chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Took the shot last year and just getting over them/Suspected vaccination failure; Shingles on face/Just getting over them; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles already).   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Took the shot last year and just getting over them/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles on face/Just getting over them). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by a patient via interactive digital media. The patient took the shingles shot last year. The patient had shingles on his/her face 3 times.  The reporter stated that he/she was just getting over them.  The reporter further stated that the doctor suggested it and he/she did not understand. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
I got my Moderna booster on November 10, 2021. About 12 days later I started feeling really itchy. My palms and the balls of my feet got swollen. On November 23rd I had hives all over my body. I started taking Benadryl which helped, but the swelling wasn't going away completely.  From November 3rd to the 7th I was on a low dose of Prednisone. It still hadn't gone away completely so I switched to Zyrtec (10 mg once in the morning) so I wasn't so drowsy. I took Zyrtec from around December 9th to the 20th, when my healthcare provider suggested that I take 10 mg of Zyrtec 2 times a day (morning and evening). I did that from December 20th until the 27th. Then my healthcare provider suggested I tried to get off of it again since the swelling and splotchiness had gone down considerably. From December 27th to the 31st I went down to just taking 1 10mg of Zyrtec a day in the morning. I stopped taking Zyrtec on December 31st and now on January 2nd my hands and feet are swollen again. The swelling means my palms and the balls of my feet get hot, itchy and tight. Generally throughout this time I have had hives or splotchiness in random spaces across my body ranging from knees, to belly button area, to lower back, to neck, to under armpits, and chest, to some splotchiness on my cheeks. These spots are itchy and hot. Taking Zyrtec regularly has helped. My skin is also way more sensitive than it was before if I scratch myself my body welts up in that area. I have photos if that would be helpful please let me know. Part of the reason I am reaching out is because I know of two other women my age who are experiencing this long lasting urticaria, two weeks post a vaccine booster. I have told them to also fill out this form.
mild headache; mild neck ache; Fatigue; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (BNT162B2), via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced mild headache, mild neck ache and fatigue on an unspecified date. Outcome of events was unknown.   Information about lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Pt developed lightheadedness. Pallor, diaphoretic. Symptoms were completely resolved within about 10 minutes.
PATIENT RECEIVED MODERNA ON 9/2/2021 THAT EXPIRED ON 8/31/2021
HE CAME TODAY ON 08/05/2022 AND INFORMED US THAT AFTER GETTING VACCINE IN MAY/16/2021 HE HAS PAIN AT INJECTION SITE AND HIS DOCTOR INSISTED HIM TO INFORM PHARMACY. HE IS CLAIMIN THAT PAIN IS DURETO CONTENT OF THE VACCINE
couldn't operate as she usually does, had to take two days off; fever; fatigue; chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (couldn't operate as she usually does, had to take two days off), PYREXIA (fever), FATIGUE (fatigue) and CHILLS (chills) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced ASTHENIA (couldn't operate as she usually does, had to take two days off), PYREXIA (fever), FATIGUE (fatigue) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 21-Mar-2021, ASTHENIA (couldn't operate as she usually does, had to take two days off), PYREXIA (fever), FATIGUE (fatigue) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided   This case was linked to MOD-2021-083344 (Patient Link).
Pt calling to report sxs following her 10/18 shingles vaccine at her Px. Reports an area of redness at the injection site measuring 1.5 inches in addition to a blistery rash at her right wrist measuring 2 inches long and 1 inch wide.
product origin unknown; complex regional pain syndrome (CRPS);  This literature marketed report was received from authors of a published article, titled as stated above, and refers to a 14-year-old female patient. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On unknown dates, the patient was vaccinated with the first and the second dose of either HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacturer unknown) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) (reported as HPV vaccine, but manufacturer was not known) (dose, route and site of administration, lot # and expiration date not provided) for prophylaxis (product origin unknown).  On the same day as the second dose of either HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacturer unknown) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) was administered, the patient experienced bilateral pain in the upper and lower extremities, including hyperesthesia/hyperalgia and temperature asymmetry. On an unknown date, reported as 11 days after symptom onset, she was diagnosed by her health care practitioner (HCP) with complex regional pain syndrome (CRPS); the HCP attributed the event onset to the HPV vaccine. On an unknown date, 49 days after onset, her symptoms resolved; thus the patient recovered from CRPS. The action taken with the suspect vaccines regarding the events was not applicable.  The reporter considered CRPS to be related to either HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (manufacturer unknown) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown). It was also reported that this case of CSRP was identified by the health care practitioner as being potentially linked to HPV vaccination.  A copy of the published article is attached as further documentation of the patient's experience.
Fever and body aches/discomfort the night of receiving vaccine, resolved by next day. Awoke the 4th day with right arm tennis elbow syndrome-  stiffness and pain when flexing/straightening arm, decrease in pain by end of day due to regular activities throughout the day. Now the 5th day post-injection, awoke with stiff/painful tennis elbow to right arm. No medications taken, awaiting resolution.
Excessive hives all over body red hot inflamed and irritated; Excessive hives all over body red hot inflamed and irritated; Excessive hives all over body red hot inflamed and irritated; Excessive hives all over body red hot inflamed and irritated; fever at 104 F; severe chills; nausea; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, administered in arm left on 30Sep2021 at 19:30 at 31-year-old (Lot Number: Ff8839) as DOSE 1, SINGLE for COVID-19 immunisation.  Medical history included COVID-19 (not ongoing). Patient was not pregnant and was not pregnant at time of vaccination. There were no concomitant medications. Patient did not receive other vaccine in four weeks. The patient experienced excessive hives all over body red hot inflamed and irritated (medically significant) on 01Oct2021 with outcome of not recovered, fever at 104 F (medically significant) on 01Oct2021 with outcome of not recovered, severe chills (non-serious) on 01Oct2021 with outcome of not recovered, nausea (non-serious) on 01Oct2021 with outcome of not recovered. The events did not require therapeutic measures. The patient underwent lab tests and procedures which included body temperature: 104 Fahrenheit on 01Oct2021. It was reported that the patient have been breaking out in excessive hives all over her body red hot inflamed and irritated since the day after vaccination, she also had 104 F fever with severe chills and nausea. Patient did not test for COVID-19 post vaccination.
Nausea, no eating or drinking, pale, shortness of breath, high fever- 104, lymphangitis, swelling and redness approximately 7 inches wide, with red streaks from sight injection.  Could not walk.
Redness swelling, pain at injection site going up neck, muscle pain, a headache, shivering, fever, nausea, sharp stomach pain. Could not sleep all night.
Localized erythema and inflammation post-injection; tenderness and mild moderate pain. Pt monitored for 1 hr minimally and instructed to take BENADRYL / IBUPROFEN. No h/o adverse injection site was noted. Pt reported warm compresses to be helpful in reducing swelling.
Initial symptoms were sensativity to light, headaches, extreme fatigue;  Initial symptoms were followed by cognative issues, joint pain including costochondritis (swollen, painful, inflammed sternum, shoulder, elbow, ribs); moody and inability to do physical activity due to joint pain and fatigue;  Irritability and light-headedness; mouth sores; developed sensativity to dairy; hair loss; miscarriage; anxiety; flushing; allergies; and a myriad of other random complaints.  Over a number of years I visited an eye doctor, general physicians, two chiropractors, urgent care, a naturopath, an allergy Md, an endocrinologist, a rheumatologist, etc.   I've had numerous diagnostic tests while dealing with these issues.
Seizure; This is a spontaneous report from a non contactable other HCP.   A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on 02Jun2021 as single dose for COVID-19 immunisation.  Medical history included seizure disorder.  Concomitant medications were not reported.  On 02Jun2021 the patient experienced seizure (assessed as medically significant) with outcome of unknown.  The event resulted in emergency room/department or urgent care visit. Therapeutic measures were taken as a result of seizure, not further specified.   No follow-up attempts possible; information about lot/batch number cannot be obtained. No further information is expected.
injection site still swollen, red and itching frequently; injection site still swollen, red and itching frequently; injection site still swollen, red and itching frequently; This is a spontaneous report from a contactable consumer, the patient. A 40-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6207) via an unspecified route of administration in the left arm on 14Mar2021 at 09:45 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patients medical history included systemic lupus erythematosus (lupus SLE as reported). The patient had no known allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. 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 14Mar2021, the patient experienced injection site swelling, red and itching. The patient reported that 1 week later, injection site was still swollen, red and itching frequently. Therapeutic measures were taken as a result of events and included treatment with ice packs and ibuprofen. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of vaccination site swelling, vaccination site erythema and injection site itching were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient came in for flu shot and Hep B (on alternate schedule for Hep B).  Was given flu shot and Hep A instead (his Hep A series was complete in 2021)- so received a 3rd Hep A shot.
Informaiton was received from a heatlh professional concerning an 11 year old make who on 31 JAN 2005 was vaccinated with a dose of Varicella virus vaccines live.  There were no concomitant therapy.  The health professional reported that on 15 FEB 2005 the patient developed a case of mild breakthrough characterized by about 16 itchy lesions.  The patient was notted to be afebrile.  Unspecifiied medical attention was soutght.  At the time of this report the patient's breakthrough persisted as he was still "breaking-out".  Additional informaiton was requested.
COVID-19 Infection Narrative: Patient received dose of Pfizer COVID-19 vaccine on 2/23/21. On 3/5/21 the patient presented to the emergency department with fever of 102.4 F, chest pain, dyspnea on exertion, non-productive cough and diarrhea. Pt was tested and found to be positive for COVID-19 infection. Patient initiated on remdesivir and dexamethasone for treatment of COVID. Remdesivir discontinued due to new onset acute kidney injury. Patient completed course of dexamethasone. Patient discharged home on 3/9/21. Has not received second dose of vaccine.
Pts mom came in and showed me picture of childs arm. Arm looked red and enflamed in the area of shot. I explained to mom to keep it iced down and take tylenol. If it got worse or more painful to see dr.
No adverse effects.; a patient received an improperly stored dose of GARDASIL 9; This spontaneous report was received from a nurse referring a patient of unknown age and gender. Information about pertinent medical history, drug reactions/allergies and concomitant therapies was not provided.    On 18-NOV-2019, the patient received an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R032768 and expiration date 31-AUG-2021; strength, dose and route were not reported) for prophylaxis (product storage error). No adverse effects were reported. The vaccine underwent temperature 10.1 Celsius for a duration of 1 hour. There was a previous temperature excursion at 10.6 Celsius for a duration of 15 minutes. The call was because of data logger.
Myalgia, RespDepression, CoughWheeze, fatigue Narrative:
6 days after receiving the 2nd Moderna shot, she developed an itchy, red, and swollen area in the shape of a rectangle on her right upper arm.  It resolved after 3 days.
Left arm ache in shoulder muscle at injection site. Shoulder muscle area hurts to lift arm or put any pressure on arm such as lying down
pt started feeling pain & soreness in area of inj became progressively worse;became red w/in 24hr;pt devel low grade temp 101.1-dx macular lesion @ inj site;ax lymph node to be 1cm & tender redness between shoulder & elbow of arm;
Began with spasm in lower back following day of shot, spasm came on again and were debilitating. These pains never went away. Glands in groin area swelled up.  Pain began inside hips and up spine. Pain behind collar bones. Pain shooting down left leg. I am now 5 days in and still have spasms  and severe pain in lower back, between shoulder blades and inside hips that won?t go away.
vaccine related varicella Patient started with rash 07/06/2021 and seemed to be a little worse on 07/07/2021 so came into the office for a check. Dr diagnosed with vaccine related varicella and took patient out of daycare for 10 days.
Side effects - Headache, Muscle pain, Chills, Joint pain, Fast Heartbeat
Lightheaded; Sweating; Chills; Fever 103.7 F; This spontaneous case was reported by an other caregiver and describes the occurrence of DIZZINESS (Lightheaded), HYPERHIDROSIS (Sweating), CHILLS (Chills) and PYREXIA (Fever 103.7 F) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced DIZZINESS (Lightheaded), HYPERHIDROSIS (Sweating), CHILLS (Chills) and PYREXIA (Fever 103.7 F). At the time of the report, DIZZINESS (Lightheaded), HYPERHIDROSIS (Sweating), CHILLS (Chills) and PYREXIA (Fever 103.7 F) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided
ivy flush; it feels like rushing of cold water inside her veins and it's been for 4 days; This is a spontaneous report from contactable female consumer (patient herself) via a Pfizer Sponsored Program Support. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on 17Mar2021 as dose 1, single for Covid-19 immunisation. Patients medical history and concomitant medications were not reported. Patient experienced ivy flush in her body in an unspecified date. She explained that it feels like rushing of cold water inside her veins and it's been for 4 days. It comes and goes away after she took the 1st dose of vaccine. The outcome of event for unknown.   Follow-up attempts completed. No further information expected.
This spontaneous report as received from a nurse refers to a patient of unknown age. No concomitants were reported. On 22-MAY-2014, the patient was vaccinated with VAQTA INJ, lot K000943, expiration date 26-SEP-2016 (dose, frequency, route of administration and indication were not reported) that was exposed to 8.8C for 10 days. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. On 02-JUN-2014 a phone call was placed to reporter. The receptionist stated they do not have any one that name employed at this facility. No further information is available at this time. This report is linked to 1405USA013915 and 1405USA0139161406USA004906, 1406USA004908, 1406USA004909, 1406USA004913, 1406USA004914, 1406USA004915, 1406USA004863, 1406USA004874, 1406USA004881, 1406USA004891, 1406USA004896, 1406USA004897, 1406USA004900, 1406USA004901, 1406USA004814, 1406USA004830, 1406USA004831, 1406USA004832, 1406USA004833, 1406USA0048371405USA013915 by the same reporter link. Additional information is not expected.
Subconjunctival hemorrhage; This is a spontaneous report from a contactable hcp.   A 65-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 12Jun2021 (Batch/Lot number was not reported) as a single dose, for covid-19 immunisation  .  Medical history included , ongoing hypertension , ongoing diabetes mellitus (AODM , ongoing hypercholesterolaemia. Concomitant medication(s) included amlodipine (AMLODIPINE) taken for hypertension from an unspecified start date and ongoing; valsartan (VALSARTAN) taken for hypertension from an unspecified start date and ongoing; rosuvastatin (ROSUVASTATIN) taken for hypercholesterolaemia from an unspecified start date and ongoing; metformin (METFORMIN) taken for diabetes mellitus from an unspecified start date and ongoing; glimepiride (GLIMEPIRIDE) taken for diabetes mellitus, start and stop date were not reported. On 21Jun2021, the patient experienced subconjunctival hemorrhage.  The outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
A nurse reported the inability of several subjects to respond to the Hep B vaccine recombinant (Engerix-B) immunization series. The subjects were males and females in their 50's and 60's. The # of injections varied. The nurse stated that seroconversion was increasingly difficult to obtain with increasing age of the subject. A specific subject has not been identified; therefore this report is considered non-reportable. Comment: This case has been linked to case #A0384251A due to the same reporter.
Underdose; exposure via skin contact; Inadvertent exposure to vaccine; sore arm; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date).   On 12th June 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 12th June 2019, unknown after receiving Shingrix, the patient experienced accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. In June 2019, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm, accidental underdose, exposure via skin contact and inadvertent exposure to vaccine were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that a fellow pharmacist administered dose 2 of Shingrix to a male patient and some of the vaccine leaked down the patient's arm  which led to accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. The patient noted that the arm was not sore as it had been after dose one. The patient was concerned they may not have received the full dose. This case has been linked with case US2019AMR116516, reported for the dose 1 of the same patient.
Mother brought child into HD. Had runny nose, lacy rash over trunk of body moving up into back of hair on head. No obvious fever, temp not taken. Otherwise bright, active and happy. Advised to call personal physician. Taken to MD then to ER because of 100.6 fever that evening. ER diagnosed roseola and no vaccine reaction. 11/30/2001 spoke with mom, child much better. Was told to continue to get scheduled vaccines.