chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse other health professional refers to a 19 years old female patient. The patient's historical drug included ZITHROMAX Z-PAK given for an ear infection. The patient's current condition included allergy to amoxicillin. On 21-FEB-2014 the patient was vaccinated intramuscularly in the left deltoid with the first dose of GARDASIL lot # H021346, expiration date: 01-OCT-2015. The nurse reported that on 22-FEB-2014, the day after the vaccination the patient developed a red rash on their neck and chest. The patient's rash spread to the upper back over the next couple of days. The patient tried treatment and he used hydrocortisone cream (OTC) but it didn't help. At this time of this report the patient did not recover. She sought medical attention and she contacted the office. The relatedness between the red rash and the vaccination with GARDASIL was not reported. Additional information has been requested.
Attendee received 1st dose Pfizer vaccine in the Left Upper arm at 15:25. Attendee was directed to observation area. At 15:30 voiced complaints of nausea, feeling hot, and was diaphoretic. Attendee was escorted to the cot to lie down. 15:42 - Attendee stated she felt better, skin warm and dry.  16:00 -No voiced complaints- skin warm and dry.  16:15 - Denied any symptoms. Advised her that if she experienced more symptoms to seek medical attention and attendee left the site independently.
pt recv vax JUN95 & 27MAY97 pt to MD w/full blown chickenpox;
I have been having joint pain in multiple sites: three different sites. I have been tested for Gout. And my uric acid levels are elevated but not enough to create an acute attack. Hip, knee, and ankle - I have had three separate attacks and each one was in a different joint. I was taking Indomethacin -that is just symptoms relief. Doctor was called to order lab work.
no adverse event; inappropriate schedule of vaccine administered; This spontaneous report has been received from a lawyer, via a Plaintiff from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 2102USA001220), concerning a 74-year-old female patient. The patient's medical history and concurrent condition were not provided. .  On approximately 04-NOV-2014, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, route, lot # and expiration date were unknown) for prophylaxis in a medical center.   On approximately 27-OCT-2016, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, route, lot # and expiration date were unknown) for prophylaxis in a medical center (inappropriate schedule of product administration). There was no adverse reaction or side effects experienced.; Sender's Comments:  US-009507513-2102USA001220:
This spontaneous report as received from a pharmacist refers to a patient of unknown gender and age. The patient was vaccinated with PNEUMOVAX23 on 14-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that the patient had possibly been vaccinated twice with PNEUMOVAX23 in one week. The patient received an injection with PNEUMOVAX23 on 14-JAN-2013. However, the patient may or may not have been administered another dose of PNEUMOVAX23 by another doctor earlier in the week. No adverse effect was reported. The patient did not seek medical attention because of the possible second administration of PNEUMOVAX23. Additional information has been requested.
Patient stated she awoke the next morning with elbow discomfort. Did not indicate any trauma to the elbow area. Patient has not self-treated discomfort.
I have had Covid now 3 times since 2020; I have had Covid now 3 times since 2020; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2020, outcome "not recovered" and all described as "I have had Covid now 3 times since 2020". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2020) Positive, notes: I have had Covid now 3 times since 2020.  Clinical information: it was reported that the patient had COVID then 3 times since 2020. The patient was vaccinated and had boosters. The patient seeks help from Pfizer.  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5/BNT162B2] has been requested and will be submitted if and when received.
PATIENT DEVELOPED ARM SORENESS WITHIN ONE HOUR OF RECEIVING VACCINE. PAIN IS STILL PRESENT AT TODAY'S APPOINTMENT (11/17/17).
Patient was in to receive his second dose of the COVID vaccine. He reported no known issues after his first dose and remained in the pharmacy for the recommended 15 minute observation period following the vaccine without any problems. He reported to us today that around 45 minutes after having received the vaccine, he started to have a choking episode, something that he commonly experiences with his Parkinson's Disease, so he and his wife didn't think much of it. This seemed to evolve into nausea and dry heaves with excess mucus production that lasted for hours. Because of the duration, they decided to contact his insurance company's nurse line who recommended he go to the Emergency Department to rule out COVID and pneumonia  He was admitted to the ED and ultimately found to be negative for both COVID and pneumonia, at which point they decided that his Parkinson's exacerbation might have been the result of having received the vaccine. He has since been discharged and is doing well.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patient was vaccinated with (Oka-Merck) PROQUAD. Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The nurse reported that the patient was administered (Oka-Merck) PROQUAD that was stored improperly (on an unknown date). No adverse effects reported. Nurse also stated that since the excursions, 5 doses of (Oka-Merck) PROQUAD had been administered. This is one of two reports from the same source (other case # 1407USA000488). Additional information has been requested.
Low grade fever , tired ness , headache and swelling and pain at injection site  lasting more than 72 hours
Pt recvd 2 Engerix-B vax on 12APR91 & 17MAY91 & 12 hrs p/2nd inject devel swelling of hands & feet, myalgias & arthralgias, & burning, itchy soles of feet & palms; tx meds; As of 30OCT91 pt gets achy hips;
Myalgia, Arthralgia, Fever, injection site pain, fatigue, chills Narrative:
Per patient - she noticed some itching of her right arm the day following her vaccine then it proceeded to get red and have some warmth to her right arm exclusively.  She said she applied some cortisone to control the affected area.
This spontaneous report as received from an Office Manager refers to a 17 week old patient of unknown gender. On 25-JAN-2013, the patient was vaccinated with live, oral ROTATEQ dose 1 , 2 ml, oral (lot # reported as 0285AE, exp. 31-OCT-2013). The reporter stated that the patient received the first dose of live, oral ROTATEQ at age of 17 weeks old. No adverse effects have been reported. Additional information has been requested.
dec appetite, 11 days post vax erythematous macular on trunk, few on face & arms;
presented to hosp ER 3AM w/dx of allerg urticaria given solumedrol & DPH;d/c 430AM w/rx for DPH PNR itch & pred;still tight throat-stopped pred caused inc hyperactivity;
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced injection site pain, injection site warmth, injection site swelling, injection site inflammation and injection site erythema. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the injection site warmth was unknown and the outcome of the injection site swelling, injection site inflammation and injection site erythema were recovered/resolved. The reporter considered the injection site pain, injection site swelling, injection site inflammation and injection site erythema to be related to SHINGRIX. It was unknown if the reporter considered the injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient declined to provide concomitant medications. In 2018, the patient received SHINGRIX in left upper arm. At some unknown time after receiving the SHINGRIX, he had absolute tenderness and soreness with warmth at the site of injection by the next day following the day when the vaccine had been administered. There was swelling, inflammation, slight redness, and warmth at the injection site of which tenderness and soreness at the injection site was described to have been extended in that those symptoms lasted for at least a week. The swelling and redness were gone with no apparent evidence of any symptoms seen by just looking at that injection site. When the patient pressed his arm, he still had soreness and slight tenderness with the tenderness described as being deeper into the muscle. He had no doctor's office or emergency room (ER) visit for any of the symptoms.  He was referred to his healthcare professional (HCP) before the call ended. The patient had denied permission to contact their physician. The patient said it would be okay to contact him by phone for further related questions. The patient declined to provide the facility of vaccination or his date of birth. No further information was provided.
no adverse event; VARIVAX was inadvertently administered after expiration; This spontaneous report as received from a nurse practitioner referring to a male patient of unknown age and race.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  The nurse stated that on 06-APR-2021 (reported as today), the patient was inadvertently administered with varicella virus vaccine live (oka/merck) (VARIVAX) after expiration date, 1 time dose (lot # S010296, expiration date 03-APR-2021, exact dose, frequency and route of administration were not reported) for prophylaxis. No additional adverse events were reported. It was provided that the vaccine was purchased with private funds and facility type was provided as public health clinic/ hospital. An agent had confirmed that no temperature excursions have occurred. Digital Data Logger was not involved. The vaccine was not available for return/evaluation because that was the last one.
My 16 year old son started having ?normal? side effects with the addition of hip joint pain on Sunday, August 29. He began having chest pain in the morning on August 30, which persisted throughout the day. He went to Football practice and began having trouble breathing. We went to an urgent care at the Children?s campus when he got home at the advice of his primary care physician. They did a chest X-ray and ekg, which appeared normal. Still, the chest pain is persistent as of today, August 31. We have a follow-up appointment with cardiology this Thursday, September 2.
TEMP. 100.5 AFTER IBUPROFEN, HEADACHE, MALAISE, BODY ACHES, CHILLS
Arm fevered, swollen & painful. Swollen down below elbow. Went to PCP & was given antibiotic & steroids. Was told cellulitis.
her whole body was covered with spots/ spots did not truly went away but lightened/Her doctor states that the Moderna shot caused what she has which is psoriasis; This spontaneous case was reported by a patient and describes the occurrence of PSORIASIS (her whole body was covered with spots/ spots did not truly went away but lightened/Her doctor states that the Moderna shot caused what she has which is psoriasis) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A, 011A21A and 017F21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high, Penicillin allergy, Sulfonamide allergy and Drug allergy.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced PSORIASIS (her whole body was covered with spots/ spots did not truly went away but lightened/Her doctor states that the Moderna shot caused what she has which is psoriasis). The patient was treated with RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis, at an unspecified dose and frequency. At the time of the report, PSORIASIS (her whole body was covered with spots/ spots did not truly went away but lightened/Her doctor states that the Moderna shot caused what she has which is psoriasis) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not had other vaccines in the 4 weeks prior to COVID-19 vaccine. Reporter stated that patient was okay after first dose. The next day after the 2nd dose patient whole body was covered with spots. Patient went to her dermatologis, primary care and was treated with all stuff. The spots did not went away but lightened. Patient was given anti-biotics and steroids. After the 3rd shot in Oct2021, she again got covered with spots and they have not gone away since. Patient doctor states that the Moderna shot caused psoriasis. Patient had gone to 5 doctors and used 15 creams. No concomitant medication were reported.
A report has been received from a Health Professional concerning a, subject of unknown gender, who had been receiving FLUMIST. FLUMIST started on 05-Feb-2016. It was reported that preschool aged (4 years old) child was inadvertently received expired FLUMIST. The outcome of the event of administration of expired FLUMIST is unknown. The report was considered to be non-serious.
headache; body ache; chills; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PAIN (body ache) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache), PAIN (body ache) and CHILLS (chills). At the time of the report, HEADACHE (headache), PAIN (body ache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were provided No treatment were provided
FACILITY ASKED US TO VACCINATE THEIR RESIDENTS  AND SAID THIS PATIENT HAD NO PREVIOUS DOSES OF COVID VACCINE THEY CONTACTED US TODAY TO SAY THEY HAD MADE AN ERROR AND PATIENT HAD PREVIOUSLY  RECEIVED TWO DOSES OF MODERNA COVID 19 VACCINE. THIS WAS NOW THE THIRD DOSE GIVEN TO THE PATIENT  WE RECORDED THIS ADMINISTRATION AND REPORTED EVENT.  CLINIC WILL MONITOR PATIENT  SO FAR NO ADVERSE EFFECTS
Patient presented to the ED and was subsequently hospitalized on 4/6/21 for respiratory failure with hypoxia and hypercapnia. She spent some time in the ICU.
The patient developed redness, pain, and itching at the injection site; The patient developed redness, pain, and itching at the injection site; The patient developed redness, pain, and itching at the injection site; This spontaneous report was received from a medical assistant referring to a 4-year-old female patient. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.   On 07-APR-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml, lot #U039254, expiration date: 09-JUN-2023, subcutaneously for prophylaxis (strength was not provided).  On 09-APR-2022, the patient developed redness, pain, and itching at the injection site (vaccination site erythema, vaccination site pain and vaccination site pruritus). On 10-APR-2022, the family was advised to draw a circle around the redness. When the patient came into the office on 11-APR-2022 (reported as today), the redness was past the circle. The patient received treatment with acrivastine (BENADRYL) cream every 4-6 hours. At the time of reporting, the patient had not recovered from the events. No cancer or overdose.  The causal relationship between the events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was not reported.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA004476:
Had first COVID-19 shot on 03/18/2021. 04/06/2021 started to have right lower leg pain. Was seen at urgent care were and xray was done that was negative. Urgent care doctor sent him for ultrasound right lower leg on 04/10/2021 which was negative. He was started on antibiotics and Prednisone. Was seen by PCP whom felt he needed to be seen by vascular. He was seen by Dr. on 04/16/2021 who felt it was a pulled muscle, but he want a repeat ultrasound of right lower leg done. 04/19/2021 ultrasound of right lower leg was done and showed a DVT. He was started on low does baby aspirin 81mg. A follow up ultrasound was ordered for 04/26/2021 to check status of DVT.
10cm area red, hot and painful. Treatment; Benadryl and Diprolene cream, left deltoid. Some residual itching as of 12/20/00.
Tue 4/12: 8pm started to feel ill, mild chest & sinus congestion, warmer than normal cheek areas, loss of energy, weakness, mild headache. Wed 4/13 AM : Continued symptoms, additionally with deep chest congestion, coughing dry & phlegm. PM: started to medicate with Tylenol, Mucus & Sinus Relief & Vicks Vapor Rub on chest and nose. Thurs 4/14 AM: Felt a little better, heat in cheek areas were gone, all other systems were present.   PM: Feeling a reduction of symptoms. Friday 4/15 AM: Had a light breakfast, could not taste food. PM: Had a light meal, could not taste food. Symptoms about the same, head aches gone. Sat 4/16 AM: Woke up feeling much better, Had a light breakfast and my taste had returned.  Sat 4/16 PM: Chest & Nasal Congestion was greatly reduced. Energy level was better.  Worked in the lawn for about an hour. Sun 4/17 AM: Occasional cough, reduced Nasal congestion. Energy level & strength improvement.   Currently: recovering from adverse reaction to shot.
Information has been received from a Nurse Practitioner concerning a 20 year old female patient who was recently diagnosed with chronic fatigue syndrome. In July 2010, the patient was vaccinated with a first dose of GARDASIL and she was vaccinated with the second dose of GARDASIL again in August 2010. Concomitant therapy included KLONOPIN. In August 2010, one month after the first dose of vaccine the patient experienced "joint pain, chronic fatigue and weakness, leg pain, and aching muscles". It was reported that the patient sought medical treatment which was "methadone" and MOBIC. She had thyroid level, complete blood count and electrolytes lab was drawn but the results were not reported. The patient's joint pain, chronic fatigue and weakness, leg pain and aching muscles was not subsided at the time of this report. The patient sought unspecified medical attention. Follow up information was received from the Nurse Practitioner (N.P) who reported that the patient had no medical history and experienced low back pain a few weeks after dose one in July 2010. After dose 2, she began experiencing symptoms of arthralgia, myalgia, weakness and fatigue. It was reported that the patient had been evaluated by neurologist, endocrinologist and was also seen at the clinic. She had been diagnosed with chronic fatigue syndrome and fibromyalgia. The office nurse reported that the vaccines were given elsewhere. She checked and could not find reference to the physician or office where GARDASIL was administered. Nurse Practitioner was looking for information pertaining to GARDASIL and similar reports. The health care professional contacted during telephone follow up could not supply the following information; exact dates of vaccination, Lot #, and other healthcare provider name contact information. Follow up information received from the nurse practitioner, stated that the patient received GARDASIL in July 2009 (also reported as July 2010) with complaints of back pain and myalgias within 2-3 weeks of injection. It was also stated that the patient then received her second injection the following month with complaints of worsening myalgias in addition to arthralgias, muscle weakness, persistent fatigue, leg pain and generalized unwell feeling. The nurse indicated that the patient was diagnosed with fibromyalgia in September 2009 and chronic fatigue syndrome in February 2011. It was indicated that the patient was a healthy, vibrant 18 year old prior to the GARDASIL injection with persistent pain and fatigue over the last 1.5 year, post injection. The patient's function overall was reported as poor with chronic pain regimen. No further information is available.
dizziness and was light headed for about 30 seconds; terrible balance; shortness of breath after being sedate for a long period of time; tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness and was light headed for about 30 seconds), BALANCE DISORDER (terrible balance), DYSPNOEA (shortness of breath after being sedate for a long period of time) and TACHYCARDIA (tachycardia) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced DIZZINESS (dizziness and was light headed for about 30 seconds), BALANCE DISORDER (terrible balance), DYSPNOEA (shortness of breath after being sedate for a long period of time) and TACHYCARDIA (tachycardia). On 05-Feb-2021, DIZZINESS (dizziness and was light headed for about 30 seconds) had resolved. At the time of the report, BALANCE DISORDER (terrible balance), DYSPNOEA (shortness of breath after being sedate for a long period of time) and TACHYCARDIA (tachycardia) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Feb-2021, Blood pressure measurement: 128/72 mmHg. On 05-Feb-2021, Body temperature: normal normal..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. No Treatment information  provided   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: No new/updated information.