chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen arm; Body ache; headaches; Arm sore; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8730) via unspecified route of administration in the left arm on 22Mar2021 at 10:00 (at the age of 50-years-old) as a single dose for Covid-19 immunisation. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had not been tested positive for COVID-19 since having the vaccine. It was reported that the patient was on medication for blood pressure and thyroid. On 22Mar2021, the patient experienced arm pain, it was reported that the pain was really sore at upper arm and underneath arm. After 3 days, on 25Mar202, the patient woke up with whole body aching, headache and swollen arm. It was reported that the patient was taking TYLENOL since getting the shot. The clinical outcome of the events arm pain, headache, body ache and swollen arm were unknown. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  No follow-up attempts are needed. No further information is expected.
Patient has 2.5cm pale circle surrounding injection site -circle is not raised nor indented-merely looks as if pigment is gone. some pinkened area (about .5cm) inside pale circle
febrile illness began early AM on 9/6/99;9/799 T105.5;very faint rash-mostly on face 9/8/99;
Wrong Covid dose/booster given to patient.  A Peds dose was given when it should have been a regular dose.
pt describing a rash contracted p/a vax;described a macular itchy rash that moves around body-trunk to extremities;had no known fever & no muscle pain;rash is still evident 5wk post vax;referred to PMD;poss immun rxn;
Numbness in middle finger of right hand. Right hand colder than left. Lasted about one hour. Took two Benadryl capsules as per pharmacist.
brain fog; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to the company on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (brain fog) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 026620A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included GABAPENTIN, MELOXICAM, ESCITALOPRAM OXALATE (LEXAPRO) and VITAMINS NOS for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced FEELING ABNORMAL (brain fog). At the time of the report, FEELING ABNORMAL (brain fog) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details not provided.
Patient called the pharmacy on 8/20/21 with complaint of fever, flu-like symptoms, pain, and nausea. She was instructed to take Tylenol or ibuprofen but stated she vomited the ibuprofen back up and did not feel well. Patient was recommended to follow up in the ER if her symptoms did not improve. She went to the emergency room and was given an IV and was prescribed an antibiotic, nausea medication, and itching medication. Patient was discharged from the ER in the same day.
SYMPTOMS SELF-RESOLVED AFTER HOLDING ASPIRIN AND OTC NSAIDS.
Body aches, tired, achy all over no energy even 6 days after getting the vaccine
Nausea, vomiting, chills, joint pain, fever up to 101.4C.
This spontaneous report was received from a medical assistant referring to a female patient of unknown age. The patient's medical history and concurrent conditions were not reported. Concomitant medication included sterile diluent (manufacturer unknown). On 20-MAR-2018, the patient was administered an improperly stored GARDASIL 9 (lot: N026814; Expiry date: 15-JUL-2020 and lot: N021572; Expiry date: 01-MAY-2020) reconstituted with a properly stored sterile diluent (lot and expiry date not reported) for prophylaxis. The vaccine was exposed to 47 °F to 77°F (67.3°F) for 10 hours, 30 minutes. There was no previous temperature excursion. There was no involvement of digital data logger. This is one of the several reports linked via same reporter link.
CHIEF COMPLAINT:   Pt here with son. Pt recently covid+, received abx. Since pt has been home 5 days from hosp, decreased ADLs, incontinence, increased confusion. Pt tremulous.        REVIEW OF SYSTEMS:     Review of Systems is as per HPI. All other systems reviewed and negative.
In addition to swelling and redness on and around the injection site, the patient also had an unusual red line extending on the surface of the skin from the arm to the neck but the mark was far above the injection site so it did not look like an infection.
The patient reported significant pain in the left arm at the time of injection. Her pain continued for several days following the injection despite use of Extra Strength Tylenol. Additionally, she noted decrease in mobility of the left arm. She was seen by her primary care provider and referred to orthopedics. She reported having and MRI along with medical management.
pt recv vax 6JAN98 & adm to hosp 20JAN98 for fever, URI, anorexia, mult sz episodes;eval for sepsis, meningitis, viral encephalitis, head trauma, EEG all non diagnosis;
Veteran reported Nausea for one day starting 3 hours after the first dose of vaccine.
pt recvd vax 25SEP95 & 15NOV95 pt devel a rash, to MD & was dx w/chicken pox;rash consisted of 25 to 50 gen pustules, one of which was located on soft palate;there was no assoc fever;25NOV95 pt dx w/concurrent beta hemolytic strep infect
Patient presented with a rash on the underside of the left arm. It was warm to touch but not itchy.  I advised patient to followup with doctor. She was prescribed an antibiotic.
Patient's mother called on 4/14/21 to report that her daughter have been having severe headaches, severe abdominal and leg pain since getting vaccine on Monday night
I have a knot under my arm on the side I got the vaccine; weird; diarrhea; he got a lump under his arm pit; had a scratchy throat afterwards; I was a little tired/tiredness; This is a spontaneous report from a contactable consumer. A 20-year-old male patient (Patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6025), via an unspecified route of administration, administered in Arm Left on 21Mar2021 11:40 (at the age of 20-year-old) as dose 1, single for COVID-19 immunization. Medical history included scoliosis surgery from an unknown date. The patient's concomitant medications were not reported. On 21Mar2021, the patient experienced he was a little tired/tiredness, on 22Mar2021, the patient had had a scratchy throat afterwards, on 23Mar2021, the patient experienced he got a lump under his arm pit and on 24Mar2021, the patient had diarrhea. The patient also had a knot under my arm on the side, he got the vaccine and weird on an unspecified date. The caller stated that, he got his first dose Sunday and yesterday he got a lump under his arm pit and he read all that and it seems like it is pretty normal. He got a scratchy throat and then he got the runs today he thought that was a little bit weird to be 4 days out and he has had 4 trips to the bathroom. He confirms the the first dose was given on Sunday 21Mar2021. The scratchy throat started the day after the vaccine, he confirms Monday the 22Mar. He says it is not bad, it is just like an irritation. The patient was a little bit tired but from what he hears that is normal. The diarrhea started today, 24Mar, that is ongoing and about the same, it is persistent and tiredness that was the day of the vaccine, sunday. It is not overbearing. He just feels blah. The outcome of the events he was a little tired/tiredness, I have a knot under my arm on the side I got the vaccine and weird was unknown, for events had a scratchy throat afterwards, he got a lump under his arm pit and diarrhea was not recovered.  No follow-up attempts are possible. No further information is expected.
Approximately 6 hours after receiving the vaccine I began having chills. Within 2 hours, I had a severe headache, muscle aches, and nausea. I took 1 Extra strength Tylenol at 4:00pm but it didn?t seem to help. At 7:00 pm I took 2 ibuprofen, again didn?t seem to help.  Finally fell asleep around  10:30 pm. Woke at 12:00am chills and body aches gone,fatigue,  headache and nausea remained- slightly diminished. Fell asleep and slept through until 7:00am, felt better with a  mild headache , fatigue, and upset stomach through the day(March 14).  Low energy and slight headache remain on March 15th.
patient has had significant arm pain, can't move arm from 11-25 to 11-30.  Patient now reporting able to move arm better.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  Clinical course: Paxlovid Treatment start date was 11May2023, Indication was Treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Severe shooting pain up arm and into collar bone and left shoulder area immediately as vaccine was given and lasting over 7 days. Severe headache began within 2hrs.
17-year old was vaccinated with Moderna at an employer-site vaccine event. No adverse outcomes known.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2006, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated for a blistering vesicular outbreak 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. The outcome of the events was unknown. Causality assessment was related.
pt recvd vax;c/o rash & itching w/in about 24 hrs of vax;she had also started hydroxine during the same interval;
In the evenings I get inflamed itchy skin and raised welts on my body.; This is a spontaneous report from a contactable consumer or other non hcp. A 56-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6199, Expiry date: unknown, at the age of 56 years), dose 2 via an unspecified route of administration, administered in Arm Left on 06Mar2021 10:00 as dose 1, single for covid-19 immunisation. The medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: 6200, Expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 17Feb2021 17:00 as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient experienced inflamed itchy skin and raised welts on her body in the evening on 09Mar2021 20:00. Not every single day. And usually in the evenings. It looked terrible and she had photos of that and stated that she never had skin reactions like that. The location changed. After about 30 minutes it calmed down. Hoped it would go away. The patient did not receive any treatment for the event. The outcome of event was not recovered.  No follow-up attempts are possible; No further information is expected.
Injection site feels hot; Weakness; Injection site redness; This spontaneous case was reported by an other health care professional and describes the occurrence of ASTHENIA (Weakness), VACCINATION SITE WARMTH (Injection site feels hot) and VACCINATION SITE ERYTHEMA (Injection site redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No medical history was provided by the reporter.     On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced ASTHENIA (Weakness), VACCINATION SITE WARMTH (Injection site feels hot) and VACCINATION SITE ERYTHEMA (Injection site redness). At the time of the report, ASTHENIA (Weakness), VACCINATION SITE WARMTH (Injection site feels hot) and VACCINATION SITE ERYTHEMA (Injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concurrent conditions, medical history, or concomitant medications. In September 2015, a pharmacist at a pharmacy administered ZOSTAVAX to the patient to obtain permanent prevention and protection against shingles and zoster-related injuries/conditions (dose, route, and lot # not provided). In January 2016, the patient was treated by a physician's assistant at a medical group for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was not recovered. Causality assessment was related. Additional information has been requested.
Swelling, induration, tenderness redness (blanches) at injection site (L) deltoid swelling/induration about 3" x 2 1/2" rednes s about 3 1/2" x 3".
Patient received her first MMR and Varicella vaccine on 4/22/22. On May 4th we received a call that the patient had broken out in a widespread, non itchy rash on May 2nd 2022.
Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA302803 (same reporter). This case involves a patient (between the ages of 6 months to 3 years and gender was not reported) who received 1.0ml of vaccine FLUZONE QUADRIVALENT (number not reported) via unknown route in unknown administration site instead of 0.5ml on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to overdose. It was not reported if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
Swelling, redness at site. Treated with cephalexin 250mg/5ml 6mL TID x 10.
Pt admitted 11-10 with generalized weakness and numbness to entire body and extremities. MRI , neurology consultation 11/24/08-records received for DOS 11/10-11/14/08-DC DX: Paresthesia. Hiccup. Generalized numbness involved arms, legs, chest and abdomen began on 11/7/08-Weak feeling barely able to weight bear. Unable to urinate or defecate without pushing hard. Seen on 11/8/08 for viral illness. At time of discharge able to move bowels but bladder weakness remains.
pt reported to pharmacy after 1 week with bruising at site of injection, bruising size of a half dollar.
Fever of 102.5, vomiting and developed cough about 12 hours after vaccine
PATIENT HAD RASH, SLIGHTLY SWOLLEN AND RED AT THE INJECTION SITE WITH NO ITCHING.
Heart rate increased; Upper body ache/Lower body ache; Headache; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE INCREASED (increased heart rate), MYALGIA (Upper body ache/Lower body ache) and HEADACHE (headache) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Chemotherapy. Concomitant products included OLAPARIB (LYNPARZA) for Chemotherapy.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced HEART RATE INCREASED (increased heart rate), MYALGIA (Upper body ache/Lower body ache) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (increased heart rate), MYALGIA (Upper body ache/Lower body ache) and HEADACHE (headache) had not resolved.            Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up information received on 3-JUN-2021,contains no newinformation.
swelling for approx. one week; induration; This case was reported by a nurse via sales rep and described the occurrence of swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling and induration. On an unknown date, the outcome of the swelling and induration were recovered/resolved.   It was unknown if the reporter considered the swelling and induration to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The nurse mentioned that there was a staff member who received a dose of Shingrix and had induration and swelling for approximately one week. The reporter did not consented to follow up.
FLU LIKE SYMPTOMS; ARM SORENESS; This spontaneous report received from a consumer 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced flu like symptoms, and arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The batch number was not reported and same has been requested. The outcome of the flu like symptoms and arm soreness was not reported. This report was non-serious.
Vomiting, photophobia, eye burning, nausea, myalgia, dizziness. The day of the injection and persisting for 48 hours.
Tdap vaccine (2nd dose) given on March 7, 2011. Tdap #1 given on 8/5/2008.