chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I developed occular migraines first, then my left eye started twitching and now the whole left side of my face twitches all night and during the day some also.  I have seen 2 neurosurgeons.   It keeps me up a lot at night.  It is terrible and embarrassing.  They asked if I had had Bell's Palsy.  One neurosurgeon thinks that for some reason all of the sudden I am having hemifacial spasms.
This vaccination was given to me at my workplace by my nursing supervisor. The injection itself was very painful locally. By the end of my shift (4-6hrs later) I was unable to lift my right arm over my head due to severe joint pain and limited range of motion. This pain persisted for 3-4 months before slowly healing and impacted my ability to exercise and perform activities of daily living.
Rec'd vax day before trip to FL.2-3 wks into trip started /w a cough which persisted 3 wks &bad enough to make pt want to lie down.Cough meds helped break up cough.FL extremely warm.Came home/p Thanksgiving-feels tired.Due to travel or ill?
SM developed redness, swelling and pain at injection site each time she received the anthrax vaccine.
Pt received her second Moderna vaccine on 08/06/21 around 1000. Pt states that she woke up around 0330 on 08/07/21 feeling very warm and light-headed. She then took her dog outside and upon re-entering the home, fell against the wall, and called for help (to her husband). Per her husband, he found her slumping against the wall for support, shortly before experiencing a syncopal episode with what he describes as convulsive movements. He estimates she was unresponsive for approx. 1 minute.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 31-AUG-2018, the patient was vaccinated with an improperly stored dose of PROQUAD (recombinant Human albumin) (strength and route were unknown) (lot# R006216 and expiration date 28-AUG-2019) for prophylaxis. The sterile diluent (MERCK) was properly stored. No adverse event was reported. The excursion temperature on 22-SEP-2017, 17-OCT-2017, 06-DEC-2017, 07-DEC-2017, 30-JAN-2018, 23-FEB-2018, 18-MAY-2018, 05-JUL-2018, 15-AUG-2018 was 6 degree Celsius for maximize 8.75 hours. The excursion temperature on 02-MAR-2018, 27-AUG-2018 was 7 degree Celsius for maximize 8.75 hours. The excursion temperature on 07-DEC-2017 was 8 degree Celsius for maximize 15 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001959.
SLEEPINESS; DIZZINESS; FEELING WEAK; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: not reported) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced sleepiness, dizziness, feeling weak, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the feeling weak, nausea, sleepiness and dizziness was not reported. This report was non-serious.
Her mother got Covid from her father who refused to quarantine. Caller included that her mother is triple vaccinated with the Pfizer Covid-19 vaccine, and the last booster was in Sep2021.; Her mother got Covid from her father who refused to quarantine. Caller included that her mother is triple vaccinated with the Pfizer Covid-19 vaccine, and the last booster was in Sep2021.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 87 year-old female patient received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) at the age of 87 years as dose 3 (booster), single, administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single and administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (ongoing), notes: Was diagnosed decades ago. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Her mother got Covid from her father who refused to quarantine. Caller included that her mother is triple vaccinated with the Pfizer Covid-19 vaccine, and the last booster was in Sep2021." Clinical course: Caller does not have the product details for the Covid-19 Vaccines. The patient received and stated that she had the vaccination card. Caller was unable to provide the NDC, Lot, or expiration dates for the Covid-19 vaccines that patient received.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt experienced redness to right arm and swelling. Pt was treated with Keflex, ice for 24 hours and then warm soaks.
10/31/2008 8pm -soreness in right deltoid.  Dizzy & lightheaded.  8:30 pm- chills-fever 9pm- temp 102.3 degrees, Tylenol 9:30 PM Temp 103.1 degrees.  10pm- Fever broke, chills, sweating then fever back up again. 11 pm- More Tylenol 11:50 pm until 48 hrs later continued to have high fever.  Sweating, achiness, ringing in ears & one episode of hallucination.  Continued to alternate Tylenol & Motrin.  Arm & hand swollen.  11-1-08 Benadryl.  Fever over.  Deltoid red/painful.  Arm swollen.  11-3-08- swelling & redness reduced.  11-5-08- resolved.
Patient came into pharmacy on 5/1 with a warm, red rash extending from deltoid to just above elbow (starts laterally and then transitions anterior on way down to elbow).  Rash was not painful and patient had no other symptoms.  Patient states it starts actually lower than injection site, but cannot tell where injection site is being 2 days after injection. Rash started morning of Sunday, 4/30, and patient says has grown overnight to a larger area.  Patient has been icing rash for the only treatment.  Patient was instructed to watch the rash over 1-2 more days to see how it progresses.  Instructed to contact primary care/urgent care if rash is not improving or gets worse in the next 2 days.  Patient knows they can call us as well with any questions.  Plan to follow up on Wednesday with patient.
Complained of redness, and swelling of left arm with mild pain for duration of 2 days following administration of pneumonia shot.  To MD on  10-22-04.  Diagnosis of cellulitis. Prescription given for Augmentin XR times 5 days.  Treated with warm compresses.
Patient started with rash/hives to face appoximately 2 1/2 hours after receiving FluMist. Pt given Benadryl and instructed to take every 8 hrs as needed and see allergist. The rash increased to facial swelling and spread to arms and legs. Rash lasted for 48 hrs pt was then put on Orapred (an oral steroid).
Dr was Informed of incorrect vaccine administered.  MMR, Varicella, influenza#2 ordered.  Nurse gave MMRV, Varicella, influenza#2.   Dr. called on call - spoke with Dr.  Possible augmentation of varicella reaction - slight increased chance for fever, injection site reaction, mild rash; no concern regarding immune system or immune system response.  Discussed with poison control and no concern with toxicity of any vaccine components.    Dr. called mom multiple times and finally able to connect with her at 110pm 2/6/21.  Explained immunizations administered and discussion of potential increased risk for fever, injection site reaction, mild rash.  Apologized for clinic error.  Mom expressed understanding that this happens sometimes.  She voiced understanding what to monitor for.  She said that Patient was doing overall pretty normal, maybe slight increased fussiness but still laid down for nap at normal time.  We will check in daily for the next couple days through the spruce app and mom knows that I can be reached during the days on this app weekdays and weekends.   Mom reports baby is more fussy, developed a slight temp on 2/7/21 around 3:00 am.  So sight reaction noted.  Mom treated with alternating tylenol/ibuprofen.  Will continue to monitor and stay in touch with Dr. if any other symptoms arise.    Reported to Agency on Monday 2/8/2021 and was instructed to fill out this form.   RN
10/4 ? SI joint injection left side from the 2nd pain doctor Continued physical therapy  10/14 ? extra appointment with rheumatologist ? discussed pain and pain going down my leg and turned into sciatica ? she said you need an epidural and to go see someone else Continued physical therapy  11/2 ? saw my internist ? said I needed an epidural, did blood work to make sure Continuing PT  11/10 ? Doc showed us the inflammation on the left, showed diminished sensation on my left leg and diminished strength, increased weakness on my left leg. I didn?t realize my left leg was weak. Did a epidural ? pain got worse for a few days and then after a couple weeks, pain did not subside  11/26 ? went and saw him again and did a 2nd epidural from a different approach. The pain is getting worse even though everything we?ve tried (even with the 2nd epidural) should have helped. It used to be pain when I was laying down, etc. Now it hurts when I also sit down, etc. I?ve also had to use Vicodin a few times to manage the pain.   Questioning future vaccinations in regards to current health conditions after the 2nd vaccination and 3rd
Patient started to develop pain, redness, and tenderness around the injection site. She states the symptoms started 10/29/14.
C/o right jaw clicking reaction beginning 5-7-11 that has not resolved. Also noted seen at hospital that day due to right calf pain, chills, fever, noted continued to have shooting pain from left thigh, overall achiness, and had difficulty walking. C/o feels like knot in back of leg and right calf feels heavy.
Extreme headache; nausea; sweating; shivering; back soreness; neck soreness; arm soreness; overall weakness; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 22Apr2021 at 13:45 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. Medical history included eosinophilic esophagitis, gastroesophageal reflux disease (GERD) and allergic to gluten and dairy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 01Apr2021 at 12:15 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. On 22Apr2021 at 23:00, the patient experienced extreme headache, nausea, sweating, shivering, back or neck or arm soreness and overall weakness. The events did not result in doctor or other healthcare professional office or clinic visit, emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme headache, nausea, sweating, shivering, back or neck or arm soreness and overall weakness were recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient is currently pregnant, due October 25, 2021; Patient has had 2 previous pregnancies without complications. Patient noted with symptoms that began at about 0100 on 9/15/2021 of headache, chills, sweats, joint pain and states that it feels like joints are swollen.  Temperature is not available. Denies hives or shortness of breath. Patient took Acetaminophen between 0500-0600 for headache with relief of headache noted. Patient has had Tdap vaccine in the past with no reaction. Patient is vaccinated for Covid. Headache, chills and sweats have improved but patient is still achy in joints.
Dad says patient had hives and some vomiting. Dad has given child BENADRYL 1/4tsp.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 67-year-old female patient who received SHINGRIX for prophylaxis. On 1st July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 1st July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, chills and fatigue. In November 2018, the patient experienced pain. On an unknown date, the outcome of the injection site pain, chills, fatigue and pain were unknown. It was unknown if the reporter considered the injection site pain, chills, fatigue and pain to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX in left arm. After receiving a dose of SHINGRIX vaccine, the reporter's wife experienced pain at injection site, chills, achiness and fatigue. The patient planned to follow up with her physician on an unknown date. For tolerance to 2nd dose, refer case US2018GSK208988.
This spontaneous report as received from a medical assistant (M.A.) refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 13-OCT-2015, the patient was vaccinated with the third dose of improperly stored oral, ROTATEQ (lot # L000571, expiration date 26-JUL-2016) (dose unspecified). No concomitant medications were reported. No adverse effects have been reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Report A0372678A describes "seizure-like symptoms" in a vaccinee of unspecified age and gender who received diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). Medical history, concurrent conditions and concurrent medications were not provided. During the week of 06/10/2002 the week of 06/10/2002, the pt received an injection of Infanrix; the number of previous injections of Infanrix was not reported. An unspecified time post-immunization, the pt experienced "seizure-like symptoms". Treatment and outcome were not known. Additional information has been requested.
This case was reported by a nurse and described a 44 year old female subject who had a decreased response to vaccination with Engerix-B. The subject's medical history included non smoker. On 08 August 2005, the subject received the third dose of Engerix-B (lot AHBVA077AB). On 14 November 2005, a hepatitis B surface antibody test revealed a titer "below five." The nurse considered the decreased therapeutic response to be related to vaccination with Engerix-B.
Positive test for SARS-Cov2; Positive test for SARS-Cov2; This is a spontaneous report received from a contactable reporter(s). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 25Oct2021 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 14Mar2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "elevate cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN (ongoing); ENALAPRIL (ongoing); HCTZ (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Positive test for SARS-Cov2"; NASAL CONGESTION (non-serious), outcome "unknown", described as "mild to moderate congestion"; PRODUCTIVE COUGH (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Apr2022) Positive; (16Apr2022) Positive, notes: ACE RAT; (17Apr2022) Negative, notes: ACE RAT; (18Apr2022) Negative, notes: ACE RAT; (21Apr2022) Positive; (28Apr2022) Negative, notes: covid test (RAT). Therapeutic measures were taken as a result of drug ineffective, covid-19, nasal congestion, productive cough.  Additional information: Paxlovid (PF-07321332/Ritonavir. administration of Paxlovid (PF-07321332/Ritonavir) on 13Apr2022-18Apr2022, batch number is unknown.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received
pt recv vax 13MAY96 & 23MAY96 pt devel 3-4 dozen lesions;It was unk whether the pt devel a fever;the reporter noted that the pt had prev been in puerto rico;
Mild vertigo, nausea and fever. Exam: mild mystagmus. Rx: meclyin
Information was received on 09-JUL-2018 from a lawyer regarding a case in litigation. A male patient, age unspecified, was inoculated with ZOSTAVAX on 10-DEC-2008 at a medical center as recommended for routine adult health maintenance for prevention of shingles. It did not prevent shingles as intended and subsequently the patient contracted a persistent strain of herpes zoster. On or about 20-NOV-2014  the patient was treated by a physician at a medical center for a blistering vesicular outbreak which was then diagnosed as shingles. The patient was treated with acyclovoir, lidocaine, and gabapentin for management of his painful symptoms and excruciating pain. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
FluLaval administered after temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number GF9PM, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-Oct-2022 Reporter's comment: A pharmacist called to ask for information about the administration of Flulaval to 7 staff members.  The Flulaval vaccines that were administered were exposed to room temperature for a few weeks.  The reporter did not provide exact data about time and temperature of the excursion, but mentioned that vaccines were out of refrigeration approximately from 15th September 2022 to 10th October 2022 and then vaccines were administered to the staff members. The reporter did not provide either the exact date of administration nor the identifiers of the 7 people that received this vaccine.  The reporter asked about the stability of Flulaval when exposed to temperatures higher than recommended and asked if the staff members had to be re-vaccinated. The reporter consented to follow-up. This case was for 1 of 7 linked patients reported by same reporter. Additional supportive information: The patient was administered Flulaval after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022AMR157003:Same reporter US-GSK-US2022AMR157006:Same reporter US-GSK-US2022AMR157005:Same reporter US-GSK-US2022AMR157001:Same reporter US-GSK-US2022156225:Same reporter US-GSK-US2022AMR157002:Same reporter
This 76  year old female received the Moderna Covid shot on  1/30/21    and went to the ED on 2/26 /21     and was admitted  on2/26 /21 with the following diagnoses listed below. I63.9 - Acute CVA (cerebrovascular accident)
Expired vaccine administered to patient/Nursing employee gave 7 vaccines to patients from a vial that was 12 or more hours punctured.; vaccine greater than 12 hours in refrigerator; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient/Nursing employee gave 7 vaccines to patients from a vial that was 12 or more hours punctured.) and PRODUCT STORAGE ERROR (vaccine greater than 12 hours in refrigerator) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 24-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient/Nursing employee gave 7 vaccines to patients from a vial that was 12 or more hours punctured.) and PRODUCT STORAGE ERROR (vaccine greater than 12 hours in refrigerator). On 24-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient/Nursing employee gave 7 vaccines to patients from a vial that was 12 or more hours punctured.) and PRODUCT STORAGE ERROR (vaccine greater than 12 hours in refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Follow Up information was received on 03-Sep-2021 and contains No new information. On 06-Sep-2021: Follow up received on 06-SEP-2021 and contains no new information.
Information has been received from a physician and office manager concerning a female who was vaccinated on an unspecified date with an unknown # of doses of GARDASIL (lot#'s not reported).  Subsequently the patient developed HPV.  The patient sought unspecified medical attention on an unspecified date and her outcome was not reported.  Additional information has been requested.
Patient immediately became lightheaded and flushed.  Started complaining of itching, and "tickling in throat".  Became anxious.  Offered Epipen, she refused.  Patient taken to ED by POU.  Patient treated and released by ED.  ED gave EPI Benadryl injections.  Saline IV.