chrisvoncsefalvay/vaers-outcomes huggingface dataset:
numbness down his arm (Left) radiating to his fingertips; shooting; he has less grip in the affected(Left) hand; nerve damage; electrical sensation (like he is being shocked); This non-serious case was reported by a consumer via call center representative and described the occurrence of numbness in hand in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (For tolerance of 1st dose refer case US2023AMR120556).   On 18-AUG-2023, the patient received the 2nd dose of Shingrix (left deltoid). In AUG-2023, less than 3 weeks after receiving Shingrix, the patient experienced numbness in hand (Verbatim: numbness down his arm (Left) radiating to his fingertips), shooting pain (Verbatim: shooting), grip strength decreased (Verbatim: he has less grip in the affected(Left) hand), nerve damage (Verbatim: nerve damage) and electric shock sensation (Verbatim: electrical sensation (like he is being shocked)).  The outcome of the numbness in hand, shooting pain, grip strength decreased, nerve damage and electric shock sensation were not resolved.   It was unknown if the reporter considered the numbness in hand, shooting pain, grip strength decreased, nerve damage and electric shock sensation to be related to Shingrix.     It was unknown if the company considered the numbness in hand, shooting pain, grip strength decreased, nerve damage and electric shock sensation to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR120556   Additional Information: GSK Receipt Date: 31-AUG-2023 It was reported that after the second Shingrix vaccine, the patient experienced a shooting, electrical sensation (like he was being shocked), and numbness down his arm (Left) radiating to his fingertips. He stated he had nerve damage, as he had less grip in the affected (Left) hand. Both doses of the vaccine were administered in the upper left arm. The reporter consented to follow up. For tolerance of 1st dose refer case US2023AMR120556.; Sender's Comments:  US-GSK-US2023AMR120556:1st dose
Red, swollen and itchy on and around injection site, 8 days after 1st dose. Also swelling of the face within 3 hours after first shot.
Received Afluria Influenza Vaccine on Sunday, Nov 2, 2008. On Thursday, November 6, I began feeling ill. I developed a full blown case of the flu with fever, chills, aches, respiratory symptoms etc.  By the beginning of the following week I was unable to go to work.  I AM RARELY SICK & NEVER MISS WORK. I was really sick.  Since this reaction I have heard other anedotal stories of more than a few people getting the flu within a week after receiving a flu shot. I will not get a flu shot in the future and I wanted the reaction reported!
Upper respiratory infection; This spontaneous case was reported by a consumer and describes the occurrence of UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 20-Sep-2021, the patient experienced UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection). At the time of the report, UPPER RESPIRATORY TRACT INFECTION (Upper respiratory infection) outcome was unknown.            No concomitant medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in No treatment information was reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Meningioma surgery in 2020, fully recovered from that" (unspecified if ongoing), notes: Meningioma surgery in 2020, fully recovered from that; "health cold" (unspecified if ongoing); "flu relief" (unspecified if ongoing). Concomitant medication(s) included: VILAZODONE, start date: 15Oct2021. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Clinical course: Patient reported, I stopped paxlovid Thursday morning and just tested positive again today and symptoms returned. I tested negative Friday and Sunday after treatment. Sore throat, runny nose have returned.
ear pain; less of an abdominal rash; a gradual worsening of tinnitus to the point where I am unable to sleep it is so loud; a gradual worsening of tinnitus to the point where I am unable to sleep it is so loud; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: ED6955, Expiry date: not reported) via an unspecified route of administration, administered in Arm Left on 01Apr2021 05:00 (at the age of 56 years old) as dose 2, single for COVID-19 immunization. Medical history was no, and concomitant medications were not reported. Historical vaccine included: the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6206, Expiry date: not reported) via an unspecified route of administration, administered in Arm Left on 09Mar2021 05:15 (at the age of 56 years old) as dose 1 single for COVID-19 immunization. The patient was non-pregnant at the time of vaccination. The facility where the most recent COVID-19 vaccine was administered was in pharmacy or drug Store. The patient had not received any other vaccine within 4 weeks. list of any other medications the patient received within 2 weeks of vaccination was no. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID post vaccination. The patients hospitalization prolonged was no. On 02Apr2021 (after the second vaccine), the patient experienced less of an abdominal rash but have had a gradual worsening of tinnitus to the point where she was unable to sleep it was so loud. It began in her left ear and has increased along with ear pain. In the last few days, it has moved to her right ear as well, also an extremely loud high-pitched noise. It is constant, has not lessened or stopped for the last 3-4 weeks. It is intolerable and she need to understand how to treat this. The patient was on a waiting list to see a doctor but have not gotten in yet. The patient did not receive any therapeutic measures for the events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Patient developed intussusception requiring surgical intervention on 6th day following vaccine admin.   11/25/08 Reviewed hospital medical record of 9/22-10/05/2008. FINAL DX: no d/c summary available.  Admitted for intussusception; exp laparotomy w/ileocecectomy w/primary anastamosis; inverted Meckel's diverticulum. Records reveal patient experienced bloody stools Tx w/parenteral nutrition, NGT, narcotic pain meds.  Failed diet progression, developed firm abd distention, increased pain & irritability.  Dx w/postop ileus.  Returned to OR for re-exploration & repair of anastamotic leak 9/28, remained intubated & admitted to PICU.  Had bilious emesis prior to intubation & concerned for aspiration.  Extubated by next day & transferred to regular floor.  Progressed well, tolerated oral feeds, completed antibiotics & d/c to home  .
Approximately 3 days after my booster shot I experienced the following symptoms: My speech was slurred, and had difficulty swallowing food and taking medications. Eventually went to the ER and they did a CT Scan, Blood work, MRI and the result they thought it was Bell's Palsy. Eventually the ER physician got in touch with my primary doctor's partner and ordered a swallow sturdy and it was determined that my epiglottis was not functioning. So I had to be admitted to the hospital for 4 days and was placed in a feeding tube that went into my nose to my stomach. When I was in the hospital my doctor diagnosed me with Guillain-Barre Syndrome and was prescribed to have an IVIG infusion while I am in the hospital and had another outpatient appointment for IVIG infusion. The treatments did help me recover and as of today 02/23/2022 I am recovering and still have a bit of issue with my speech and slowly back to normal. Also to note, that during my illness I have lost a total of 20 pounds.
Patient with 2 Pfizer COVID vaccinations, last dose 04/15/21, who admitted with weakness associated with COVID infection and inability to complete self care.  Provider discharge note below.  "Patient came in with COVID previously.  She was discharged in stable condition.  She was found to also have fluid overload and anemia.  The anemia was from a GIB and cirrhosis.  She doesn't want transfusion so is getting Erythropoietin monthly.  She is also getting oral iron.  She got 2 doses of IV iron while she was here. She had increased JVP, crackles and edema(on top of her chronic lymph edema.  She has history of cirrhosis as well and is on lasix as chronic. This though is likely a acute on chronic diastolic heart failure exacerbation. She had aldactone added here.  She also got some IV lasix here with improved fluid status.  She will be sent on lasix and aldactone.  She should have follow up labs next week for this and the anemia.  She came back to the hospital because of weakness from the recent COVID infection.  She was unable to take care of herself at home.  PT an OT saw her and recommended SNF care for rehabilitation.  Patient will be discharged to local clinic for further care."  Of note, patient has since died with date of death 03/16/22.  Provider discharge note to hospice below:  "Older woman with advanced cirrhosis presented obtunded with profound hypothermia from nursing home where she was undergoing rehabilitation.  ER evaluation raised the concern for sepsis; discussion with her niece who is her only family member and POA led to the conclusion that the patient would not want intervention and would choose under the circumstances to receive only comfort care and hospice.  Hospice was consulted and the patient transferred to local facility for her ongoing care."
Headache, Diarrhea, NauseaVomiting, fatigue, arm pain at injection site Narrative: Per nursing report: "took 2nd dose vaccine yesterday [8/12]. C/o headache since last night [8/12], sore arm, fatigue, nausea, and diarrhea. States was not able to come into work today [8/13] due to symptoms."
Patient received her dose at age 17, two months shy of her 18th birthday, as such she received the dose at an inappropriate age.
Patient filled out form without stating history of fainting (only known after patient fainted and patient's mother was contacted). Patient fainted after 5 minutes of vaccination as patient was walking out of the vaccination room. Patient was dizzy and "fainty." Called EMS for care and transport to ER due to possible head injury during fall.
Child recently moved from another country, no immunizations available.  Child was on catch up schedule.  First dose of DTaP given 2/5/08.  Second DTaP ordered on 5/16/08.  Tdap was given to patient.  CDC was called to report vaccine incident.  At this time CDC also notified that this was the incorrect catch up schedule for child over 7.  Child should have started series with Td.  CDC informed us that these two immunizations should be counted as off label usage and child should receive next Td in 6 mo.  No adverse event reported at the time of incident or since 5/16/08.
died from Pfizer vaccine of anaphylactic reaction; This is a spontaneous report from a non-contactable consumer. A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for Covid-19 immunisation. Medical history included hypersensitivity (there was something he was allergic to it's what is used in contrast imaging). Concomitant medications were not reported. The patient had an anaphylactic reaction to the vaccination and through the anaphylactic reaction he passed away. The patient died on an unspecified date.  It was not reported if an autopsy was performed.  Information about lot/batch number has been requested.; Reported Cause(s) of Death: Anaphylactic reaction
headache; fever; This spontaneous case was reported by a non-health professional and describes the occurrence of HEADACHE (headache) and PYREXIA (fever) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and C39C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy. Concomitant products included LISINOPRIL and OMEPRAZOLE for an unknown indication.   On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, 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 experienced HEADACHE (headache) and PYREXIA (fever). At the time of the report, HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications were not reported.   Treatment information was not provided.   This case was linked to MOD-2021-283366 (Patient Link).
1 day post vaccination 3/30, developed at injection site a large edematous, not, solid lump measure 3in x1in. Constant Pain with redness. At 2pm 3/30, developed low grade fever 99 degrees Fahrenheit. Nausea, severe joint and generalized muscle pain as well as dizziness- had to leave work. Relieved moderately with MOTRIN 400mg. 8hours later on 3/30 pain in arm and severe joint and muscle pain returned. On 3/31 redness on arm and swelling measured 3in by 2 in, painful to light touch, still very firm. Muscle pain relieved with MOTRIN, able to work. Fatigued, no fever. Sun 4/1 severe arm pain, still red 3in x 2in firm, painful to light touch, TYLENOL minimize pain. No further joint, muscle pain nor any fever.
Patient started experiencing persistent muscle pain after injection. Is now receiving medical treatment and physical therapy due to it.
Within a week went to hospital with severe chest pains. Diagnosed with inflammation around and in my heart
Severe mouth pain; Pain in teeth; Pain in teeth; Rash on forehead; Rash on chin; This spontaneous case was reported by a nurse and describes the occurrence of ORAL PAIN (Severe mouth pain), TOOTHACHE (Pain in teeth), GINGIVAL PAIN (Pain in teeth), RASH (Rash on forehead) and RASH (Rash on chin) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025l20a) for COVID-19 immunisation.     No medical History Information Reported.     On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced ORAL PAIN (Severe mouth pain), TOOTHACHE (Pain in teeth), GINGIVAL PAIN (Pain in teeth), RASH (Rash on forehead) and RASH (Rash on chin). At the time of the report, ORAL PAIN (Severe mouth pain), TOOTHACHE (Pain in teeth), GINGIVAL PAIN (Pain in teeth), RASH (Rash on forehead) and RASH (Rash on chin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information reported.
I am having a delayed reaction to Moderna vaccine 8 days after 1st shot.  Upper left arm has rash and skin is raised and very red around the injection site. Very itchy but no pain or other symptoms. Concerned whether I should get the second shot.
Right bicep was red and swollen when she awoke on 10/08/20.  Over the next week her symptoms progressed.  She developed a rash all over her whole body. Has some tingling in the mouth.  She developed a right lower leg ulcer.  On 10/15/20 she was referred to wound care for the ulceration on the right lower leg.  The injection site reaction on the right bicep she was trying to manage at home with the use of hydrocortisone and Benadryl. Patient states that she feels as though the rash is continuing to get worse.  It is itchy.  Was sent to the Emergency Room for further treatment and evaluation to rule out Stevens-Johnson syndrome.
This medically confirmed literature report (initial receipt 24-Aug-2015) concerns a 44 year-old female patient. On an unspecified date, the patient received Influenza virus vaccine (manufacturer and batch number not provided) via the intramuscular route. On an unspecified date, the patient experienced flu-like symptoms such as malaise, fever, and rhinorrhea within a week after inoculation. The patient did not complain of taste dysfunction. The SIT (Smell Identification Test) score was 16/40 which was not suggestive of malingering (<6). The patient was diagnosed with anosmia. The PEA (phenyl ethyl alcohol) test scores were -5.36 left, -3.31 right and -5.10 bilateral. The Whole-Mouth test identification test score was 90% correct. The outcome was not reported. Reporter's comments: The authors reported that the smell dysfunction was not attributed to any one season's vaccination program and they were presented to the center over the course of 10 years. The patients attributed the chemosensory/olfactory disturbances to an influenza vaccination. As with the SIT and the olfactory tests, neither the influences of ever having had an influenza vaccination nor the total number of lifetime inoculations were associated with the test measures. The present study suggested the possibility that, in rare cases, influenza vaccinations may be associated with olfactory dysfunction. In these patients whose smell loss was attributed to causes other than influenza vaccinations, the magnitude of vaccination influences was too weak to overcome the primary basis for their loss. There were no associations apparent between quantitative smell or taste test scores and reports of having one or more lifetime influenza vaccine inoculations. The benefits of receiving an influenza vaccine would seem to clearly outweigh its potential side effects.
About an hour after the vaccine chest was pounding while vaccuuming/doing housework; Felt a fast heartbeat; Dizziness; Then skin felt hot as if I'd been running/ heat sensation in my skin.; This is a spontaneous report from a non-contactable consumer or other non hcp. A 36-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration, administered in left arm on 27Feb2021 (age at vaccination was 36-year-old) (Batch/Lot Number: EN6200) as single dose for COVID-19 immunization.  Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient was not taking any other medications prior two weeks. The patient had no known allergies. On 27Feb2021, about an hour after the vaccine the patient experienced chest was pounding while vacuuming /doing housework, felt a fast heartbeat and dizziness. The patient was recovered after sitting down for a moment. Then skin felt hot as if she had been running, but she had not been running. she recovered within a couple hours from the heat sensation in her skin. No treatment was received for the events. The outcome the events was recovered on 27Feb2021.  No follow-up attempts are possible. No further information is expected.
Patient attended a covid booster clinic at a local college, completed the booster paperwork, and a bivalent booster was administered. Patient had not received a primary dose and this was missed when reviewing the consent form.  As a requirement patients remain for observation for 15 mins following their shot. The patient did not have any reactions during the 15 minute wait time. Patient did report fatigue that developed that afternoon, otherwise no unexpected side effects were present.
Muscle or body aches  Headache  New loss of taste or smell  Congestion or running nose
Really high blood pressure after the second dose. When he exercised for 30min, he checked his blood pressure and it was 191/94; This is a spontaneous report from a contactable consumer (patient himself) via a medical information team. An 85-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation and experienced elevated blood pressure after the first dose. Patient to report that he experienced really high blood pressure after the second dose. Patient mentioned that he was on medications now. He also mentioned that when he exercised for 30 min, he checked his blood pressure, and it was 191/94. The event was considered as non-serious by the consumer. On an unspecified date, the patient underwent lab tests and procedures which included blood pressure: Really high blood pressure after the second dose, blood pressure: 191/94 (he also mentioned that when he exercised for 30 min, he checked his blood pressure, and it was 191/94). The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Vaccine was injected as an intramuscular injection. Health department notified us with our error. Vaccine does not need to be reinjected.