chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician and described the occurrence of swelling arm in a 47-year-old subject of unspecified gender who was vaccinated with BOOSTRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of BOOSTRIX in an unknown arm. There was no swelling at the injection site, but swelling was present on the same arm of the injection on the opposite side. The vaccine was given in the tricep, but swelling occurred in the bicep. Reporter was trying to determine if there was another reason for this event of if it might be vaccine related. At the time of reporting the outcome of the event was was unspecified. Additional information received via a sales representative noted that the subject was a male. It was reported that there was dramatic swelling in the injected arm in the bicep and tricep region. The event was indicated to have began 48 hours after immunization which took place on 05 April 2010. The event remained unresolved. Follow-up information was received via the subjects physician later in the day on 15 April 2010, the same day of the initial report. It was reported that the healthy 47 year old male subject presented for a physical on 05 April 2010. The subject was due for a tetanus booster so BOOSTRIX was administered at 0.5 ml in the left arm. It was commented that this was the first dose of BOOSTRIX for this subject but it had been greater than 10 years since the last tetanus. On 08 April 2010 the subject called the office reporting arm swelling. The subject was seen in the physician's office on 09 April 2010 with upper arm swelling and same hand and finger swelling. The subject had not improved over the weekend and was seen on 12 April 2010 with dramatic swelling primarily of the upper arm of the injection, but swelling was not noted primarily at the injection site. Arm was also warm with heat. Steroids and antibiotics were started and the subject was instructed to elevate his arm. He was seen on 13 April 2010 and steroids were increased and subject was placed out of work. The subject was not better on exam on 14 April 2010. An MRI was performed that revealed that the issue could be mild cellulitis of bicep, no tricep involvement and no abcess seen. Again the subject was instructed to keep the arm elevated. As of 15 April 2010, the subject seemed to be improved, but within 5 minutes of having arm in down position, his arm and fingers showed swelling. Creatinin, CK and blood cultures and counts were done. Blood count was 15,700 and primarily neutrophils. An ortho consult was pending. The physician added that at the time of reporting, venous congestion appeared with purple and redness of the arm. For the first time, the subject was complaining of pain and tenderness. Pain medication was added to the subject's regimen.
Patient received HPV #3. Patient was scared and crying. Dad had to hold patient down. After vaccine was given patient said she felt dizzy. Patient laid down on exam table for 5 minutes. BP 111/67. Patient stated she felt better and sat up. Gave patient water and crackers due to not eating her lunch. BP 96/70. Patient stood up BP 102/70. Walked patient to car and informed parent if patient feels dizzy again have her lay down and if condition gets worse take to ER.
Headache; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Aug2021 at 14:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy (reported as no medical history). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), paracetamol (TYLENOL) and unspecified hair skin and nails vitamins; all for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Jul2021 at 14:30 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. On 06Aug2021 at 00:00, the patient got a headache afterwards (which the patient was aware that it was common) but only since getting the second dose and that headache had been persistent for over a month now. The patient had to take medication for it every single day and also reported that she never had frequent headaches before this. The event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of reported event and included treatment with unspecified medications. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache was not resolved at the time of this report.
Client reports redness and swelling to injection site (Left Arm) as well as headache and and body (bone) aches that started a few hours after receiving the vaccine on 8/7/21 and is ongoing today 10/8/21.
One day after hep A vaccination, pt developed vomiting and had four afebrile seizures within 3 days. Also had culture-negative, diarrhea. After treatment with phenobarbital for 2 weeks, she developed rash, fever adenopathy and hepatitis/hepatic dysfunction persistinf for 2 1/2 weeks. Now improving. All infectious workup was negative. Had lymphocytosis, mild anemia, elevated AST/ALT (up to 500's), low albumin. On date of vaccination, 8/26/02, the child fell in the yard and sustained a broken tooch and a swollen, bruised lip.
Headache, Myalgia, NauseaVomiting, Fatigue, Chills, Shortness of Breath, Injection Site Pain Narrative:
Information has been received from a physician concerning a 77 year old male with diabetes, hypertension, arthritis and coronary artery disease who on 20-Aug-2007 was vaccinated SC with a single dose of Zostavax (lot #656858/0356U).  "One week after vaccination", on approximately 27-Aug-2007 the patient developed pain and a rash which followed the "radial and medial" nerve path down from the injection site on his arm to his hand.  Unspecified medical attention was sought, and the patient was diagnosed with shingles.  The patient was treated with valacyclovir (Valtrex) and over the counter medications for the pain.  At the time of this report the patient was recovering.  No further information was provided.  There was no product quality complaint involved.  Additional information has been requested.
5/2/2021,  around 9:00 am,  after I got up hives started to appear on arms and legs symmetrically, then became very dense and covered the whole area. Applied Diphenhydramine Hydrochloride on the hives, most hives disappeared after about two hours around 8:00 pm, hives appeared again in more area, including arms, legs, chest, back, face and neck, hands, applied Diphenhydramine Hydrochloride again, and most hives disappeared  5/3/2021 Got up around 10:00 am, and immediately hives started to appear and spread all over the body and covered all skin. Applied Diphenhydramine Hydrochloride, some hives remains and some new ones keep coming up throughout the day so far (around 4 pm)
Pt states that 1 week after receiving vaccines he broke out in red patchy areas which itched. Pt raised his shirt and revealed healed site on chest wall and left VQ and right LE (brown patch) near ankle. Also stated he went to the beach same week.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was inoculated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. In 2016, the patient was treated at a medical center for a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient's mother reports within several minutes of receiving her seasonal influenza vaccine she noted patient to have redness and itching of her face, neck, upper arms, chest, and upper back associated with scattered hives. No nasal, ocular, lip/tongue/oral/laryngeal, pulmonary, neurologic, GI, or CV symptoms. No illness, exercise, medication use, latex exposure, or known insect bites/stings today. By report patient has received seasonal influenza vaccines in the past without adverse reactions. No prior adverse vaccine reactions. No history of egg allergy or known medication allergy.
Tuesday 12/22/20, right side of face was itchy and swollen, both top of eyelids red and itchy, took bendryl and it relieved symptoms
became ill 13OCT93 w/chills possible fever, nausea; unable to eat; felt cold, freezing;
patient came to office for booster dose of Pfizer Covid-19 vaccine. Instead of getting .2ml of Pfizer Covid-19 5-11 dose she received .2ml of Pfizer Covid19 6m-4yr. Mother notified immed
redness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness on the injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness on the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (redness on the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Severe side effects; This case was reported by a physician via call center representative and described the occurrence of adverse event in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunodeficiency.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced adverse event. Shingrix was discontinued. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional details were received as follows: This case received via chat.  The age at vaccination was not reported. The reporter reported that reports a male patient with immunodeficiency had severe reaction to the first dose of Shingrix and wants to avoid the second dose if first dose efficacy was reasonable. He later adds this patient had no adverse reaction just severe, known and reported side effects. The reporter consented to follow up. No further details provided via chat.
Developed itching and redness to bilateral arms and face approximately 20 minutes after vx admin.  Admin Benadryl 25mg po x 1 per S.O.  1400-itching nearly resolved, redness decreased.
14AUG96 pt recv vax & became a bit red & sore, had a knot on 15AUG96 pt c/o abd cramping, t100, rash & knot on lt deltoid became larger & on 16AUG96 mom describes baseball sized knot on lt deltoid, sore, rash covering swollen area;
Began to lose hair in handfuls coming from root. Lasted for at least 4 months.
Diagnosed with tennis elbow in the right arm and was on prednisone for a week; Feeling sick; Sinus infection; sore throat on left side; congestion on left side; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick), SINUSITIS (Sinus infection), OROPHARYNGEAL PAIN (sore throat on left side), SINUS CONGESTION (congestion on left side) and EPICONDYLITIS (Diagnosed with tennis elbow in the right arm and was on prednisone for a week) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced MALAISE (Feeling sick), SINUSITIS (Sinus infection), OROPHARYNGEAL PAIN (sore throat on left side) and SINUS CONGESTION (congestion on left side). On an unknown date, the patient experienced EPICONDYLITIS (Diagnosed with tennis elbow in the right arm and was on prednisone for a week). The patient was treated with PREDNISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MALAISE (Feeling sick), SINUSITIS (Sinus infection), OROPHARYNGEAL PAIN (sore throat on left side), SINUS CONGESTION (congestion on left side) and EPICONDYLITIS (Diagnosed with tennis elbow in the right arm and was on prednisone for a week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details were not reported by the reporter.
The night after I took the first Moderna shot, I sweat so much that it went thru my bed matress and onto the hardwood floors that became warped the next work. I called Moderna to file an insurance claim. And they told me this was a normal side effect. I wish they had told me to put a plastic pee protector sheet on first which would have avoided my warped floors. I have a bid for $3000 to fix the warped floors. Furthermore, my girlfriend left me. Shes and anti-vaxxer and couldn't stand the musty smell of the matress. I have a high blood pressure now. 160/120. I can't tell if that's from the vaccine or the fact that my anti-vaxxine girlfriend left me. Should I go see a doctor or a psychiatrist?
Pt lightheaded 5-10 minutes after the shot while going out of the office. Was pale and bradycardic to 52/min; BP-70/50. He was given orange juice and recovered. Pt had no lunch.
Pt devel polyarthralgia following vax w/rubella; dx of rheumatic fever & strep infect were ruled out;
8/21 Zoster vaccine administered; 8/27 a pock sore on L forehead; 8/28 L forehead & cheek tingling & slightly numb; 8/29 tingling/numbness spread to chin on L; symptoms lessened by late afternoon; 8/30 symptoms very mild; 8/31 same; 9/1 tingling/numbness on L forehead, around eye, around L mouth and in evening L side of tongue swollen; went to health dept. to get info to file VAERS form and nurse visited with me; 9/2 all symptoms continue; health dept. nurse called to see how I was and encouraged me to call doctor which I did; doctor checked for other neurological problems and potential for stroke - everything was clear; he conceded it must be a reaction from the vaccine - strange as it was;  the health dept. nurse also said it was a reaction they had not see or heard about prior to my case; doctor gave me an anti-viral prescription to fill out if I developed a rash or the tingling/numbness went into my neck/throat; 9/3 symptoms present but lessened towards evening; 9/4 symptoms seemed nearly gone early in the morning but kicked in again later; later in the day symptoms subsided considerably; 9/5 symptoms very slight; 9/6 symptoms very slight; out in sun briefly and L cheek bone area became very agitated by the sun - iced it to get it calmed down and stayed out of sun; 8/7 symptoms very slight; with hat on in sun got just the slightest reaction on L cheek bone area;9/8 symptoms gone. Did not have the anti viral prescription filled.
Information has been received from a Licensed Practical Nurse (LPN) concerning multiple unspecified patients of unknown age and gender. No concurrent condition, medical history and concomitant therapies were reported. On unspecified dates, the patients received doses of improperly stored ROTATEQ (lot # L010837 with expire date of 06-FEB-2017 or L013192 with expire date of 19-JAN-2017, dose and dose number not reported) orally. The vaccines had been exposed to temperature of 48.4 F for 50 minutes. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I had the Moderna covid Vaccine on 5/8/2021 for the fist shot with no adverse reactions I had the second Moderna vaccine on 6/18/2021 with severe headache , muscle cramps, joint pain, nausea, and could not get out of bed for three days. on 7/03/2021  I experienced heavy bleeding with thick clotting which  completely caught me by surprise since I have not had a menstrual cycle in years.  I am in menopause so this should not be happening.
22lb weight loss concerning for malignancy vs progressive autoimmune process; progressively worsening hyperkeratotic lesions on feet and penis; progressively worsening hyperkeratotic lesions on feet and penis; pain/stiffness of hands, shoulders, and feet; pain/stiffness of hands, shoulders, and feet; pain/stiffness of hands, shoulders, and feet; 22lb weight loss concerning for malignancy vs progressive autoimmune process; 22lb weight loss concerning for malignancy vs progressive autoimmune process; dermatopathology from punch biopsy of L foot is consistent with reactive arthritis; This is a spontaneous report from a contactable physician. A 49-year-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular on 09Jun2021 (Batch/Lot number was not reported) at the age of 49 years old as dose 1, single for COVID-19 immunisation. Medical history included current tobacco user and known allergies to penicillins. There were no concomitant medications (other medications in two weeks: none). It was unknown if other vaccine was received in four weeks. The patient presented with progressively worsening hyperkeratotic lesions on feet and penis, pain/stiffness of hands, shoulders, and feet, and 22lb weight loss concerning for malignancy vs progressive autoimmune process. Symptom onset was 4 days after receiving 1st dose of Pfizer COVID19 vaccine (13Jun2021). PET scan was negative for malignancy, and dermatopathology from punch biopsy of L foot is consistent with reactive arthritis on 13Jun2021. Given negative work up for typical causes of reactive arthritis (no GI symptoms, negative gonorrhea/chlamydia and STD screening) based on timeline of events and discussion with rheumatology, dermatology and dermatopathology thought to be triggered by covid vaccination (COVID received on 09Jun2021). Adverse events start date was 13Jun2021. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and Hospitalization for 7 days. Treatment for the adverse events was prednisone course. It was unknown if patient has history of COVID-19 prior to vaccination. The patient underwent SARS-CoV-2 test (nasal swab) with result of negative on 13Aug2021. The patient was recovering from all the events.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Hyperkeratosis, Penis disorder , Musculoskeletal stiffness, Pain in extremity , Arthralgia, Neoplasm malignant, Autoimmune disorder, Weight decreased, Arthritis reactive  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.
This spontaneous report as received from a nurse refers to a patient of unknown age. On 02-DEC-2013 the patient was vaccinated with RECOMBIVAX HB. Dose, lot and expiry date were unknown. The patient was administered RECOMBIVAX HB that was exposed to an unsupported temperature excursion. No adverse effect was reported. Additional information has been requested.
Pt was given a pediatric dose (age 6 mos - 4 yrs) of moderna booster rather than adult dose, no symptoms following dose, pt did not get appropriate dosing; error found when provider was reconciling vaccines in state immunization system.
On June 6 I had  a sore throat, body aches and fatigue.  I tested positive for Covid using a home test.  Subsequently experienced sinus drainage and congestion , cough and lost of sense of taste/smell
MOM STATES VARICELLA INJECTION SITE IS RED, SWOLLEN AND WARM TO TOUCH. EXAMINED IN OFFICE,DX: POST VACCINATION CELLULITIS. TX: AUGMENTIN, ICE; CBC, BLOOD CULTURES, CRP.
Abrupt stop in speech development, loss of eye contact, increased sensitivity, favors routine, repetition to abnormal extent. Diagnosed with sensory disorder and possible attention deficit or communication disorder. Received therapy thru EIP; in special preschool where receives speech and occupational therapy.
Had the shots and still got shingles/ suspected vaccination failure; Shingles; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the shots and still got shingles/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and still experienced shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Hand tremors- treated by pcp - subsided after 8 weeks Labrinthitis - treated by pcp - ongoing