chrisvoncsefalvay/vaers-outcomes huggingface dataset:
started as an erythematous area over the vaccine site, with itching, and over the next 2 days it expanded a couple of centimeters making it 3x4 cm, until day 7 I had become a 7x7 erythematous area, with induration, warmth, and tender to touch, evaluated by a physician and recommended starting antibiotics, started doxycycline 100 mg twice a day, and by 24 hours of starting medication swelling was improved, with a complete resolution on day 7 of antibiotics, a very small area of discoloration remains, but it is likely to my skin color.
neuropathy/idiopathic neuropathy; polyneuropathy, unspecified; chronic right flank pain; post herpetic neuralgia; left hand tremor; essential tremor; burning pain; dysesthesias on the right flank in a T6 distribution; numbness in the feet; post-herpetlc neuritis; poor balance; parenthesis in both feet and legs; sensorimotor peripheral neuropathy in lower extremities; This case was reported by a lawyer and described the occurrence of peripheral sensorimotor neuropathy in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information was received on 12 June 2020 via medical records (case now medically confirmed). As per pharmacy record, on 08 July 2018, the patient received suspect included Shingrix vial kit. As per record, on dated 06 November 2019 the patient who presents for evaluation of chronic right flank pain and neuropathy. For her right flank pain agree with post herpetic neuralgia. Her left hand tremor likely benign essential tremor . The patient states she developed burning pain and dysesthesias on the right flank in a T6 distribution and was diagnosis with shingles. This problems started over 20 years ago. The patient had flares where the pain would be intense for several months then die down. The patient complaint numbness in the feet but no pain in the feet. The patient had diagnosis of idiopathic neuropathy, patient complaint of left hand tremor when using the hand. The patient had paresthesia in both feet and legs. The patient assessment included polyneuropathy, unspecified, post-herpetlc neuritis, poor balance and essential tremor.On 06 February 2020, the patient had EMC (electromagnetic compatibility) examination showed abnormal study, there was electro diagnostic evidence of length dependent, axonal, sensorimotor peripheral neuropathy in lower extremities.
pt recv vax 20MAR98 1130AM ate lunch 12noon;1PM back to work & began feeling panicky & nervousness;loud sudden noises caused excessive rxn;no trouble breathing or local rxn;130PM left work;145PM vomited & dry mouth;
Patients undiagnosed lymphoma was activated/reactivated following Pfizer COVID-19 booster shot.; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative.  A female patient in her 40's (unknown if pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: LYMPHOMA (medically significant), outcome "unknown", described as "Patients undiagnosed lymphoma was activated/reactivated following Pfizer COVID-19 booster shot.".  Clinical course: Event took place after use of product.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available,The casual association between the reported "LYMPHOMA" and suspected drug cannot be completely excluded.  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.
Flu-like symptoms; Body aches; Fever; Soreness in right arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (Body aches), VACCINATION SITE PAIN (Soreness in right arm) and PYREXIA (Fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No relevant medical history was provided.  Concomitant products included VALPROATE SEMISODIUM (DEPAKOTE), QUETIAPINE FUMARATE (SEROQUEL), ATORVASTATIN, PANTOPRAZOLE, LITHIUM, GABAPENTIN, TEMAZEPAM, PRAZOSIN and SERTRALINE for an unknown indication.    On 18-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jul-2021, the patient experienced VACCINATION SITE PAIN (Soreness in right arm). On 19-Jul-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). 19-Jul-2021, the patient experienced PAIN (Body aches) and PYREXIA (Fever). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), PAIN (Body aches), VACCINATION SITE PAIN (Soreness in right arm) and PYREXIA (Fever) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2021-260527 (Patient Link).
Dark red "hot" rash extending to elbow and up into neck region on left arm. Distinct border (problem both shots given in left deltoid per patient). Can't tell which vaccine caused problem.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 08-OCT-2015, the patient was vaccinated with improperly stored (exposed to the following temperatures and cumulative time frames colder than 36 F: In September 2015, the coldest temperature was 34 F for 346.7 hours (over 14 days); In October of 2015, the coldest temperature was 34 F for 492.6 hours for a total of 839.3 hours (35 days); In November of 2015, the coldest temperature was 34 F for 192 hours, for a total of 1,031.3 hours (43 days)) VAQTA injection, 0.5 ml (lot # L018499, exp. date: 25-FEB-2017) (route and strength 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.
I want to report that the Moderna vaccine aggravated my nasal allergies - that I had been arrested/resolved for ~ 6-8 years - returned with a vengeance on 2/19 (after my first shot on 2/15)! Runny nose, congestions, headache, sinus pressure, tearing, and my HORRIBLE sneezing (it scares people!!). I used some my nettie pot, tried a couple other things, and prayed. This resolved for a few days - followed by a couple more bouts. I had my second shot on 3/15; I have had some sneezing with it - but not as bad so far.
This spontaneous report was received from a registered nurse and refers to 2 unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 28-APR-2017, the patients were vaccinated with doses of improperly stored VARIVAX lot # M032493 with expiration date on 06-JUL-2018 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 13 degrees Fahrenheit for 9 hours. Digital data logger was used to record the excursion. The vaccine underwent previous temperature excursion of 7 degrees Fahrenheit for 17 hours and 30 minutes. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002688:
Facial/ arm chest rash Swollen eyes Bilateral Corneal Edema Blurred vision  Significant decreased vision Inability to see to read phone/computer screen About 5-10 minutes after taking vaccine took a long acting antihistamine as per my allergist?s recommendation.  Tests: Automatic Tonometer eye test Slit lamp test Treatment: Prednisone 60mg daily x 6 days (first treatment in ER)  Outcome:  Decreased vision with significant inability to see for about  1 month
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient recieved both covid pfizer bivalent and flu shot. Patient got up to walk out of vaccination room and fainted. Husband caught patient because he was walking behind her. She sat in the chair and drank some water. Patient was responsive and did not want us to take blood pressure or call ambulance. Patient sat for about 15 minutes then got up and walked out on her own. Patient stated that this is the second time shes fainted in the recent weeks.
pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, on 26Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced pain at the injection site on 26Feb2021. The patient received no treatment for the event. The patient would like to know if it's okay to take paracetamol (TYLENOL) after the first dose. The outcome of event pain at the injection site was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Flu like symptoms: Weakness, achy joints, fever of 102*F, chills, headache. Cough, and difficulty taking deep breath. Sleepiness. Dizziness. Could not stand for long periods.  Fever finally broke around 9pm. Chills turned to sweats. By 10:30pm, felling better, but still weak and joint aches. Went to bed, sweat most of the night.
Acute cerebellar ataxia with falling headache, horizontal nystagmus, ankle clonus
Typical soreness in left shoulder that lasted 2 days but then everything was fine. On August 31st I developed symptoms of muscle aches, headache, chills and fatigue. These symptoms were consistent for 2 weeks with intensity dropping the last 4 days. I also started (09/01/2020) with a rash on my left forehead and sensitivity/discomfort along the left side of my scalp to my left eye region. Dyesthetic sensations along the same area
She has a large area of redness, that is very painful to the touch and hot.  There is a lump but it is a few inches away from the sight of injection.  She is going to try Acetaminophen and cold compresses and then followup with her primary care physician if not better in a day or two.
This spontaneous report was received from a pharmacist via company representative refers to a female patient of unknown age. The patient was vaccinated with a dose of ZOSTAVAX (dose, route not reported), (lot# reported as H012579, exp. 28-SEP-2012) on 29-OCT-2012. On an unknown date, after receiving ZOSTAVAX, the patient developed "a red spot at the injection site". The patient only spoke with the pharmacist. At the time of the report patient's state was reported as not recovered. Additional information is not expected.
Patient developed radiating pain in arm that she received Boostrix in about five days after administration. The pain continued to get worse and her doctor told her take Ibuprofen, ice the arm, and move it around to "work out" the muscle. She did all this but pain continued.
AE details for lack of efficacy of Covid vaccine as AE was realized after call; AE details for lack of efficacy of Covid vaccine as AE was realized after call; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "AE details for lack of efficacy of Covid vaccine as AE was realized after call". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Reporter was a pharmacist from an infusion company who was calling on behalf of one of her patients. Reporter states that her patient has taken Paxlovid within the last month and was asking how long should patient wait to get their Pfizer Covid19 booster vaccine after taking Paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
At 5 minutes felt swollen pain at upper cheekbone and upper teeth area (sinus area), at 10 minutes felt lips swelling, then it went down and I thought I was ready to go a little after waiting 30 minutes and then looked in the mirror and saw my entire face , neck and chest area was covered in giant red welts. They were growing and we called the EMT over - he took my blood pressure and O2 and then told him I was going to take liquid Benadryl. He went away and not more than a few minutes later, a hive appeared at the corner of my mouth. I called the medical person back over and he got the EMT who called his boss and called an ambulance to come. By the time the ambulance got there, the rash was going down and dissipating. I called my allergist office who told me that as long as it was only a rash that was going down, I could opt to go home. My breathing was fine. I opted to go home and telehealthed with my allergist in the after noon. He told me to take a zyrtec to be covered for 24 hours with allergy meds. And instructed me that if I chose to get the second vaccine in the set then I need to do it in a hospital setting or at his office if they are able to obtain vaccines.
Hives showing up beginning right before first shingles vaccine but well after my 2nd Covid vaccine (almost one month).  These hives itch, are red, hot, and raised.  They come on all over my body and come and go.  They are getting worse.  I have no new detergent, soaps, food, etc.  Some hives look like chicken pox but some large, covering half my back.
Case number PHEH2013US0205834 is an initial spontaneous report from nurse received on 02 OCT 2013 and a follow up report from the nurse received on 18 NOV 2013. This report refers to a patient of an unknown age and gender. On an unknown date, the patient was accidentally vaccinated with only MenCYW-135 liquid component of MENVEO (batch number: not reported) intramuscularly and did not receive Men A lyophilized conjugate. It was reported that the patient did not experience any adverse event after the mal-administration . No other information was available. Follow up report from the nurse received on 18 NOV 2013. The patient's condition was updated.
Patient came to the pharmacy on Saturday morning 8/11/12 stating that she got flu vaccine on 8/7/12 (Tuesday). Felt fine at the pharmacy got home and became sick. She had diarrhea, swelling at vaccine site, slight fever. She said she couldn't leave her house to come to the pharmacy till now 8/11/12. She looks fine but still shows skin discoloration where the vaccine site was with no visible swelling.
This spontaneous report as received from a licensed vocational nurse refers to a patient of unknown age, unknown gender. On 07-JUN-2013 the patient was vaccinated subcutaneously with 0.5 ml an improperly stored PROQUAD (lot # H020137, expiry date 07-MAY-2014). The PROQUAD (Merck) had had multiple excursions over the past three months reaching the highest temperature of 11F for a total time of 500 hours. The nurse stated that she did not believe that the PROQUAD overall average temperature remained between 58F and 5F. No adverse effect reported. The outcome of the event was unknown. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Vaccine was administered past the BUD/Administration date of Moderna vaccine past the BUD (i.e. past 30 days at fridge temperature) of 05-Sep-2021; product storage error; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past the BUD/Administration date of Moderna vaccine past the BUD (i.e. past 30 days at fridge temperature) of 05-Sep-2021) and PRODUCT STORAGE ERROR (product storage error) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (product storage error). On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past the BUD/Administration date of Moderna vaccine past the BUD (i.e. past 30 days at fridge temperature) of 05-Sep-2021). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered past the BUD/Administration date of Moderna vaccine past the BUD (i.e. past 30 days at fridge temperature) of 05-Sep-2021) had resolved. At the time of the report, PRODUCT STORAGE ERROR (product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was not reported. No treatment medications were provided. 13 doses of Moderna vaccine were inadvertently given past the vaccine beyond use-date (i.e. past 30 days at fridge temperature) of 9/5/21.   This case was linked to MOD-2021-320876 (Patient Link).; Sender's Comments: This case concerns a 26-year-old, male subject with no relevant medical history who was administered with an expired Spikevax product for his second dose of the vaccine. No information on the first dose received by the patient. There were no reported AEs/SAEs associated with this expired product administration. The rechallenge was not applicable in this situation. Causality was not provided by the reporter or not applicable. The benefit-risk relationship of the vaccine is not affected by this report. This case was reviewed via RA
Patient with previous history of sangioedema reaction to vaccine or medication received J&J COVID single dose vaccine and had throat and chest tightness. Treated by EMS, transported to hospital. The vaccine does not require a second dose. CDC recommendations are that no further action is needed at this time.
Vaccine was mixed incorrectly; Patient given just adjuvent; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Vaccine was mixed incorrectly) and inappropriate dose of vaccine administered (Verbatim: Patient given just adjuvent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date - 01-NOV-2023 The nurse reported that the Shingrix vaccine was mixed incorrectly and just given adjuvant which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow-up.
Three days after getting the Vaccine, I woke up to seeing floating black spots, impairing my vision. I feel dizzy when I stand. It has been non-stop for two days and would like to know if it will stop. Thank you!
One week after vaccination, there was swelling in the armpit of the same arm of injection. The swelling was tender, but went away after about 2 days. About 3-4 days later, a red, tender rash developed in the armpit of the same arm of injection. The rash is dry and burns to the touch. There is also a small patch of rash on the right armpit (not arm of injection). The rash on the left armpit completely covers the area.
Case number PHEH2016US031851, is an initial spontaneous report received from a healthcare professional (medical assistant) on 01 Dec 2016. This report refers to a 21 years old pregnant female patient. Past medical history and concomitant medication were not reported. It was reported that she was 27 weeks pregnant. This pregnant female patient was vaccinated with FLUCELVAX QUADRIVALENT (batch number: not reported) intramuscularly on 10 Nov 2016. Further she was vaccinated with a second dose of FLUCELVAX QUADRIVALENT (batch number: 185886) intramuscularly at a dose of 0.5 ml on 01 Dec 2016 (inappropriate schedule of vaccine administered). The case was assessed as non serious. No adverse event was reported following this maladministration (inappropriate schedule of vaccine administered) and (vaccine exposure during pregnancy).
Information has been received from a physician concerning a female who was vaccinated SC with a dose of zoster vaccine life (Oka/Merck). Concomitant therapy included influenza virus vaccine (unspecified). Subsequently, the patient developed painful, itchy, "shingle like blisters and rash" at the injection site after vaccination. No further information was available. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
I tested positive for COVID-19 on 4/22/2023. I had a sore throat, headache, fatigue, red throat on left side. No fever or chills. I did have a runny nose but no congestion. I also noticed a red lump on my arm where I received the injection at. It was sore and swollen. I started Paxlovid on 4/23/2023. by the next day, I didn't have a sore throat or headache anymore.
felt feverish with no measurable fever; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 10Apr2021 as dose 2, single (Lot number: EW0158, Expiration Date: Jul2021) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing), notes: GERD; "airborne allergies" (unspecified if ongoing), notes: airborne allergies Caller says this was diagnosed when he was a very tiny child. Concomitant medication(s) included: FEXOFENADINE oral taken for rhinitis allergic; LANSOPRAZOLE oral taken for gastroesophageal reflux disease. Vaccination history included: BNT162b2 (First dose , NDC: not provided on the card, EXP: 31Jul2021, LOT: EN6207, his first shot was fine.), administration date: 20Mar2021, when the patient was 58-year-old, for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious) with onset 11Apr2021, outcome "recovered" (Apr2021); PYREXIA (non-serious) with onset 11Apr2021, outcome "recovered" (Apr2021), described as "felt feverish with no measurable fever". Therapeutic measures were taken as a result of pyrexia, fatigue.  No follow-up attempts are needed. No further information is expected.