chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arexvy - Change in PT/INR; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of prothrombin time abnormal in a 86-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7SY2S, expiry date 19-OCT-2024) for prophylaxis.   Concomitant products included warfarin.   On 27-SEP-2023, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced prothrombin time abnormal (Verbatim: Arexvy - Change in PT/INR).The outcome of the prothrombin time abnormal was unknown.   It was unknown if the reporter considered the prothrombin time abnormal to be related to Arexvy.   It was unknown if the company considered the prothrombin time abnormal to be related to Arexvy.   Additional Information: GSK Receipt Date: 13-OCT-2023 A reporter called to report that patient was vaccinated with Arexvy.  The patient had been under Warfarin treatment at the same dose for a very long time.  After the vaccination with Arexvy, the patient tested for PT/INR and since this changed he had to double the Warfarin dose. The healthcare professional mentioned that the patient had not changed his diet or other medications and now the patient was testing the PT/INR weekly. The healthcare professional asked for any information regarding Arexvy in patients under Warfarin treatment. The healthcare professional mentioned that next week after seeing the PT/INR results she would ask the patient if he would allow us to follow up.  The case number was shared and the healthcare professional would inform if the PT/INR was back to the value before vaccination.
The pt's grandmother reported that a 2 month old male pt received vaccines on 10/23/00. Reportedly, the next day, the pt developed continuous crying, seen in physician's office. The pt was hospitalized on 11/22/00 due to respiratory failure, bruising around the mouth, petechia and swollen tongue. Pt was discharged on 12/20/00 with a dx of Shaken Baby Syndrome with brain damage, blind and deaf. Pt is on feeding tube and Phenobarbital for seizures. No further info is available. Upon internal review, seizures were considered an other medical event. this is an amended report. The pt's age has been changed to 7 wks old. This is corrected report as amended. Mailed follow-up correspondence received on 06/12/2001 stated: the vaccine administered physician did not report this adverse event. F/U mail follow up correspondence rec'd from (WAES01061938) on 7/9/01 specified that the Hepatitis B vaccine given to the patient was Recombivax HB. F/U other business numbers include F200100677,F2001006771 and U200100437. F/U faxed correspondence received on 9/4/01 reports, "This is an amended report. The pt's age has been changed from a 12 to a 7 week old". F/U info rec'd on 11/26/01 from a physician indicated that  this was not a reaction to vaccine and that it was whaken baby syndrome as previously reported. The physician noted that he did not report the event as a possible vaccine reaction. No further information was available because the physician was not at the practice where the child was seen. The physician felt that continous crying, respiratory failure, bruising around mouth, petechiae, swollen tongue, brain damage, blind, deaf and seizures were not related to the therapy with hepatitis B vaccine. Upon internal review, seizures were considered to be an other important medical event. From faxed correspondence received on 09/04/2001 states that "this is an amended report. The pt's age has been changed from a 12 to a 7 week old. From follow-up correspondence received on 11/26/2001 it was reported,"This was not a reaction to vaccine, it was Shaken Baby syndrome as I previously reported. I did not report it as a possible vaccine reaction. I do not have any other information, as I'm not at the practice where this child was seen." The pt's grandmother was the initial reporter per the physician.
Fever; Tiredness; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the right arm on 10Apr2021 at 16:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from on an unknown date in Feb2021 and ended on 20Feb2021. The patient had no known allergies to food, medications or other products. Prior to the vaccination, the patient was diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021, the patient had fever, tiredness and fatigue since the day patient took the first shot of vaccine. It had been 12 days and still the patient had fever up to 101.6. The patient had COVID-19 during the month of Feb2021 and quarantine ended on 20Feb2021 and therefore felt chances of having corona were highly unlikely. On an unknown date in Apr2021, the patient underwent body temperature and the result was up to 101.6 (units unspecified). No therapeutic measures were taken as a result of the events. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, it was unknown whether the patient had been tested for COVID-19.  The clinical outcome of the events fever, tiredness and fatigue were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient went home after the vaccine and called our office and spoke with the NP reporting the symptoms. Initial call was made at 12:50 PM where symptoms were reported: patient woke up projectile vomiting, she was more fussy than usual, parents were not sure if she had a fever but they denied that she had difficulty breathing, they reported 3 episodes of emesis. Per the physicians orders we advised the Parents were advised to come into the office to be examined, and also to give a dose of BENADRYL before coming in (Parents were unable to give dose as they were en route to office- dose to be given at the office). The parents where the doctor examined a pinpoint rash on her trunk. NO swelling of lips, tongue, difficulty breathing, drooling, diarrhea or further emesis once at the office. She was given a dose of BENADRYL 12.5 mg/5 ml) (3.75 ml) and transported to the hospital via parents despite doctor's recommendation to go via ambulance and administer EPIPEN before travelling there. In the ED, patient appeared well with no distress, no respiratory distress and negative for any abnormalities on physical exam. The rash mildly erythematous macular rash mainly distributed over the trunk. Because there were 2 systems involved (GI and SKIN, the child was given epinephrine 0.1 mg injection and ZANTAC in the ER Epinephrine injection given at 3:49 PM no 10/26/18. They observed her for two hours and then discharged her home with BENADRYL, ZANTAC and ORAPRED. Dr. talked to the parents today and received an update that she is better today, no fever, no vomiting, almost seems to be back at baseline. Reinforced the continuation of medication that was given from the ED, and a follow-up made for Monday to be seen at Pediatrics. Told to call 911 or our answering service over the weekend if any symptoms occur. Parents verbalized understanding and had no further questions or concerns at that time. (Patient does have a known suspected egg allergy and per recommendations did receive the Flu Vaccine on this day).
This is a spontaneous report from a contactable nurse via Pfizer sales representative. A female patient of unspecified age (reported as 65, Unit: unknown), and ethnicity received PREVNAR 13 via unspecified route of administration on unspecified date at single dose for immunization. Patient medical history and concomitant medications were not reported. The patient experienced "pain at the injection site" on unspecified date. Event took place after use of product. Outcome of the event was unknown. No follow up attempts are possible. No further information is expected.
Heart arrhythmia on EKG which is ventricular tachycardia; A spontaneous report was received from a healthcare professional concerning a 22 years old, female patient who experienced Heart arrhythmia on EKG which is ventricular tachycardia(ventricular tachycardia).   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 13 Feb 2021, the patient received their first of the two planned vaccine doses of mRNA-1273 (Batch number not provided) in her left arm with no associated symptoms.  On 13 Mar 2021, prior to the onset of the symptoms, the patient received their second of the two planned vaccine doses of mRNA-1273 (Batch number not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 14 Mar 2021, the patient's heart rate got up to 206bpm and was seen in the emergency room and stayed overnight. On the same day the EKG(Electrocardiogram) was performed for the patient which revealed heart arrhythmia, which is ventricular tachycardia and was advised that she might need a surgery like defibrillator placement for lifetime or ablation. She was reported to be home from work for a week while on cardiac monitor and appropriate surgery will be decided after results are received after a week of monitoring.  cardioversion was reportedly performed, which was able to bring back her heartbeat back to normal.  The event ventricular tachycardia was considered as medically significant.  Treatment for the event included cardioversion.   The patient received both scheduled vaccine doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the event, Heart arrhythmia on EKG which is ventricular tachycardia, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pneumovax given 11/14/05 right arm. Seen 11/16/05 C/O low grade temp 99.5, bright erythema; splotchy warm around right upper arm. 2% Cellulitis. Keflex 500mg  t t.i.b. every  5 days. Benadryl 25mg t every 6 hrs prn.
Patient came to the pharmacy today 4/25/2019 to report an adverse event she experienced after receiving her 2nd dose of SHINGRIX vaccine. She stated six hours after receiving the vaccination she experienced an extremely rapid heart beat. She said it felt like a jackhammer. She said this lasted for 10 minutes and then went away. She did not seek medical attention but wanted to report it today. I told her I would document the event and I recommended that she call her PCP to report it to them for further evaluation.
postherpetic neuralgia; shingles; Myalgia; nerve pain; chronic pelvic floor pain/pelvis aches; bilateral numbness in legs; Pudendal neuralgia/pudenda I nerve block; Chronic pain syndrome; hip ache; This case was reported by a lawyer and described the occurrence of post herpetic neuralgia in a patient who received SHINGRIX for prophylaxis.   On an unknown date, the patient received SHINGRIX (intramuscular). On an unknown date, unknown after receiving SHINGRIX, the patient experienced post herpetic neuralgia and shingles. On an unknown date, the outcome of the post herpetic neuralgia and shingles were unknown.   It was unknown if the reporter considered the post herpetic neuralgia and shingles to be related to SHINGRIX.  The initial information received on 29 September 2020 via medical records. As per the pharmacy records on 04 August 2018, she had SHINGRIX, 0.5 ml, intramuscular injection. As per the records dated 18 January 2020, Patient states that she started (Physical therapy) PT in July 2018. Patient stated that she had pudendal nerve pain. Patient stated that she tried to return to PT but she got shingles 3x. Patient stated that she was hospitalized with the shingles and was discharged to PT due to medical complications. On 05 November 2018, she had past medical history significant for gastroparesis who presents with severe pain of the right hip and leg region which started shortly after bilateral obturator injections for pelvic pain, in preparation for pelvic rehab. The patient states when she woke up from the procedure, she had bilateral numbness in the legs. The left leg normalized within several hours; however, the right leg took longer to normalize. Once the numbness went away, she experienced burning, aching pain in the right groin region. She outlines an area that is similar in distribution to the L 1 dermatome. She also notes pain in the right buttock region. The pain at times will go down the back of her thigh ending above the knee. She describes it as burning. 28 November 2018 There is mild osteoarthritis of the hips. As per records dated 07 April 2020, she had PudendaI neuralgia since 04 March 2020. She had Patient had 100 percent relief with both the right pudendal nerve block and posterior femoral cutaneous nerve block.
received only the MenA component; received only the MenA component; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA762A, expiry date 30th November 2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-NOV-2022 Reporter's Comments: A nurse reported that a female patient received only the Men A component of Menveo. The consented to follow up. Additional Supportive Information: the patient received only the Men A component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine.; Sender's Comments:  US-GSK-US2022170328:same reporter
No additional adverse effect reported; PROQUAD that underwent a temperature excursion was administered to the patient; This spontaneous report was received office staff member and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions or allergies, pertinent medical history and concomitant therapy were not reported.       On 10-AUG-2021, the patient was vaccinated with an improperly store dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), lot # T032145 expiration date 20-MAR-2022 (dose and route were not reported) for prophylaxis. The vaccine underwent a temperature excursion from 6 to 14 (12.6°F) Fahrenheit degrees (°F)  for 45 minutes. There was no previous temperature excursion. No additional adverse effect and no product quality complain were reported.       This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2109USA001014:
Pt tolerated well, however, dose was the 2nd bivalent dose that the patient got and it should not have been given.
Patient received dose 1 of Pfizer Biontech on 10/13.  On 10/23, patient complained of pain and swelling from a boil on her buttock that was bleeding and emitting pus.  She said that the infection may have been there for some time... maybe months, but it was smaller and causing no pain and she was hoping it would go away. It never caused her so much pain and concern until after her covid shot. On 10/25 a doctor in her pediatricians office lanced the boil and prescribed antibiotics, ointment, and baths.  A culture test of the bacteria is also being performed.  Her situation will be closely monitored over the next weeks.
hives developing over several days lasting 3 weeks. Identified as 'strong immune reaction' as opposed to allergic reaction by Dr.
I took the vaccine at 9:59am. first of all, i was feeling very dizzy and sleepy about 2 hours after taking the vaccine (Moderna); and then another hour later, i got arm pain, and i could feel clearly my heart beat, which lasted over an hour; and then feel a little headache, and slept for 1 and half hours, and feeling good. ate some snacks and dinner.... around 11:20pm that night, i got a little fever (about 2 hours, getting better after drinking some water) but feel so much arm pains. the next 3 days, i had got the same fever and little headache every night (11:00pm to 1:00am) and 2:00 to 4:00pm, and arm pains last 4 days.
This spontaneous report as received from a physician refers to a 8 week old patient of an unknown gender. On 29-JAN-2014 the patient was vaccinated with a dose of GARDASIL, intramuscularly (dose, frequency were not reported) in the right thigh in error. No product confusion discovered, just medication error. No adverse event reported. Additional information has been requested.
Pt's husband sched pt for Zostavax vaccination. Pt given vaccination. Went to document vaccination and discovered pt had already received vaccination on 11/8/2007. Pt/spouse informed. Pt had no immediate signs or symptoms. PCP notified, CDC called for recommendations. Pt informed per CDC-No great risk for severe injury but at greater risk for local reaction. Pt informed to call w/any adverse reactions. I will call pt in a few days for f/u.
After receiving 3rd injection patient reported feeling light headed and nauseous. Cool towel applied to patients neck and this nurse began to fan patient. Within a couple minutes patients eyes rolled backwards and she went limp and made a snoring noise. Patients left arm was extended straight and her legs stiffened. This nurse and mom assisted patient to the floor. Within less than a minutes patient opened her eyes and began to cry and state she was scared. Patients arm and legs relaxed. Patient remained on floor for an additional five minutes and then was assisted to chair for an additional period without any further complications. Mom states the patient has a doctors appointment in a few days and she would discuss incident with him.
I gave the patient her flu shot and it started bleeding so i held the alcohol swab on it, then she said i dont feel well. after that she went into a seizure and was about to pass out. her boyfriend informed me she has low blood sugar sometimes so i went and got her juice, water, and crackers. she sat in our waiting area about 30 minutes until her mom and dad came to pick her up
couldn't sleep; had severe paresthesia of the right side of my scalp down my neck on the right side; I couldn't sleep nor function normally; pain; pulling and tingling sensation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 22Apr2021 06:15 (Lot number: EW0169) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "pencillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Dose administration time:3.30am, dose vaccine location: left arm, Lot number:EW0150, Dose brand: Pfizer, Dose product: COVID-19), administration date: 01Apr2021, when the patient was 60 years old, for Covid-19 immunization. The following information was reported: INSOMNIA (non-serious) with onset 02May2021, outcome "recovered with sequelae", described as "couldn't sleep"; PARAESTHESIA (non-serious) with onset 02May2021, outcome "recovered with sequelae", described as "had severe paresthesia of the right side of my scalp down my neck on the right side"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 02May2021, outcome "recovered with sequelae", described as "I couldn't sleep nor function normally"; PAIN (non-serious) with onset 02May2021, outcome "recovered with sequelae", described as "pain"; PARAESTHESIA (non-serious) with onset 02May2021, outcome "recovered with sequelae", described as "pulling and tingling sensation". The events "couldn't sleep", "had severe paresthesia of the right side of my scalp down my neck on the right side", "i couldn't sleep nor function normally" and "pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of insomnia, paraesthesia, loss of personal independence in daily activities, pain, paraesthesia.  Additional information: No other vaccine in four weeks and no Other medications in two weeks. Patient had severe paresthesia of the right side of her scalp down my neck on the right side starting at about 2 weeks after the 2nd shot. she couldn't sleep nor  function normally due to the pain, pulling and tingling sensation, it has since subsided considerably but has not gone away. This lasted several weeks and went to the dr and insisted on an MRI as she couldn't tell if this was her scalp or inside my head. It was reported that patient did not have covid prior to vaccination nor tested covid post vaccination.  No follow-up attempts are possible. No further information is expected.
For 36 hours after the injection, I had severe fatigue, fever, chills, and body aches -- very similar to flu symptoms. This was the first time I have ever had a reaction to a flu shot, except for a temporary sore shoulder.
This spontaneous report was received from a medical assistant refers to a female patient of unknown age. The patient concurrent condition included blood pressure. On 20-NOV-2013, the patient was vaccinated with VARIVAX (merck) (dose, route and frequency was not reported) because the patient works in the medical field. Concomitant medication included water pill. On 11-FEB-2014, the patient visited the physician office and had blood work completed which showed her to be pregnant. The medical assistant stated that based on the last menstrual period, the patient was 5 weeks and 3 days pregnant. Additional information has been requested.
grandma called 21SEP92 PM letting me know that infant died of crib death 20SEP92;
Body aches; Feeling feverish; Chills; Nausea; A spontaneous report (United States) was received from a physician concerning a female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced feeling feverish, chills, body aches, and nausea.    The patient's medical history was not provided. No relevant concomitant medications were reported.    On 23 Dec 2020 at approximately noon, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On 23 Dec 2020 after receiving vaccine the patient started feeling feverish, has chills, body aches, and nausea. The reporter stated that the symptoms had continued the morning of 24 Dec 2020.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The events, feeling feverish, chills, body aches, and nausea, were considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
3 hours later began dry cough, shortness of breath. 1 hour after that my face was swollen, mostly lips and eyes, eyes red, with yellow discharge forming in eyes. Began feeling extremely cold and shaking, even though wrapped in blankets. Body aches and skin irritated to fabrics. Took chlortrimiton and water and went to bed. Woke up with face and eyes still puffy but no other symptoms, went away by lunchtime the next day.