chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site/Her arm was hard and warm; itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site; itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site/Her arm was hard and warm; itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site; Major depressive episode; fever; chills; headache; fatigue; A spontaneous report was received from a consumer concerning a 64 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever/ pyrexia, chills, headache, fatigue, major depressive episode/ major depression, itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site/ vaccination site pruritus, itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site/ vaccination site induration, itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site/ vaccination site warmth, itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site/ vaccination site rash.  The patient's medical history was reported by the reporter as patient had a major depression well controlled with medicine. Concomitant medications taken by the patient included duloxetine hydrochloride.  On 15 Mar 2021, prior to the onset of the event, the patient received first of their two planned doses of mRNA-1273 (Lot number: 044A21A) through unknown route at left arm for prophylaxis of COVID-19 infection.  On 16 Mar 2021, patient developed fever (101.0 F for which she took an Aleve), chills for 24-36 hours, headache, fatigue for 3 -4 days. She took another Aleve the next day. On 20 Mar 2021 she had a major depressive episode. On 27 Mar 2021, she developed an itchy, hard, warm, 4X2 1/2 inches oblong rash at injection site. Patient reported that she was doing a little better with the depression and the arm was hard and warm at the time of reporting too. The event major depressive episode was medically significant.  Treatment activities for event was done with naproxen.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, fever, chills was resolved on 18 Mar 2021, headache, fatigue was resolved on 20 Mar 2021, itchy at injection site was resolved on 27 Mar 2021, rash at injection site was resolved on 28 Mar 2021, major depressive episode was recovering/resolving, hard, warm at injection site was not recovered/ not resolved.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Cellulitis of primary reaction site from initial vaccinia vaccination with lymphangitis and four lymphadenopathy R axilla plus drainage; rx'd with five days Braxid x L 500mg (2/d)
This spontaneous report as received from a female consumer of unknown age who refers herself. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, strength, route of administration not reported). On an unknown date the patient experienced developed redness and swelling at the injection site after administration of ZOSTAVAX. The outcome of injection site swelling and injection site erythema was unknown. The relatedness was not reported. Additional information has been requested.
Information has been received from a physician concerning a 6 year old white female with no medical history who on 12/02/1998 was vaccinated in the right thigh with a dose of varicella virus vaccine live.  There was no illness at the time of vaccination.  The physician reported that on 04/14/2004, the patient developed vesiculopapular lesions.  It was unknown if medical attention was sought.  At the time of this report, the outcome was unknown.  Additional information has been requested.
Pt came into Rx on Friday 8/28 complaining of sore/burning Right arm. She said it started around 11am on Friday. It was warm to touch & red. She stated she couldn't raise arm without it hurting. I advised ice & call Dr if it doesn't. She went to ER Sat 8/29 morning with 102 fever & was diagnosed with cellulitis/phlebitis per pt (didn't see actual discharge papers Pt was given antibiotic doxycycline hyclate 100m BIDx10days from ER doctor.
Patient was given vaccine one week early. First Vaccine was administered: 06/06/2021. Second Vaccine was administered: 06/20/2021
Her cousin had taken a shot and got the virus/does not know what product; Her cousin had taken a shot and got the virus/does not know what product; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Her cousin had taken a shot and got the virus/does not know what product".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Patient had immediate large red swelling at injection site.  Swelling was immediate and spread about 3 inches from injection site.  No pain or other adverse effects reported by patient.
While at work a few days later my armpits begin to hurt and I had giant whelps under both of  them.
After receiving Tdap, MCV, HPV pt had seizure like activity. It is unclear if this was psychogenic event triggered by stress/fear of vac vs. syncopal episode w/tonic clonic movements.
About 6 days after I have a circular rash (almost looks like dry skin or a burn) on my inner right thigh. It has grown slightly each day. I have not sought medical attention. Lotions have not cleared the rash. I have never had a rash like this on my legs before.
Shingles; Information has been received from a lawyer, regarding a case in litigation, concerning a female patient of unknown age. The patient's medical history, concurrent conditions or concomitant medications were not reported.  On an unspecified date in 2012, the patient was vaccinated as prescribed with zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles and/or zoster-related conditions (dose, strength, route of administration and lot number were not reported).  On an unspecified date, the patient developed shingles and was treated by a doctor in an hospital. According to reporter, as a direct and proximate result of the use of zoster vaccine live (ZOSTAVAX) the patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering, medical care and treatment for these injuries, significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies, diminished capacity for the enjoyment of life, diminished quality of life, increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions and other losses and damages; and will continue to suffer such losses, and damages in the future.  At the reporting time, the patient had not recovered from the event shingles. The reporter considered the event shingles to be related to zoster vaccine live (ZOSTAVAX).
Patient states he "felt weird", tingly all over and extremely anxious. Patient was brought to observation for continued care. vs: P-92 r-16 b/p 174/92.  Repeat b/p after 15 minutes was 124/90. Patient feeling much better. Now states he had been very anxious about receiving vaccine.  B/P cuff recycled  it did not measure correctly- air in cuff. Repeated and up to 170/90, patient states it went up because he was worried about the cuff. Refused to have any more vital signs. Ambulated in unit, did well. Discharged home after 30 minutes.
He complained of the injection site being sore for 2 days, then on day 3 a red spot under the injection site appeared. On day 5 following the vaccine (July 1, 2015) there was a large circle of hives all the way around the injection site. I informed the doctor's office and was asked to bring him in because a rash isn't normal. The Dr said it was hives and that my son is allergic to something in the DTaP vaccine.
While on continuous birth control which halts menstruation I began cramping severely. Within 24 hours I began my period. Approximately two weeks later I had signs of possible but not confirmed ovulation.
Rec'd 1st dose of Engerix-B 29MAY90. This was third dose in a series of which the first two doses were w/Recombivax because of negative titers restarted on Engerix-B 7SEP90 & was given dose 7OCT90 titers have remained negative.
Report 2002000877-1 describes numbness in an adult male who received Lyme disease vaccine recombinant Ospa (LYMERIX). medical history, concurrent conditions, and concurrent medications were not specified. On an unspecified date, the vaccinee received an injection of LYMErix in his arm. he subsequently experienced numbness of the arm; the numbness spread to his chest. The nurse stated that she "probably hit his nerve to cause this reaction." Outcome of the event was not provided. The adverse event "numbness" dose not meet ICH serious criteria, but is being submitted as an expedited report by special FDA request per the June 28, 2000 letter. Comment: The nurse reported that she administered LYMErix lot LY1Y7F9; however, this is not a valid lot number. A follow up report received 7/26/2002 adds: There was no relevant medical history...On 11/30/2001, an unspecified time post-immunization, he experienced "mild" numbness of the arm. The numbness spread to his chest and down the arm to the fingers. The numbness resolved after "several hours", without treatment. (The nurse) also indicated that the event was possibly related to Lymerix.
cold; feeling sick; This is a spontaneous report from a contactable consumer (patient) received via Pfizer. A male patient of an unspecified age received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 1 via an unspecified route of administration on 09Feb2021 (Batch/Lot number was not reported) as dose 1, single, single for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced cold and feeling sick. He reported that he was feeling sick/felt like he was getting sick before the dose was given. By morning of the dose, he felt better, but "right away, felt under the weather. The patient reported that when he gets sick, it typically turns into bronchitis because he has a history of asthma. Prednisone is typically used for treatment. The patient was prescribed prednisone to take, but he is not taking it at this time because he knows it will decrease immune system and doesn't want to interfere with the vaccine working. The patient stated that he has no fever and loss of taste. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Site: Pain at Injection Site-Mild, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: pt fainted-Medium, Systemic: Flushed / Sweating-Medium
5/18/16 It was identified that Tdap was administered not Dtap.  no symptoms of issues.
Patient received vaccine morning of 3/25/21.  She developed severe abdominal pain, dizziness, and near syncope starting 11pm, prompting emergency department evaluation around 1:30am on 3/26/21.  Symptoms were self-limiting and resolved without intervention or treatment.  She was feeling better several hours later
Minor skin rash (with no itching) around injection site beginning 3-4 days following injection, and disappearing within 14 to 16 days following injection. Minor soreness at injection site, which disappeared after about 2 days following injection.
Extreme vertigo; It is debilitating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 06Mar2021 (Batch/Lot number: unknown) at the age of 67 years as 1st dose, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VERTIGO (non-serious) with onset 06Mar2021, outcome "not recovered", described as "Extreme vertigo"; ASTHENIA (non-serious) with onset Mar2021, outcome "unknown", described as "It is debilitating". Therapeutic measures were not taken as a result of vertigo, asthenia.  Additional information: The patient received first vaccine last Saturday and about 10 minutes after left the waiting period, started having extreme vertigo and still have it a week later.   No follow-up attempts are possible. No further information is expected.
I only got a mild sore shoulder with my 1st vaccination.; This is a spontaneous report from a contactable Pharmacist (patient).  A 68-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, lot # EH9899) at single dose at left arm on 16Dec2020 09:00 for Covid-19 immunisation, administered at hospital.  Medical history included GOUT, environmental allergies, psoriasis, benign prostatic hyperplasia (BPH). Concomitant medication included acetaminophen (ACETAMINOPHEN), diphenhydramine (DIPHENHYDRAMINE). The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not experienced Covid-19 prior vaccination.  The patient only got a mild sore shoulder on 17Dec2020. No treatment received. Other than that he tolerated the vaccine fine. No nausea or vomiting. Post vaccination, the patient has not been tested for COVID-19. The outcome of event was recovered.
temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003221: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209:
Small red papular to small blotchy eruption on chest, spread over abdomen and both thighs, variable sizes, shapes. No pustules. Prob erythema multiforme, doubt vaccinia.
Information regarding Prevnar was received from a pediatrician regarding a 5 month old female patient who received a first dose of vaccine in 2004 and developed pneumococcal meningitis approximately March 2004. Relevant medical history was not reported. Indication for Prevnar was immunization. Product was administered in 2004. Dose regimen was 1 dose (IM). Concomitant medications were not reported. The patient was hospitalized in March 2004. A non-specific culture was performed; the results were positive for Streptococcus pneumoniae. A diagnosis of pneumococcal meningitis was made. The infant was treated with a 10 to 14 day IV regimen of unspecified antibiotics. As of 5/10/04, the reporter indicated that the infant now looks normal but is still under observation. No additional information was available at the time of this report.
Very sore arm, cannot lift arm, swelling, redness. Feel like I have the flu, weakness, no appetite.
This spontaneous report was received from a Registered Nurse and refers to multiple unspecified patients of unknown age and gender. The patients concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, since 2011 (reported as "over the past 6 years"), the patients were vaccinated with GARDASIL 9 (doses, routes of administration, lot numbers and expiry dates were not provided). On unknown dates, the patients experienced injection site hurt. Product quality complained was not involved The outcome of the event was unknown. Causality assessment was not specified. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1705USA008994: US-009507513-1705USA014281: US-009507513-1705USA014282:
Had the shingles shot in 2018 / but got the shingles in 2020/Suspected vaccination failure; Had the shingles shot in 2018 / but got the shingles in 2020 / again in 2021; They were very painful / so painful; They / burnt like fire; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, between 1 and 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and burning sensation. On an unknown date, the outcome of the vaccination failure, shingles, pain and burning sensation were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain and burning sensation to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient had the shingles shot in 2018 but got the shingles. The patient stated that the shingles were so painful and burnt like fire, the patient got them in 2020 and broke out again in 2021. The patient stated that the shingles shot did not work and hence the patient's physician told the patient to wait 6 months then get the new shingles shot. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR091462:duplicate case
Sudden Bell's palsy to the right side of my face; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Oct2021 (Lot number: Ff2590) at the age of 32 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Von willebrands disease" (unspecified if ongoing); "thyroid disease" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE; TRILEPTAL; DOXEPIN; EUTHYROX; PAXIL [PIROXICAM]. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Fd8448, Location of injection: Arm Left), administration date: 11Sep2021, when the patient was 31 years old, for Covid-19 immunization. The following information was reported: BELL'S PALSY (disability, medically significant) with onset 29Dec2021, outcome "recovering", described as "Sudden Bell's palsy to the right side of my face". The event "sudden bell's palsy to the right side of my face" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of bell's palsy. Patient did not receive other vaccine in four-weeks. AE treatment medication included Antibiotics, steroids, medications. Patient did not have covid prior vaccination. No Known allergies.
I am by no means a doctor, but I wanted to report this for any benefit it may provide. Three days after vaccine I got a bunch of tiny dots all over my torso, upper portion of legs and a few on my arms. They are tiny pin point sized red dots that are flat and do not change color when I press on them. To the best of my knowledge, they look like Petechiae. I have never had dots like this before. I felt fine other than a little fatigue and the rash.  Not wanting to have to rush to a medical facility and spend a long duration of time indoors due to Covid-19 fears, I self ordered labs from an outside laboratory to see if my platelets were ok. I have had two CBC tests done so far.  Luckily, so far, they have looked normal. Now it is over 2 weeks after the first shot and I still have these tiny dots on my skin. I am hoping they go away on their own and I can get the second shot.
Vaccine was administered to my son into his deltoid muscle of left shoulder on Friday 11/18/2016.  He seemed fine on that Friday, however kept mentioning his shot location.  On Saturday 11/19/2016 mid-morning I bumped his shoulder and he complained about it hurting.  After looking and touching his shoulder it was red, hot, extremely swollen and tight. My husband and I called the nurses line  and they recommended he be brought into the ER.  I (due to some medical training as a chiropractor) chose to give him (based on recommendation from nurse and doctor) Benadryl and monitor him due to him not being in any immediate distress with breathing or lethargy.  Throughout that night patient cried his arm hurt and I gave him more Benadryl according to manufacture recommendations.  By next morning the swelling in his left arm had now expanded to his elbow.  We continued to administer Benadryl according to manufacture recommendations and made an appointment with his primary care physician for the next day. Monday morning when patient woke up, his left eye and face were swollen.  I took him the doctor where he was examined and prescribed and liquid steroid and referred to the infectious disease specialist.  The infectious disease doctor advised the arm swelling was likely due to a cell mediated response, however his face and eye involvement was more likely due to an allergic response to the vaccine.