chrisvoncsefalvay/vaers-outcomes huggingface dataset:
transient ischemic attack; Information has been received from a lawyer concerning a case in litigation and refers to a a 60-year-old patient of an unknown gender. No information about the patient's medical history, concurrent conditions and concomitant medications was provided. On 13-AUG-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) injection (dose, route of administration, lot # and expi8ry date were not specified), prescribed by a healthcare provider and administered by a physician for a long-term prevention of shingles and zoster-related conditions. As a result of zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered from transient ischemic attack diagnosed on 27-AUG-2015. The outcome of the event was unknown.   Upon internal review, the event of transient ischemic attack was determined to be medically significant.
Initial unsolicited report received from a Pharmacist on 27-SEP-2018. This case involves a adult patient (reported as 40 something year old patient) who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. It was an actual Medication error due to inappropriate age at vaccine administration and overdose (as it was reported that a 40 something year old patient got the FLUZONE HD vaccine). Caller did not have any of the other details on patient or lot number. No information on adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Hep B pediatric injection given at 4 months. not due until 6 months. No event or concerns took place after injection. Parents/Provider notified.
Narrative: Patient states although she is a little better than she was on Monday, she is still feeling a great deal of soreness and pain in her right arm s/p the shingles shot. She states it is difficult to even move her arm. She states she uses her left arm to help move her right arm and it takes her a great deal of time to do simple tasks, including showering and getting dressed. She denies any edema, redness, SOB, CP, or warmth to the site of the injection, stating "you can't even tell a different in my arms just be looking at it. It is all internal". - PER NURSING NOTE Symptoms: Myalgia Treatment:
Site: Pain at Injection Site-Severe, Systemic: nerve/tingling pain radiating from shoulder to fingertips-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: shoulder pain radiating from injection site down to fingertips, symptoms presented 7 days post injection, pt had to go to ER to rule out cardiac event due to pain in left arm. pain is still present to this day (day 23 post injection)
This spontaneous report as received from a 52 year old male physician via a field representative refers to himself. On an unknown date in June 2011 (about two years ago) the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). On 13-JUN-2013 the patient had developed shingles after receiving ZOSTAVAX. At the time of reporting, the patient had not recovered from shingles. Additional information has been requested.
Pt developed systemic hives, pruritis, and throat numbness.  Pt was seen in the ER.
Information has been received from a physician concerning a couple patients with no pertinent medical history who were vaccinated with the second 0.5ml doses of VARIVAX (Merck) (lot# not reported).  The patients had pain and swelling at the injection site after getting their second doses of VARIVAX (Merck).  None of the patients had an adverse event after their first doses of VARIVAX (Merck).  No lab diagnostic study was performed.  The patients sought unspecified medical attention.  At the time of the report, the patients' outcomes were unknown.  Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available.  All telephone attempts to obtain follow-up information have been unsuccessful.  Follow up information has been received from a physician concerning a 5 year old male patient with no known medical history who on 20-NOV-2009 received a second dose of VARIVAX (Merck) (Lot # 665090/1037Y) SC, left arm.  No concomitant medication.  On 22-NOV-2009 the patient developed a rash at site of injection, dark in center and redness around that, slightly edematous, no tenderness, no itch, no fever.  The patient was treated with ice and BENADRYL each 6 hours as needed.  At the time of this report, the patient was recovered.  Additional information is not expected.
After receiving the vaccine, she started to faint, slumping over her chair and fell to the floor. Her eyes were blinking quickly. She was breathing rapidly. She whispered that she was scared. I told her to take deep breaths to try and calm her. I asked if she felt hurt or if she has any trouble breathing. After about 3-5 minutes of lying on their ground, she became more alert and asked me if she fell from her chair. She didn't recall falling or that she said she was scared. I had her sit up and asked how she felt and if she had any symptoms of an allergic reaction--she said no. after another minute or 2, she was able to stand up on her own with no lightheadedness nor dizziness. I walked alongside her to another seat and she sat for another 25 to 30 minutes--she said she was completely fine before leaving with her sister
Patient with fever, (R) lower extremity weakness, fatigue - hypotension, tachycardia, in ER received aggressive IV fluid hydration IV abx and change in dose of blood pressure meds.
Left shoulder discomfort, tingling in 4th and 5th digits on left hand.  Dr. prescribed Mobic 15mg due to employee havingt symptoms for three weeks.
Donor states that one hour after the immunization he had a sore throat. Denies any other s/s and state that it was gone by the morning.
high fever, severe fatigue, elevated LFTs, nausea and loss of appetite, soaking and severe night sweats beginning the evening after vaccine administration
Information has been received from a midwife registered nurse concerning a female with genital warts who "within the last few weeks" was vaccinated with HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included imiquimod (Aldara). Subsequently "within the last few weeks" the patient experienced "swelling in genital warts". At the time of the report the patient was recovering. Unspecified medical attention was sought. Other information has been requested.
10/11/02 small erythematous papules with occ. vesicles.
I had a fever and feeling foggy. I tested positive for COVID-19. I talked to the doctor, and he prescribed me Paxlovid. I started feeling better. After taking Paxlovid I had a horrible headache. I also started having a cough and raspy throat which is still happening.
No adverse event.  Reporting clinical deviation only.  Patient was given Moderna Booster #1 too early at 4 months from Primary Dose #2.   At F/U 2 weeks later, patient stated that she is feeling OK after standard side effects on day after.
Cough, body pain, chill, diarrhea up to ten times/day.
Pt rec'd 1st dose Engerix-B experienced lightheadedness (immediately), anorexia; This was followed by nausea; vomiting started 8 hrs post vax & persisted for approx 8 to 10 hrs. sx resolved p/24 hrs, w/o treatment.
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not reported.  Treatment Information was not reported.
Covid Arm - starting on Tuesday (April 5) injection site became itchy, warm to the touch. By Wednesday (April 6) evening visible swollen area, approx 3 inch diameter. Now, morning of Thursday (April 7) area remains raised, itchy, tender and warm.   Other symptoms - feverish and unable to sleep on Monday night. Left armpit lymph nodes became painful Monday night at about 7 pm, sudden onset. Over the past three days armpit ache has varied - it comes and goes.   Only treatment was 2 Advil taken on Tuesday when armpit was painful.
Swollen sore arm, headache,  fever, chills, muscle pain, dizziness, nausea, flu like symptoms. Could not work day after vaccine due to feeling very sick.
administered Tetanus toxoid in lt deltoid; pt collasped & hit head on floor, pupils dialated eyes rolled back; jerked, administered 02 in less than 1 min pt was alert & fine;
Shortly after receiving 2nd dose, his lungs cleared up, He doesnt need to use stabilizer,doing good with lungs,could breathee really gooddoesnt have any gurgling in lungs; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Shortly after receiving 2nd dose, his lungs cleared up, He doesnt need to use stabilizer,doing good with lungs,could breathee really gooddoesnt have any gurgling in lungs) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 059E21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included MIRABEGRON (MYRBETRIQ) and SERTRALINE for an unknown indication.   On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Shortly after receiving 2nd dose, his lungs cleared up, He doesnt need to use stabilizer,doing good with lungs,could breathee really gooddoesnt have any gurgling in lungs). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Shortly after receiving 2nd dose, his lungs cleared up, He doesnt need to use stabilizer,doing good with lungs,could breathee really gooddoesnt have any gurgling in lungs) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was reported.
Per ER note:   SUBJECTIVE: 65-year-old female presented to the emergency department with the above complaint. Reported that she received the Pneumovax and flu shot last week. Shortly thereafter she broke out in itchy raised migratory rash across her lower back, arms, and legs. Was seen in emergency care and given one shot of Decadron without improvement. She returned to the urgent care for reevaluation and was diagnosed scabies and started on permethrin without improvement. She denies any angioedema, dysphagia, dyspnea or wheezing, or any other acute complaints.  ASSESSMENT: Allergic urticaria.   PLAN: 1. Kenalog 60 mg IM. 2. Discharge home with prednisone, Zantac, and Zyrtec.  3. Rest, fluids, avoid known triggers. 4. F/U with PCP or return if symptoms worsen or do not improve. Symptoms: UrticariaPruritus Treatment: RANITIDINE 150 MG BID
A few days after vaccination, he had sharp pain along the left arm, and both shoulders, a few days after  that he had two small outbreaks of rash resembling shingles on his left deltoid area, and in the bend of the left elbow. The vaccination was given into his right deltoid. He was seen in express care on 11/7/21 and was diagnosed with shingles.He was prescribed acyclovir. As of today, pain comes and goes especially at night and upon pressure
Case number PHHY2012US051978 is an initial literature report received on 12 Jun 2012. Authors searched VAERS for reports of adverse events (AEs) in pregnant women who received influenza vaccine from 01 Jul 1999 through 30 Jun 2009. This case refers to a pregnant female patient (age not specified). She had a history of asthma. She was vaccinated with influenza vaccine (manufacturer and batch number: unknown) at an unknown gestational age, on an unspecified date between 01 Jul 1999 through 30 Jun 2009. On an unspecified date after vaccination, her asthma got exacerbated. The outcome of pregnancy was not reported. The causality was not reported. Authors stated that the VAERS system does not allow for active follow-up of adverse events among pregnant women; thus, pregnancy outcome data are not available for women who had an adverse pregnancy event. Authors concluded that no unusual patterns of pregnancy complications or fetal outcomes were observed in the VAERS reports of pregnant women after the administration of influenza vaccine.
3 hours after receiving the vaccine I started experiencing stiffness in my neck. It progressive got worse. I?ve been going to the chiropractor twice a week since then and my chiropractor has had to do more adjustments than normal. She has also noticed that my neck muscles have been more tight since then. I?ve also been doing acupuncture once a week since the shot and I?m starting physical therapy on my neck today.
Participant began vomiting 2 hours after receiving vaccine. Very nauseous. Stated that she ate lunch after receiving vaccine.
Day 1: Fever of 103, tremors, severe body and muscular pain. Shortness of breath. Unable to get out of bed for the entire day, severe headaches through the entire day Day 2: fever of 101, shortness of breath, severe headache, entire left arm in pain
2nd BI-VALENT BOOSTER GIVEN ON 12/16/22 1st GIVEN ON 09212022  MODERNA LOT # AS7162B NO ADVERSE SYMPTOMS NOTED
This spontaneous report was received from a registered nurse, referring to multiple unspecified patients. The patients' medical history, concomitant medications, concurrent conditions, drug and allergy history were not provided. It was reported that on unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot number M037770, expiration date 01-JUN-2019 (dose, frequency and administration route were not reported) for prophylaxis. Temperatures and time frames registered in the data logger, were: 0°Centigrades (C) to 1°C (0.8°C) for 34 hours; 9°C to 25°C (8.7°C) for 27 hours and 26°C or warmer (26.2°C) for 27 hours. No adverse effects were reported. This is one of of several reports from the same reporter. Sender's Comments: US-009507513-1707USA005547: US-009507513-1707USA005548: US-009507513-1707USA005549: US-009507513-1707USA005550: US-009507513-1707USA005551.
started development symptoms the day after the vaccination - started having headaches, general muscle pain, fatigue, and pain, redness, itching, and swelling on injection site. As of today, 4 days after vaccine, still feel muscle pain and itching on injection site
Swelling of face (eyes almost swollen shut), hands, ankles, bad headache, jitters, light intolerance , 99.8 temp (usual is 97.5), inability to keep food down.  Lasted 32 hours, recurred 60 hours later for another 72 hours.  30 hours later, Oncologist  check blood work, believes reaction was to vaccine and not to infusion drugs as reaction not seen to those drugs in past.
The patient is 17 years and nearly 11 months. She will be fully 18 years old in few weeks by 5/11/22. She had signed up for Moderna first dose vaccine, instead of the pfizer one. So when she arrived in the pharmacy, her age was missed that she wasn't quite 18 years old yet and was given the Moderna shot instead of the pfizer as recommended. We spoke to the patient the next day and she was doing fine.
vomitted / threw up; felt weak; couldn't really walk; severe muscle pain with nausea and dizziness; severe muscle pain with nausea and dizziness; severe muscle pain with nausea and dizziness; clammy; This is very abnormal for him; ill; rash; hives; sore throat; little bumps, like pustules on the one side of his body/water bubbles; looks like shingles; upset and stressed out; This is a spontaneous report form a contactable consumer (patient's mother). A 17-year-old male patient received the second dose of BNT162B2 via an unspecified route of administration on 03Jul2021 at 22:00 (Expiration date: Unknown) as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization and the reporter stated her received his first dose of the Pfizer vaccine in a different country. On 04Jul2021, after four hours, the patient woke at 2:00 am and vomitted, felt weak, couldn't really walk, had severe muscle pain with nausea and dizziness, he threw up and clammy. When he woke up in the morning he noticed little bumps, like pustules on the one side of his body, they looked at pictures in the internet and it looks like shingles. The patient got rash, hives, water bubbles over his chest and sore throat. The patient was very upset and stressed out over this, which the reporter knows was probably not helping and the reporter was not with him. The reporter stated that this was very abnormal for him because he was an athlete. The reporter was familiar territory for him, he had never been that ill and he just want to know if this was a common side effect or if it was the side effect from Pfizer that can expect. The outcome of all events was unknown.  Information on the lot/batch number has been requested.
This spontaneous report as received from a consumer refers to himself, a 60 years old male patient with hypertension, hepatitis C, type II diabetes and heartburn. The patient had no known drug allergies. The patient was vaccinated with dose 1 of ZOSTAVAX (lot number not specified) in his left arm on 08-JUL-2012. Route was unknown. No other co-suspects were reported. Concomitant medications included carvedilol, metformin, EDECRIN, amlodipine, lisinopril and ZANTAC. On 10-JUL-2012 the patient began experiencing left foot swelling, left ankle swelling, left foot pain, "could not walk" and "hurting". These events subsided in August 2012 and then he began having right foot swelling, right foot pain, right ankle pain, "could not walk" and "hurting". The patient was started on gabapentin 300 mg, 2 tabs twice daily, as treatment for these events. The patient did not have any results of labs that have been done. As of 29-OCT-2012, all events except the right foot swelling had resolved. The patient's physician was aware of the events. Additional information has been requested.
2-3 inch lump on left arm of injection with booster shot. Sometimes itchy, sometimes painful. On my first shot, there was only some pain at injection site on left arm. With second shot, there was a small lump and itchiness at the injection site on my right arm. Now with the booster, it?s a large lump near injection site on my left arm?
lt deltoid is reddened & warm where DTP given t96.4 is to ice the area & give APAP for local reaction;
Information has been received from a register nurse concerning about 50% dialysis patients who were vaccinated with RECOMBIVAX HB 40mcg/ml (therapy route and site unknown). The nurse reported that she had noticed that 50% of the dialysis patients who received the RECOMBIVAX HB in the past responded with low titers. Follow-up information has been received from the nurse. She stated that "the 50% of dialysis patients that responded with low titers to RECOMBIVAX HB" was not what her phone call was about. She stated that she was asking about the reformulation of RECOMBIVAX HB and she did not remember saying anything about dialysis patients or low titers. Additional information is not expected.
Pt given FLUARIX 9/13/12. Pt diagnosed with Guillain-Barre and intubated on 10/3/12.
pneumonia Narrative: On 11/9/20, Patient had a presumptive positive COVID (COBAS) screen as part of routine CLC screening and then on 11/13/20, he had a repeat COVID (CEPHID) that was negative. Then on 12/22/20, he received his first COVID vaccine. On 12/26/20, he began to have c/o hurting all over. Noted history of aspiration and COPD. On 12/29/20, he began to have coughing, increased shortness of breath and runny nose with course breath sounds in his bilateral lower lobes. A chest xray was done and he was initiated on oral azithromycin and cefepime for a bilateral pneumonia. On 1/3/21, he continued to decline with increasing shortness of breath and was subsequently transferred to acute care medicine. All COVID tests have been negative since the presumptive positive on 11/9/20. He did have a CTA that ruled out PE but did show bilateral pneumonia. His antibiotics have been changed to meropenem, vancomycin and IV azithromycin. He remains on acute care at time and has not required ICU care.
Initally nausea then fever and headache followed a day later by abdominal cramps and diarrhea with dehydration.
1315-approx. 10 minutes after administration patient c/o headache, states she feels like her heart racing with palpitations. Pt is awake and alert, oriented, conversational and able to follow commands. Resp even and unlabored, rate 16. Skin warm and dry with slight pallor. Pt assisted from chair where she was seated to gurney and encouraged to lay down, and breath deeply; pt complied. Blood pressure obtained and recorded; results wnl for age and situation. Pt became tearful, stated she was crying due to h/a 5/10 and states she is scared. Patient reassured and cool moist compress applied to forehead. Continued monitoring in observation area for additional 15 minutes, during this time Patient able to sit up, at a banana, drink water, talk with parent and siblings, no longer tearful. At reassessment pt awake and alert, oriented, respiratations even/unlabored, 18/min; Skin warm and dry, normal color, no pallor noted; states she feels better, denies pain. Parent states she has episodes of anxiety, during which she has similar complaints. VS again obtained and WNL. Pt able to stand and walk, denies lightheaded, no s/s of syncope; no s/s discomfort or distress. No further complaints from pt at this time. Family instructed on post-vaccine comfort measures before departing. Medical Director notified
Coughing; Sneezing; Runny nose; Throat scratchy too; This spontaneous case was reported by a patient and describes the occurrence of COUGH (Coughing), SNEEZING (Sneezing), RHINORRHOEA (Runny nose) and THROAT IRRITATION (Throat scratchy too) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for Prophylactic vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE for Prophylactic vaccination.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Coughing), SNEEZING (Sneezing), RHINORRHOEA (Runny nose) and THROAT IRRITATION (Throat scratchy too). At the time of the report, COUGH (Coughing), SNEEZING (Sneezing), RHINORRHOEA (Runny nose) and THROAT IRRITATION (Throat scratchy too) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No concomitant product use was provided by the reporter.   No treatment medication was provided by the reporter.