chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse, and refers to a 4 year old patient of unknown gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 23-AUG-2018, the patient was vaccinated with a improperly stored Oka-Merck PROQUAD recombinant Human Albumin (rHA)(which had a lot # of R006750 and an expiration date of 03-SEP-2018; however, dosage number and route of administration were not reported), for prophylaxis. Nonetheless, no adverse effects were reported. The vaccines experienced the following temperature excursion on an unknown date: 11.3 F for 1 hour and 11 minutes. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1808USA013090.
Menveo vaccine given instead of Prevnar (which was due) The vaccine coordinator (which is I) noticed this mistake while entering vaccines into system, taking them out of inventory. Our clinic has a interface from our EMR  to system that automatically sends the vaccines to system when they are entered into our EMR system.  The vaccine coordinator brought this to nurses attention, then discussed with provider, clinic manager, notified vaccine rep., contacted communicable disease who verified child would be ok. Nurse contacted mother. Mother reports no signs, symptoms of reaction due to injection. She will continue to monitor patient and will report any change. Advised mother to bring child in for Prevnar immunization in 2-4 weeks.
Vaccine given 7 days past beyond use date. Per Pfizer manager (quality operations), their data stated, "stability assessment indicates there is no product quality impact and the vaccine was suitable for use."
headache; body ache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th December 2019, the patient received the 1st dose of Shingrix (intramuscular). In December 2019, less than a week after receiving Shingrix, the patient experienced headache and general body pain. On an unknown date, the outcome of the headache and general body pain were unknown.   It was unknown if the reporter considered the headache and general body pain to be related to Shingrix.  Additional details were provided as follows: This case was  reported by the patient's wife. After receiving Shingrix, the patient experienced headache and body ache. The reporter did not consent to follow up.
Have had redness and swelling since morning after vaccine. If i forget to take my Claritin the injection site will rash. It has been 11 days since vaccination and still having the same issues.
4" raised red hive at site of injection. Itching and pain at site, as well as itching palms, ears, and lips. Began 7 days post injection.
This case was reported by a other health professional via call center representative and described the occurrence of swelling of legs in a adult male patient who received BOOSTRIX. On an unknown date, the patient received BOOSTRIX. On an unknown date, unknown after receiving BOOSTRIX, the patient experienced swelling of legs. On an unknown date, the outcome of the swelling of legs was unknown. It was unknown if the reporter considered the swelling of legs to be related to BOOSTRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received BOOSTRIX about 10 years ago before reporting and experienced leg swelling to the product due to ingredient of horse by products. The healthcare professional reported that the patient received the vaccine at another facility when the adverse reaction occurred. The healthcare professional verified if indeed horse by products were currently used in the manufacturing process. No further information was available regarding the event.
Low blood pressure and rapid heart rate.  Resting heart usually is 70 bpm but averaged 100bpms for 24 hours. Horrible nausea and dizziness, which still continues. Woke up with severe chills 7 hours after injection.  Mild chills continue periodically since. Fever of 100+ for 2 days, mild fever continues Shortness of breath - could not sleep lying flat for the 1st 24 hours because I felt like I could not breathe.  Still short of breath when taking stairs Severe headache that has not yet gone away. Minor body aches and occasional feeling of needles being stuck in my hands the 1st 24 hours. Fatigue and brain fog, which continues.
Pain (L) shoulder ongoing seen by Occ. Health MD Dx. R/O tendonitis/bursitis. Pt ordered X-ray done.
Pt's mom states that pt c/o pain with some swelling @ injection site. Mom states following day worse, w/ redness, swelling and tender to touch. Still w/ redness and swelling today and not better.
Pt recvd vax 5NOV92 & had a sz 1 hrs p/inject; 12NOV92 devel rash on neck, torso & extremities; also c/o head cold; treated w/DPh; pt's mom indicated that pt did not improve & was seen @ ER & dx w/chicken pos; also dx w/pityriasis rosea;
nose pain; gum area swollen on right side; larger 2.5 inch x 4 inch, itching, red; larger 2.5 inch x 4 inch, itching; large area red ,2 to 3 inches; large area red, hot, 2 to 3 inches; Red rash; Itching at injection site; red rash / like mosquito bite / protruded / 3 or 4 round; swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GINGIVAL SWELLING (gum area swollen on right side), VACCINATION SITE WARMTH (large area red, hot, 2 to 3 inches), RHINALGIA (nose pain), ERYTHEMA (larger 2.5 inch x 4 inch, itching, red) and PRURITUS (larger 2.5 inch x 4 inch, itching) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shingles (Pharmacist had given a shot for shingles in the past).    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced RASH ERYTHEMATOUS (Red rash), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE RASH (red rash / like mosquito bite / protruded / 3 or 4 round) and VACCINATION SITE SWELLING (swollen). On 24-Apr-2021, the patient experienced VACCINATION SITE WARMTH (large area red, hot, 2 to 3 inches) and ERYTHEMA (large area red ,2 to 3 inches). On 25-Apr-2021, the patient experienced ERYTHEMA (larger 2.5 inch x 4 inch, itching, red) and PRURITUS (larger 2.5 inch x 4 inch, itching). On 26-Apr-2021, the patient experienced GINGIVAL SWELLING (gum area swollen on right side) and RHINALGIA (nose pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, GINGIVAL SWELLING (gum area swollen on right side), VACCINATION SITE WARMTH (large area red, hot, 2 to 3 inches), RHINALGIA (nose pain), ERYTHEMA (larger 2.5 inch x 4 inch, itching, red), PRURITUS (larger 2.5 inch x 4 inch, itching), ERYTHEMA (large area red ,2 to 3 inches), RASH ERYTHEMATOUS (Red rash), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE RASH (red rash / like mosquito bite / protruded / 3 or 4 round) and VACCINATION SITE SWELLING (swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. The treatment involved anti-itch cream for itching.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up received on 09-Aug-2021 and contains no new information.
Severe headache - started up the back of my neck and engulfed my entire head for 60 hrs before it started to subside. The headache took 6 days until it was completely gone. My neck was stiff for 3 days, fever of 100 to 101 for 2 days, joints hurt for 2 days when I had the fever. Fatigue.
Outbreak of shingles in nerve running from top of head to under left eye. Have historically had approx 10 outbreaks over 20+ years. RECEIVED BOTH SHINGRIX SHOTS IN 2019.  Contact me if you need more info.
Began with on going high fevers, then was unable to walk to stand, became hypothmeric, and lethargic. Sent to hosp and admitted. Needed spinal tap, and many tests exposing him to much radiation. He is still having hypothermic temperatures and requiring on going tests.
Shot was taken around 9:30AM- waited 20min for any reactions and none at that time just a sore arm. Around 8:00/8:30 PM face turned blood red, and skin began to get blotchy on chest and neck. Arms turned red and started getting hives. Felt like a severe sunburn. Elevated heart rate- oxygen levels were fine. resting heart rate was around 115BPM. Took zyrtec and felt fine. Redness went away around 6:30AM on 09/09.
Vaccine administered early afternoon. Patient reports start of not feeling well med evening time. She woke up in hives all over face, neck, trunk hands etc. Not breathing difficulties reported, did go to Clinic and get prednisone pack and steroid injection.
Intense  swelling; Red; Rash at 7 days at the injection site and Looked like cellulitis; Looked like cellulitis; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (Looked like cellulitis), SWELLING (Intense  swelling), ERYTHEMA (Red) and VACCINATION SITE RASH (Rash at 7 days at the injection site and Looked like cellulitis) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history were reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE CELLULITIS (Looked like cellulitis), SWELLING (Intense  swelling), ERYTHEMA (Red) and VACCINATION SITE RASH (Rash at 7 days at the injection site and Looked like cellulitis). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE CELLULITIS (Looked like cellulitis) had resolved and SWELLING (Intense  swelling), ERYTHEMA (Red) and VACCINATION SITE RASH (Rash at 7 days at the injection site and Looked like cellulitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment drug included oral prednisone and was taken for five days.; 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.
The vial undergo temperature excursions; 13 patients received  an expired vaccine for a booster dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (13 patients received  an expired vaccine for a booster dose) and PRODUCT TEMPERATURE EXCURSION ISSUE (The vial undergo temperature excursions) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     no Allergies were reported.  Previously administered products included for Product used for unknown indication: pfizer (As primary series). Past adverse reactions to the above products included No adverse reaction with pfizer.    On 28-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (13 patients received  an expired vaccine for a booster dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The vial undergo temperature excursions). At the time of the report, EXPIRED PRODUCT ADMINISTERED (13 patients received  an expired vaccine for a booster dose) and PRODUCT TEMPERATURE EXCURSION ISSUE (The vial undergo temperature excursions) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.   It was reported that no other vaccines given within 1 month prior to Moderna COVID-19 vaccine It was reported that dosages received in January with the same lot number, 045L21A. They were put in the freezer and from 23-Feb-2022 until the 12-May-2022 they administer them to 13 patients, all booster dosages, after they expired. Maximum and minimum temperatures reached were 44.6 degree F and 38.8 degree F. Excursion duration were reported as 3 months. Vials were moved from freezer to refrigerator on 20-JAn-2022. The vial undergo any temperature excursions. Number of vials/doses impacted: 660 doses, and they have now 520.  No treatment medication reported.   This case was linked to MOD-2022-572778 (Patient Link).
She woke up screaming of pain and couldn't move her legs, they were stiff and felt cold. After calming her down and massaging her knees she managed to start moving her legs and be able to bend them. She had pain still in her knees after being able to move them. Took her to doctors because she cant walk without pain. Doctor dismissed our concern and said she pulled a muscle somehow in her sleep to give MOTRIN only for pain. She also had a stomach pain along with the leg stiffness. She still continues to have the knee pain in one leg and the stomach pain.
sore arm; Chills; Headache; Fever  99.9 temp; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (sore arm), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever  99.9 temp) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 and Migraine.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever  99.9 temp). At the time of the report, PAIN IN EXTREMITY (sore arm), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Fever  99.9 temp) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Body temperature: (Borderline) Body temperature 99.9 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information  provided. No Treatment information  provided
Nausea, vomiting, and fever, shaking chills, myalgia headache, malaise - 3hrs. Post-vaccination, lasted 4 hrs.
numbness; tingling; pain; neuropathy in both hands and both feet; Joint pain; muscle soreness; mild weakness in hands and feet; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) via an unspecified route of administration, administered into left arm on 07Sep2021 11:15 (at the age of 43-year-old) as dose 2, single for COVID-19 immunisation. Medical history included L4-5 spinal hernia, removal of L4-5 spinal hernia on Dec2019, sciatica and neuropathy on L leg due to spinal hernia. Patient was not pregnant. Concomitant medications included acetylsalicylic acid (ASPIRIN 81); ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10), dhea (DHEA) and unspecified prenatal vitamins. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) administered into left arm on 17Aug2021 11:45 AM (at the age of 43-year-old) for COVID-19 immunisation. On 08Sep2021 03:00 patient experienced neuropathy in both hands and both feet, joint pain, muscle soreness and mild weakness in hands and feet. On 08Sep2021 15:00 patient experienced numbness, tingling and pain. Patient did not receive treatment for the events reported. Outcome of events was recovered with sequelae.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the reported information, the causal association between the event neuropathy peripheral and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
I broke with itchy rash all over my body; then another patch on my arm that actually black; I broke with itchy rash all over my body; then another patch on my arm that actually black; I had rash, red spot, or other rash all over my body; it's most severe on my right arm; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6198 and expiry date was not reported), via an unspecified route of administration, on 26Feb2021 (age at vaccination was 68 years), as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter stated that she like to report the side effect of Covid-19 vaccination. On an unspecified date, the patient broke with itchy rash all over my body, then another patch on her arm that actually black. When paraphrased the above concern, the patient stated that she had rash, red spot, or other rash all over my body and it's most severe on her right arm. Reportedly the patient was still little itchy. The patient received treatment with Lotrimin for events. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Within days, patient lost language and began to verabalize completely differently than he had been. Also began staring and avoiding eye contact. From age 12 1/2 months on until present, at age 18 months. Seemed to worsen further after last months shots as well and physician finally referred us to a speech pathologist for an analysis, of which patient scored 50's and 60's on the questions we were asked and was deemed language delay, receptive delay and probably autistic tendancies. Awaiting referral for a treatment plan to begin. We are military and will have to wait until we relocate this month and once there, the pathologist said she would recommend for us daily in home therapy for patient.  07/14/2008 MR received for OVs 2/13/2008-7/10/2008.  Seen for 12 mon WCC 2/13/08. PE WNL. Vocab of 5 words. Failed gross motor questionaire-to be referred to Easter Seals. Seen again 6/23/08 for 15 mon WCC. PE WNL. Not using words to communicate. Assessment: Normal routine H&P. Delayed Milestones-Language/Speech.  Parents concerned about only saying 2 words. Refered for speech tx. Speech/Language eval  with Assessment -Development Disorder-Language (Mixed Receptive-Expressive). (+) Screen on 1st level of PDDST-II which warrants further f/u.  Unable to fully test due to age. 1/25/2010 Follow-up: Autism, specifically Regressive Austim, abnormal brain function for learning skills/retaining ability for speech.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age, who was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 31-MAY-2012 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 17-OCT-2016, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles with complications. The patient was prescribed Valacyclovir for management of his 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, and pain and suffering, and other damages. Additional information has been requested.
Pt has large localized reaction following 5th DTaP administered. Thigh has swelling and induration, feverish approximately 1/2 of upper thigh where  vaccine was administered.
This spontaneous report was received from a Registered Nurse concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient began the HPV vaccination series with GARDASIL lot number K006960, expiration date 19-FEB-2017, then, on an unknown date, the patient received GARDASIL 9 lot number L020015, expiration date 16-AUG-2016 (dose and route were not reported) both for prophylaxis; as a second dose in the HPV vaccination series (interchange of vaccine products). It was reported that the patient received both vaccines before their respective expiration dates. No adverse effects were reported. Additional information has been requested.
After 14 hours from my third Pfizer Covid Vaccine, I woke up with pain on my left chest area.  I tried to stretch and use ice compression to see if it helps. It felt like a constant muscle spasm but when I breath in, it cause a sharp pain around my chest and radiate to my back shoulder blade. The injection site is welted red and very hard and warm to the touch.