chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown demographics. On an unknown date, patients were vaccinated with a dose of VARIVAX (Merck) (lot number and expiry date reported as H020601 and 13-NOV-2014 respectively, dose and route unspecified) (expiry date was also reported as 03-NOV-2014) which was stored in the refrigerator at 41 degrees Fahrenheit (F) for 49 days. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown demography. Patient's concurrent conditions and relevant medical history was not reported. On 13-APR-2015, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (lot number: K007983 with expiration date of 03-JUN-2016), 0.5 ml, subcutaneous. Concomitant medications were not reported. No adverse events were reported. The outcome of the events were unknown. The causality of the events with (Oka/Merck) was not reported. Product quality issue was not involved. This case is linked to # 1504USA021167 via same reporter link. Additional information has been requested.
Patient stated had no previous doses on informed consent form. shot was processed and given for moderna on 07/21/21. checking the maine immpact registry on 08/18 prior to giving 2nd dose it was discovered that patient had Johnson and Johnson covid-19 vaccine on 04/09. patient did not report exeriencing any adverse effects from 1st dose of moderna. he was informed taht he would not be elligible to receive any additional doses of Moderna at this time.
presented to the ED complaining of worsening cough and shortness of breath on 2/3.  Patient started to have intermittent fever, chills, body aches and diarrhea since last week; Chest x-ray showed bilateral lung infiltrates consistent with COVID-19 disease. ID was consulted and she was started on Veklury along with Rocephin 1gm daily, Azithromycin 500mg daily, steroids and lovenox. HD #3, she required 4L NC but was stable. Her urine culture grew Klebsiella and she was started on Nitrofurantoin. Her inflammatory markers fell nicely. HD #4, her ddimer has a slight elevation and her 02 requirement fell to 2L NC; home on O2
Information has been received from a Licensed Practical Nurse concerning a female patient with no pertinent medical history and erythromycin allergy who "17 years ago", in approximately April 1993, at 11 years of age was vaccinated with a dose of VARIVAX (Merck) (route and lot # unknown). Concomitant therapy included prenatal vitamins. The Licensed Practical Nurse reported that currently the patient had negative varicella titers. The patient sought unspecified medical attention. At the time of reporting, the patient's outcome was unknown. Additional information has been requested.
Case PHEH2016US23135 is an initial spontaneous report received from pharmacist on 08 Sep 2016. This report refers to 31 year old pregnant female patient. Past medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1618701) at a dose of 0.5 ml intramuscular on 07 Sep 2016. It was reported that, the patient who was 16 week pregnant received MDV vaccine instead of FLUVIRIN PFS. The patient was still onsite when she called and spoke with reporter and had demonstrated no adverse events. After administration the vaccine the pharmacist later realized that the ACIP (Advisory Committee on Immunization Practices) advised to use the preservative free and reporter wanted to see if safety data was available regarding FLUVIRIN and pregnancy. No adverse event was reported following this vaccine exposure during pregnancy.
No problems until around 1PM noticed a irritation, marked with bright red  areas on inside of upper portion of cheeks and some redness under top lip.  Progressed quickly - and around 4PM noticed discomfort increasing. Around 1430 my  upper lip began to swell and it looked like their was fluid under reddness.  On my way to ER the swelling continued , and got worse traveling to the other side of my lips and above my lips to under my nose.  While at ER my bottom lip started to also swell.
The civilian vaccinator was aware that the patient was supposed to receive Pfizer. She states that she accidentally grabbed a Moderna vaccine and then administered it. After the dose was administered, it was logged as Pfizer. The vaccination assistant/scribe noticed a moderna syringe/needle and identified the error afterward. The pt was counseled and understands that she should consider herself fully vaccinated.
Pt called public health office on 2/17 and reported she had recieved the vaccine on 2/5/21 but did not develop symptoms until 2/12/21. She stated on 2/12 she developed redness at the injection site that has spread down her arm with mild itching. She said she self medicated with Benadryl with no change in symtoms. She states today on 2/17 that redness is still present. Instructed pt to report on vsafe website adn that I would make report into VAERS system. Instructed pt to make appt with her PCP for further evaluation and recommendations for treatment
Over the last few weeks the patient has had decreased appetite, dizziness, and nausea. She tested positive for COVID-19 on 10/16/22 by home test. Patient brought in to the ED by EMS for shortness of breath along with her other symptoms. She was admitted to the hospital 10/19-10/24 for management of acute hypoxic respiratory failure secondary to COVID pneumonia as well as atrial fibrillation with RVR.  Patient has received the COVID vaccine and booster series.
Pt. waited 20 due to an local reaction to the vaccine. Mother had to leave BENADRYL was given at clinic. 4cm erythema, warm (L) thigh (PROQUAD).
This spontaneous report was received from a consumer refers to her male friend of an unknown age who on an unknown date, was vaccinated under the skin with a dose of ZOSTAVAX (dose and lot number not reported). No other co-suspects were reported. No concomitant medications were reported. The consumer reported that her friend got a shingles about a year after getting the "shingles shot" on an unknown date. The consumer stated that her friend ended up in the hospital for 2 weeks. No treatment information was reported. At the time of the report, the patient's outcome was unknown. The relatedness for the patient got shingles about a year after getting the shingles shot was unknown for ZOSTAVAX. Additional information is not expected.
It was reported that a 24 year old female patient received a dose of Fluzone SV '01-'02 administered IM on 11/26/01 in her left deltoid by a doctor. The night after dose was received, the patient experienced pain and redness at the administration site, fever and was unable to sleep due to the pain. Physician stated that on 11/27/01 a massive warm lump was present at the site of injection or just slightly above injection site. Patient took Tylenol for the pain. Patient stated that she was not able to use her left arm the day following vaccination. Used warm compresses for pain. Physician will be following up with patient to see when symptoms resolve.
15 month old female patient who was inadvertently administered QUADRACEL instead of DTAP with no reported adverse event; 15 month old female patient who was inadvertently administered QUADRACEL with no reported adverse event; Initial information received on 26-Oct-2021 regarding an unsolicited valid non-serious case from a Physician via other healthcare professional and non-healthcare professional/consumer via Medical Information (MI) (Reference number- 00829028).  This case involves a 15 month old female patient who inadvertently vaccinated with DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [DTAP], (wrong product administered and product administered to patient of inappropriate age).  The patient's medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included Influenza Vaccine (Flu) and Hib Vaccine (Hib) for Prophylactic vaccination.  On 18-Oct-2021, the patient received a 0.5 ml first dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5851AA and expiry date: 25-Mar-2023) (Suspension for injection) via an intramuscular route in the left thigh for prophylactic vaccination.  It was an actual medication error case due to Wrong vaccine administered (with respect to use of QUADRACEL and DTAP) and inappropriate age at vaccine administration (with respect to use of QUADRACEL) (latency on same day).  It was reported "Call received from reporting a dose of QUADRACEL was inadvertently administered instead of DTAP to a 15 month old patient".  At the time of reporting, no 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 holder's compliance with the requirements set out in the 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.
Within approximately one hour my chest began to feel tight and my heart began to pound in my chest. My throat also began to feel tight and my head felt foggy, like things were unclear.
Patient got their flu shot on 10/29/21 at 3 pm and started to notice adverse effects on 10/29/21 at 5:30 pm and experienced the following adverse events: worried, no appetite, shakes, fever, cold, lots of sweating, black stooling in the eyes and peripheral corona. The patient woke up the following day at 2 pm and started to feel better on 11/09/21.
MenA Lyophilized Conjugate Component not reconstituted with MenCYW-135 Liquid Conjugate Component before administration of vaccine to patient. Patient only received Liquid Conjugate. Vaccine not effectively administered. Re-vaccination required.
Information has been received from a registered nurse concerning a 28-year-old female who completed the varicella virus vaccine live series in 2003. Subsequently, a negative titer was drawn. The patient is currently doing well. Unspecified medical attention was sought. There was no product quality complaint. The reporter also indicated that one other patient had a negative titer (WAES #0402USA01444). Additional information has been requested.
This spontaneous report was received from a doctor of pharmacy concerning an approximately 58 year old male patient with high blood pressure and no drug reactions or allergies. The medical history of the patient included shingles and was exposed to someone with the shingles on 19-MAR-2013. On 25-MAR-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date reported as J000435 and 10-APR-2014 respectively, dose and route unspecified). Concomitant therapies included gabapentin and unspecified pain medications. On an unknown date, approximately in March 2013 (reported as now), the patient experienced shingles. The patient sought medical attention (contacted pharmacist). The patient was treated with valacyclovir. The outcome of shingles was reported as not resolved. VZVID packet accepted and faxed to the pharmacist. The relatedness for shingles was unknown for ZOSTAVAX. Additional information has been requested.
Reported left arm injection site pain, dull headache, chills and a rapid hear rate. Went to ED due to heart rate.
worsening on the ringing in his ears after vaccination; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (worsening on the ringing in his ears after vaccination) and MYALGIA (sore arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036a21a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (worsening on the ringing in his ears after vaccination) and MYALGIA (sore arm). At the time of the report, TINNITUS (worsening on the ringing in his ears after vaccination) and MYALGIA (sore arm) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient Height was reported 7 6 not provides values. Concomitant medication was reported as "a bunch". Patient completed all 3 doses. Adverse event did not cause to seek medical care (office visit, Urgent care, ER, hospitalized) to the patient. The patient was experienced a similar event in the past.
A rash on her wrist; This spontaneous case was reported by a consumer and describes the occurrence of RASH (A rash on her wrist) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (A rash on her wrist). At the time of the report, RASH (A rash on her wrist) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  Treatment information was not provided.
swelling towards the arm pit, chest, slowly moving to the rib cage and stomach/ I'm actually swollen/ abnormal retention in the area/ Puffiness; swelling towards the arm pit, chest, slowly moving to the rib cage and stomach; The pain moved from my arm, chest/sore arm; The pain moved from my arm, chest; Drowsiness; Shoulder pain; Hard to set my arm to the side of my body; May be effecting Multiple lymph nodes, puffiness that can be seen; This is a spontaneous report from a contactable consumer. A 25-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 14Sep2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Sep2021, consumer experienced swelling towards the arm pit, chest, slowly moving to the rib cage and stomach. Consumer stated, He had initial swelling. He was a body builder. He has developed muscles. He noticed in the definition of his chest muscles. The pain moved from my arm, chest. He was actually swollen. Hard to set my arm to the side of my body. The swelling moves around. It's an abnormal retention in the area. (maybe affecting) Multiple lymph nodes; puffiness that can be seen. Previous to the vaccine everything was ok. There was swelling now. Pain in arm,  lymphadenopathy from  document "how long side effects last: Swollen lymph nodes (lymphadenopathy), which generally resolved within 10 days, was likely to have resulted from a robust vaccine-elicited immune response. from VR no information on puffiness/abnormal retention that was moving from arms to chest, rib and stomach. Consumer stated that he was still experiencing. Added he did feel the typical sore arm; he noticed when he was working out, he was drowsy before lifting; he has some shoulder pain; then he noticed a swelling going toward his armpit and chest; now it was slowly moving to his ribcage and stomach. Adds he was fairly lean so maybe he can just see it; but he was asking is this normal? Therapeutic measures were taken as a result of all events. The outcome of events was not recovered.  lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Injection site skin reactions - Red, itchy, swollen, and painful rash at injection site
Father called the pharmacy to report that his son was out of it, had chills, fatigued and just not feeling like his normal self.
This case was reported by a consumer via call center representative and described the occurrence of chills in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 10th October 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 10th October 2018, less than a day after receiving SHINGRIX, the patient experienced chills, ear pain, pain, injection site pain and axillary pain. On 11th October 2018, the patient experienced rash. On an unknown date, the outcome of the chills, ear pain, pain and axillary pain were recovered/resolved and the outcome of the rash was not recovered/not resolved and the outcome of the injection site pain was unknown. It was unknown if the reporter considered the chills, ear pain, rash, pain, injection site pain and axillary pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm. The patient reported soreness up to her ear and under her left arm. The patient was a little sore the day before reporting, at the injection site and she had chills and was achy last night. The patient also had a rash start the day of reporting on her trunk. The patient claims that she only gets a rash when she had a virus.
Bivalent Covid vaccine administered to patient 5 weeks after 'beyond use date' and therefor dose is not valid. Patient did not have any adverse reactions after vaccine administration.
Bivalent (12 and older) administered as primary dose. No adverse signs or symptoms.
Its been a week my arm has about a 2 inch diameter red and hard behind it. and itches
The adverse effect i am having now is that, i am having insomnia, rectile dysfunction, and i do not even have the desire to have sex. inaddition got tired easly without doing any work, i was not experiencing any of these symptoms prior to the vaccine. now i donot know what to please, i need help immidiately.
noticed palpable supraclavicular swollen lymph nodes/swelling of supraclavicular lymph nodes on the right side; soreness in her right shoulder; This is a spontaneous report from contactable nurses.  A 34-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Deltoid Right at age of 34-years-old on 26Jun2021 (Lot Number: EW0182) as DOSE 1, SINGLE for covid-19 immunisation. Family history included Lupus. There were no concomitant medications. The patient previously received flu shot in Oct2019 at age of 32 years old for immunization and experienced allergies, weak and rashes on the leg. The patient experienced noticed palpable supraclavicular swollen lymph nodes/swelling of supraclavicular lymph nodes on the right side and soreness in her right shoulder in 2021. Clinical course reported as: nurse confirmed she received the vaccine on 26Jun2021, and the symptoms began about five days after, she was unsure of exact date or time of day, but reported she woke up and felt it, her shoulder was sore, and she thought ok because she just had the vaccine, and shoulder was sore, so it could be, and caller clarifies it was the right shoulder, and then she noticed the swelling. Nurse stated the swelling was persistent, it's not tender, but it's palpable and mobile, and added, when you feel it, it's slightly tender, but it's mobile and palpable, and small like a pea. No treatment received for the events. Outcome of soreness in her right shoulder was recovered in Jul2021, other event was not recovered. Event swelling of supraclavicular lymph nodes on the right side was reported as serious due to medically significant. Event soreness in her right shoulder was reported as non-serious.  The nurse classified the events as related to bnt162b2.; Sender's Comments: A contributory role of BNT162B2 to event noticed palpable supraclavicular swollen lymph nodes/swelling of supraclavicular lymph nodes on the right side and soreness in her right shoulder is considered possibly based on temporal association and known safety profile. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
This case was reported by a healthcare professional and described the occurrence of not responding to therapy in a female subject of unspecified age who was vaccinated with TWINRIX, GlaxoSmithKline.  On an unspecified dates the subject received 3 doses of TWINRIX (unknown).  At an unspecified time after vaccination with TWINRIX, the subject experienced not responding to therapy.  Laboratory results revealed that the subject was not immune.  At the time of reporting the outcome of the event was unspecified.
About 1/2 after receiving the shots my daughter started to complain that she was experiencing traveling numbness.  First her arm, then her leg.  She said the sensations kept moving around her body. Within an hour she was having blotches in her vision and felt extremely nauseated and was struggling to walk.  She became very weak and achy.   A doctor friend said it was somewhat normal and that she should lay down for a bit.  After about another hour she started to feel somewhat normal again.  She did complain of her hand bothering her several times on several different days.  Two months later she was at the ER 3 times for seizures and then hospitalized for 2 weeks.  Her diagnoses was anti-NMDA receptor encephalitis.  She is still in recovery.  The doctors do not know why or how the encephalitis occurred.  several of the symptoms mimicked what occurred after the vaccines were given but on a much more intense scale.
Redness swelling and tenderness in area of site in first 24 hours follow by fever up to 101.6 (0) and general malaise and leg pain.
Stomach cramping, muscle pain in arms, torso, legs, severe diarrhea, weak, unable to eat.