chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Weakened my immune system; Shingles; The nerve pain has been debilitating; The nerve pain has been debilitating; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNE SYSTEM DISORDER (hospitalization), outcome "unknown", described as "Weakened my immune system"; HERPES ZOSTER (hospitalization), outcome "unknown", described as "Shingles"; NEURALGIA (hospitalization), ASTHENIA (hospitalization), outcome "unknown" and all described as "The nerve pain has been debilitating".  Clinical information: The patient was hospitalized after receiving a Covid vaccine. Patient reported that the vaccine weakened her immune system and she got shingles. Patient was out of medication and taking every other day to save pills until approval. Patient is on Xeljanz XR 11 mg.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient reports chills the evening of receiving vaccines. She could not sleep. In the morning, chills are gone and she reports nausea and headache. No self-treatment measures taken.
early second dose of Havrix; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 18-month-old female patient who received HAV (Havrix 720) (batch number ep47e, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX 720).   On 14th April 2022, the patient received the 2nd dose of Havrix 720 and Havrix Pre-Filled Syringe Device. On 14th April 2022, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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: 18-APR-2022 Reporter's Comments: The nurse reported that the patient received an early second dose of Havrix. The reporter consented to follow up. Additional Supportive Information: As the patient received an early second dose of Havrix, which led to shortening of vaccination schedule.
On 6/15/05 rash began, temp 101f . on 06/16/05 more rash, velvety, temp 102.3 cough, runny nose, matted eyes in the am.
Approximately 1 hour after inoculation, I experienced the following adverse symtoms: Sore and aching muscle pain throughout body flu like  feeling hot/flushed on surface of body- 2 days face, hands, soles of feet red/hot sensation, -2 days hand muscles, modality, hard to move and grip- 2 days loss of appetite- 1 day break out of red blisters under tongue and lips- on going since day 1 of vaccination excessive fatigue and sleepiness- 2.5 days night sweats- 1 day coughing- 3 days
2 minutes after administration, the patient was speaking to his father, dozed off to one side and had tremors.  Patient immediately was able to open eyes and was shaking.  Pharmacist advised patient to take deep breaths and relax until paramedics arrived.  Patient had a few sips of water while waiting.  Patient was fine after 15 minutes.
mild myocarditis; This is a literature report.  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (J&J), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (medically significant, life threatening), outcome "unknown", described as "mild myocarditis". The event "mild myocarditis" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: electrocardiogram: st abnormality; left ventricular end-diastolic pressure: 60-65 %; troponin: 0.04 ug/L.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event myocarditis with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200292737 Same Article/Event/Drug and Different patient;US-PFIZER INC-202200292737 Same Article/Event/Drug and Different patient
Flu like symptoms; side effects as testicular discomfort/problem with the testicle area, not a pain but a discomfort like puberty that kind of situation, discomfort in that area; penis swelling in the "circumcision area" that lasted for only one day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 41 year-old male patient received bnt162b2 (COMIRNATY), administration date 05Jan2022 (Lot number: FJ7611) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "circumcision" (unspecified if ongoing), notes: many years ago. There were no concomitant medications. The following information was reported: TESTIS DISCOMFORT (non-serious) with onset 07Jan2022, outcome "not recovered", described as "side effects as testicular discomfort/problem with the testicle area, not a pain but a discomfort like puberty that kind of situation, discomfort in that area"; PENILE SWELLING (non-serious) with onset 07Jan2022, outcome "recovered" (08Jan2022), described as "penis swelling in the "circumcision area" that lasted for only one day"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "Flu like symptoms".  Follow-up (26Jan2021): This is a spontaneous follow-up report received from the same contactable Consumer. Updated information included: Patient details (DOB, Age, height, weight, age at vaccination), dosage regimen (Lot number), Event information (onset date, stop date, outcome of event)  Follow-Up (02Feb2022): Follow-up attempts are completed. No further information is expected.
expired dose of Menveo was administered to patient; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA520A, expiry date 30th April 2022) for prophylaxis.   On 12th May 2022, the patient received Menveo. On 12th May 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 13-MAY-2022 Reporter's comment: Nurse reported an expired dose of Menveo was administered to patient. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: The patient received dose of Menveo that was already got expired on 30th April 2022, which led to expired vaccine used.
This spontaneous report as received from a nurse refers to an unknown number of patients of unknown ages with no pertinent medical history/drug allergies or drug reactions reported. On an unknown date, the patients were vaccinated with a dose of PROQUAD route, anatomical location, lot# and expiration date were not reported), that had been improperly stored. There was no concomitant therapy reported. No adverse effects reported. This is one of two cases from the same reporter. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of tremor limb in a 87-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included back disorder and neuropathy (affecting feet and legs). On 26th February 2019, the patient received SHINGRIX (intramuscular). In February 2019, 9 hrs after receiving SHINGRIX, the patient experienced tremor limb and unsteadiness. On an unknown date, the outcome of the tremor limb and unsteadiness were recovering/resolving. It was unknown if the reporter considered the tremor limb and unsteadiness to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on left arm. On 27th February 2019, the patient experienced arms quivering, legs shaking, and he was not steady on his feet. He did use a walker and his wife had to hold him steady. Till the reporting time, the patient was improving. The reporter consented to follow up.
Within 24 hours after vaccination developed serious Bell's Palsy that required ruling out CVA 48 later.
Redness, pain, swelling left shoulder with limited range of motion.  Fever, chills, fatigue.  All symptoms commencing within 12 hours of immunizations. Also note this patient was given pneumococcal vaccine (PPSV23 Given 0.5 mL 04/24/2015 IM LD Merck & Co. Inc S004548 ) in the same arm on the same date.  Uncertain which vaccine is the culprit. Will commence cefadroxil for cellulitis
red areas on face with swelling of lips; red areas on face with swelling of lips; This is a spontaneous report from a contactable pharmacist. A 32-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular, administered in Arm Left on 14Oct2021 (Batch/Lot Number: FE3592) (at the age of 32 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 on unknown date for covid-19 immunisation. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced red areas on face with swelling of lips on 14Oct2021 with outcome of recovered on Oct2021. Benadryl was used for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient been tested for COVID-19  No follow-up attempts are possible. No further information is expected.
Patient felt lightheaded and fell (faint) in store's wine aisle. He regain consciousness shortly after. Paramedics believed he was having a vasovagal response.
At 3:30 p.m. reaction began with red watery eyes and coughing, by 5:00 p.m., face, throat and lip swelling, accelerated heart rate with body aches and restlessness.  Began to improve by approximately 7:00 p.m.
Increasingly worse stomach cramping; loose bowel movements; This is a spontaneous report from a contactable other health care professional. A 59-year-old female non pregnant patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Unknown), via an unspecified route of administration on the right arm on 24Mar2021 at 12:00 (at the age of 59-year-old), as a first single dose for COVID-19 immunisation. Medical history included hashimotos thyroiditis. Concomitant medications included: Estradiol (VAGIFEM), Thyroid (ARMOUR THYROID) 120 mg, turmeric (MANUFACTURER UNKNOWN) and ginger (MANUFACTURER UNKNOWN) all for an unknown indication. The patient was allergic to celiacs sprue and latex. 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. Since the vaccination, the patient had not been tested for COVID-19. On 24Mar2021, at 18:00 the patient experienced increasingly worse stomach cramping with loose bowel movements. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome for the events increasingly worse stomach cramping and loose bowel movements was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
SEVERE LEVELS OF CREATINE KINASE; PAIN; ARMS SWOLLEN; This spontaneous report received from a patient via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included stomach pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 25-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested No concomitant medications were reported.  On Thursday 08-JUL-2021, patient was hospitalized due to severe levels of creatine kinase and she experienced pain and her arm was swollen. The doctors was shocked to see such high levels of creatine kinase and they have been running tests of all sorts. The Laboratory data included: Creatine kinase high (NR: not provided), patient stated that all the tests were done and it showed no problems with her heart, nerves, chest. The treatment medications (dates unspecified) included hydrocortisone/Cortizone ,IV, antibiotics for stomach relief from all treatment medication. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe levels of creatine kinase, pain and arms swollen was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210727837- covid-19 vaccine ad26.cov2.s-Severe levels of creatine kinase, pain, arms swollen. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Swelling, redness, stiffness, tiredness lack of focus from 06/12 to 06/24 23.
Patient received the vaccination.  Approximately 20 seconds after receiving the dose patient said "I'm going to faint'.  Patient appeared to  faint but also appeared to be having a seizure.  The patients legs appeared to go rigid and he make movements with his arms. He appeared very pale.  The patient "came to" within approximately a minute?  Patients mother and I were able to lay Patient down on the floor. I asked his mother if she would like us to call 911 and she said yes.  Prior to the incident, I discussed Patients past history of seizures with his mother. She sail he had seizures when he was younger and had been on medication, but he was no longer on any medication and had been seizure free for approximately 5 years.
Dermatographic urticaria; onset of rash that comes and goes everywhere but soles of the feet and inside mouth and nose.  Appeared 12 days after booster shot.  Started treatment of 40mg of prednisone per day for 5 days with no change.  Now have doubled Xyzal dose, added fomatidine (20mg) twice/day; and added singular on November 16
One day post vax the pt developed a fever of 101F. Three days post vax the pt developed a grapefruit sized welt at the injection site and was treated with oral and topical diphenhydramine and applications of ice. He recovered. A copy of this report has been forwarded to Merck, the manufacturer of Pneumovax.
has been at least 1 year since they received the first dose; This case was reported by a other health professional via interactive digital media and described the occurrence of incomplete course of vaccination in a unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on unknown date, atleast 1 year from reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter mentioned that, it has been atleast one year, patient has received 1st dose of Shingrix. The reporter asked if they should start over and do 2 doses or just give a booster. This case has been linked with US2021AMR134420, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR134420:Same reporter
02/2023 I started feeling numbness, heaviness, fatigue and all generally unwell. I went to the ER because I suspected it was a stroke and after several tests it was negative for a Stroke. I had recently started a course of medication for gene mutation and it caused a drug interaction. I was referred to an Allergist and he confirmed that it was a drug interaction.
since 2 weeks she has an episode of dizziness, vertigo,it's states from the ears; Since 2 weeks she has an episode of dizziness vertigo, states it's from the ears/It is horrible because you get dizzy and she still has it bad and still has her dizziness; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (since 2 weeks she has an episode of dizziness, vertigo,it's states from the ears) and DIZZINESS (Since 2 weeks she has an episode of dizziness vertigo, states it's from the ears/It is horrible because you get dizzy and she still has it bad and still has her dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Dizziness (The patient had dizziness, started last year before the vaccination.) in 2020 and Vertigo (Had last year before the vaccination.).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced VERTIGO (since 2 weeks she has an episode of dizziness, vertigo,it's states from the ears) and DIZZINESS (Since 2 weeks she has an episode of dizziness vertigo, states it's from the ears/It is horrible because you get dizzy and she still has it bad and still has her dizziness). At the time of the report, VERTIGO (since 2 weeks she has an episode of dizziness, vertigo,it's states from the ears) outcome was unknown and DIZZINESS (Since 2 weeks she has an episode of dizziness vertigo, states it's from the ears/It is horrible because you get dizzy and she still has it bad and still has her dizziness) had not resolved.            No concomitant medications reported. No treatment information was provided.
After vaccine patien got very lightheaded and dizzy. Felt like he might faint, layed him down with leg s up improved within a few minutes. stayed 30 minutes and felt fine after
2nd dose is scheduled for 24Feb2021 (33 days later); This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose is scheduled for 24Feb2021 (33 days later)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Medical history was not provided).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose is scheduled for 24Feb2021 (33 days later)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose is scheduled for 24Feb2021 (33 days later)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This report refers to a case of inappropriate schedule of vaccine administration for mRNA-1273, lot # unknown  with no associated AEs.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administration for mRNA-1273, lot # unknown  with no associated AEs.
Case number PHEH2013US024644, is an initial spontaneous report from a nurse received on 21 NOV 2013. This report refers to a 3-year-old male patient who was accidentally vaccinated with FLUVIRIN 2013/2014 (batch number: 131001) intramuscularly on 20 NOV 2013. No adverse reaction reported following this medication error (inappropriate age at vaccine administration).
Multiple Myeloma; This serious case was reported by a consumer via call center representative and described the occurrence of multiple myeloma in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In JUL-2021, the patient received the 1st dose of Shingrix. In DEC-2021, between 4 and 6 months after receiving Shingrix, the patient experienced multiple myeloma (Verbatim: Multiple Myeloma) (serious criteria GSK medically significant). The outcome of the multiple myeloma was unknown.   It was unknown if the reporter considered the multiple myeloma to be related to Shingrix.     It was unknown if the company considered the multiple myeloma to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-JUL-2023 In December 2021 she was diagnosed with multiple myeloma and the doctor recommended her not to administer the second dose of Shingrix. She received her second dose in August 2022 and completed her Shingrix series. The reporter did not consent to follow up.
Morbilliform rash with blisters and swelling. Ranging from large patches to multiple areas of small bumps across different areas (legs, thighs, neck, ribs, arms).
Dizziness, Myalgia, Arthralgia, fatigue Narrative:  Other Relevant History:
Mother called today (8-11-16) to report reaction of child to immunization on 8-8-16.  Mother reports that child received two (2) vaccines in the (R) arm, which is fine and one (1) vaccine in the (L) arm which became red and swollen below the area of injection but in Deltoid area.  She also states that the child ran fever of between 101 & 102 degrees Monday night and Tuesday.  She reports that she took the child to a clinic and was advised to give Benadryl and that no antibiotic was needed at this time.  They also advised for here to report reaction to the Health Department which she did this morning.  Mom reports no further fever or vomiting, only redness, swelling at site and warm to the touch.  I advised mom to continue with the Benadryl as instructed and to give Children's Ibuprofen for pain/inflammation and to apply warm compresses frequently.  She plans to follow-up with me tomorrow to monitor for improvement.