chrisvoncsefalvay/vaers-outcomes huggingface dataset:
numbness on his left leg and one time with left arm/His left leg went numb seven or eight times; could not walk; This is a spontaneous report from a contactable consumer (the patient). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EW0164, expiry date Aug2021), via an unspecified route of administration on 13Mar2021 (at the age of 61-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: hypertension and allergic to bees. The patient had an EpiPen. He would have to use it if he ever got stung. He has never had to use an EpiPen. Concomitant medications included: hydrochlorothiazide/ lisinopril (LISINOPRIL + HIDROCLOROTIAZIDA) taken for hypertension, for maybe 8 years. The patient had other unspecified concomitant medications. After receiving the Pfizer COVID vaccine, the patient experienced numbness on his left leg and one time with left arm. His left leg went numb seven or eight times. His left arm went numb one time. He thought maybe it was just going to sleep. He usually slept on his arm, and it woke up that way. But he was walking, and it went numb; it was very strange. There was no pain. It began about two and a half weeks ago (2021). It has happened twice today, so he thinks it is getting worse. It was also lasting longer. Today (unspecified date 2021), his left leg went numb so much that he could not walk. He was walking, and he had to stop and stand there for 10 minutes before the feeling came back. It was very strange. His leg numbness was the most serious today. After this last episode of leg numbness, he called his insurance company, and made an appointment with his medical provider on Monday. He was reluctant to take the second dose of the COVID vaccine. The patient stated he occasionally took vitamin D, fish oil, vitamin C, and aspirin. The outcome of the event could not walk was unknown. The outcome of the other event was not recovered.
Shot site got red, also had a line about 4 inches long that was hard and itchy. After about 9 days the red mark has gone away. The hard line is now gone, but I still have some itchness in the area. I did not go to the doctor, I just waited to see if it would go away or get worse over the first weekend.  It did not get worse, but did take several days to go away.
Severe GI Bleed.  After 3 days in hospital and test, diagnosed with Diverticulosis
Chills, moderate pain, redness at injection site, muscular pain in shoulders and both arms, general malaise, weakness. It felt like I had the flu but with no fever. All subsided, (except some soreness at injection site), by early afternoon of 03/13/18.
Shingrix: Late 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date received 1st dose.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Shingrix: Late 2nd dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 09-NOV-2023 The patient was late for 2nd dose. The reporter consented to follow up.
Nerve damage; expressed continued soreness; This case was reported by a pharmacist via other manufacturer and described the occurrence of nerve damage in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 2 months after receiving Shingrix, the patient experienced nerve damage and pain. On an unknown date, the outcome of the nerve damage and pain were unknown.   The reporter considered the nerve damage to be related to Shingrix. The reporter considered the pain to be possibly related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had a patient and expressed continued soreness some 2 months later.  The reporter then speculated if this could be due to nerve damage caused by the shot and wanted to know what thought.
Body aches; Headache; Sore throat; Slight fever; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced body aches, headache, sore throat and slight fever. It was reported that event took place after use of product. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient tested positive for COVID-19 post vaccination. Patient tested due to facility wide testing. Patient running a low grade fever at time of testing. Patient placed in droplet isolation. Select vitamins added to medication regimen for increased healing.
Redness, warmth, tenderness consistent with a cellulitis. Noticed June 3, 2015. Seen in office June 9, 2015. Given KEFLEX 250mg 4 x daily for 7 days.
large local rxn w/numbness on rt side of head & whole lt side of body w/in5mins of vax;treated w/DPH & completely resolved w/in 3 days;
shingles; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 06-FEB-2013, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to inoculation with zoster vaccine live (ZOSTAVAX), the pt was treated by a healthcare provider at a practice for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the event was considered to be not recovered. The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Patient stated she "felt funny" approx 20 s/p vaccine.  NP assessed patient after  she arrived to school health office.  Pt A&O x3 sitting on exam table. Vital signs 92/76, HR 102, RR 16 PSO2 99%.  Patient stated she felt dizzy and her arm hurt. Skin pale & warm.  Given 4oz of juice & saltines. Patient felt better after 5 min.
15 MINUTES AFTER VACCINATION, PATIENT HAS A SKIN RASH ON HER FOREARMS AND FEELS LITTLE ITCHING. SHE TAKES ONE DOSE OS 2 TABLETS OF DIPHENHYDRAMINE 25MG. AFTER 6 HOURS LATER, HER SKIN RASH DIMINISHES AND SHE DOES NOT ITCHING ANYMORE. SHE DOES NOT NEED TO USE THE SECOND DOSE OF DIPHENHYDRAMINE. ON DAY 2, SHE ONLY FEELS SORENESS AND TENDERNESS AT STITE OF INJECTION. ON DAY 3, SHE FEELS SORENESS BUT WITH MUCH LESS EXTENT.
Fever Blisters / cold sores broke out all over lips, outer and inner mouth, fever chills
Patient had swollen hands 4 days after getting the 1st dose, no redness and allergy; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced patient had swollen hands 4 days after getting the 1st dose, no redness and allergy on an unspecified date with outcome of recovered. This case was reported as non-serious.  Information on Lot/ Batch number has been requested.
Patient reports she had rash on her arms, and trunk and had persistent itching on her trunk, arms, legs, and back.
Soreness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 20-Jan-2021, the patient experienced MYALGIA (Soreness). At the time of the report, MYALGIA (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Diarrhea, vomiting on third day after vaccine, nausea, light-headedness, foggy brain, given Zofran for nausea
Cough in the morning comes and goes after the 2nd primary shot; Shaking for a long time after the 2nd primary shot; Short of breath on walking and at rest after the 2nd primary shot; Shivering for a long time/Shivers come and go and last for 1.5 hours each time, 1 year and 2 months after the 2nd primary shot; Got Sick (Not known if it was COVID)/Very sick but continued going to work several months after the 2nd primary shot; This spontaneous case was reported by a patient and describes the occurrence of COUGH (Cough in the morning comes and goes after the 2nd primary shot), TREMOR (Shaking for a long time after the 2nd primary shot), DYSPNOEA (Short of breath on walking and at rest after the 2nd primary shot), ILLNESS (Got Sick (Not known if it was COVID)/Very sick but continued going to work several months after the 2nd primary shot) and CHILLS (Shivering for a long time/Shivers come and go and last for 1.5 hours each time, 1 year and 2 months after the 2nd primary shot) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced COUGH (Cough in the morning comes and goes after the 2nd primary shot), TREMOR (Shaking for a long time after the 2nd primary shot), DYSPNOEA (Short of breath on walking and at rest after the 2nd primary shot) and CHILLS (Shivering for a long time/Shivers come and go and last for 1.5 hours each time, 1 year and 2 months after the 2nd primary shot). In 2021, the patient experienced ILLNESS (Got Sick (Not known if it was COVID)/Very sick but continued going to work several months after the 2nd primary shot). At the time of the report, COUGH (Cough in the morning comes and goes after the 2nd primary shot) and CHILLS (Shivering for a long time/Shivers come and go and last for 1.5 hours each time, 1 year and 2 months after the 2nd primary shot) had not resolved and TREMOR (Shaking for a long time after the 2nd primary shot), DYSPNOEA (Short of breath on walking and at rest after the 2nd primary shot) and ILLNESS (Got Sick (Not known if it was COVID)/Very sick but continued going to work several months after the 2nd primary shot) outcome was unknown.      No concomitant medications were reported.  After the first shot, the patient was fine.  Patient stated that several months after vaccination he was sick, and he did not know if it was COVID. He did not see the doctor. He was very sick but continued going to work. It was 1 year and 2 months since received 2 shots. Ever since the 2nd shot, he got shivers on and off. It comes and goes and last for 1.5 hours. He had to clear his throat all the time. The patient never called a doctor nor visited the doctor's office for these symptoms.  No treatment medications were reported.
Influenza string B; This is a spontaneous case from initially received from other health professional (nurse) via agency (reference number: SEQ20-00382) on 27-Jan-2020, concerning a 9-year-old, female patient.   The patient's medical history was not provided. The patient had no concomitant medications.  On 28-Sep-2019, the patient was administered Flucelvax QIV [influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 261204, and expiration date: 26-Jun-2020] for prevention of seasonal influenza.  On the same day, after vaccination, the patient underwent testing and was positive for influenza, string B. On 26-Jan-2020, the diagnosis was confirmed with symptoms of feeling sick and fever. The patient received a prescription for Tamiflu (oseltamivir phosphate).  At the time of this report, the outcome for the event of influenza, string B, was not reported.   Per company, the event of influenza, string B, was assessed as serious due to the criterion od medical significance.  The reporter did not provide causality assessment to Flucelvax QIV.  Company comment: The patient experienced influenza on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is not compatible because the incubation period for flue is between one and four days. No medical history, concomitant medications and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the event is assessed as not related.; Sender's Comments: The patient experienced influenza on the same day after vaccination with the suspect product, Flucelvax QIV. Chronology is not compatible because the incubation period for flue is between one and four days. No medical history, concomitant medications and diagnostic findings were provided. Considering all the above mentioned, causality between suspect product and the event is assessed as not related.
Information has been received from a registered nurse concerning a 26 year old female patient who in 2004 was vaccinated with a dose of PNEUMOVAX 23 (lot# not reported) and a dose of influenza virus vaccine (unspecified) at the same time in the same arm. Following the administration the patient developed an anaphylactic reaction for which she was rushed to the emergency room and treated for respiratory distress, the patient was hospitalized. Subsequently, the patient was discharged and fully recovered. Respiratory distress and anaphylactic reaction were considered to be immediately life-threatening, disabling and other important medical events by the reporter. Additional information has been requested.
I have swelling in my throat. I went to my doctor. He sent me to the ear nose and throat specialist. The ear nose and throat specialist couldn't find anything wrong. But I know something is wrong. I can feel the swelling in my throat.  I also went to have my thyroid checked at the same facility, but they couldn't find anything wrong with my thyroid.
Brain Fog, Migraines, pain at base of skull and neck, Vertigo, anxiety, depression, tingles in neck and arm, vision loss and spots in eyes.
no adverse event; patient whose date or birth is 1/16/2022 received PNEMOVAX 23 on 9/7/2022; This spontaneous report was received from a registered nurse and refers to a 7-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On 07-SEP-2022, the patient was vaccinated  with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23)(strength, dosage regimen, lot #, expiry date, anatomical location, and route of administration were not provided) as prophylaxis (Product administered to patient of inappropriate age). No adverse event was reported.
Red raised bump size of silver dollar. Hot to the touch. Firm to the touch x 7 days.
Myalgia, Fever, FATIGUE/SWOLLEN LYMP NODES Narrative:
bad headache; tiredness; dry heaves; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (bad headache), FATIGUE (tiredness) and RETCHING (dry heaves) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concomitant products included APIXABAN (ELIQUIS), CELECOXIB (CELEBREX), METOPROLOL SUCCINATE and LOSARTAN POTASSIUM for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced HEADACHE (bad headache) (seriousness criterion hospitalization), FATIGUE (tiredness) (seriousness criterion hospitalization) and RETCHING (dry heaves) (seriousness criterion hospitalization). At the time of the report, HEADACHE (bad headache), FATIGUE (tiredness) and RETCHING (dry heaves) outcome was unknown.            No treatment information provided.  Concomitant medications include Eliquis, Celebrex, High cholesterol drug, Metoprolol succinate, Losartan potassium.  Company Comment: 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.   This case was linked to MOD-2021-138131 (Patient Link).; Sender'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.
Within 5 hrs patient developed diarrhea, increased lethargy and aggression. Diarrhea has continued 8 months post vaccination.  Pt became aggressive and self injurious the day following vaccination which has lasted several months. Pt had massive speech regression following vaccination. Currently seeking autism diagnosis.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as "between 19-SEP-2014 and 17-NOV-2014"), unspecified number of patients were vaccinated with a dose of GARDASIL (lot number, expiry date, dose, route were not reported), that was improperly stored. GARDASIL was unsupported with in-house stability data. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Allergic reaction; hives; This is a spontaneous report from a contactable consumer, the patient, received through the agency. A 29-year-old [non-pregnant] adult female received the second dose of intramuscular BNT162B2 (solution for injection, Lot unknown expiry information not provided) as a single dose in the left arm on 06Apr2021 at 14:00 (at 29-years-old) for COVID-19 immunization. Relevant medical history included Anaphylaxis, Polycystic ovarian syndrome (PCOS), and known [unspecified] allergies. Concomitant medications included drospirenone, ethinylestradiol betadex clathrate (YAZ); escitalopram oxalate (LEXAPRO); metformin; cetirizine hydrochloride (ZYRTEC); vitamin D NOS; and cyanocobalamin (VITAMIN B 12). The patient denied any diagnosis of COVID prior to receiving the vaccine and the patient was not pregnant at the time of vaccine. The patient denied being tested for COVID-19 since receiving the vaccine. The patient previously received COVID-19 immunization with the first dose of intramuscular BNT162B2 (solution for injection, Lot unknown expiry information not provided) as a single dose in the right arm on 16Mar2021 at 13:00 (at 29-years-old). The patient reported that on 06Apr2021 at 17:00 she experienced an allergic reaction including hives; which resulted in a visit to an emergency room/department or urgent care. Treatment for the events included intravenous steroids and oral steroids for six days after, as well as diphenhydramine hydrochloride (BENADRYL). The outcome of the events Allergic reaction including hives was recovering.   Information on batch/lot number has been requested.
Night sweats, muscle aches, headache, fatigue, dizziness, lighted headed, brain fog all began less than 24 hours after vaccination. Period cycle started early and was very intense cramps, heavy bleeding, vomiting. To date, the headache, dizziness, light headed, brain fog and fatigue are still being experienced 13 days after being vaccinated. I called a nurse line on 4/16/2021 to talk over my side effects and was told to visit an urgent care center, who then sent me to the ER for bloodwork and an MRI of the brain. Was told all results came back normal, to continue to monitor myself and make an appointment with a primary care physician if I feel the same in week.
Dizziness, Headache, Fever, Fatigue, lymphadenopathy Narrative:  . I felt some dizziness, like a migraine, with distortion of my vision on Friday evening. I had a pretty awful headache and extreme arm pain and some swelling through Saturday morning. I had a fever and general fatigue. I still have a headache and swollen, painful lymph nodes on the side I received the injection on  Other Relevant History:
Pfizer vial was expired on 4/12/22 @ 10:00am (10 weeks from date placed into the fridge). It was not removed from fridge in timely manner and was given to this patient on the morning of 4/14/22 @ 10:35 am. Pfizer manufacturer was contacted and they did say there is a two day shelf stability grace period but this dose given does fall outside of the grace period by about 35 minutes. They said to contact CDC about guidelines weather or not re-administer and once we contacted CDC, they said to contact Pfizer.  Left voicemail for patient to inform them of the situation.
ON 10/29, HPV, VARICELLA, AND FLU ADMINISTERED; 11/01 PARENT/PT RTC WITH CELLULITIS AT IMMUNIZATION SITE.  PT TREATED EMPIRICALLY BY SAME PROVIDER WITH COURSE OF KEFLEX. PT MEDICALLY EXCUSED FROM SCHOOL X 2DAYS.
No adverse event/reporting error in dose given-Patient received a Pentacel in error instead of Hib in addition to a Pediarix dose.