chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A colleague of mine developed the identical reaction (Shingles); Rash; Pain in extremity; itchy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in extremity), HERPES ZOSTER (A colleague of mine developed the identical reaction (Shingles)), PRURITUS (itchy) and RASH (Rash) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 03M2OA) for COVID-19 vaccination.     The patient's past medical history included Chickenpox (youngest of 5 aged 4). Concurrent medical conditions included Drug allergy (Allergy to Morphine, 23 years ago broke arm, reportedly had rash and treated with Benadryl).   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in extremity) and PRURITUS (itchy). On 16-Mar-2021, the patient experienced RASH (Rash). On 18-Mar-2021, the patient experienced HERPES ZOSTER (A colleague of mine developed the identical reaction (Shingles)). The patient was treated with VALACYCLOVIR [VALACICLOVIR] on 18-Mar-2021 for Nausea, at a dose of UNK, tid; NAPROXEN on 18-Mar-2021 at a dose of UNK, bid; ONDANSETRON for Nausea, at a dose of UNK, q4h and NORTRIPTYLINE for Rash, at a dose of UNK, qhs. On 17-Mar-2021, RASH (Rash) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in extremity) and HERPES ZOSTER (A colleague of mine developed the identical reaction (Shingles)) outcome was unknown and PRURITUS (itchy) had resolved.            The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable No concomitant medication were reported   This case was linked to MOD-2021-053856 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: No new information provided about patient (colleague); Sender's Comments:  MOD-2021-053856:Same reporter/different patient
Sore arm at injection site. Unable to sleep. Feeling cold followed by being too warm and back and forth between the two. Nausea. General feeling of malaise.
Vaccine Adverse Event Report May 9th, 2021 Patient had an appointment for his 2nd dose of Pfizer Covid 19 vaccine on May 9th 2021at 2:45pm. His first dose of Pfizer Covid 19 vaccine was at our Pharmacy on April 16th, 2021. Patient arrived to the appointment early; patient had been waiting for the pharmacist to return from lunch. At 2:05pm, pharmacy technician, started processing paperwork. Patient appeared normal as I, pharmacy on duty, slightly took a glance while he was at Covid 19 Vaccine Check-in window. He appeared to actively talking on phone via his wireless headphone. After processing the paperwork needed for vaccination, I went over the system to ensure the provided information was adequate before it was ready for my intern to administer the shot. Once the process was completed, as usual, pharmacy intern, took the patient to Patient Health Room for immunization. After the vaccination, as I was getting off the phone with a doctor calling in a prescription, approached and told me the patient fainted right after the vaccination, she called out my name for help, but I did not hear. Later on pharmacy technician said she was close by the area but did not hear pharmacy intern. Fortunately, the pharmacy intern said she kept calling his name and patted at the patient's shoulder softly, the patient woke up, this happened just within less than 1 minute. From pharmacy intern's report, the patient shook his head vigourously, and breathed rapidly through his lips after he woke up. Pharmacy intern instructed the patient to have a seat outside the Patient Health Room for close monitoring. I then walked outside and briefly talked to the patient. Patient stated he was perfectedly fine, said in a humor way "Yes, I passed out, but I'm perfectly fine now." Based on the vaccine administration record, patient has no medical condition. He also confirmed he had lunch before coming, so I concluded the faint was not due to hypoglycemic. I offered whether he needed anything just know that we are here. I also reassured patient to stay at least 15 minutes before he was ready to head out. it seemed like patient was actively on the phone or listened to music via his wireless headphone as I occasionally glanced at him via the mirror. Approximately 15 minutes later, patient checked in at the consultation window asking whether it was okay for him to leave. I asked him again if he was sure and felt well; he confirmed. In addition, I verified his phone number so we could call him for follow-up if needed. Shortly after the patient left, as I was ready to report the incident, I noticed his address is not within our area. I gave him a call, he answered and confirmed his address, he also said he is doing fine, just arrived at his apartment. Each team members who were involved in the event wrote the reports and kept them filed in the pharmacy records.
Significant elevated blood pressure and heartrate consistent with POTS as reported by the Journal. My spouse has complained the last few months about abnormally high heartrates near 180 bpm when simply walking. She is in fantastic cardiovascular and overall health, 5'6" tall and weighs 120 lbs. It is our thought that this could be a result of mRNA vaccination (Moderna) as she has never had confirmed or suspected COVID infection.
Flu Vaccine Oct 2017, symptoms of progressive leg weakness began less than 1 week later. Currently diagnosed and treated for CIDP.
edema and slight erythema of left lateral thigh surrounding the varicella vaccine injection site. day #1 of swelling was just itchy so mom gave Benadryl. night #2 of swelling started getting painful and child with slight limp due to pain. mom brought to clinic 1/31 and child given ibuprofen with improvement in pain. advised mom to apply cool pack as often as able. no fever since reaction started (did have slight fever after vaccine).
Shot was given underarm in the adipose tissue. Red area is very large, tender, and inflammed. There is a knot formed.
Pt recv vax on 10/28/98; on 11/19/98 pt exp nervousness & shakes
Patient came into the pharmacy on 2/6/19 asking to show the pharmacist her arm. She had a swollen area 2 to 3 inches in diameter that was red and hot to touch where she had been given the vaccine. The patient stated she had been putting an ice pack on it and was asking what else she could do. The pharmacist told her she could take Benadryl and watch it. If it became painful or the area moved, the pharmacist asked the patient to call her doctor. The pharmacist asked the patient if she could call the pharmacy the next day to discuss how it was doing. The pharmacist spoke to the patient on 2/5/19 and patient stated it was no longer warm to touch or as swollen as before. The patient stated she felt fine and it was getting better.
Developed swelling of left deltoid muscle, redness & pain at injection site the day of the injection. We applied an ice pack and administered Ibuprofen. She then developed a severe headache and spiked a temperature of 101.4 at 2:20 am (Nov 24, 2005). Deltoid was more inflamed and local pain was increased. Today her left deltoid is still swollen, with localized pain but the redness is gone.
I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 8/16/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 7/25/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) J96.00 ACUTE RESPIRATORY FAILURE 8/16/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/16/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 7/25/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/16/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 8/16/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 7/25/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) J96.00 ACUTE RESPIRATORY FAILURE 8/16/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/16/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 7/25/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/16/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 8/16/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 7/25/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) J96.00 ACUTE RESPIRATORY FAILURE 8/16/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/16/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 7/25/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/16/2021 ASTHMA COPD OVERLAP SYNDROME (ASTHMA W COPD) I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 8/16/2021 ACUTE RESPIRATORY FAILURE I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 7/25/2021 ACUTE RESPIRATORY FAILURE J96.00 ACUTE RESPIRATORY FAILURE 8/16/2021 ACUTE RESPIRATORY FAILURE J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 8/16/2021 ACUTE RESPIRATORY FAILURE J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 7/25/2021 ACUTE RESPIRATORY FAILURE J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 8/16/2021 ACUTE RESPIRATORY FAILURE
pt being to feel uneasy, and mouth tingling. No medications given resolved over 40 minutes
Information has been received from a vaccine nurse who noticed that children that are on attention deficit disorder (ADD) or attention deficit/hyperactivity disorder (ADHD) medication or with psychological needs experience syncope more often after receiving GARDASIL (lot# not provided). The patients sought unspecified medical attention. Follow-up information was received from the nurse. She said that the office had 3 or 4 patients faint after receiving GARDASIL. When they looked into it the patients were all on ADHD medicine of Psych medicine. The office decided to lay all the patients down after they received the vaccine to hopefully prevent the syncope. None of the patients were hospitalized. She did not have any patient identifiers because all of this happened over a year ago. Since they started laying patients down after the vaccinations over a year ago they have had no problems. Attempts are being made to obtain identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Patient called and questioned soreness of vaccinated arm.  Patient stated that it was warm to the touch and approximately 2" in diameter.  It was also a little "puffy", but localized to this single spot.  Patient received vaccination in the morning on 2/16/09 and called in the morning on 2/19/09.
Pt recv vax on 1/22/99; post vax pt fainted & fell to floor, pt had bump on right lateral side of head; tx=ice pack
Tested positive for COVID on 08/09/2021.  I was told it's likely the variant.
Later the night of taking the vaccine her walk became off balance. The next day she became horse and her right arm was shaking. Her appetite decreased and she didn't wont to drink. She became weak and dehydrated. She was taken to the ER and her immune system started shutting down and the ER doctors stayed they didn't know why. Before taking the vaccine she was totally healthy with no known problems.
About 16 hours after receiving the vaccine I developed a fever, chills and body aches.  I understand that this is normal, but ever since I received the first vaccine, I get these same symptoms about once a month.  It feels exactly the same way every time and it last for the same amount of time - about 24 hours.  I am fully vaccinated, including the booster, which made me the sickest out of all of them.
Started with redness, lump and warmth at the site. Ice and Motrin. Spread to inner elbow, lump size of key lime by 11/19. Saw doctor 11/19 started antibiotics. 11/20 spread to mid forearm. 11/20 almost to wrist. Antibiotic injection given.
5-16-07 Knot growing left area, no fever - given Keflex. 5/23/07 Recheck ov - monitor - papular rash around shot given. 5/29/07 Rash all over body - given Augmentin and referred to surgeon.
This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo). At the time of the report, VERTIGO (Vertigo) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Pt was given combination vaccine containing Hep B while pt had already completed 3 doses of Hep B.  Vaccine made Hep B #4
Significant round rashes inferior to the injection site, with diameters of approximately 7 cm and 3 cm respectively.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 11-NOV-2013, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and the intended purpose 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, the very virus the ZOSTAVAX vaccine is intended to prevent. In 2013, the patient was treated by home health agency for a 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.
onset of herpes zoster; This is a spontaneous report from a contactable physician.  A 86-years-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration on 04Jan2021 10:00 single dose for COVID-19 immunisation. Vaccine location was left arm. No other vaccine was received in four weeks. Medical history included hypertension, connective tissue disorder. The patient experienced onset of herpes zoster on 12Jan2021. Therapeutic measures included oral antiviral (Valtrex), topical acyclovir cream, oral analgesics. The outcome was recovering   Information about lot/batch number has been requested.
MUSCLE SORENESS THAT IS CONSTANT IN MY UPPER LEFT ARM, THE SORENESS IS SURROUNDING UPPER LEFT CHEST AROUND BREAST UP TO SHOULDERS. LEFT ARM IS GROWING WEAK. DIFFICULT TO LIFT OR RAISE LEFT ARM
Redness, pain and warm to touch at/around injection site. About 5 inches down the arm from Left Deltoid area where vaccines where administered.
The day following my second dose i had fever; Body aches; Swollen lymph nodes; Fatigue; The night of the day after the vaccine my injection site began to swell and turn red; The night of the day after the vaccine my injection site began to swell and turn red; This is a spontaneous report from a contactable other healthcare professional, the patient. A 35-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 22Apr2021 at 15:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy. The patient had unspecified known allergies. 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 vaccination. Concomitant medications included montelukast sodium (SINGULAIR); taken daily for allergies from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 02Apr2021 at 15:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 08:00, the day following her second dose, she had experienced fever, body aches, swollen lymph nodes and fatigue. On 23Apr2021, the night of the day after the vaccine her injection site began to swell and turned red. 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 reported. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, body aches, swollen lymph nodes, fatigue and the night of the day after the vaccine her injection site began to swell and turn red was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pt. developed redness, pain & swelling of left upper arm, for which he sought care in ER on day #3 post-vaccinations. He received pain medication and antibiotic script.
pt brought to ED with AMS, weakness, difficulty walking; pt found to be positive for COVID; CVA; CT of head/neck showed thrombus above right carotid artery bulb; placed on Aggrastat infusion; transferred to ICU; pt experienced asystole, ROSC achieved; grim prognosis; pt experienced cardiac arrest with ROSC; pt expired in the hospital
Swelling at injection site of Quadracel on the left arm that started after the vaccine and is still present the next day, but is improving
Over 24 hrs after vaccination (L) deltoid area developed 5 x 6 cm red indurated area without blisters - had watery eyes after vaccination. To use heat, Ibuprofen or ALEVE and recheck on 11-4-14 in OHC.
Hives that developed within 15 minutes to arms, back, torso; no dyspnea or wheezing
Grogginess, headache, chest pain, fever above 101 degrees, congestion, cough, exhaustion, abdominal cramping lasting more than 2 weeks.
Patient reported numbness in the left side of head and neck within one hour following COVID-19 vaccination.  Patient reported this to clinic via telephone and was advised to go to a local urgent care facility.  No other information available at this time.
5-month-old received Pediarix after temperature excursion; This case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 5-month-old female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st January 2023, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 31st January 2023, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 01-FEB-2023 Reporter's Comment: The reporter was a medical assistant. The reporter reported that the patient received Pediarix vaccine which was involved in a temperature excursion of 31.4 Fahrenheit for 15 minutes. The reporter did consent to follow up. Additional supportive information: The vaccine was exposed to 31.4 for 15 minutes degree Fahrenheit, which led to incorrect storage of drug This case had been linked with US2023AMR016941 by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2023AMR016941:same reporter
Information has been received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB (dose, strength, frequency, lot# and route were not reported). No adverse effects were reported. This is one of several cases from the same reporter. Additional information has been requested.
DIZZINESS AROUND THE 10TH, SMALL RED HOT CIRCLE AROUND INJECTION SITE  BOTH STARTED AROUND THE 10TH.  RED CIRCLE IS GROWING SIZE
Employee fully vaccinated for COVID-19 became symptomatic on 8/18/21 and tested positive on 8/19/21.
Fever; Chills; Red swollen arm with knot at injection site; Red swollen arm with knot at injectionsite; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EH6208) via an unspecified route of administration in the arm right on 19Mar2021at 11:15 (at the age of 62-year-old) as a single dose for COVID-19 Immunisation. Medical history was reported as thyroid and high blood pressure Concomitant medications were reported as lisinopril (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and escitalopra (MANUFACTURER UNKNOWN) for an unknown indication from unspecified date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL9269) via an unspecified route of administration in the arm left on 26Feb2021at 11:30 (at the age of 62-year-old) as a single dose for COVID-19 Immunisation. The patient did not have allergies to medications, food, or other product. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not tested for COVID-19. The patient had not symptoms associated with COVID-19. On 20Mar2021 at 14:00, the patient experienced fever, chills and red (vaccination site erythema) swollen arm with knot at injection site (vaccination site swelling). The patient did not receive treatment for the reported events. 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 events fever, chills and vaccination site erythema and vaccination site swelling was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient with COVID Vaccinations who admitted with complications from COVID with COVID detected PCR.  Provider d/c note:  "Patient was admitted and started on remdesivir, dexamethasone along with serial breathing tx, brisk improvement in her symptoms. Patient able to quickly wean down to 2L O2 which patient uses at home, mainly when she sleeps. Patient was instructed to wear O2 continuously for the next few days-weeks, pt expressed understanding. Patient otherwise remained hemodynamically stable throughout the hospital stay. "
PAIN ON INJECTION SITE,SWELLING ON INJECTION SITE,INFLAMATION ON UNDERARM PIT WITH GANGLIOS.
Site: Bruising at Injection Site-Severe, Systemic: Nausea-Mild
1 week after vaccine injection: at injection site itchy, swelling, redness, warm increasing throughout day
Myalgia, Arthralgia & whole body aches/pain INFLUENZA 0.5 ML ONCE
patient developed swelling around eyes and a small rash on the face that was resolved with one dose of diphenhydramine 25 mg.