chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of facial swelling in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose.  On an unknown date, less than a day after receiving SHINGRIX, the patient experienced facial swelling. On an unknown date, the outcome of the facial swelling was unknown. It was unknown if the reporter considered the facial swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist stated that, they have one store with a patient who reported facial swelling within 24 hours after receiving SHINGRIX vaccine. The reporter wanted to know if there was any literature on facial swelling. This case was linked with US2018GSK093923, reported by the same reporter.
approx 3hr p/vax pt began high pitched screaming & temp 102 ax;mom called MD & took pt to hosp they said this was d/t DTP & gave motrin in ER & sent pt home;MD saw pt 17OCT96 & pt was OK;
auto- immune disease-eosinophilic faciitis.; Swelling of joints; edema; fatigue; muscle contractures; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 66-years-old female patient received bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number: EM9809, Expiration date: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 12Feb2021 11:45 as SINGLE DOSE for covid-19 immunisation. No covid prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. NO covid tested post vaccination. Medical history included hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 22Feb2021 07:00 the patient experienced adverse event Triggered a response of auto- immune disease-eosinophilic faciitis, swelling of joints, edema, fatigue, muscle contractures. No covid tested post vaccination. The Therapeutic measures were taken as a result of events includes Steroid shot in joint, fluid removed. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome for all the events was reported as recovering.   Information on Lot/Batch number was available. Additional information has been requested.
Pt had Varivax on 02/24/1996. Break through chicken pox lesion on 12/07/2001. No history of known contact with chicken pox or herpes zoster.
A 51 year old female and employee received her influenza vaccination, which was the FLUZONE HD formulation, on 10/5/2017 in an employee flu clinic. She filed a compensation report the following day, 10/6/2017, stating the following: Severe swelling post flu shot. Swelling from shoulder to elbow and itching on right side of body from head to thigh. Arm from shoulder to elbow is twice the size of left arm, red and hot. Increased trouble breathing using asthma inhalers. Pain in elbow joint comes and goes. Since the adverse drug reaction happened after the employee left the flu clinic, there is no other documented information, including why the patient received a high dose formulation of the vaccine or if she has any known allergies.
Information has been received from a nurse concerning a 48 year old white female, with allergies to tetracycline and "gold shots", who on 12/18/01 was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot 641115/1159L), administered SC, in the left arm. The pt had pharyngitis and an upper respiratory infection at the time of vaccination. Subsequently, on 12/20/01, the pt developed a swollen, red and hot arm. The pt stated that she had a "large, red, hot area due to pneumonia injection". She was in no distress, but stated it was "painful". Unspecified medical attention was sought. Additional information has been requested.
Approximately 3 hours after receiving vaccines child began vomiting and jerking and shaking uncontrollable and became unconscious; per mother, "had a seizure". Was taken to ER. Child was lethargic after coming around before becoming alert again. Vitals showed elevated temp. records did not show immediate temp, but when taken at 8:15, temp was 101.7 rectally. Child was given antipyretic. Temp showed steady decline at 9:15 and 10:15. No further seizure activity and child discharged to follow up with pmd next day. Diagnosis of Febrile Seizure. MD stated had ear infection and placed child on Amoxicillin. Has pending neurology consult. Mother states she has had history of seizure activity as well in the past.
Fever of 103+ starting 11 hours after shot received, lasting several hours, then lowered to 101.4 for the following day until evening.
I had terrible ringing in my ears and my whole head, postnasal drip, cough, chills, and exhaustion. I had a fever of 101. For one day I had a headache. The symptoms came and went. The ringing has not gone completely. On 09/14/2022 I got a COVID-19 test and it was positive within five seconds. I took Advil.
Client admitted to hospital on 7/14/2021 with COVID-19 symptoms, she was not admitted to ICU or intubated. Writer does not have access to any further details on this case. Please contact admitting hospital if further information is needed.
This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to a 15 year old female patient. On an unknown date that patient was vaccinated with her first dose of RECOMBIVAX HB 5/0.5 mcrg/ml, dose/frequency: 0.5 ml (route and lot # not reported) at her birth, and the second dose three weeks later, with the third dose at six months after the first dose. No adverse effects reported. The outcome of event was unknown. Additional information has been requested.
Fluzone Highdose Quadrivalent indicated for 56 years old is lower than indication 65 years old and higher with no reported adverse event; Initial information received on 03-May-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 56-year-old male patient who experienced fluzone highdose quadrivalent indicated for 56 years old is lower than indication 65 years old and higher with no reported adverse event while receiving vaccine influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Hepatitis B Vaccine Rhbsag (Yeast), Pertussis Vaccine Acellular 3-Component, Polio Vaccine Inact 3v (Vero), Tetanus Vaccine Toxoid (Pediarix); Pneumococcal Vaccine Conj 7v (Crm197) (Prevnar); and Rotavirus Vaccine (Rotavirus Vaccine). for prophylactic vaccination.  On 22-Mar-2022, the patient received a dose of suspect influenza quadrival a-b high dose hv vaccine ( form, strength, dose, frequency, route, lot number, expiry date, indication unknown).   On an unknown date the patient developed a non-serious  event fluzone highdose quadrivalent indicated for 56 years old is lower than indication 65 years old and higher with no reported adverse event (off label use) (unknown latency) following the administration of influenza quadrival a-b high dose hv vaccine.  No lab data reported.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment.  Outcome: Unknown.
Information has been received from a woman working in a physician's office concerning a child who was vaccinated with a dose of Varivax. "Very recently," in 2006, the patient experienced breakthrough chickenpox. It was reported that the child was being boostered. It was also noted that the child was in an unspecified stage of breaking out with lesions. IT was reported that the patient's experience was currently ongoing. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow-up information from a physician indicated that he was aware of the breakthrough of chickenpox at the local school, but had "no idea" about any additional information. Additional information is not expected.
skin discoloration inside of bicep near the injection site; was tender and sore; was tender and sore; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 34 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Aug2021 (Lot number: fc3181) at the age of 34 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: fa7485, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 05Aug2021, when the patient was 34 years old, for COVID-19 immunisation. The following information was reported: SKIN DISCOLOURATION (non-serious) with onset 30Aug2021, outcome "recovering", described as "skin discoloration inside of bicep near the injection site"; PAIN (non-serious), TENDERNESS (non-serious) all with onset 30Aug2021, outcome "recovering" and all described as "was tender and sore". Therapeutic measures were not taken as a result of skin discolouration, pain, tenderness.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are possible. No further information is expected.
Developed Guillain Barre Syndrome diagnosed on 7/15/22.  Subsequently developed CIDP, diagnosed on 09/16/22  Treated at Hospital, transferred to Rehab x 2.  Transferred to Rehab.  Treated continuously with PT and OT. Transferred to Skilled Nursing
4MAR92 2 day p/recvd 1st dose of Engerix-B pt became nauseated, flush, got hot & then cold & devel hot flashes; 5MAR92 devel chills, nausea, became flush 3 days p/recvd 1st dose of vax; 30MAR92 pt recvd 2nd dose of vax w/no rxn;
4 weeks post 2nd shot, exhaustion, lethargy and low grade fever commenced for 5 days.  In addition, large swollen pymph nodes under right armpit.
Within 8 hours he had a hard lump about 1/4" away from site of injection which was tender and red. Also some swelling under his arm by mother's account. Lump was the size of a puppy's ball - that resolved but redness persists 3 days after immunization.
On 9/18/15 started with tingling in feet then a few days later tingling in hand. Saw MD and was given ELAVIL then progressive weakness and absent reflexes in hands and legs then saw neurologist.
Pain/soreness, burning, swelling and harness on site of injection that became larger on second day: patient experiencing chills and fever: tingling on the whole arm: still feeling sick as of this moment.
4/20/12 p.m. Mom called to report diarrhea, N/V, sipping fluids. 4/23/12 p.m. Mom called to report 4/21/12 fever 100 degrees, no vomiting; 4/22/12 "feeling better; 4/23/12 HA, ears & cheeks red, fever 101.9 degrees, "weak" eating & drinking well.
Pt. was given Varicella in (L) sub-cu arm, noticed redness, swelling, and streaking with dime sized welt, injection was given at 11:40 AM and at 11:45 that was reaction was noticed, provider was called and pt was checked, and BENADRYL was ordered and ice was applied to affected area. Pt. was called 6/30/10 and report doing ok, with redness and swelling completely gone.
Severe Shaking Chills myalgias for several hours. Resolved spontaneously. Fatigued the next day.
Soreness at injection site. Lyme symptoms rapidly worsening with neuropathies, central nervous system deficits and autoimmune disease. Recovery is ongoing.
Child received Varicella vaccine 1/24/04. Developed rash 9/1/04; diagnosed chicken pox 9/2/04. Has about 20 lesions.
overall soreness, extreme soreness in arm, headache, flulike symptoms: chills, weakness, fatigue, nausea, dizziness (the last two symptoms were brief)
Red rash 3" wide x 10" long extending from 2" red diameter injection site (R) upper arm to elbow.
8/16: No side effects 8/17: slight fever, body chills & aches, slight headache, back pain moving around neck and back 8/18: Woke up in extreme back pain still moving around. BUT my lower back pain was excruciating. My tailbone hurt and my legs were numb, I couldn't walk. Spinal Cord inflamed.  I should have gone to the ER.
A case of HZ dermatitis after COVID and varicella vaccinations in an immunocompetent person who was previously seronegative and who had no history of chickenpox.  Information has been received from the author's of the published literature article as stated above referring to a 35-year-old healthy male patient. The patient's concurrent conditions and medical history were not reported. There was no concomitant medications reported.  On an unspecified dates, the patient received the first and the second dose (6 weeks before the onset date of event) of covid-19 vaccine (BioNTech-Pfizer)(strength, dose, route, lot number and expiration date were not reported) for prophylaxis. Later, on an unspecified date, the patient received the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strength, dose, route, lot number and expiration date were not reported) also for prophylaxis, because he was a health care worker with no antivaricella IgG antibodies. Subsequently, 3 weeks later he presented with severe stinging pain from the right side of the abdomen to his back. At the time of presentation, the patient denied any recent trauma, medical or cosmetic procedures, or foreign travel. Methocarbamol and topical diclofenac gel were prescribed. Three days later, he developed multiple mildly tender plaques on an erythematous base corresponding to a T5 to T11 dermatomal distribution. He had no history of immunodeficiency, malignancy, or immunosuppressive therapy. He was initiated on valacyclovir at 1 g thrice daily. In 3 days, the erythema began to resolve. Both pain and rash completely resolved after 2 weeks.   Authors report a case of herpez zoster (HZ) dermatitis after BioNTech- Pfizer and varicella vaccinations in an immunocompetent person who was previously seronegative and who had no history of chickenpox. In this case, the COVID-19 vaccination may have influenced the development of HZ after the varicella vaccination. Arguments that support a link among COVID-19 vaccination, varicella vaccination, and HZ include the following: (1) rapid onset of rash after vaccination, (2) eruption on the same side as the vaccinated arm for both vaccines, (3) several previous cases of HZ after COVID-19 vaccination, and (4) cases of HZ reported after various vaccinations.  A copy of the published literature article is attached as further documentation of the patient's experience
Tingling in mouth and throat, nausea and chest tightness  that started about 15 min after vaccine. Chest tightness resolved after 15 min. Tingling in mouth improved but lasted the rest of the day. Nausea also the rest of the day. Second dose of Benadryl 50mg PO taken that evening
On 6/12/00, the pt's left arm was red and swollen from shoulder to mid upper arm.
Fever - 101 (high) , vomiting (2-3 times) body aches, chills, headache. Lasted approximately 60 hours
Pateint developed right sided facial paralysis on saturday, with weakness of the right cheek and drooling.  Seen at the Doctor's office today and diagnosed with Bell's palsy; started treatment with Prednisone and Valacyclovir.  Patient will follow up in 1 week or earlier if needed.
Varicella vaccine place in (R) thigh 7/18/16. No other vaccines placed in (R) thigh. Redness/erythema started night of 7/26/16. Presented to office 7/27. Started as 4" bumps - dime size. Erythema now confluent, with some papules, 2.5 cm diameter.
Near-death flu symptoms: Nausea, headache, aches, chills, fever, lethargy.
6APR93 pt presented for 3rd set of shots @ 10mo of age; legal guardian informed clinic of continuous screaming adverse reaction following last set of shots on 2fEB93 & that the MD had said pt was not to receive pertussis again;
? On Friday, April 16th an individual under the age of 18 received the Moderna COVID-19 vaccine as a part of a 500-dose vaccination clinic.   o 16 yo male whose parent signed him up for an appointment utilizing the personal vaccination code for an appointment  ? Moderna COVID-19 vaccine is indicated for ages 18 and above.  The administration error was found upon review of records by the pharmacy team the evening of Friday, April 19th.
Left arm very sore after injection #1 01/29/2021, so injection #2  02/19/2021 in R arm. Mild AE, fatigue, GI upset for 2 days. About 3/24/2021, developed diffuse hives bilateral elbows & upper arms, spreading over next week to thighs, ankles, flank; now general. Intense pruritus, sleep disruption, clothing irritates, unable to focus on anything else. No prior history of allergic rash or hives. Derm consult 4/1/2021: ?hypersensitivity reaction? no cause known. Oral antihistamines, topical corticosteroids. Modest transient relief, new lesions occurring today.
No adverse effects noted at time of submission. Patient received complete series of Pfizer vaccine previously, then received Moderna vaccine today (3rd dose of mRNA). Patient did not disclose previous vaccinations, was discovered after the fact. Pfizer dose #1 on 4/30/21, Pfizer dose #2 on 6/24/21, Moderna dose #1 7/15/21.
patient that received dose of MMR II began to experience joint pain in the hands and knees; This spontaneous report has been received from a nurse concerning a 52-year-old female patient. The patient's medical history, concurrent conditions, historical drugs, drug reactions/ allergies and concomitant medications were unknown by the reporter.    On 11-DEC-2019, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA) (recombinant human albumin) (M-M-R II) for immunization, 1 dosage form via subcutaneous on her right upper arm (concentration and frequency of vaccination scheme were not reported). Lot number S010706 has been verified to be a valid lot number, expiration date reported and validated as 08-APR-2021.  On 18-DEC-2019, the patient began to experience joint pain in the hands and knees (arthralgia). It was reported that the patient did not seek medical attention and that no treatment was given for the event, but the reported did not know if any laboratory tests were performed.      At the time of reporting, the patient had not recovered from the joint pain in the hands and knees.   The causal relationship Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and joint pain in the hands and knees was not reported.
After the booster, I have been dizzy and I have been falling a lot. I also have vertigo often. I have also been having blurry vision today. I was sick for 3 1/2 days with a fever, chills, fatigue and a sore arm.
This is a spontaneous report from a consumer or other non HCP. This report was received via a sales representative. A 18-years-old female patient received TRUMENBA, via an unspecified route of administration on 14Feb2019 at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fatigue non-serious on an unspecified date with outcome of unknown, coughing non-serious on an unspecified date with outcome of unknown, swelling at injection site non-serious on an unspecified date with outcome of unknown , joint pain non-serious on an unspecified date with outcome of unknown. The information on the batch number has been requested.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 at 10:00 as dose 1, single (Lot number: EN6208), in right arm, on 13Apr2021 as dose 2, single (Lot number: GR3729), in right arm and on 12Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 65 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant) with onset 20Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 20Jun2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive for COVID; Positive, notes: After 15 days, tested positive again with returning symptoms. Therapeutic measures were taken as a result of covid-19.  Clinical course: The patient did not receive no other medications in 2 weeks. The patient received Paxlovid from 21Jun2022 to 26Jun2022 for COVID 19 treatment. Tested positive for COVID. After 15 days, tested positive again with returning symptoms.  No follow-up attempts are possible. No further information is expected.
Four days following first dose, sudden numbness developed followed by weakness in right leg. Initially attributed to peroneal neuropathy and did not seek medical help. Second dose was received and left foot numbness developed followed by weakness. Symptoms ascended to knees the next few days and was admitted to the hospital. MRI's, x-rays, blood work, lumbar puncture were performed. Treated with 4 days of IVIG. EMG performed to diagnose with Guillain-Barre Syndrome.
(1) Vaccine administered in RA by medical assistant. Patient not examined by MD. (2) Patient returned 1 day later with erythema and induration of 5 x 4cm at vaccine site. Pt noted to also have a red throat and infected ear lobe. KEFLEX started.
Very sore left arm, chills, runny nose, cold like symptoms, sore throat, body ache, eyes are watering profusely
Information has been received from a consumer concerning a 6 year old female with no pertinent medical history and no drug reactions/allergies who in approximately 2001 was vaccinated SC with a dose of mumps virus vaccine live.  There was no concomitant medication.  In approximately 2001, after vaccination, the patient developed an injection site reaction, stopped eating and became more irritable.  Subsequently, about a week after the injection, the patient recovered.  The were no lab diagnostic studies performed.  Unspecified medication attention was sought.  There was no product quality complaint.  Additional information has been requested.
This spontaneous report was received by a nurse, referring to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies was provided. On 30-JAN-2018, the patient was vaccinated with an improperly stored dose of VARIXAX injection, subcutaneously (lot number N010107, expiration date 28-MAR-2019) for prophylaxis. (Product storage error) (Poor quality product administered). No adverse effects were reported. The administered dose of vaccine experienced a temperature excursion of 2.5 degrees Celsius (-9°C to 8°C) for 18 hours 11 minutes. There was a previous temperature excursion of -9°C to 8°C for 3 hours 19 minutes. It was reported that sterile diluent administered concomitantly was properly stored. A data logger was involved. This is one of several reports received from the same reporter.
Symptoms: Fever between 12 -104, migraine headache, body ache, Joint pain, nausea Time course: 3 days today. Sx started on on 6/6 Tx: ibuprofen, tylenol, fluids