chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle aches; Pain; Headache; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th February 2020, the patient received Shingrix. In February 2020, less than 2 weeks after receiving Shingrix, the patient experienced muscle pain, pain and headache. On an unknown date, the outcome of the muscle pain, pain and headache were unknown.   It was unknown if the reporter considered the muscle pain, pain and headache to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experienced muscle pain, pain and headache.
This spontaneous report as received from a medical assistant refers to an unspecified number of unspecified patients. On an unspecified date in 2015, the patients were vaccinated with improperly stored dose of MMR II (lot# K024038, expiration date 26-NOV-2016, albumin status rHA; L012479, expiration date 10-APR-2017, albumin status rHA). No adverse effects have been reported. This is one of several reports received from the same source. Additional information has been requested.
Eczema all over forehead, lips and neck.; This is a spontaneous report from a contactable consumer (patient) reported that a 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration, administered in arm left on 20Apr2021 16:00 (at the age of 50-years-old) as 2nd dose, single dose for covid-19 immunisation. The vaccine was administered at the Pharmacy/drug store. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), administered in arm left on 30Mar2021 02:00 PM (at the age of 50-years-old) as 1st dose for covid-19 immunization. On 02May2021 at 12:00 PM, the patient experienced eczema all over forehead, lips and neck. Therapeutic measures were taken as a result of eczema all over forehead, lips and neck as the patient received Cortizone. The outcome of the event was not recovered. Since the vaccination, the patient has not been tested for COVID-19.   Information on the lot/batch number has been requested.
Information has been received from a pharmacist concerning a patient who was vaccinated with a dose of ZOSTAVAX.  Subsequently, following the vaccination, the patient had an injection site reaction.  It was reported that the patient had a "red and swollen arm more extensive than other administrations".  It was unspecified if medical attention was sought.  At the time of this report there was no additional information at the time of the report.  No product quality complaint was involved.  Additional information has been requested.
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 29-JUL-2013, the patient was inoculated with ZOSTAVAX at a medical center as recommended for routine adult health maintenance and 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 of herpes zoster. On or about 22-AUG-2016, the patient was treated at an internal medicine and geriatric office for a vesicular outbreak, which was diagnosed as shingles. He was prescribed acyclovir and gabapentin for management of his painful symptoms and chronic pain. 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.
Son reported that he was having difficulty breathing.  Also complained that his throat felt tight and like he felt like a "fish out of water".  He was treated for Anaphalaxis using an Epi pen and taken to the Emergency Room.  Was also given Prednisone and Benedryl.
8-23-07 TC from mother. Noticed rash on child last evening around 9 PM after coming home from football practice. Rash on stomach area only. This morning noticed rash around injection site on left arm, torso, back, buttocks, and thigh. Mom says it looks like chicken pox. No fever, slept well. Refer to MD if needed.
RN stated? I am sorry but I injected it into the bone?. Did not see him pull back. No further information given.
Lower extremity body aches 24 hours following second injection; Severe headache starting 24 hours after second injection and mild lingering headache for 96 hours following the second injection.; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 03Sep2021 at 18:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included unspecified allergy and medical history was reported as not applicable. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included estradiol/norgestimate (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Aug2021 at 18:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. On 04Sep2021 at 18:00, the patient had mild lingering headache for 96 hours following the second injection. On 04Sep2021 at 18:30 (24 hours following second injection), the patient experienced lower extremity body aches and severe headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event severe headache starting 24 hours and mild lingering headache for 96 hours following the second injection, lower extremity body aches 24 hours following second injection was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient lost consciousness for about 10 seconds. Pharmacist had patient lay down with feet up and patient was conscious and felt better. He ate 2 candies and drank 1 cup of water because pt felt lightheaded. Patient BP was 126/87 after lying down for 15 minutes. Patient insisted on leaving and felt ok to drive home. Patient stated he would grab something to eat before leaving the store.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Mild, Systemic: Shakiness-Mild, Additional Details: He felt lightheaded, tried to stand up and get the pharmacy staff's attention, then fell. He said he doesnt remember the fall. The pharmacy staff helped him to sit up and he asked for water. He felt sweaty and clammy, asked the pharmacist to hold his hands. The LVN came over to check on him and started taking his BP, he then felt nauseated and threw up. The pharmacy called 911, the EMT came and every thing checked out normal. The LVN called his family and he is resting in the LVN's room.
At 14 hours headache was worse with upper chest pain; At 14 hours headache was worse with upper chest pain and non stop "dizzyness"; About 12 hours after shot started with headache; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 16Apr2021 at 09:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and type 2 diabetes. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 26Mar2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 21:00, about 12 hours after the shot, the patient experienced headache. On 16Apr2021 at 23:00, at 14 hours after the shot, the headache was worse with upper chest pain and non-stop dizziness. Felt better on 18Apr2021 at 12:00. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events about 12 hours after shot started with headache and at 14 hours headache was worse with upper chest pain and non-stop dizziness was resolved on 18Apr2021 at 12:00.  No follow-up attempts are needed. No further information is expected.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 09-MAY-2016 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 14-AUG-2016, the patient was treated at a medical center and emergency department for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed valacyclovir and acetaminophen (+) hydrocodone for management of her painful symptoms. As a direct and proximate result of these malfunctions, 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, pain and suffering, and other damages. Additional information has been requested.
Breakthrough case admission after 2 vaccines Moderna 2/27/21 Lot# 010A21A;  Moderna 3/27/21 Lot# 018B21A;
This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. No medical history, current conditions and concomitant therapies were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously (lot # and expiration date were not reported). On an unknown date, within 24 hours of receiving the ZOSTAVAX, the patient experienced one-inch radius that was itching at the injection site. She went to the doctor and he told her to apply a hydrocortisone cream. The pharmacist contacted the patient about a week later and the patient stated that she had recovered from the event (reported as "oh I'm totally fine"). The outcome of itching at the injection site was recovered. The patient sought medical attention, she went to the doctor. The relatedness between the event and ZOSTAVAX was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Hematologist/oncologist diagnosed patient on 4/12/21 with hemophagocytic lympohistiocytosis (HLH) with CNS involvement.  Patient met 6/8 HLH-2004 diagnostic criteria.  6/8 results were able to be evaluated; awaiting 2/8 evaluable.   Probability per provider of having HLH is greater than 99%  using the validated H Score.   The trigger for the HLH appears to be deranged immune activation by the COVID-19 vaccine within the setting of prolonged immunosuppression for transplanted heart.    Due to presenting with severe headache and elevated protein in CSF = Intrathecal chemotherapy was initiated.    Treatment:  HLH-94 Regimen  Dexamethasone  Etoposide  Possible Rituximab  - will only start if EBV DNA is positive
Injection itself was painless, but sharper more persistent pain developed several hours after injection and worsened into the night. Arm swelled significantly over the night  and is painful to move at all.
Delayed vasovagal response with possible seizure.  911 called and arrived minutes later.  Pt was sitting in chair and was lowered to the floor when she slumped and started to have a seizure.  As soon as she was on the floor she snapped awake.  She was disoriented for a moment but was aware.  After a few minutes she sat back down in chair and her blood pressure was taken.  it was 139/81 with HR of about 79.  The fire department came in at this point.  Eventually, the fire dept released her as she was with her mother.
This spontaneous report was received from a pharmacist refers to an adult patient of unknown age and gender. the patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in approximately 2017, the patient was vaccinated with an expired dose of ZOSTAVAX expiration date 18-JUL-2017 (dose, route, anatomical location and lot# were not reported) for prophylaxis. The expiration date was misinterpreted due to "expiration dating convention" which was "2017JULY18".
Patient fainted a few minutes after her vaccination. She regained consciousness within a few seconds. Paramedics were called and she was examined. She was okay and declined transport to the hospital.
Breakthrough case admission after 3 vaccines  Pfizer 1/27/21 Lot# EL9264;  Pfizer 2/17/21 Lot# EN6201;  Pfizer 12/13/21 Lot# FJ8757
Found out I was pregnant day after shot week later I was bleeding for 3 days kind of like a period then it stopped on the 25 I started having high fevers chills facial flushing went to walk in clinic on 27 said I have strep throat took antibiotics 5 days in still having fever chills flushing went to primary dr  did blood work showed I had infection blood pressure started becoming high went to obgyn pregnancy hormone low was told not a good pregnancy  on 5/14 went to have pregnancy terminated blood pressure very high  on 5/17 back at primary dr with high fever chills facial flushing again blood pressure still high put on a water pill to control blood pressure went back to obgyn everything good from procedure hormone levels almost back to zero
fever; chills; tired; achy body& muscles; headache; This is a spontaneous report from a non-contactable consumer. This consumer reported for herself that,  A 49-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: ER8729), dose 2 via an unspecified route of administration, administered in arm left on 08Apr2021 16:45 as dose 2, single for covid-19 immunisation (age at the vaccination 49 years old). Historical vaccine, the patient took first dose bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot: ER2613), dose 1 via an unspecified route of administration, administered in arm left on 18Mar2021 17:00 as dose 1, single for covid-19 immunisation, the patient experienced tired. Medical history included asthma, post-traumatic stress disorder and fibromyalgia from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. She also had known allergies to Sulfa, Vicodin and Dilaudid. Concomitant medication(s) included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported; fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported; montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) taken for an unspecified indication, start and stop date were not reported; formoterol fumarate, mometasone furoate (DULERA) taken for an unspecified indication, start and stop date were not reported. The patient previously took vicodin and experienced drug hypersensitivity, dilaudid and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation and experienced fatigue. It was reported that, after the second shot on 08Apr2021 following morning on 09Apr2021 04:00 patient experienced fever of 104.1 F, chills, tired, achy body & muscles and headache. She did not receive any treatment for the events. Lab data included, on 09Apr2021 patient experienced fever of 104.1 F. Patient did not take any other vaccine in four weeks. She did not have covid prior to vaccination. She was not tested for covid post vaccination. The outcome for the events was recovering.  No follow-up attempts are possible. No further information is expected.
Initially, the symptoms were a sore throat and congestion that progressed into body aches and pains and a low-grade fever. I took an at-home COVID-19 on 01/09/2023 which came back positive. The next hour, I contacted my doctor via telehealth appointment with the nurse practitioner where I explained my symptoms. I was prescribed PAXLOVID and hydration. Within 3-5 days, I was feeling a lot better. However, I started tingling in my fingertips in my right hand right after that lasted until about 02/23/2023. I knew it was sciatica because I had suffered from it before. The sciatica dissipated on its own, but the tingling persisted until I went to my cardiologist appointment on 01/27/2023. He indicated that people were reporting abnormal symptoms after contracting COVID-19 and insisted to continue resting. After traveling for about a month, I came back and all of my pains sort of settled on their own. As of now, I still have tingling in my right hand periodically.
Large local reaction with erythema, heat, swelling and generalized fever, myalgia and malaise which developed gradually over 3 days. Required 2 days off work and po steroids to treat.
n/v, fever & chills approx 1 1/2 hr p/inject; 14OCT t104 w/nausea & vomiting; given anti-nausea med; 16OCT given ATB but to keep food down; cont to get worse; adm to hosp 19OCT w/lower lobe pneumonia treated w/IV ATB;
1345 c/o ringing in ears-observed; 1355 c/o face feeling hot-flushing noted; 1400 c/o dizzy feeling IV therapy monitor 02; 1405 SOB & lump in throat, epi given;
Patient received Varicella booster on 6/8/07. Reported swelling, redness and pain at site of injection on 6/9/07. Ibuprofen PRN discomfort.
Red bumpy rash scattered all over; Swollen lymph nodes; Swollen face and eyes; Swollen face and eyes; This is a spontaneous report from a contactable consumer (patient). A 13-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FC3182), via an unspecified route of administration, administered in left arm on 26Aug2021 (at 13 years old) as dose 1, single for COVID-19 immunization. Medical history was not reported. There were no concomitant medications. The patient had no COVID prior vaccination. The patient was not COVID tested post vaccination. The patient experienced red bumpy rash scattered all over, swollen lymph nodes, and swollen face and eyes, all on 27Aug2021. The events resulted in a doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care visit. Therapeutic measures such as steroid and antihistamine shot were taken as a result of the events. The outcome of the events was not recovered.   Follow-up attempts are completed. No further information is expected.
Tested +  for Covid after receiving 2 does of Moderna Dose 1  1/5/21 Dose 2  2/4/21
1 week after injection into right arm it began to itch, turn red and become slightly painful. Cold compress and hydrocortisone cream helped.
Weakness, weight loss, fatigue, feeling faint, feeling irritable, sensation of warmth.
Information has been received from a certified medical assistant concerning a 10 year old male who on 05-JUN-2006 was vaccinated with his first dose of Vaqta (Lot # 652087/0937R) intramuscularly. There was no concomitant medication. On 05-JUN-2006, the patient became "nauseous and breaking out in a bright red rash that lasted about 30 or 40 seconds after being vaccinated with first dose of Vaqta". The patient had no relevant diagnostic tests/laboratory data. Subsequently, the patient recovered from nauseous and breaking out in a bright red rash. Additional information has been requested.
Information has been received from a physician concerning a large female who received one dose of Gardasil. Subsequently, the patient was found dead in her truck from a blood clot that traveled from her legs to her lungs. The cause of death was reported to be a blood clot. Additional information has been requested.    3/5/08 Autopsy states COD as pulmonary thromboembolus w/deep vein thrombosis of right leg & obesity as contributing factor.
COVID Breakthrough. Patient was admitted to deliver her baby and tested positive. Asymptomatic.
Right arm, red and swollen and hot to touch- per patient- right wrist to the upper arm.  Patient called into today 11/7/16 to report this reaction, swelling much less and redness only slightly at right elbow now.
Complained of "splotches" to anterior chest wall, denied itching, SOB, facial swelling. Admits to feeling anxious. Had only yogurt today prior to vaccine, no full meals. No hx of vaccine reaction or HTN. Escorted from monitoring area to rapid response area. VS performed and monitored for 40 minutes. Rash began to improve independently within moments. Husband at bedside reports hx of becoming flushed and red when anxious. Remained asymptomatic throughout the entire encounter.  VS 1 pm: 212/113 pulse 108 resp 18 sp02 97%  VS 115 pm 192/110 pulse 105 resp 18 sp02 98% seated in chair, no redness to chest or back, husband at bedside, asymptomatic  VS 130 pm 198/118 pulse 102 resp 18 sp02 98% reports feeling 100%, asking to go home  Consulted with medical director on site. Husband will transport home. Red flags reviewed. Agrees to eat and remain well hydrated.  Incident appears related to underlying anxiety and not vaccine adverse reaction.  There was also Flushing and Tachycardia reported! Pt was monitored and was ok! Was also scheduled for 2nd dose
This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. On an unknown dates the patients were vaccinated with improperly stored RECOMBIVAX HB (dosing regimen unspecified) (lot # L027733, expiry 13-SEP-2017). Excursion details are as follows: which were exposed to the following conditions, were administered to unspecified patients: temperature: 31.55 F, Time frame: 45 seconds, there was no previous temperature excursion. It was a call because of a data logger. No adverse effect reported. No further information was provided. This is one of the several reports from the same reporter. Additional information has been requested.