chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Paxlovid indication=Treatment of COVID-19; Paxlovid indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 56-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, 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), outcome "unknown" and all described as "Paxlovid indication=Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Anti-viral details: Paxlovid, Treatment start date: 28Jun2022, Treatment stop date: 03Jul2022, Indication: Treatment of COVID-19, Oral, rebound infection, If treatment ae: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the eventS cannot be completely excluded.
Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with improperly stored (Merck) VARIVAX (lot # K007981, expiration date 03-JUN-2016; strength, dose and route not reported). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Local swelling @ injection site. Patient had no other symptoms, given a CLARITIN 10 mg tab (on her request), waited 30 min in store, swelling decreased.
Shot was at 2 pm on Friday the 8th. On Sunday night around 8pm I got sudden very bad stabbing constant pain under my left rib. Lasted all night till Tuesday morning. Also on Monday evening I got very sudden bad headaches that came on with change on position. Standing or bending over or even rolling over in bed that night. They only lasted for about 10 to 15 seconds but even woke me up from sleep.  All symptoms left by Tuesday the 12th before lunch time.
Information has been received from a healthcare worker concerning a 32 month old white female with no allergies or medical history who on 06/14/2004 was vaccinated subcutaneously in the left (site not specified) with a first dose of varicella virus vaccine live.  There was no illness at the time of vaccination.  Subsequently, the patient experienced chickenpox.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Follow up information received from the healthcare worker who reported that on 02/14/2005 the patient developed varicella.  There were probably greater than 50 to 70 lesions.  The patient recovered uneventfully.  No further information is expected.
This spontaneous report as received from a nurse refers to an approximately 1 month old female patient with no pertinent medical history, drug reactions or allergies. The nurse reported that the original hepatitis b vaccine (manufacturer unknown) (therapy type, dose, route, lot# and expiration date were not reported) series patient received total of 4 doses, in May 1994, July 1994, November 1994 and August 1995. The nurse could not provide why the patient received 4 doses of hepatitis b vaccine (manufacturer unknown). The patient did not take any concomitant medication. The patient entered nursing school and titer was drawn for hepatitis B in June 2014 but result was low titer and she was recommended for revaccination(also reported as a treatment for low titers). The patient started RECOMBIVAX HB (therapy type, dose, route, lot# and expiration date were not reported) series for revaccination in July 2014 and received second dose in August 2014 and third dose on 05-JAN-2015, The nurse reported that the third dose of RECOMBIVAX HB for revaccination was administered a few days earlier than recommended schedule. The outcome of the event of "low titers for hepatitis B" was unknown. The patient sought an unspecified medical attention. The relatedness between the event of "low titers for hepatitis B" and RECOMBIVAX HB was not reported. Additional information has been requested.
Mom reports child developed a fever of 101 on the evening IZ was administered, also c/o "tummy being full". Tylenol and Ibuprofen given alternately q4 to keep fever down. He fever related seizures (see encounter 8/22).
12/31/2020Asthma Wheezing. 1/3/2021  Increase severity for chocolate allergies. Haven?t improve  Fatigue and tiredness 1/3-1/5/2021
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 3/29/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED HX OF ACUTE KIDNEY INJURY J96.91 HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY 4/24/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED HX OF ACUTE KIDNEY INJURY
Information has been received from a physician and a mother concerning a 7 year old boy with "bad immune system", asthma, eczema and allergy to amoxicillin and a history of dermatitis and molluscum who on 16-OCT-2001 was vaccinated with VARIVAX (Oka/Merck).  Concomitant therapy included albuterol and montelukast sodium (MSD).  The mother reported that her son had shingles from the VARIVAX (Oka/Merck).  The patient has been having outbreaks on his hips and waistline.  The mother could not remember when the outbreaks started.  Her son currently has an outbreak on the back of his neck.  She said the outbreaks seem to happen when he is in the sun.  The patient has been hospitalized for asthma, but not for the outbreaks.  As of 27-MAY-2008, the patient's outbreak on the back of his neck persisted.  Outcomes of asthma and outbreak on his hip and waistline were not reported.  The physician confirmed the patient has shingles and explained that he was exposed to severe sunlight that she feels exacerbated things.  The patient's mother also reported that the patient had been hospitalized for asthma, but not for outbreaks (hospitalization date not reported).  Additional information has been requested.
Tdap & Hepatitis B vaccination given on 8/20/07. Developed a rash on neck, chest, abdomen, and back on 8/25/07. Noted red raised bumps approx 5mm in diameter, irregular shape, and non itchy. On 8/29 c/o mild HA and feeling little more tired than usual. Denies any fever or any other symtoms. Eval by MD and was diagnosed as viral. 9/1/07 Rash continue to spread over chest, neck,trunk,groin, and back....irregular shape red raised areas. Denies fever or itching. Evaluated by physician and was started on prednisone 10mg tab (2 tabs qd x3dys, 1tab qdx2dys, 1tab qod x2days).
Pain at local site of injection 9-14-2011, persistent soreness. In 8 days pt reported increased pain, redness of shoulder, dyspnea, LUQ pain, progressively decreased (L) shoulder ROM. Seen by orthopedist: Dx adhesive capsulitis (L) shoulder. Treatment by ortho/physical therapy to regain shoulder ROM.
pt unresponsive w/abn posturing x 3min;in ER t40.8C but otherwise stable;discharged to home p/eval;dx acute viral synd vs vaccine adverse event;
The next day participant had severe headache. Left arm pain last about a month. Did not go to the doctor.
pt normally happy & smiling p/shot pt looked washed out; did not respond to simple verbal responses; did not have a fever or was not irritable; sx lasted 5 days; mom had a regular appt w/pt's MD 29AUG94; MD recommended no pertusis vax;
Immediately after the Menveo vaccine was administered the pt complained of pain and numbness in his arm.  Pt also instantly developed a rash that spread to torso and back.
Expired Pediarix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number MK944, expiry date 05-MAR-2023) for prophylaxis.   On 08-MAR-2023, the patient received the 1st dose of Pediarix (left thigh). On 08-MAR-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: Expired Pediarix administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 08-MAR-2023. The reporter reported that a patient received his dose of Pediarix on his left anterolateral thigh which was expired and mentioned that vaccine was stored properly prior to the event.  As per the reporter the 1st dose received of Pediarix was 2 weeks late, per the package insert dosing schedule of the 1st dose should be given at 2 months. Consent to follow up with HCP obtained. The patient received an expired dose of Pediarix, which led to expired vaccine used.
Patient has gone more than 35 days without getting the second dose of the Moderna COVID-19 vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient has gone more than 35 days without getting the second dose of the Moderna COVID-19 vaccine.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has gone more than 35 days without getting the second dose of the Moderna COVID-19 vaccine.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has gone more than 35 days without getting the second dose of the Moderna COVID-19 vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment and concomitant medications were provided.   Reporter did not allow further contact
Menstrual period started one week after vaccination, only seven weeks postpartum and breastfeeding
skin rashes; This spontaneous case was reported by another health care professional and describes the occurrence of RASH (skin rashes) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (skin rashes). At the time of the report, RASH (skin rashes) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment information was unknown.
Heart racing; Sick to stomach; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart racing), ABDOMINAL PAIN UPPER (Sick to stomach), FATIGUE (Fatigue) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concomitant products included FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced PALPITATIONS (Heart racing), ABDOMINAL PAIN UPPER (Sick to stomach), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, PALPITATIONS (Heart racing), ABDOMINAL PAIN UPPER (Sick to stomach), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medicines included medicines for thyroid, blood pressure and nasal steroids.  Treatment advil
Localized rash (red, raised bumbs, slightly itchy) developed at injection site 1 week after vaccination.  As a precaution, took 1 Benadryl (generic) tablet and applied topical hydrocortisone cream to the rash when noticed symptoms. Rash still apparent next day.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 12-OCT-2009, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 09-AUG-2016, the patient was treated at a medical facility for a vesicular rash, which was diagnosed as herpes zoster, or shingles. The patient was prescribed prednisone, VALTREX and gabapentin for management of her painful symptoms and chronic pain. On or about 05-DEC-2016, the patient sough subsequent treatment from a medical facility for a persistent vesicular rash, which was diagnosed as post-herpetic neuralgia a chronic condition of pain and nerve damage secondary to herpes zoster infections. The patient was prescribed hydrocodone bitartrate and NORCO and gabapentin for management of her painful symptoms and excruciating pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sore injection site arm; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site arm) and HEADACHE (Slight headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site arm) and HEADACHE (Slight headache). On 22-Mar-2021, VACCINATION SITE PAIN (Sore injection site arm) and HEADACHE (Slight headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment details were provided    This case was linked to MOD-2021-079985 (Patient Link).
Extreme intense muscle pain to shot area, left arm, left shoulder around back to the right shoulder.  started on 6th day with max pain on 8th/9th day.  pain subsiding on day 10.  treated with Advil/Acetaminophen Dual-Action and lidocaine medicated rub.
7 days after injection, injection site began itching and swelling it was painful and warm to the touch and its border was expanding by the evening of the 8th day i realized what i was experiencing wasn?t normal and sought medical treatment that evening.    also noticed swollen lymph nodes under my left arm and at inside of elbow.
Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 years old female patient who received an expired fifth dose of 0.5 mL DAPTACEL (frequency once) lot C5065AA expiry date: 08-Oct-2018 via unknown route in the left deltoid on 26-Oct-2018. The patient's medical history and concomitant medications were not reported. Concomitant medications included FLUZONE QUADRIVALENT for Immunisation; POLIO VACCINE INACT (IPV) for Immunisation; and MMR for Immunisation. It was an actual medication error due to expired vaccine used. It was reported that, patient did not had side effects. 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 and Module VI of the 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.
large hives on the lower part of her right arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (large hives on the lower part of her right arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced URTICARIA (large hives on the lower part of her right arm). On 16-Mar-2021, URTICARIA (large hives on the lower part of her right arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not take anything to alleviate the symptoms. No concomitant information was reporte
First period after 2nd vaccine does a noticeable difference in flow - very heavy bleeding. Bleeding through 1 maxi-pad in 1 hour or less. Cramps so painful that it's hard to walk.
Experienced mild chest pressure within minutes of second dose of Pfizer-BioNTech Covid-19 vaccine I am still experiencing mild (2/10) chest pressure over 12 hours after vaccine (from 8:30 am - 10:40 pm). No other symptoms.
Pt. in observation was feeling tingling of arm, paramedics assessed blood pressure was high 174/80.  Once symptoms subsided paramedics release pt. to leave.
I had muscle pain and felt feverish the night after I received the treatment. My temperature was 99.4 but I am normally in the 97 range, so this is abnormal for me. The next morning I had a splitting headache (one of the worst I've ever had) that made it extremely difficult to walk. When I laid down, the headache would get significantly worse for several minutes. I would estimate a 7/10 on a pain scale for that location. Treated with ibuprofen with symptoms subsiding the next day.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patients medical history, concurrent conditions and concomitant therapies were not reported. Approximately in August 2015 (reported as from 04-AUG-2015 to 17-AUG-2015) improperly stored GARDASIL (dose and route of administration were not reported; either with lot #K023432 and expiry date on 18-JUN-2016 and/or lot #K006960 and expiry date on 19-FEB-2017) was administered to multiple unspecified patients. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
pt recvd vax & exp irritability & fever w/t100.5 to 101.4 ax; amt of time that is nursing has dec & became inc lethargic & was not interested in feeding; exp upper resp sx; PE nl x/purulent rhinorrhea; dx viral URI;
Pt arrived to post observation area post 2nd dose of Moderna. Pt reports received this injection in her L arm and now reporting L arm pins and needles feeling radiating up and down from injection site to fingertips and L side of face. Pt states after 15 min, sx resolved in arm but was now in forehead. After another 15 min, Pt reports all symptoms resolving and no other sym, no resp symptoms, no itching or troubles breathing. Pt states similar episode from first vaccine. Pt states then reporting tingling in lips. EMTs called to evaluate. EMTs evaluate Pt, obtained vitals. Pt denied swelling, SOB, throat/tongue. Per evaluation by EMTs, client and husband were discharged by EMTs. Client feels comfortable to go home with husband and husband is driving. Pt states symptoms resolving.  VS per EMT at 1415 BP 148/78 HR 82
1st shot on 4/8/2021, very tired and fell asleep on couch about 7:30 p.m., woke up at 3:00 a.m. feeling nauseous, sore from vaccine area up to side neck muscle and had a humming sound in my head, like an irritating fluorescent light bulb noise.  This did not stop. 2nd shot on 4/30/2021, tired, not sore, but the ringing seemed to be pitch higher:(  It has not gone away and it is 5/21/2021.  I had an appointment with a ENT doctor on 5/18/2021.  Will Pfizer pay for any issues that may arise?
Patient complain of dizziness 5 minutes after receiving 2nd dose of vaccine. Parents states that she only have seasonal allergies, no other know allergies. Patient had similar reaction to 1st dose. Vital signs monitored within normal limits. Offered juice, cracker and water. Dad at bedside. Patient was able to verbalized her needs. Alert and Oriented 4x.
SPINE HURT, SORE THROAT, VERY TIRED off and on still   6:45 PM WED face went numb had hard time with my words, arms and legs very heavy, almost felt like having a pancreatic attack with out the throwing up.
Patient developed shortness of breath 3 days after receiving the 1st dose of Pfizer vaccine. She presented to Urgent Care and had an elevated d-dimer, ESR and CRP and was advised to go to the ER for further workup.
3x5 raised, red, warm area right posterior arm ice pack at home, Ibuprofen, Benadryl
6NOV to SHC c/o viral illness & ingrown toenail;sx fatigue, body aches, S/T, nodes, cough w/sputum;13NOV RTC c/o flu like sx & rash, joint pain, stiffness etc;rash-viral rx MMR related;
Two days after receiving the booster shot (3rd dose) of the Moderna COVID-19 vaccine, I began to have a very loud ringing in my right ear.  I've had some degree of tinnitus for years, but this was markedly louder and worse than what I usually experience.  It was constant for about 1-2 weeks and is now more intermittent.  However, it hasn't gone away and I still have a noticeably louder ringing in my right ear throughout the day than what I've previously experienced.  I do not plan to receive any more COVID-19 vaccines due to this issue, unless it becomes mandated by my employer.  Hopefully they would allow an exemption as I think this is a serious issue and do not want it to worsen.
shingles; other zoster-related conditions; Information has been received from a lawyer regarding a case in litigation and refers to an currently 69-year-old patient of unknown gender. The patient's concurrent condition, concomitant medication or medical history were not provided. On or about 01-APR-2012, the patient was administered the zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions, by a pharmacist. Subsequently (unspecified date), the patient was treated by a health care provider for the following injuries resulting from patient's zoster vaccine live(ZOSTAVAX) use: shingles and other zoster-related conditions (ill-defined disorder). At the reporting time, the outcome of the events was not provided. The reporter considered the events to be related to zoster vaccine live(ZOSTAVAX).
Menstrual cycle started 4 days after getting booster shot. My usual cycle lasts 36-40 days and I bleed for about 6 days with cramping on the first and second days. Current menstrual cycle started 2 weeks earlier than expected and I have been bleeding for 2 weeks straight with no cramping at all.