes that 0.5ml was injected instead of 0.3ml. A moderna was given to the previous patient and that is why there is the likelihood of the error
A couple days post vaccination with first Shingrix dose, patient began experiencing transient vision loss and blurry vision. This has continued for over a month post vaccine and symptoms continue. She has been referred to neurology with no explanation found yet for her vision disturbances.
Leg pain, limping, general feeling of malaise the rest of the day immediately following the injections.  Five days later, work early in the morning with a fever of 100 F all day long.  Fever of 100 F continued through the night and the next day (so 2 days/nights total of 100 F fever with no drop, even with tylenol dosage).  Fever dropped down to 99 the day afterwards (so, 7 days after injection), and then temperature was back to normal range by midday.  Then, on 4/11/21 (17 days after injections), woke up in the middle of the night with intense leg pain.
pt recv vax SEP96 & exp sweating & muscle tremors;sweating to the point of where hair is wet everyday;also reported ringing in ears;tightened diaphragm & sweating over whole body;
After receiving his booster dose; pericarditis; short of breathe; losing his voice; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 24 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for Covid-19 Immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "After receiving his booster dose"; PERICARDITIS (medically significant), outcome "unknown", described as "pericarditis"; DYSPNOEA (non-serious), outcome "unknown", described as "short of breathe"; APHONIA (non-serious), outcome "unknown", described as "losing his voice". The events "after receiving his booster dose", "pericarditis", "short of breathe" and "losing his voice" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: nothing was found; x-ray: nothing was found. Therapeutic measures were taken as a result of pericarditis, dyspnoea, aphonia.  Additional information: It was reported that, about 7-8 days after receiving his booster dose began losing his voice while trying to just talk because he was short of breathe. Reporter states her son was placed on antibiotics prophylactically and given an inhaler. Caller states her son has a condition that requires him to take immunosuppressant infusions once per month and due to this he often becomes symptomatic of things later than normal. Caller states her son has begun to make slow improvements over the last few weeks. Caller says they are seeing a Cardiologist today and she wants to make sure he considers pericarditis. Caller states her son is not in danger now, but she would like to know what the timing is and the side effect comes about.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Got vaccine and came down with Shingles/Suspected vaccination failure; Wicked case of Shingles; Extremely painful; Deep nerve pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure, shingles, pain and post herpetic neuralgia were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and post herpetic neuralgia to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-Mar-2022 Reporter's Comments:  This case was received from consumer via interactive digital media. The patient self-reported this report. The stated that he/she got Shingle vaccine and came down with a wicked case of the Shingles and it was extremely painful and still deal with deep nerve pain, so he/she advised to be careful. Additional Supportive Information: This case described the occurrence of suspected vaccination failure This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.