chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-NOV-2014, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 14-NOV-2015, the patient was treated the same physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
On May 29, 1999 the pt developed a red raised rash on the face, neck, trunk and extremities. The child also experienced itching. On May 31, 1999 the child was presented the ER with sx. Upon admission the child was dx wit chickenpox. Advised to F/U with local MD.
Within 4 hours of Tdap and Varivax administration, patient experienced redness,itching,and swelling of Left upper arm.Mom applied cool compresses and gave Benadryl over the weekend and then came to the office about 72 hours later.
Pt had welts and warmth on arm (not on injection site) pt complained of burning sensation.
3 days p/vax pt devel hives & swollen ankles per mom;went to clinic & recv decadron & was better the next day;
Severe pain, swelling and erythema at site of vaccination of Pneumovax booster. Known to be over 15 years since her 1st pneumovax.
I developed nerve inflammation in my cervical vertebrae that radiated down my arm and resulted in trouble sleeping, performing work, and daily activities without great pain. I have never had pain from this region nor of this type before. After trying multiple NSAIDs and steroids, I was given an epidural injection that calmed down the inflammation. Additionally, approximately one month after my booster dose (Pfizer FF2588 received at Pharmacy, I developed somewhat similar extreme pain originating from my lumbar spine and radiating down my left leg with greater pain that caused me to be unable to walk more than 10 feet at a time. Again, tried NSAIDs, I had a cortisone injection in my knee (the place where the pain largely manifested itself) and nothing helped until I had two epidural injections (two locations) in my lumbar spine. Throughout this time, I was seeing my chiropractor 2-3 times weekly and he was not finding that my spine had changed or was experiencing major subluxations. I also had not sustained any injury. He shared with me that he has a patient who is a medical doctor and that person had said that he/she had noted some unusual, strong inflammation in patients after they received their Covid vaccine.
This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient. A 90 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in left arm, administration date 24Feb2021 (Lot number: EL9266) at the age of 90 years, as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Multiple allergies", start date: 1961 (unspecified if ongoing); "Neuropathy" (unspecified if ongoing). The patient took concomitant medication. Vaccination history included: BNT162B2 (DOSE 1, SINGLE (Lot No: EN9581) intramuscularly, administered in left arm), administration date: 03Feb2021, when the patient was 90 years old, for COVID-19 immunisation. The following information was reported: VACCINATION SITE DISCOLOURATION (non-serious) with onset 25Feb2021, outcome "not recovered", described as "there was an area, approximately 1" in circumference, around the vaccine injection site that was pink"; VACCINATION SITE PRURITUS (non-serious) with onset 25Feb2021, outcome "not recovered", described as "Injection site itching". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site discolouration, vaccination site pruritus.Additional information: The patient reported that she received two unspecified allergy shots in her left arm since the first BNT162B2 vaccine dose, and gets allergy shots every other week (has been getting these allergy shots for a long time). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient also clarified that itching at the injection site was not extreme.
Information has been received from a physician concerning a 17 year old female who on 09-FEB-2007 was vaccinated with Gardasil (Lot #655205/1426F). On 27-APR-2007 the patient received her second dose of Gardasil (Lot #655619/1427F) which was given in her left upper arm. Concomitant therapy included medroxyprogesterone acetate (DEPE-PROVERA) which was given to the patient on 27-APR-2007 in the right arm. It was reported that the patient did not experience any adverse effects with the first dose of the vaccine of Gardasil. However, on approximately 01-MAY-2007 the patient experienced warmth, pain and hardness at the injection site where Gardasil was given. It was reported that the patient sought unspecified medical attention. No further details were provided. Additional information has been requested.
DIZZINESS; TINGLING IN THE ARMS; This spontaneous report received from a parent concerned a 24 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included autism, and allegry to clindamycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and batch number: 1808609) dose was not reported, administered in right deltoid on 18-MAR-2021 at 09:00 am for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced dizziness. On 18-MAR-2021, the subject experienced tingling in the arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, and tingling in the arms. This report was non-serious.
Patient admitted to hospital 7 days after receiving 2nd booster of vaccine.   Found to have an type 1 MI.    Discharged back to nursing home on day 3
Information has been received from a physician concerning a 24 year old female with no medical history and no drug allergies who "last week" on approximately 12-JUL-2006 was vaccinated with HPV vaccine rLI 6 11 16 18 VLP vaccine (yeast) (0.5 ml).  Concomitant therapy that day included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid.  The vaccines were administered in different arms.  Subsequently, "12 hours after vaccination" the patient developed a rash throughout her whole body that lasted for two days.  Unspecified medical attention was sought.  The patient recovered two days after injection.  Additional information has been requested.
A report has been received from a health professional, concerning a three years old male patient. Patient's medical history and concomitant medications were not reported. There was no family history of Bell's palsy. The patient received nasal FLUMIST on 20-Nov-2012. The family noticed that the patient developed weakness on the left side of his face and the he was unable to close his eyes. The patient developed Bell's palsy on 16-Dec-2012. Action taken with influenza vaccine was not applicable. The patient recovered from the event of Bell's palsy on an unspecified date. He was given a brief course of prednisone (7 days steroid treatment with prednisone 10 mg, 3 tablets daily for 5 days, then 1 tablet daily for 5 days and also received VALTREX 500mg three-quarter tablet three times a day for 7 days) at that time. On 07-Feb-2013, on neurological exam, he was alert and cooperative. His running and jumping have been normal and he has had no double vision. There were no birthmarks and there were no cranial bruits. Easily closed his eyes bilaterally and they seen normal nasolabial creases bilaterally. Extraocular movements were intact and his fundus was normal. There was a normal walk and a normal run with good finger-nose testing. There have been no other neurological deficits. His head circumference was 48 cm. The reporter assessed the event of Bell's palsy to be serious with the seriousness criteria of important medical event. Follow up of insignificant information received by AstraZeneca/MedIummune 10-May-2013 from Physician: New reporter added. Form completed date updated. Summary of follow-up information received by AstraZeneca/MedImmune 20-May-2013 from physician: new reporters were added, start date of the event updated, outcome of the event updated, other diagnostic test was added, narrative updated.
The Medical Assistant reported a temperature excursion for refrigerated vaccine.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 03-MAR-2021, 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) dose 1 (units not provided)(strength, route, dose number, frequency, and anatomical location were unknown) with lot # 1687291 and expiration date 11-SEP-2022 for prophylaxis.The patient was asyntomatic.  The administered dose of vaccine experience the temperature excursion on one of these dates, 22-FEB-2021, 25-FEB-2021, 02-MAR-2021, 05-MAR-2021, 09-MAR-2021, 15-MAR-2021, and 19-MAR-2021, of 35.6, 35.7, or 35.9  degrees Fahrenheit for 15 minutes; on 17-MAR-2021, the temperature excursion of 35.7 degrees Fahrenheit for 30 minutes;  on 18-MAR-2021 and 28-MAR-2021, of 35.2 and 35.9 degrees Fahrenheit for 45 minutes; on 25-MAR-2021, of 35.2 degrees Fahrenheit for 4 hours and 15 minutes; on 26-MAR-2021, of 35.4 degrees Fahrenheit for 2 hours and 45 minutes; or on 27-MAR-2021, of 35.9 degrees Fahrenheit 1 hour and 30 minutes.  There was no digital data logger involved, and no previous temperature excursion. The vaccine program did an audit, and they were unaware of the excursions.  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; devicelotnumber: 1687291; expirationdate: 11-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA002850: US-009507513-2105USA003504: US-009507513-2105USA003505: US-009507513-2105USA003506: US-009507513-2105USA003507: US-009507513-2105USA003508: US-009507513-2105USA003509: US-009507513-2105USA003510: US-009507513-2105USA003511: US-009507513-2105USA003512: US-009507513-2105USA003513: US-009507513-2105USA003514: US-009507513-2105USA003515: US-009507513-2105USA003516: US-009507513-2105USA003517: US-009507513-2105USA003518: US-009507513-2105USA003519: US-009507513-2105USA003520: US-009507513-2105USA003521: US-009507513-2105USA003522: US-009507513-2105USA003523: US-009507513-2105USA003524: US-009507513-2105USA003525: US-009507513-2105USA003526: US-009507513-2105USA003527: US-009507513-2105USA003528: US-009507513-2105USA003529: US-009507513-2105USA003530: US-009507513-2105USA003531: US-009507513-2105USA003532: US-009507513-2105USA003533: US-009507513-2105USA003534: US-009507513-2105USA003535: US-009507513-2105USA003536: US-009507513-2105USA003537: US-009507513-2105USA003538: US-009507513-2105USA003539: US-009507513-2105USA003540: US-009507513-2105USA003541: US-009507513-2105USA003542: US-009507513-2105USA003543:
Pt vaccinated with TTOX developed 3x3CM area of redness at injection site. Warm to touch.
redness over arm and elbow; Bumps over injection site and arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Bumps over injection site and arm) and VACCINATION SITE ERYTHEMA (redness over arm and elbow) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction. Concomitant products included VITAMINS NOS for an unknown indication.  On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 22-Feb-2021, the patient experienced VACCINATION SITE MASS (Bumps over injection site and arm). On 24-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness over arm and elbow). The patient was treated with ALCOHOL at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency.   At the time of the report, VACCINATION SITE MASS (Bumps over injection site and arm) and VACCINATION SITE ERYTHEMA (redness over arm and elbow) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Chills beginning 4 hours after 2nd dose. Extreme swelling in right lymph node in neck. Severe rash up neck, over the right ear, across right cheek, around right eye and across right side of nose. Our family doctor examined patient on Thursday, 2/25 and said it would get better on it's own. It continued to worsen and he was very ill with vomiting, low grade fever and chills. On Monday 3/1 he went to the ER was put on Kefflex antibiotics. The diagnosis was cellulitis.  After 7 days of treatment he is much better, the rash has dried up and only red scabs are left to heal.
3.2.21 chest pain, jaw pain increased heart rate, headache,high blood pressure. I continued to work until 3.5.21 heart rate continued to be high 185 BPM when normally 55- 54 BPM. I went to the emergency room, thought I was having a heart attack, sweats, chest pains, high heart rate and was hospitalized.
MOTHER CALLED TO NOTIFY THE PROVIDER THAT THE PATIENT WAS SEEN IN OFFICE YESTERDAY 8/8/19 AND RECEIVED THE MEN B VACCINE. YESTERDAY NIGHT THE PATIENT BEGAN TO FEEL LIGHT HEADED AND FELL TO THE GROUND MOTHER SAID HE WAS "OUT OF IT FOR 5 SECONDS" THEN IMMEDIATELY VOMITED.  MOTHER DECIDED TO JUST KEEP AN EYE ON HIM THE REST OF THE NIGHT AND HE SEEMED WELL. TODAY HE IS WELL-APPEARING AND DENIES ANY N/V, HEADACHE, PAIN, NO LOCAL REACTION SURROUND THE INJECTION SITE. PT IS EATING AND DRINKING WELL.
DT 0.5ml IM on 8/22/05. Awoke on 8/23 with fever, myalgia and arthralgia and HA.
Light headedness, dizziness followed by syncope lasting approximately 2 minutes treated with Benadryl 50 mg PO.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE NON ST ELEVATION MI  9/27/2022 -- RECURRENCE OF SAME SYMPTOMS
she could feel it on left side of chest; Had Lymph node swelling; Had Lymph node swelling and pain there; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 73-year-old female patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: EN6306) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lyme infection", start date: 2020 (unspecified if ongoing); "mild stroke", start date: 2020 (unspecified if ongoing); "cellulitis" (unspecified if ongoing); "AFIB" (unspecified if ongoing); "allergic to a lot of antibiotics" (unspecified if ongoing); "cough" (unspecified if ongoing); "sinus" (unspecified if ongoing); "congestion" (unspecified if ongoing). Concomitant medication(s) included: CORICIDIN HBP COUGH AND COLD taken for cough, sinus disorder, nasal congestion; ATENOLOL taken for cerebrovascular accident.  The following information was reported: CHEST PAIN (non-serious), outcome "recovering", described as "she could feel it on left side of chest"; LYMPHADENOPATHY (non-serious), outcome "recovered", described as "Had Lymph node swelling"; PAIN (non-serious), outcome "recovered", described as "Had Lymph node swelling and pain there". Relevant laboratory tests and procedures are available in the appropriate section.
atypical shingles on right flank; redness on right flank; pain on right flank; tiredness; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 6th November 2019, 25 days after receiving Shingrix, the patient experienced shingles, localized erythema, flank pain and tiredness. On an unknown date, the outcome of the shingles, localized erythema, flank pain and tiredness were recovering/resolving.   It was unknown if the reporter considered the shingles, localized erythema, flank pain and tiredness to be related to Shingrix.  Additional case details were reported as follows: The patient reported for herself. The patient received Shingrix in her left arm. The patient went to the emergency room as advised by her physician on 6th November 2019. The patient planned to continue follow-up with her physician on an unknown date. The patient consented to follow up. There is discrepancy in the reported event outcome in XML file and narrative. However it was captured as per XML file.
Injection site pain; General malaise; Sleepy; Chest tightness; This is a spontaneous report from a contactable physician, the patient. A 34-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL0140), via an unspecified route of administration in the left arm on 08Jan2021 08:00 AM (at the age of 34 years) as a single dose for Covid-19 immunization. The patient's medical history was not reported. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Historical Vaccine included the first dose of BNT162B2 on 18Dec2020 11:45 AM (at the age of 34 years) in the left arm for Covid-19 immunization (Lot Number EL0140). On 08Jan2021 11:00 AM the patient experienced injection site pain, general malaise, sleepy, chest tightness. The patient was treated for the injection site pain, general malaise, sleepy, chest tightness with acetaminophen (Manufacturer Unknown) 500mg oral every 6 hours. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events, injection site pain, general malaise, sleepy, chest tightness, was recovering.
3 days after 2nd vaccine had severe itch all over my body excluding genital area and scalp. I was frantic, agitated, and jittery.  Used Benadryl 25-50 mg at a time, a variety of itch lotions and itch powder, and baking soda bath to little relief. Spoke with MD who prescribed Zyrtec, Pepcid, Prednisone (5 days), and hydrocortisone cream 1%.  Temporary relief. The itch resumed after Prednisone and I visited 2nd MD who prescribed Prednisone in a different dosage, Atarax which treated the jitters and agitation. I continued with the hydrocortisone as it gave good relief. Duration: 17 days. No hives, no rash just blood bruising on both arms and skin abrasions from the scratching. This was my second dose of Moderna. No problems with the first. I will not take it again.
This case was reported by a other health professional via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 4-year-old female patient who received KINRIX (batch number MH9T7, expiry date 29th September 2017). On 25th April 2016, the patient received KINRIX. In May 2016, less than a month after receiving KINRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site itching and injection site rash. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema, injection site itching and injection site rash were not recovered/not resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site itching and injection site rash to be related to KINRIX. Additional details were provided as follows: This case was not associated with product complaint. The healthcare professional reported that the patient experienced monthly a 2 to 2.5 inches raised red rash with swelling, itchy at the injection site which lasted for 3 to 4 days after receiving KINRIX. The rash occurs every month. On 23rd November 2016, the patient was last seen at the practice office and rash was present at that time.
This case was reported by a consumer via call center representative and described the occurrence of swelling arm in an adult female patient who received SHINGRIX. On 7th April 2018, the patient received the 1st dose of SHINGRIX. On 7th April 2018, unknown after receiving SHINGRIX, the patient experienced vaccine administered at inappropriate site. In April 2018, the patient experienced swelling arm, chills, contusion, general body pain, injection site itching, erythema of extremities and slight temperature. On an unknown date, the outcome of the swelling arm, contusion, injection site itching and erythema of extremities were recovering/resolving and the outcome of the chills, general body pain and slight temperature were recovered/resolved and the outcome of the vaccine administered at inappropriate site was unknown. The reporter considered the swelling arm and erythema of extremities to be almost certainly related to SHINGRIX. It was unknown if the reporter considered the chills, contusion, general body pain, injection site itching and slight temperature to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient received SHINGRIX on left arm. Less than a week, after receiving SHINGRIX the patient experienced swelling arm, chills, contusion, general body pain, injection site itching, erythema of extremities and slight temperature. According to the patient, SHINGRIX was administered in the back fatty part of arm leading her to believe it was administered incorrectly. She felt that SHINGRIX was not administered in the deltoid, which led to vaccine administered at inappropriate site. The patient also felt that this contributed to the increased amount of swelling in her left arm. The patient had spoken with her physician. The patient had denied permission to contact her physician.
Impending doom, tingling throughout body, coughing, choking, pulse 102.
Multiple symptoms: sudden onset insomnia with no mental health issues Period re-started after menopause Chest pain difficulty breathing sensory neuropathy
PATIENT HAS RECEIVED A HIGHER DOSE THAN INDICATED 1.8 MLS
C/O cough, chills, headache, runny nose, congestion, and malaise.
Approx 5 minutes after injection, pt experienced facial itching, redness, progressed w/in 5 min to SOA, wheezing, vomiting - pt tx with CLARITIN, BENADRYL, epi x 2, albuterol nebulizer tx - transferred to Hosp by EMS.
9 days after injection I had developed large swollen red patch near injection site about 5 inches long it was also extremely itchy. I used topical benadryl for about a week to get it to go away.