chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning an adult patient who within the lst week (approximately November 2005) was vaccinated SC with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine. Concomitant vaccine therapy administered on the same day included a dose of influenza virus vaccine (unspecified). The physician reported that within the last week (approximately November 2005) the patient developed redness only, at the injection site. It was mentioned that the patient may have been given a steroid. It was also mentioned that the nurse gave both shots in the same arm but no record could be found. There were no laboratory studies performed. The adverse event improved and the patient is recovering. There was no product quality event reported. No further information was available regarding the adverse event. The patient sought unspecified medical attention. Additional information has been requested.
A serious spontaneous report of fell down and went into seizures after FLUMIST has been received from a consumer concerning an eight-year-old female, subsequent to FLUMIST. The patient's medical history included three episodes of seizures, with the same characteristics as the current event, one year ago after taking TAMIFLU. The patient is not taking an concomitant medications. The patient received FLUMIST on 06-Oct-2009 at her pediatrician's office. Approximately one to two hours after receiving FLUMIST, the patient "fell down and went into seizures". The reporter, a friend of the patient's mother, noted that she did not witness the event but reported that it was described to her as the patient's "eyes rolling in the back of her head and periods of blacking out or sleeping, at which time she was unresponsive." The reporter added that when the patient's "eyes were open it didn't seem like she was focused and she was clumsy or could not grab things." The patient was taken to the emergency room (ER) and discharged from the ER the same day. The reporter was not aware of the treatment provided to the patient while she was in the ER. The event lasted approximately two hours and after the patient vomited, the event resolved. The sponsor assessed the seizure as an important medical event. Follow-up: 24FEB2010: Third follow-up attempt, no response No further information available.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 20-OCT-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot No. K001631, exp. 24-FEB-2017) (dose and site not reported). On an unspecified dates, the GARDASIL vaccine had six temperature excursions: 416, 24, 168, 336, 1172 and 80 hours respectively. The lowest recorded temperatures were 30 (-1.111111111 Celsius degrees) and -3 (-3 Celsius degrees). The highest recorded temperatures were 49 (9.444444444 Celsius degrees), 46 (8.333333333 Celsius degrees), 50 (15 Celsius degrees) and 48 (8.888888889 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Lymph node is swollen and uncomfortable under left arm pit.; Uncomfortable under left arm pit.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 05Apr2021 at 10:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, migraines, seasonal allergy and allergy to NSAIDS. Concomitant medications included tizanidine (MANUFACTURER UNKNOWN), montelukast (MANUFACTURER UNKNOWN), sumatriptan (IMITREX), paracetamol (TYLENOL) and multi v (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the right arm on 15Mar2021 at 10:15 (at the age of 46-years-old) as a single dose for COVID-19 immunisation and took aspirin (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 06:30, the patient experienced lymph node was swollen and uncomfortable under left arm pit. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events lymph node was swollen and uncomfortable under left arm pit was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Pt presents to hospital with seizure at 48 -72 hours within vaccine administered. Currently workup pending.
Hives. Epinephrine at urgent care on 4/7/18 approximately 5 PM with IM steroids and BENADRYL IM. BENADRYL at home approximately midnight 4/7/18. Rx steroids at Hospital on 4/17/18 12 PM. Started on PO steroids 4/8/18 at 9:30 AM. Throat was burning. Still has some hives today in office.
Initial unsolicited report received from a Consumer on 24 May 2016. This case involves a 16-years-old female patient who was vaccinated with a intramuscular dose of MENACTRA (batch number, expiration date, dose, site of administration was not reported) on an unspecified date in 2014. Illness at time of vaccination was reported as unknown. Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as asthma, seasonal allergies. Concomitant medications were not reported. On an unspecified date in 2014, following vaccination, patient developed weakness and pain in her lower legs. Symptoms progressed to the patient walking pigeon toed, her feet were became very cold with decreased circulation. Pain began at her sacral bone and continues down her legs to her toes. Her left foot was turned inwards and she had a hard time walking. She had been to her primary care physician and neurologist, and it was reported that there had not been a definitive diagnosis. It was reported that blood work: within normal limit. It was reported that patient underwent acupuncture for a time, that did help with the pain at first. The patient was not recovered from events. it was also reported that symptoms began slowly over a period of time and there had been no improvement. Case was considered as serious due to seriousness criteria: disability. List of documents held by sender: none. Sender's Comments: In this case, the patient developed Pigeon toe with left foot inwards, due to this she has difficulty in walking. pain over sacral area with radiating to lower leg and decreased circulation with cold feet after receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Time to onset is unknown. The final diagnosis was also not identified. Further information on the medical confirmation of the case, patient's medical history, treatment provided, lab data confirming the final diagnosis, etc. will be required for complete assessment. Based on the information available, a role of the vaccine cannot be assessed.
Experienced extreme muscle contractions 2 weeks after the second dose of the vaccine; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 46 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 46 years as dose 2, single for covid-19 immunisation. Family history included: "Disease Parkinson's" (unspecified if ongoing), notes: Family history includes Parkinson's disease (mother). Concomitant medication(s) included: NICOTINE. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: MUSCLE CONTRACTIONS INVOLUNTARY (non-serious) with onset Feb2021, outcome "recovered", described as "Experienced extreme muscle contractions 2 weeks after the second dose of the vaccine". Therapeutic measures were not taken as a result of muscle contractions involuntary.  Additional information: Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was reported that patient received more than 3 doses and the patient also received fourth dose of BNT162b2 (BNT162B2; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. The reporter stated that I do not have any further information. The person who reported the event indicated that he would be willing to provide follow-up information to Pfizer.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Case number PHEH2015US023222 is a spontaneous report initially received from a pharmacist on 09 Nov 2015. This report refers to a 28 year old female patient. Past medical history was not reported. The pharmacist was unsure of the vaccination status of the patient but in 2014 the patient received FLUARIX (other manufacturer) and tolerated the vaccination. Concomitant medications were none in patient profile. She was vaccinated with FLUVIRIN (batch number: 1514701) multi dose vial (MDV) intramuscularly at a dose of 0.5 ml into the left arm on 09 Nov 2015 at 11:00 AM. On 09 Nov 2015, a few hours after vaccination, the patient experienced pain in both ears. The event outcome was recovered. The seriousness and causality of the event was not reported. Follow up received from pharmacist on 29 Dec 2015: updated vaccination history, dose and anatomical location of FLUVIRIN, outcome of the event and other clinically relevant information in the narrative.
Swelling at site and soreness. It progressed to sensitivity to touch, loss of range of motion without pain, and at this point the pain goes from the shoulder to the fingers. I am unable to sleep on that arm without pain and it is difficult to put that arm into a sleeve or reach for anything without experiencing pain. It also prevents me from doing any needlework that brought me great pleasure.
Loss of taste; Off label use; A third (booster) dose of BNT162b2 was administered; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Oct2021 at 07:30 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included influenza vaccine (MANUFACTURER UNKNOWN) via an unspecified route of administration in the left arm on 19Sep2021 for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation. The patient received flu vaccine within four weeks prior to the COVID-19 vaccine. On 02Oct2021, the patient experienced loss of taste. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event loss of taste was not resolved at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
9/19/2017- Tdap Injection administered. 9/28/2017-Noticed an abscess at injection site on left arm, notified Nursing Supervisor, Nurse Practitioner, Supervisor. Nursing Supervisor notified Medical Director of incident and asked if CNP could treat me. This was approved and I was given KEFLEX 500mg 1 tablet, four times a day x 10 days. 10/3/2017- while meeting with a client I noticed the abscess begin to drain. I notified Primary Med. nurse and CNP who instructed me to come back to be seen. Nursing Supervisor, Nurse Practitioner assessed the area, irrigated the area with normal saline, and applied triple antibiotic and dressing. I was instructed to go to emergency room if symptoms worsened. 10/4/2017- Nursing supervisor and Primary Med. nurse assessed area and noticed that site was looking better but the fluid had moved to another pocket in my arm. Nursing Supervisor informed my supervisor of this and I was sent home. 10/5/2017- Nurse Practitioner and Nursing Supervisor inspected area to check drainage. Site is looking better no redness and no longer hot. Drainage is clear, noticed puss still in areas. CNP advised me to go see PCP today. Primary med. nurse scheduled appointment for today. I notified supervisor who will notify HR.
Narrative:  PT PASSED AWAY DUE COVID 19. HE HAD RECEIVED THE COVID 19 VACCINE.
Received Tdap - 10/14/08 @ 2 pm - c/o (R) ear itching before she went home form school. 10/15/08 - (R) ear swollen/red - (L) ear swollen. Since Wed., has noticed area red, and swollen on (R) skin area, abdomen and currently has an edematous area on the back of her neck with red outline. Mother states she did run fever - area appear to disappear after several days. Currently no temperature.
49 y/o male returned from clinic after first does of Moderna covid Vaccine around 11pm on 03/16/2021. After vaccine dose at  1012 waited 15 minutes and was released to return.  Around 1130 patient (self) noticed itchiness between fingers and a tightness in pulmonary system, and light headed ness ( Patient has a history hay fever and mold). Patient took 25mg orally loratadine and had relief of symptoms 30-45 minutes after ingestion around 1145. On 03/17/ 2021 around 1130 am lightness of head, pulmonary tightness and itchiness between fingers and flush around the face again took 25mg Loratadine at 1209hrs  now at 1252hrs symptoms subsided .
Chills and marked shivering over a period of approximately 3 hours. The shivering was extreme enough at the outset that it was difficult to walk. Initially, heavy bedclothes and an electric blanket had little effect. The effects gradually decreased so that sleep was possible by the 4th hour. No effects were apparent by 7:30 am.
patient  had a couple of shots in December and thought she had an allergic  reaction .took benadryl and was ok  . I gave the shot and had her wait for thirty minutes . After ten minutes she said she was feeling funny  ,maybe just anxious ,pulled up another chair by her and her neck up was getting red ,gave her thirty ml of liquid benadryl and called 911 ,she got better while I was on the phone ,no closing of throat .emergency services arrived and she decided to go to the hospital
Within 36 hrs of injection - became very weak unable to get off the sofa achy - everywhere headache lasted 4 days rash all around neck low BP lowest 68/46 P 63 runny nose dry non-productive cough doc visit 9/8 chest x-ray done pneumonia - antibiotic started (right lower lobe) 9/30 re-examination chest x ray healing some pneumonia persists.
This spontaneous report as received from a medical assistant refers to a 14 months old male patient without or drug reactions/allergies and a history of cleft palate repair when was 4 months old, which was vaccinated on 29-OCT-2012 with a dose of VARIVAX (Merck) (lot number reported as: H011913, expiration date: 14-JUN-2014) (dose, indication and route were not reported) and a dose of M-M-R II (lot number reported as: 1450AA, expiration date: 13-SEP-2013) (dose, indication and route were not reported). Concomitant medications included: FLUZONE. The medical assistant reported that on 08-NOV-2012, the patient developed vesicular rash on the elbows following vaccination with VARIVAX (Merck) and M-M-R II. The vaccines of FLUZONE, VARIVAX (Merck) and M-M-R II was placed on separate sites on 29-OCT-2012. The patient was treated with TYLENOL for the adverse event. The patient sought medical by office contact. At the time of the report, the patient was recovering from the adverse event. The relatedness for the adverse event was unknown for M-M-R II and VARIVAX (Merck). This is one of the several reports from the same source. Additional information has been requested.
This spontaneous report was received from a nurse via a company representative and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On an unknown dates, the patient was vaccinated with three doses of unidentified Merck HPV vaccine (strength, route of administration, dose, frequency, lot number and expiration date were not reported) (reported as the patient completed GARDASIL series). On an unknown date, the patient was inadvertently vaccinated with the fourth dose of unidentified Merck HPV vaccine (strength, route of administration, dose, frequency, lot number and expiration date were not reported). It was unknown if GARDASIL or GARDASIL 9 was used for completed series and for extra fourth dose. No adverse effects were reported. Product quality complaint was not involved. Additional information has been requested.
Chills throughout the the night. Felt a little nauseated in the morning. Lasted about 18 hours.
flat rash around injection site; redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (flat rash around injection site) and VACCINATION SITE ERYTHEMA (redness around the injection site) 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 VACCINATION SITE RASH (flat rash around injection site) and VACCINATION SITE ERYTHEMA (redness around the injection site). At the time of the report, VACCINATION SITE RASH (flat rash around injection site) and VACCINATION SITE ERYTHEMA (redness around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medicines was not reported by reporter  Treatment information was not provided   This case was linked to MOD-2021-017996 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: follow up received on 16-jun-2021 contains no new information
Half hour after receiving injection, patient experienced hives that went down side of arm. Patient took BENADRYL and hives turned into a bump on bicep that still has not gone away three days after injection. Patient will call doctor one week after injection if still symptomatic.
Pt received Td, pneumonia and flu on 11/16/05. On 11/18/05 arms sore, shoulders upper body. Appt to doctor due to knee 11/17/05. Next week could not use upper body. 11/29/05 DR cortisone inj- anti inflammatory seldane. MRI performed 12/9/05 recommend WNL - head and neck U/S to R/O stroke. Back to MD 12-12-05 stated had to be Tetanus and Diphtheria. Dx inflammatory myopathy. Had a fever 12/9/05 has been running a low grade fever. Start prednisone today - 12/16/2005. Flu vaccine adm by Medical Center on same day 11-16-05 as pneumonia and Td. Flu adm in right deltoid. Phone CMC 12-19-05 spoke to  person to report reaction at 2:06 pm. Instructed HD completed a varies report form.
I was at a checkup and had an X-Ray. They thought I had Pneumonia and was prescribed Doxycycline Hyclate. They said I needed another x-ray a month later and when I went in, they still saw a mass on my lungs. That is when they scheduled a CT scan and PET Scan. I went to a Pulmonologist, and he told me that I had lung cancer and that I needed surgery as soon as possible. I had the operation on 01/31/23. They took out 10 lymph nodes and the middle lobe of the right lung and told me that I did not have cancer. They sent off a specimen to the Clinic, and I still don't have the results yet. I go back to the Pulmonologist on 5/31/23 for the results.
About 8pm I began t experience total body itching.  At 11pm the itching was too much to allow for sleep.  I took two Gabapintin 300mg.  At 4AM I went to sleep.  I contactedmy dermatologist.  He suggested the vaccine may have started a Grover's response.  He asked that I add Zyrtec (over the counter) to my meds.  He asked that I continue hydrating my skin with Vanicream cream.  I folllowed his advice.  The itching stopped on Sunday.  I continued with the Zyrtec but stopped the Gabapintin.   Today, Tuesday, I am having muscle tightening, especially in my legs.
Lot numbers not documented for dose 1 and 2.  Runny nose and congestion started 10/4/21
JOINT, HAND, ARM AND SHOULDER PAIN. SEVERE NAUSEA, LEG TINGLING AND PAIN. CHEST PALPITATIONS. GENERAL WEEKNESS AND TIREDNESS.
On 10/9/2021 the first night post vaccine, I awoke to my right leg completely asleep, pins and needles sensation and very little mobility. On 10/10/2021 the following night I awoke to the same symptom only not as pronounced. That night I want to the local emergency room to rule out anything serious such as a stroke blood clot exc. Blood was drawn with negative results for anything requiring emergency medical attention. I was allowed to leave.  On Monday 10/12/2021 that evening I felt my heart racing and my left arm felt numb.  I checked my self into the local Er and an EKG and blood was drawn everything came back ok and I was allowed to leave. The ER doctor prescribed me some pills for anxiety. The days prior I began to experience brain fog and twitching in my muscles.
Chills; Nausea; Fatigue; This is a spontaneous report received from a contactable healthcare professional.  A 52-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "Heart conditions" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown"; FATIGUE (non-serious), outcome "unknown".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200071855 Same patient and product; different dose and event.
Pt received one dose of Flulaval which is indicated for adult use only.  Injection was given in the left deltoid.  Per pt no reaction to vaccine.
Twenty four hours after booster vaccination with Moderna (dose 3) and concurrent w/ known side effects of the vaccine, I experienced mid-cycle menstrual spotting on days 12 through 15 of my cycle. I have never experienced mid-cycle spotting, I was not under stress, and the 36 cycles prior averaged 27 days in length.