chrisvoncsefalvay/vaers-outcomes huggingface dataset:
accidentally gave the patient a third dose of Menactra on 08May2019, no adverse effects; Initial information received on 08-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 18 years old female patient who accidentally given a third 0.5 ml dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6204AA and Exp. Date 08-May-2020) via intramuscular route in the right deltoid on 08-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was reported that Menactra was given in Aug-2013, the second Menactra dose was in Mar-2018, and the nurse practitioner accidentally gave the patient a third dose of Menactra on 08-May-2019.   It was an actual medication error case due extra dose administered.  No adverse reaction was reported.  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.  Information on the batch number was requested for first and second dose.  List of documents held by sender: none.
Coughing a lot; Cold like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing a lot) and NASOPHARYNGITIS (Cold like symptoms) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Coughing a lot) and NASOPHARYNGITIS (Cold like symptoms). At the time of the report, COUGH (Coughing a lot) and NASOPHARYNGITIS (Cold like symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took cough syrup for the treatment of symptoms.
This spontaneous report as received from a consumer mother refers to her 23 year old daughter with lactose intolerance, mittelschmerz no drug reaction/allergies. The patient's medical history included chickenpox when young but her titers tested low and she had to get the vaccine before starting school. On 16-JUN-2013 and 15-JUL-2013 the patient was vaccinated with VARIVAX (Merck) dose 1 and dose 2, respectively (doses, route and lot numbers not provided). Concomitant medication included birth control therapy (unspecified). On 22-JUL-2013, reported as 1 week after second dose of VARIVAX (Merck), the patient developed a rash with itchiness, lesions like red "bug bites" and pustules. The patient had not seen a doctor or sought medical attention. No lab diagnostic tests were performed. The patient used calamine lotion as a treatment for the events. The patient rash was beginning to scab over. The outcome of pustules and lesions like red "but bites" was unknown. The causal relationship was not provided. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 01-MAR-2017, the patient was vaccinated with improperly stored dose of M-M-R II (lot# L049314 with expiration date 03-DEC-2017; site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained. Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113: US-009507513-1705USA009742:
fast heartbeat; head ache; achiness; runny nose; sore arm; weakness in legs; hot flash; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), PAIN IN EXTREMITY (sore arm), ASTHENIA (weakness in legs), HOT FLUSH (hot flash) and DYSPNOEA (shortness of breath) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMLODIPINE, METOPROLOL, EZETIMIBE, DRONEDARONE HYDROCHLORIDE (MULTAQ), ATORVASTATIN, RIVAROXABAN (XARELTO) and VITAMIN D3 for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced RHINORRHOEA (runny nose), PAIN IN EXTREMITY (sore arm), ASTHENIA (weakness in legs), HOT FLUSH (hot flash), DYSPNOEA (shortness of breath) and PAIN (achiness). On 03-Mar-2021, the patient experienced TACHYCARDIA (fast heartbeat) and HEADACHE (head ache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) for Adverse event, at an unspecified dose and frequency. On 03-Mar-2021, RHINORRHOEA (runny nose), PAIN IN EXTREMITY (sore arm), ASTHENIA (weakness in legs), HOT FLUSH (hot flash) and PAIN (achiness) had resolved. At the time of the report, DYSPNOEA (shortness of breath), TACHYCARDIA (fast heartbeat) and HEADACHE (head ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Doctor prescribed Loratadine for rash all over body but it is not working; body is getting worse and really bad; getting red, and swollen; getting red, and swollen; This is a spontaneous report received from a contactable consumer or other non-HCP. A 49-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0173), via an unspecified route of administration on 11May2021 (age at the time of vaccination 49-years-old), as a single dose for COVID-19 immunization. The patient's medical history included Hernia. The patient's concomitant medications included Loratadine 10mg, and Pantoprazole. The patient previously took first dose of BNT162B2 vaccine, (age at the time of vaccination 49-years-old), as a single dose for COVID-19 immunization. No prior vaccinations. On an unspecified date, the patient experienced Doctor prescribed Loratadine for rash all over body but it is not working; body is getting worse and really bad, getting red, and swollen. On 05Jul2021, the patient underwent lab tests and procedures which included blood test: everything was fine, she needs to go to the Dermatology (for rash treatment). Reporter stated, patient went to the Doctor to the Hospital, 3 times and it's been like 2 months and Doctor prescribed her a medication Loratadine as treatment, but that is not working. The outcome of all the events was not recovered.  Follow-up (04Aug2021): Follow-up attempts are completed. No further information is expected.
No additional AE; Nurse reported VARIVAX was administered after TE; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On 28-SEP-2023, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (1 dosage form, lot #X000532, expiration date 04-JAN-2025, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Product storage error).   The suspect vaccine experienced a temperature excursion of 8.1 degrees Fahrenheit for 3 hours. No additional adverse events (AEs) or product quality complaints (PQC) were reported (No adverse event). No previous temperature excursion.
Swollen, painful (R) deltoid - 4 days total now prednisone rx.
a nickel-sized hive & 4inch area of redness occurred immed p/inj SC into pt rt arm redness resolved 45min;hive is persisting;ice applied to area or pt observed;referred to MD for eval p/30min;still has lump @ inj site;
This spontaneous report as received from a company representative refers to a patient of unknown age who was administered GARDASIL. On an unknown date the patient was vaccinated with GARDASIL. On an unknown date the patient experienced inappropriate schedule of vaccine that was administered. The outcome of inappropriate schedule of vaccine administered is unknown. Additional information is not expected.
Within 4 hours of receiving flu vaccine, patient experienced "jitteriness and shaking", also had increased blood pressure and heart rate per school nurse. Unable to obtain complete blood pressure reading at our office due to shaking, systolic = 104, unable to hear diastolic. Heart rate not recorded. Given MOTRIN and BENADRYL in office, in the evening given a dose of hydroxyzine.  Slept most of the afternoon and most of the evening, tired on the morning of 10/11/17, but no longer having tremors.
Phone call from Mom today reporting child received Fluzone vaccine on 11/8/04 had diarrhea stool on way home from clinic and has had 2 to  every day since.  Called PCP and was told it was probably a virus but mom was concerned because sister-in-law did not let her children receive flu vaccine because she was "afraid of the mercury".  Consoled mom by reading adverse reactions reported in literature - none of which included GI disturbance.  Child has had all other childhood immunizations without incident.
no adverse effects; A patient received improperly stored vaccine; This spontaneous report was received from a physician and refers to a 16-months-old female patient. Information regarding the patient's concurrent conditions, medical history and historical drugs was not provided.  It was reported that on 24-NOV-2020, the alarm sound were the vaccines were stored it was off and the temperatures were out of range. The vaccines were removed and placed in the pharmacy while they were back in the normal range. Once the temperature was back in range the vaccines were on the office.   On 30-NOV-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) first dose, 0.5 milliliter on the right thigh lot # S021388 and expiration date 09-JUL-2021 administered as prophylaxis.  Concomitant therapies reported administered on the same date included vaccination with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) and hepatitis A virus vaccine (unspecified).  The improperly stored dose of the suspect vaccine experienced a temperature excursion of 37.9 degree fahrenheit (°F) for 7 hours and 12 minutes; no previous temperature excursions were reported.  The call was made due to a digital data logger. No office log was available. No adverse symptoms were reported.  Lot number S021388 is an invalid lot number for varicella virus vaccine live (Oka/Merck) (VARIVAX). Lot number S021388 does not match any company product as confirmed by lot verification team.
Information has been received from a registered nurse concerning an 8 week old female, with a history of congenital suluxation of the hip, who on 06 Dec 2006, at 2:00pm, was vaccinated with a first oral dose of Rotateq (lot 654970/0777F). Concomitant vaccines administered on the same day included a dose of Pediarix, a dose of Hib conj vaccine (manufacturer unknown), Hepatitis B vaccine (manufacturer unk) and a dose of Prevnar. At the time of vaccination the patient had an upper respiratory infection, after family contact, and esophageal reflux. The patient's parent reported to the office a three day history of watery diarrhea and vomiting beginning on 09 Dec 2006. The patient's mother described the diarrhea as water, frequent, and green. The patient's status was reported as unknown. There were no laboratory or diagnostic test performed. Medical attention was not sought. Additional information has been requested. Follow-up information form a physician indicated that the patient had watery diarrhea beginning on 09-DEC-2006. It was reported that the patient recovered on approximately 12-DEC-2006. Additional information is not expected.
Approximately 2 weeks subsequent to receiving varicella virus vaccine live the pt developed 8 small bumps around the injection site.
Flu like symptoms, headache, fever, shivering, body aches, weakness, tiredness, pain at injection site for 5 days.
Severe fatigue, Fluid retention (15 lbs) swelling of legs and stomach.  Very high heart rate 118-120.  Various BP low then high.  Numbing and tingling in arms and legs.  Sleeping 18 hrs / day.  No energy. Shortness of breathe.
The patient presented to the pharmacy on 05/02/19 after noticing a diffuse redness/swelling on her left arm above her elbow and below the immunization site (the patient was still wearing the bandage on the location where the shot was given).  She stated that her arm was not itchy, hot, or particularly sore. I informed her that some redness/swelling was fairly common. I helped the patient take pictures of her arm with her camera phone so she could watch over the next few days to ensure that the redness was not spreading. I also advised her to let her doctor know if she developed any hives, difficulty breathing, if the redness spread, etc.
grade 1 covid-19 (Non-serious); This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (grade 1 covid-19 (Non-serious)) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylaxis.  Co-suspect products included non-company products INFLUENZA VACCINE (INFLUENZA VIRUS VACCINE POLYVAL.) for Prophylaxis and INFLUENZA VACCINE for Prophylaxis.  The patient's past medical history included Appendicitis in 1979 and Appendectomy in 1979. Concurrent medical conditions included Presbyopia since 2018. Concomitant products included COVID-19 VACCINE for an unknown indication.  On 22-Nov-2021 at 11:42 AM, the patient received first dose of INFLUENZA VACCINE (INFLUENZA VIRUS VACCINE POLYVAL.) (Intramuscular) .5 milliliter. On 22-Nov-2021 at 11:43 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 05-Jan-2022 at 8:00 AM, the patient experienced COVID-19 (grade 1 covid-19 (Non-serious)). At the time of the report, COVID-19 (grade 1 covid-19 (Non-serious)) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered COVID-19 (grade 1 covid-19 (Non-serious)) to be not related.   Patient received both Herpes Zoster subunit vaccine and influenza virus vaccine. Patient received both Flu Seasonal QIV Dresden and Influenza Vaccine Quadrivalent Pre-Filled Syringe Device. 44 days after receiving COVID-19 Vaccine Moderna and Flu Seasonal QIV Dresden, patient developed  grade 1 COVID-19. The patient experienced fever on 03-Jan-2022 and symptoms of runny nose and sore throat. The reporter considered that there was no reasonable possibility that the COVID-19 may have been caused by COVID-19 Vaccine Moderna and Flu Seasonal QIV Dresden. The patient did not taken any medication or treatment.  Company Comment: This is a spontaneous case concerning  a  57-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious event Covid-19. The events occurred 44 days after the unspecified dose of mRNA-1273 COVID 19 Vaccine. The event outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: Company Comment: This is a spontaneous case concerning  a  57-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious event Covid-19. The events occurred 44 days after the unspecified dose of mRNA-1273 COVID 19 Vaccine. The event outcome was reported as unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
pt recvd vax on 15MAR93 p/lunch; mom states on 16MAR93 about 830 notice while bathing pt had baseball size knot @ site of DTP LA & swelling down arm to hand & up to neck & ear, also swelling into chest; mom called MD & met @ ER;  staph infe
Left shoulder pain, numbness, tingling. Treated by Urgent care, Primary care, Emergency Dept, Sports Med and PT.
Breakthrough case admission after 4 vaccines Pfizer 4/10/21 Lot# Ew0150;  Pfizer 5/1/21 Lot# Ew0164;  Pfizer 11/9/21 Lot# FF2593;  pfizer 5/17/22 Lot# FM9992
Fever of 101.8F, shivers, and sever vertigo. Vertigo resulted in me falling down multiple times and hitting my head on the stairs. I could not see where I was going and what was in front of me.
pt recvd vax 30JUN05 @ 11 aprpox 1300 pale, diff breathing, listless, lethargic; ER visit, nl labwork & CXR, abd xray;interosseous fluid bolus, sxs resolved; hospitalized overnoc for observation; shock-collapse synd
Syncope, Headache. Faint within 10 min. of vaccine. "Pressure" in head day of vaccination and continued on day following (reported).
Slight dizziness 20-25 mins after, achy arm (about 1 and 1/2 days)  and minor headaches for about half day
4am 1/16: fever, chills, headache, and myalgia. Allodynia of scalp trunk and thighs, Acetaminophen and Aspirin helped somewhat. 9pm severe fatigue, followed by worsened fever,  worsened headache, throat tightness, nausea, myalgia, and waking hourly until 8am. Oral temp at 9am (1/17) was 100.6. Acetaminophen plus aspirin helped. 1/17 all day headache, malaise, poor appetite, and crying. 1/18 woke every 3rd hour to change clothes from night sweats. By 9 am had abdominal cramps, low grade headache, still malaise, and still low appetite. Still not recovered fully.
7/30/07 (Info. per Mom) Child c/o lt. arm sore, red at shot site. No fever. No comfort measures done. Then next day 7/31 child c/o lt. up. arm hurts, red, hot to touch, temp. 101 by mouth, Tylenol given by Mom. On 8/1/07 Mom took child to see her doctor. On 8/1/07 at 1:20 PM rec'd a call from clinic that child presented and treated for increased lt deltoid red, swollen, hot to touch at inj. site only. Child sent home w/ Mom. Rx Claritin 10mg/d PO until sx subside, alternate Tylenol and Motrin po every 4 hr. until sx subside. Cool pack to upper lt. arm area prn. No fever noted at clinic visit. F/U as need. No other S/Sxs noted.
flush; joint pain; chills; headache; swollen lymph nodes above clavicle; muscle aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (flush), ARTHRALGIA (joint pain), CHILLS (chills), HEADACHE (headache) and LYMPHADENOPATHY (swollen lymph nodes above clavicle) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced FLUSHING (flush), ARTHRALGIA (joint pain), CHILLS (chills), HEADACHE (headache), LYMPHADENOPATHY (swollen lymph nodes above clavicle), MYALGIA (muscle aches) and PYREXIA (fever). On 05-Mar-2021, FLUSHING (flush), ARTHRALGIA (joint pain), CHILLS (chills), HEADACHE (headache), MYALGIA (muscle aches) and PYREXIA (fever) had resolved. At the time of the report, LYMPHADENOPATHY (swollen lymph nodes above clavicle) outcome was unknown.            No relevant concomitant medications were reported.  Treatment details included Motrin.
COVID-19; COVID-19; This is a solicited report from a Non-Interventional Study (FACILITATED COLLECT) based on information received by Pfizer from regulatory authority, manufacturer control number: 21K-163-4106907-00.    A contactable consumer (patient) reported that a 67-year-old male patient received bnt162b2 (manufactured by Pfizer, Batch/Lot number was not reported), first dose intramuscular on 08Jan2021 at the age of 66-year-old as single dose, second dose intramuscular on 13Feb2021 at the age of 66-year-old as single dose for covid-19 immunization; adalimumab (HUMIRA, Solution for injection in pre-filled pen, Batch/Lot number was not reported), subcutaneous from an unspecified date to an unspecified date, at citrate free for psoriatic arthritis. The patient's medical history and concomitant medications were not reported. The patient experienced covid-19 in 2021. Solicited report by a consumer of a 67-year-old male with events of non-serious first COVID injection like had been hit with a baseball bat on arm, second COVID injection shot had pain, knee pain/started hurting as stands on concrete a lot with job and causes stiffness, COVID and some days pain, some days less and some extra pain with HUMIRA (ADALIMUMAB). There was no reported medical history. On an unknown date, the patient experienced some days pain, some days less and some extra pain. In 2021, the patient experienced COVID. On 08Jan2021, the patient experienced first COVID injection like had been hit with a baseball bat on arm. On 13Feb2021, the patient experienced second COVID injection shot had pain. On 13Feb2021, the second COVID injection shot had pain resolved. In September 2021, the patient experienced knee pain/started hurting as stands on concrete a lot with job causes stiffness. In 2021, the first COVID Injection hurt like had been hit with a baseball bat on and COVID resolved. Pfizer Biontech Covid-19 Vaccine (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient underwent lab tests and procedures which included COVID-19 virus test: unknown results in 2021. The action taken in response to the events for adalimumab was unknown. The outcome of events was resolved.   The reporter's causality for the event of COVID with adalimumab was not provided. Causality as per reporter (Drug/Vaccine) for COVID-19 with bnt162b2 was Possible.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events drug ineffective and suspected COVID-19 cannot be totally excluded.
Site: Pain at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Flushed / Sweating-Medium
Evening of vaccine administration client had swelling at injection site raised approx 1/4" and diameter approx 1". Next day blister size of a half dollar arose at inj. site surrounded by bright red ring/swollen and hot. Client took BENADRYL/and ibuprofen at that point. Client reports swelling reached size of donut and she had a headache, backache and acid reflux for next four days 1/29-1/30-1/31 and 2/4 when sx began to subside. Then on 2/7/2015 injection site became swollen, hard and very painful. Client went to ER that evening where physician dx it as an allergic reaction, no test were done and no medication was given. Client has recuperated completely and had no further reaction.