chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a consumer to a 67 year old female patient. The patient's concurrent condition included arthropathy. The patient's concomitant therapies included citalopram, omeprazole, and valacyclovir hydrochloride. The patient's medical history was not reported. The patient's historical drugs included codeine. On 23-APR-2019, the patient was vaccinated with PNEUMOVAX 23 injection (strength, dose, frequency, and route of administration were not reported; lot # R033342 and expiration date 03-AUG-2020) to prevent pneumonia. On 24-APR-2019 (reported as the next day), the patient was sick to her stomach and experiencing severe arm pain. She had a fever of 103.7. The patient vomited nonstop for 2 days. Her arm was swelled around the injection site, and she had a raised rash. She sought medical attention, hence, went to urgent care where she saw 3 physicians, who gave her cream (unspecified) for the rash and medicine for nausea. She did also see a dermatologist who told her there must have been a bad toxin (product contamination microbial) that got into the vaccine that caused her reaction. She had a large scab on the injection site that was black, the tissue there was dead and was still healing. She said her doctor told her she would have a large scar when it was completely healed. The patient's daughter took pictures of her arm.  The patient reporter she has never had a reaction to a shot before this. The outcome of nausea, injection site necrosis, rash papular, vaccination site swelling, vomiting, pyrexia, pain in extremity, abdominal discomfort and injection site scab was reported as not recovered. The causality assessment between the events and therapy with PNEUMOVAX 23 was not reported. Upon internal review, the injection site necrosis was determined to be medically significant. Lot number was reported in the source document but the expiration date was not. But, when entering the lot number in the system automatically auto-populated the expiration date.
Patient complains of radiating pain from injection site up arm into neck.  Time course of adverse event unclear, but patient states started "after" shot.  Patient seen by physician who suspects possible nerve damage from needle injection, and recommends physical therapy.
Fever that lasted 4 hours. headache and fatigue that lasted 16 hours. Took Advil which helped symptoms.
About 24 hours after shot, started having a headache. Took Tylenol, it helped Around 28 hours after shot, had fatigue, flu like symptoms- chills, felt warm feeling throughout body, nausea, headache. It lasted for about 8 hours. Had a taste in my mouth for about 12 hours after shot.
Information has been received from a 62 year old female, who is a physician, with high blood pressure, hyperglycaemia, high cholesterol and fibromyalgia who on 8/29/06 was vaccinated with a dose of varicella zoster virus vaccine live. Concomitant therapy included Atenolol (manufacturer unk) or telmisartan (Micardis) or Metroprolol Succinate (Toprol XL Tab), Maxide, imipramine HCL, rosuvastatin calcium (Crestor), Rosiglitazone maleate (Avandia) and niacin (Niaspan). Between 9/23/2006 and 9/25/2006 she had lesions appear  on her neck which were swollen red and raised. No itching was noted. At the time of the report, the pt had not recovered and was getting worse. No medical attention was sought. There was no product quality complaint involved. Additional information has been requested. Additional information indicated the physician developed two areas of papulopustular rash which lasted a few days and was not painful. Follow up information was received which indicated the patient developed erythema, oedema, rash erythematous, and skin ulcer on 23-SEP-2006. The patient did not recover. No further information is expected.
enlarged lymph nodes  left arm, back of neck and groin, extreme joint pain, fatigue
Rash on back (T4/T5) with some pain and discomfort. Wife (MD) thinks it may be a Zoster infection.   Swollen lymph node on right armpit.
pt recv vax 15JUL98 & 28JUL98 pt devel thrombocytopenia (platelets >100,000);
PATIENT RECEIVED PNEUMOVAX RIGHT DELTOID ON 10/18/07.  NOTED SWELLING, TENDERNESS, AND "RED" SPOTS APPROX. ONE INCH BELOW INJECTION SITE ON 10/20/07.
This spontaneous report as received from a Registered Nurse refers to 6 patients of unknown demographics. The patient's medical history and current conditions are not reported. On 16-SEP-2014 the 6 patients were inadvertently administered improperly stored RECOMBIVAX HB injection 10 Y (strength, dose and frequency not reported) (Lot # and expiry date not reported). No adverse effects reported. Product quality complaint was not involved. The outcome of the events was unknown. This is one of the several reports received from the same reporter and Linked to cases MARRS # (1410USA007243, 1410USA007242, 1410USA007240 and 1410USA007241). Additional information has been requested.
Approximately 2 days after the second injection, a large red flat rash (about 3" x 3") began to form on my R arm, around and beneath the injection site.  Shortly after that, an extremely intense itching set in and lasted for 48 hours or so.  The itching was extreme, and not helped by either Benadryl or topical hydrocortosone cream.  The itching was  worse than that produced by exposure to poison ivy.     I experienced a similar reaction to the second Shingrix (shingles) injection, although the red rash that occurred after this injection was a bit raised and welt-like, in places.  Itching was also extreme, and very difficult to tolerate.  It, too, lasted about 48-72 hours.    Interestingly, I did NOT have this type of reaction to my annual flu shot this year, nor have I ever had such a reaction before.    I'd like to know what inactive ingredients are common to both the Shingrix and Pfizer vaccines, as I suspect that something like that is the culprit.  Also seeking advice about what to do when boosters are recommended, if they are, for Covid-19.
At 1:30 on 1/28/2021 my arm started hurting and felt hot, about 5:30 pm that evening I was feeling nauseous, developed a runny and stuffy nose, and a sore throat,  I extremely  tired but I couldn?t get to sleep from the arm pain and nausea..  January 29, 2021 @ 6 am  I was having all the same symptoms when I woke up, and I had a restless night from runny nose, coughing, and sinus drainage .   1/30/2021 still same symptoms and now a cough.  1/31/2021  When I woke my head was pounding, I was still nauseous and vomiting
CYTOKINE RESPONSE; CONTINUED PAIN; ADVERSE REACTION IN MY KNEE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included knee injury, and knee surgery, and concurrent conditions included breast implant illness. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 09-APR-2021 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 cytokine response, continued pain, and adverse reaction in my knee. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cytokine response, continued pain and adverse reaction in my knee was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
The day following immunization mother states child developed a "runny nose." On 9/8/02 he developed diarrhea which persisted thru 9/12/02 when mother called our immunization clinic. Child was seen by a private MD on 9/9/02 because of diarrhea, decreased appetite and fever to 99 degrees. As of 9/12/02 child was stable experiencing diarrhea dx 5 daily. Mother advised to schedule another office visit with the private MD.
injection site pain; body aches; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2020, the patient received the 2nd dose of Shingrix. On 9th July 2020, 1 days after receiving Shingrix, the patient experienced injection site pain and general body pain. On an unknown date, the outcome of the injection site pain and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and general body pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix and experiencing body aches and injection site pain. The reporter did not consent to follow up.
case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Shingrix for prophylaxis. On 12th September 2018, the patient received the 1st dose of Shingrix. In September 2018, less than a week after receiving Shingrix, the patient experienced pain in arm. In September 2018, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient received a dose of Shingrix in left arm. The patient reported that she had some pain in the left arm following the injection. The caller not sure of the onset of the pain. She stated it hurt for 2 days and went away. She did not want to provide any additional information including date of birth.
Pt recvd vax 21OCT92 & several hrs following vax pt exp GI upset & distress; pt also exp mild asthma attack; seen in ER & treated w/Donnatal, Proventil & Epi;
21JAN97 fever 103 on 23JAN devel full body rash;saw MD on 23JAN & 24JAN & t104.5;MD sent to ER was given ATB & APAP;fever down 27JAN rash remains sl;
Started shortly after midnight?. Chills for 3 hours, feeling as I had been buried in snow. Then, a fever of 100.2, took an Aleve, one hour later the fever was 101.2, took another Aleve and put a cool washcloth on my forehead.  Fever back to normal  at 6:00 a.m.  Then a huge headache and aches in my neck and shoulders. After 16 hours, the pain went away and I was really tired for three days. I wanted someone to know this because I am getting my booster this coming Friday, November 12,2021. I am hesitant on getting it since I had severe reactions to be my Covid-19 second shot.
vaccinated for shingles / have the shingles/ suspected vaccination failure; shingles; very painful; This case was reported by a consumer viainteractive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In January 2021, the patient received Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional information was provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had Shingles at the time of reporting and stated that it was very painful. The patent guessed he/she was in the 15 percent and the shots were only 85 percent. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation of shingles were not provided.
SORENESS; TIREDNESS; 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: Unk) dose was not reported, administered on 15-MAR-2021 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 16-MAR-2021, the subject experienced soreness. On 16-MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the soreness and tiredness was not reported. This report was non-serious.
Parent stated 1 hr. after vaccines client stated son had rash all over body and was s.o.b. Had son take hot shower and breathing improved rash lasted 4 hrs. No medical follow up obtained by client. Recovered at home.
(L) thigh with 7 cm local rxn at site of DTAP, with mild edema and mild erythema.
Initial information received on 06-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 51 years old female patient who was given an expired dose of FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant Medication was not reported. On 06-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI826AC (exp date: 30-JUN-2018) via intramuscular route in the left deltoid. It was a case of actual medication error due to expired vaccine used. It was not reported if any adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
was reported that patient experienced:confirmed covid.; was reported that patient experienced:confirmed covid; low O2; Shortness of breath; This is a Spontaneous report from a non-contactable health care professional based on the information received by Pfizer(Manufacturer Control No: LRN4341875). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; ), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunization. Medical history included multiple sclerosis from an unknown date and unknown if ongoing.. Concomitant medication included ocrelizumab (OCREVUS). On an unspecified date, The patient experienced :confirmed Covid, low o2,  shortness of breath. The event were considered medically significant. Events of low 02 and shortness of breath required an emergency room visit.. The reporter states 'two MS patient now greater than 1 month post second vaccine (both Pfizer) with lab confirmed Covid. Both with medically significant illness, neither required hospitalization. The patient underwent lab tests and procedures which included sars-cov-2 test: lab confirmed covid on an unknown date. The clinical outcome of the events was unknown,   No follow-up attempts are possible; information about lot batch number cannot be obtained. .
Generalized papular, urticarial rash the evening after receiving 1st Rabies vaccine for post-exposure.
Cellulitis B thighs-recommended warm compresses-Keflex antibiotics.
panic attack sunday night around 1030-11pm. Had to seek treatment from my family physician to get some antianxiety pills.  As of 12/23/20 I still wake up with severe anxiousness. If COVID weren't around I would have went to the ER. I have never experienced anything like that in all my life.
Severe Pain on Injection, progressively worsening shoulder pain with increasingly restricted motion over the next several weeks. Orthopedic surgeon appointment on 11/20/15, had an xray-received a steroid injection into the shoulder joint.  Pain improved for 1-2 weeks and then returned.  Shoulder MRI on 3/7/16 with f/u appointment with orthopedic surgeon on 3/9/16.  Received another steroid injection, surgeon recommended surgery, scheduled PT to begin at the end of the month instead.
Febrile seizure seen at Hospital on 03-08-09. No activity since.
Prolonged and severe upper left arm pain.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old patient of unknown gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the arm left on 17Apr2021 at 10:00(at the age of 57-years-old) as a single dose for COVID-19 immunisation. The medical history included fibromyalgia, high blood pressure (HBP) and allergy to a blood pressure (BP) medicine and an unspecified medicine for acid reflux. 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 vaccination. The concomitant medications included amlodipine (MANUFACTURER UNKNOWN) and gabapentin (MANUFACTURER UNKNOWN), all from unknown dates for unspecified indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the arm left on an unknown date in Mar2021 at 09:00(at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient previously took pregabalin (LYRICA) and experienced allergy. On 23Apr2021, the patient experienced prolonged and severe upper left arm pain. On an unknown date, the patient underwent ultrasound testing and the result was not reported. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported event included treatment with lidocaine patch(MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event prolonged and severe upper left arm pain was not resolved at the time of this report.
Pt recvd 1st dose of Engerix-B 25FEB92 then found out was 3 months pregnant;
APPROXIMATELY 5 HOURS AFTER INJECTION, MOM NOTICED REDDENED AREA, APPROXIMATELY QUARTER SIZE, AT INJECTION SITE, R ARM. AREA WAS RED, WARM, AND SWOLLEN.  BY NEXT MORNING THE AREA WAS APPROXIMATELY 2-3" IN DIAMETER. MORE SWOLLEN TODAY. SITE IS TENDER TO TOUCH.
Itchy welts started by elbow and progressed up and around entire arm to shoulder over a 3 day period. It was not warm to the touch.
tested positive for COVID-19; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not provided.  Treatment information was not provided.  The patient will take second shot on 24-Sep-2021
Woke up and couldn?t get out of bed room was spinning counterclockwise severe dizziness and nausea. Severe dizziness to look up, down and basically any direction but straight ahead. Ringing in ears as well. Went to get a covid and flu rapid test thinking possibility I might have either one. Both were negative. Physicians assistant checked my ears for sign of ear infection and also checked my blood pressure sitting and standing. She couldn?t find anything that might be causing severe dizziness. I continue to have severe dizziness approximately 10 episodes day. Sometimes it?s so extreme, I almost fall over into floor if I don?t move very slow in my activities.
pt was vaccinated with covid 19 vaccine (Janssen brand) at 04:52p.m given intramuscular at left arm administered by CP. At 04:54pm pt reported being nauseous and light headed and sweaty. RN assisted pt and checked vital signs BP 80/ 50 mmhg, PR 62,, RR 20, T 97.2 Oxygen saturation is 100% at room air. EoA on sight assessed pt, no SOB noted. No Chest pain. Pt is alert oriented to self, time, location and date. Initial interventions done. Pt was assisted im a laying position safely with legs elevated. Every 15 minutes vitals check done and recorded. Pt verbalized that she gets anxious with needles and haven't eaten anything for lunch yet. Pt refused to call 911. Pt BP was. Checked at 05:13pm and it was 110/70mmhg PR 74bpm, RR 16, t 97.2 and Oxygen saturation of 100%. Pt was gradually placed in a sitting positioned  and reported feeling way better. NO   more complai nts of dizziness or nausea. Pt  was given health teaching about expected side effects and when to call advise nurse or 911. Pt is  discharged with no complaints. Stated she appreciated us for our immediate care for her. Pt was assisted to the car with 2 friends driving her home. Incident was reported to nurse provider. RN.
Patient vaccinated x3 (Moderna) : 2/5/21, 3/5/21, 1/18/22  Patient admitted to hospital ICU on 1/21/22 after testing positive for COVID19
Severe right leg (thigh knee and calf) pain 7 days after vaccine; Severe right leg (thigh knee and calf) pain 7 days after vaccine; Severe back muscle spasm 1 day after injection; This is a spontaneous report from a contactable nurse (patient). A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EL1284), via an unspecified route of administration on left arm on 29Dec2020 at 11:30 (at the age of 35years) at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included allergies: Sulfa. The patient's concomitant medications were not reported. The patient experienced severe back muscle spasm 1 day after injection (30Dec2020). Severe right leg (thigh knee and calf) pain 7 days after vaccine (05Jan2021). There were no treatment given for the events. The events were considered non-serious by the patient as did not results in death, non-life threatening, did not cause/prolong hospitalization, non-disabling/incapacitating and no congenital anomaly/birth defect. The adverse events result in doctor or other healthcare professional office/clinic visit. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The COVID-19 test (nasal swab) on 12Jan2021 was negative. The outcome of the events was recovered for pain in extremity and arthralgia in 2021 and for muscle spasms on an unspecified date.
Severe arm pain for 2 days (right) gradual decrease in pain for 3 weeks, still cannot sleep on affected arm, difficulty raising arm over head.