chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her 12 month old daughter who has a history of urinary reflux of the right kidney. On 05/29/2001, the pt was vaccinated with one dose of varicella vaccine. Concomitant therapy that day included one dose of MMR vaccine and one dose of Prevnar. Other concomitant medication included Bactrim. On 06/09/2001 the pt developed a cough and did not sleep well. On 06/10/2001 the pt's mother reported that her daughter felt warm, and on 06/11/2001 the pt developed a temp of 102.3 deg. F and was pulling on her ear. On the same date, she was taken to the doctor's office and the mother reported that the doctor said "she probably just had a cold." The physician later reported that pt was diagnosed with croup. On 06/13/2001, the pt developed spots and was described as having approximately 5 dozen on her stomach, 3 dozen on her back and was beginning to develop them on her neck, cheek, ear and into her hair. The mother reported she called the physician and he said it sounded like chicken pox. Upon follow-up, it was reported by the physician that no adverse events were noted "here in our office" and that the pt recovered. No further info is available.
This spontaneous report was received from a pharmacist, via a company representative, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9, (route of administration, lot # and expiration date were unknown), in the following series: 0, 4 and 6 months. No adverse effects were reported. Additional information is not expected, no permission for further contact was provided.
PT HAD RASHES ON THE FACE, NUMBNESS ON THE RIGHT ARM, DIZZINESS. EPINEPHRINE WAS ADMINISTERED 0.25 CC. IM
Hives and itching on left arm. Mild shortness of breath but no wheezing, facial or mouth swelling and no difficulty swallowing. O2 sat 99% on room air. Given 50 mg of Benadryl, EMS called and transported to ED in stable condition
Pain, redness, warmth and swelling at site of vaccine (Hep B). Patient went to ER and had ultrasound.
Unilateral numbness; migraine; headaches; pressure behind eyes; pressure in one ear; pain in left chest; cramps legs, feet, side-noted well hydration; short/sharp pain in side; forgetfulness; body aches; tired; rash; pressure in chest with deep breaths; pounding heart (yet normal heart rate); This is a spontaneous report from a contactable consumer or other non-HCP. A 31-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0164), via an unspecified route of administration, administered in left arm on 17Apr2021 as dose 1, single (at the age of 31-years-old) for COVID-19 immunization. Medical history included Allergic reaction to yellow jacket (bees) (Allergy to arthropod sting), gluten (intolerance). Concomitant medications/other medications within 2 weeks of vaccination included ibuprofen; paracetamol (TYLENOL); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). Facility where the most recent COVID-19 vaccine was administered as Doctor's office-urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 17Apr2021 the patient experienced unilateral numbness(entire left side of body for 3 days), migraine, headaches, pressure behind eyes, pressure in one ear, pounding heart (yet normal heart rate), pain in left chest, cramps legs, feet, side-noted well hydration, short/sharp pain in side, forgetfulness, body aches, tired, rash, pressure in chest with deep breaths. A few more days of unilateral numbness even during prednisone treatment. Lab test includes normal heart rate (unspecified date). Therapeutic measures were taken as prednisone as a result of unilateral numbness, migraine, headaches, pressure behind eyes, pressure in one ear, pain in left chest, cramps legs, feet, side-noted well hydration, short/sharp pain inside, forgetfulness, body aches, tired, rash, pressure in chest with deep breaths. Device Date mentioned as 27Sep2021. The outcome of all events was unknown. Follow-up attempts are completed. No further information is expected.
Rash & swelling.  Received vaccine at 10:00a this morning.  Site was mildly sore but that greatly increased from 5:30p-7:30p and hasn?t improved.  Applied heat a couple times with a bean bag warmed in the microwave.  Was getting ready for bed at 10:00p and noticed the rash.  I hadn?t looked at the injection site since 5:00p but there was no rash at that time.  It does not itch nor is it raised.  I took a picture and drew an outline to see if it gets worse.  There is some mild swelling in the area as well.
Pt's email: "About 4 hours after the injections I developed a rash all over my body (purple splotches about the size of freckles, not raised or itchy), my muscles tightened up a lot and got achy (especially muscles I'd worked out in the past day), and I started shaking uncontrollably (I couldn't insert the power plug into my phone to recharge it). I called the advice nurse since I was home alone and was concerned that the symptoms could advance quickly and no one would know I was in trouble. Since I didn't have trouble swallowing, breathing or have a significant temperature the advice nurse didn't recommend I head in to Emergency and had a doctor call me a couple of hours later. The symptoms subsided over the next hour. The doctor recommended that I take 1000 mg of TYLENOL, which I did, and all was fine thereafter". Pt has had Influenza vaccinations in past.
Information has been received from a health professional concerning an approximately 21 week old male patient who on 10/29/01 was vaccinated with the first 0.5 ml dose of Haemophilus b conjugate vaccine (+) hepatitis B vaccine (yeast). Concomitant therapy on 10/29/01 included a dose of diphtheria toxoids/pertussis vaccine/tetanus toxoid (manufacturer not reported) HIB conjugate vaccine (manufacturer unknown) and poliovirus vaccine (manufacturer not reported). On 01/07/02, the patient was vaccinated with the first 0.5 ml dose of Hepatitis B vaccine recombinant (yeast) (manufacturer unknown). Concomitant therapy on 01/07/02 included the second dose of 0.5 ml dose of HIB conjugate vaccine (manufacturer unknown), the second 0.5 ml dose of diphtheria toxoid/pertussis vaccine/ tetanus toxoids (manufacturer not reported) and the first 0.5 ml dose of poliovirus vaccine (manufacturer unknown). It was reported that the the patient had his shots at 2 months and 4 months and about 2 days later, developed nodules on both of his legs. The reporter's office thought that the patient might have an infection,and they gave him an "INO" procedure. The physician at the office sent the patient to a dermatologist to see if he had an allergic reaction to the vaccine. The dermatologist then sent the patient to a university, where they thought the patient was allergic's to the alumnium in the vaccines. It was reported that the patient sought medical attention (physician's office). No other information was provided. Additonal information has been requested.
PERIPHERAL NEUROPATHY SYMPTOMS; This spontaneous report received from a consumer concerned multiple patients of unspecified race and ethnicity. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, 1 total, start therapy date was not reported for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patients experienced peripheral neuropathy symptoms. Consumer stated that there are 'several hundreds if not thousands of people' who are having peripheral neuropathy symptoms, after receiving all three available covid-19 vaccines (non-company vaccines included) and definitely some of them (exact number is unknown) received the Janssen Covid-19 vaccine. The consumer read this on social media boards. It was stated that 'Young healthy people' are reporting this. No more information was reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of peripheral neuropathy symptoms was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211020241.; Sender's Comments: V0: 20211021687 -covid-19 vaccine ad26.cov2.s- peripheral neuropathy. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
No additional AEs reported; GARDASIL 9 was administered following a temperature excursion; This spontaneous report was received from an office manager referring to a 12-year-old male patient.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 30-NOV-2022, the patient was vaccinated with one dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) pre-filled syringe injection, administered as prophylaxis (there were five possible lot # of the vaccine administered: lot #1775811, expiration date: 07-DEC-2023; lot #1775827, expiration date: 27-JUN-2024; lot #W009829, expiration date: 19-OCT-2024; lot #U032681, expiration date: 26-OCT-2023; and lot #1780876, expiration date: 09-NOV-2023; however, it was not specified which one was received by the patient) (strength, dose, route of administration, anatomical location, and vaccination scheme were not provided). It was reported that the vaccines suffered from three temperature excursions with a total of 25 minutes (on 09-SEP-2022 for 8 minutes; on 16-SEP-2022 for 5 minutes; and on 03-JAN-2023 for 12 minutes). The excursions were not noted until it was noticed that an employee mistakenly cleaned the data logger more than once a day (product storage error). There were no additional adverse events (AEs) reported in the patient (no adverse event).  This is one of several reports received from the same reporter.
Approximately 5 minutes after receiving the vaccine, patient reported moderate lightheadedness with blurred vision.  In the next 10-15 minutes, patient started to report mild SOB (thought it was anxiety) and fatigue.  Patient's fatigue increased and was visible by eye droop, bilateral and some head swaying.  Rapid Response called and patient taken to the ED for observation and to be seen by a provider.  Follow up call on 12/30 made.  Patient reported that her symptoms continued once in the ED, but was released after several hours because all testing completed in the ED was normal.  Patient reports all symptoms have resolved except for muscle pain in the arm she received the vaccine.  Patient contacted her primary.  Writer asked patient to ensure she talks with her provider to determine if she should receive the 2nd dose.
Patient received the flu shot at 1500. By 1630 her throat started to itch and burn and her chest began to hurt. By 1920 she became short of breath and took a BENADRYL at 1930. When she presented to the emergency department at 2100, worsening facial itching, worsening facial swelling, and difficulty breathing. Patient was given BENADRYL, PEPCID, and SOLUMEDROL 125mg injection. Patient was discharged from the emergency department with improving symptoms at 2200.
Sore arm with first and second; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 10:00 (Lot number: Ew0150) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Asthma, possible fibromyalgia; "Possible Fibromyalgia" (unspecified if ongoing), notes: Asthma, possible fibromyalgia; "Known allergies: Sulpha antibiotics" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies, codeine", notes: Sulpha antibiotics, codeine. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Sore arm with first and second".  Additional information: Patient did not recieved any treatment. Patient did not had covid prior to vaccination and not covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
continuous headache; right arm whelp/pain; diarrhea (two days); ringing in ears (both); hot legs (as if lower body dipped in icy hot or bengay); tight throat
Per reported event - Received 2nd mandated Pfizer injection right deltoid today at 8:30 am at the  medical pavillion.  Within 30 minutes felt itchy on inside of right upper arm, and then noted red, raised rash. Rash spread across  upper chest to upper left arm. 10:30 am Benadryl 50 mg  IM left gluteal muscle. 11: 30 am Sent to ED via ambulance for worsening of respiratory symptoms
So sick; A spontaneous report was received from a patient on unknown age and gender who received Moderna's COVID-19 Vaccine and experienced the event "so sick".  There were no medical history and concomitant medications provided.  On 27 Dec 2020, the patient received the first of two planned doses of mRNA-1273 (Lot number was unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 29 Dec2020, the patient reported that they took the shot 27 Dec 2020 and were so sick. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, so sick was unknown.; Reporter's Comments: This case concerns a patient of unknown age and gender who received the first of two planned doses of mRNA-1273 (Lot number was unknown) intramuscularly for prophylaxis of COVID-19 infection and experienced a non-serious unlisted event "so sick" two days later. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Edema, erythema, and pain at right upper arm subcutaneous injection site. MD treatment: AUGMENTIN.
Pt presents to clinic with c/o redness and swelling in lt upper arm, reports mild tenderness, rates 2/10. Pt had a PREVNAR 13 on 3/22. Reports that he just noticed the redness and tenderness yesterday. Red area noted approx. 3" diameter on lt upper arm. No drainage or open area.
Came down with shingles - May 14; Mid July - muscle weakness left leg, September - left calf paralyzed, fasciculations, abnormal EMG, paralysis expanding to feet, consulted 2 neurologists who do not have any answers.
Almost 3 weeks ago I received my 2nd Pfizer vaccination for COVID. I had some swelling in my armpit. A hard bump also appeared between my right leg and crotch. My armpit feels 100%, but the bump has not gone away. Concerned, I wanted to get it checked out. I set up an appointment for the earliest possible, 6-29-2021.
It is not clear if this reaction was a direct result of the flu vaccine, but no other cause was found.  Patient developed significant swelling on the right side of her face on the next morning following administration of the vacccine.  She awoke with this swelling.  There were no other associated symptoms or complaints, and the swelling resolved without incidence throughout the day.  Patient was advised to seek consultation with the physician, however because her condition continued to improve, she did not see a physician.
No additional AE; inadvertently administered ROTATEQ after 15 weeks of age; This spontaneous report was received from an other healthcare professional (HCP) and refers to a 15 weeks and 4 days old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-APR-2023, the patient was inadvertently vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml, lot number: 1938974, expiration date: 30-APR-2024, administered for prophylaxis (strength, and route of administration were not provided) after 15 weeks of age (product administered to patient of inappropriate age). No symptomatic side effects were reported during the time of the call and no additional adverse event details were provided (no adverse event).
About 2 minutes after receiving vaccine the individual reported feeling light headed.  He also described an uncomfortable tingling sensation in his throat.  Blood pressure had been normal prior to vaccination and became elevated.  After about 30 minutes of persistent reaction, one dose of epi-pen (generic) was given.  About 3 minutes after receiving the epinephrine he felt safe to stand up and more to a more comfortable chair.  Lightheadedness, throat sensation, and elevated blood pressure resolved.  He stayed another 15 minutes for observation and has no return of symptoms.
14 mo girl w/ SCID s/p 1 dose ROTATEQ at 2 months of age admitted to hospital for failure to thrive 10/08 transferred to another hospital in 11/08. Found to be Rotavirus Ag (+) and subsequently diagnosed with SCID. Now s/p bone marrow transplant x 2 with chronic rotavirus shedding/infection.
Information has been received from a registered nurse concerning a 6 year old female with no relevant medical history who on 7/15/03 was vaccinated on the left side SC with a first dose of varicella virus vaccine live. There was no illness during vaccination. On 5/5/04, at 10:00 AM, the patient developed only 11 pox. There was no diagnostic laboratory tests performed. Subsequently, the patient recovered on 5/11/04. Additional information has been requested.
Since 12 Mar2021 I have had my  menstruational period every day, give and take a few days.  My second dose of the vaccine was on 25Feb2021 and my schedule period was on 2Mar2021. I have my routine period that week and then it began again on 12Mar2021 and I have not stopped spotting since.
left arm started swelling , redness during the night. Mom noticed in am. Redness from shoulder to elbow, no circumferential but covers all dorsal aspect.
mild form of Bell's Palsy; This case was reported by a consumer via media and described the occurrence of bell's palsy in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was recovered/resolved.   It was unknown if the reporter considered the bell's palsy to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself/himself. The age at vaccination was not reported. The patient had a mild form of bells palsy after the shingles vaccine. The follow up would not possible as contact information was not available.
pt recv vax in 11/96 & in 7/98 pt devel chickenpox w/greater than 50 lesions & a rash. MD attention sought
intense headaches; Chills; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced intense headaches and chills in Jan2021. Caller stated he received the 1st dose of COVID vaccine on 29Dec2020 and experienced no side effects up until yesterday (Jan2021) wherein he experienced intense headaches and chills. The patient wanted to know if it's normal to experience this a few days after getting the vaccine and if there is a similar case that has been reported. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Vial was expired on 01 Apr 2022, initially refrigerated on 04 Apr 2022 and was administered on 16 Apr 2022; Vaccine was expired on 01 Apr 2022 and was administered on 16 Apr 2022/ Expired vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01 Apr 2022 and was administered on 16 Apr 2022/ Expired vaccine administered) and PRODUCT STORAGE ERROR (Vial was expired on 01 Apr 2022, initially refrigerated on 04 Apr 2022 and was administered on 16 Apr 2022) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01 Apr 2022 and was administered on 16 Apr 2022/ Expired vaccine administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 01 Apr 2022, initially refrigerated on 04 Apr 2022 and was administered on 16 Apr 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01 Apr 2022 and was administered on 16 Apr 2022/ Expired vaccine administered) and PRODUCT STORAGE ERROR (Vial was expired on 01 Apr 2022, initially refrigerated on 04 Apr 2022 and was administered on 16 Apr 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that they thought that the vaccine expired in Jun-2022, however it was expired on 01-Apr-2022. Date the vial was initially stored in refrigerator was on 04 Apr 2022. Vial had not undergone any temperature excursion.  Treatment medication was not provided by the reporter.
Vial was stored in the refrigerator for 7 days post puncture; Received expired 2nd booster 7 days post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster 7 days post puncture) and PRODUCT STORAGE ERROR (Vial was stored in the refrigerator for 7 days post puncture) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2022 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2022 at 9:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster 7 days post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was stored in the refrigerator for 7 days post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired 2nd booster 7 days post puncture) and PRODUCT STORAGE ERROR (Vial was stored in the refrigerator for 7 days post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  On 19-May-2022, the vial was initially stored in the refrigerator and was first punctured on same date about 9:30AM. The vial was stored in refrigerator post puncture. The vial did not undergo any temperature excursions. It was in the refrigerator for 7 days post puncture and was exposed to room temperature for more than 24 hours.  On 26-May-2022, the patient received expired second Booster.   This case was linked to MOD-2022-583054 (Patient Link).
Fever followed by complex febrile seizure.  Treated in ER.  Given Ativan to stop seizures.  Remained in hospital overnight for observation.  Released from hospital on 6/15/14.